Treatment of Critical Limb Ischemia

Overall Strategy for Treatment of Critical Limb Ischemia
Many of the principals of basic treatment discussed in relation to patients with intermittent claudication also
apply to patients with CLI, although the urgency for rapid treatment of the latter group will alter the emphasis. For
instance, the management of risk factors such as hyperlipidemia is not of any immediate importance in patients
with CLI. By contrast, other important aspects in the immediate basic treatment of patients with CLI, such as ade-
quate control of pain, do not apply to claudication.
The principal urgent components of basic treatment of CLI are the control of pain and any infection in the
ischemic leg, prevention of progression of thrombosis if this is thought to be a precipitating factor in the ischemia,
and the optimization of cardiac and respiratory function. While instituting basic treatment, the full precise mor-
phology of the PAD should be simultaneously established by some form of imaging technique. This will determine
further management of the arterial lesion. In a small group of patients, often delayed referrals, ischemia and gross
infection in the leg pose an immediate threat to the patient’s survival. An immediate major amputation is manda-
tory and can be life saving in these cases, for instance, in a patient with gas or septic gangrene.
In most patients, the various options for endovascular techniques, arterial surgery, or thrombolysis can be
carefully weighed. The primary aim is revascularization to provide sufficient blood flow to relieve the rest pain
and heal skin lesions. Most patients with CLI have multisegment arterial disease, and often the elimination of
the most proximal obstruction might be sufficient to achieve these aims. It is, however, important to resist the
temptation to only treat a relatively easy proximal lesion in the presence of extensive distal disease where the
marginal improvement in blood flow may be insufficient to achieve healing. This applies especially where there
has been tissue loss. For instance, angioplasty for relatively minor iliac stenosis is unlikely to achieve healing
of a foot ulcer in the presence of extensive infrainguinal disease (see also p. 210).
In general, if there is a balanced choice between an endovascular and a surgical procedure for a particular
lesion, then the former is preferred because it usually avoids a general anesthesia, poses a lesser systemic stress,
and has fewer serious complications. However, the choice between an endovascular and a surgical procedure
depends largely on the exact level and extent of the arterial disease; hence the need for a collaborative discus-
sion of each case between endovascular and surgical specialists. For the same reason, in this section the opti-
mal technique for revascularization is discussed on an anatomic basis.
Having identified the best interventional techniques in a particular case, the risks and chances of success have
to be weighed. There is no doubt that in some cases in which the risks of revascularization are high and the
chances of success low, there is a place for a primary major amputation or noninterventional therapy. Although a
number of techniques are available for assessing the risks and benefit of a particular revascularization procedure
in a particular patient, they are still far from perfect. This is reflected by the number of patients who have an attempt
at a series of revascularization procedures that fail to achieve their purpose even in the short term and culminate
in a major amputation.
There may be additional considerations in deciding whether to advise a patient to have a prim-ary amputation.
Not infrequently, patients with CLI will have other serious conditions limiting mobility, for instance, a neurological
deficit from previous stroke. In fitter patients, it is necessary to estimate the chances of a patient fully mobilizing
on an artificial limb. There may be an argument for primary amputation in a patient who is likely to mobilize well
on a prosthesis and in whom the chances of a successful revascularization are slight.
More recently, available treatment options have been extended by the possibility of pharmacotherapy as a prin-

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cipal treatment. Published evidence so far only relates to the use of pharmacotherapy in patients with CLI who
were unsuitable for any form of revascularization or in whom attempts at revascularization have already failed. In
these selected patients, pharmacotherapy may help to avoid or delay a major amputation and should be consid-
ered. The possibility of pharmacotherapy as a primary alternative to revascularization has not so far been stud-
ied. Its more established role is as an adjunct to either endovascular or surgical revascularization, where there is
some evidence that adjunctive pharmacotherapy improves early and medium-term results at very little risk.
In summary, the management of a patient with CLI should proceed rapidly in conjunction with delineation of
the arterial lesion. This is followed by a decision on the optimal form of revascularization, which, if successful, will
reverse the changes of CLI with minimum risk. If both surgery and endovascular techniques are equally feasible
and likely to succeed initially and durably, the latter is preferred to surgery. The second decision is whether to
apply this form of revascularization or proceed to a primary amputation. Pharmacotherapy is a useful adjunct, but
its role as primary treatment is not yet established.

Basic Treatment for Critical Limb Ischemia

Control of Pain
A hallmark of CLI is ischemic rest pain and painful ulceration. Etiology of the pain is multifactorial, but it is pri-
marily related to ischemia of the skin in the distal extremity. Pain control is a critical aspect of the management of
these patients. Ideally, relief of pain is achieved by reperfusion of the extremity. However, while setting up reper-
fusion, adequate pain control must be a goal of management in all patients. Furthermore, in patients for whom
revascularization is not possible, acetaminophen, nonsteroidal antiinflammatory drugs, or narcotics may be nec-
essary. Pain control should be individualized and multifactorial.
Physicians should assess pain severity and adequacy of pain relief in all patients at regular visits. Several pain
scales are available, but simple scales that range from 0 to 10, with “0” indicating no pain and “10”indicating the
most severe pain, are useful. Such scales should be evaluated and recorded in the chart at each visit. Initial
attempts at pain relief should include the use of acetaminophen or nonsteroidal antiinflammatory drugs. Caution
should be used in the latter in patients with hypertension or renal insufficiency. Patients with severe unrelenting
ischemic pain also may require narcotics for adequate pain relief. Control of pain is usually more effective if anal-
gesia is given regularly rather than on demand. In patients undergoing intervention, narcotics also may be required
during the postoperative period. Placing the affected limb in the dependent position provides partial relief of ischemic
pain in some patients. Tilting the bed or use of a reclining chair therefore may be helpful measures in addition to
analgesia.
Spinal cord stimulation has also been used in patients with inoperable severe lower extremity ische-mia (see
also p. 280). However, it currently cannot be recommended in patients with CLI. See Recommendation
82 (below). Epidural block is another effective form of pain control in various ABPI cases.

RECOMMENDATION 82: Pain control in critical limb ischemia
Adequate treatment of ischemic pain is mandatory in all patients with critical limb ischemia and may
require short-term use of narcotics. Pain control should be individualized and multifactorial. However,
pain control treatment should not delay definitive treatment of the arterial lesion.

Foot Care in Patients With Critical Limb Ischemia
Patients with chronic CLI must pay particular attention to proper foot care and avoid trauma to their extremi-

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ties. These patients should be evaluated by a podiatrist and evaluated for proper foot care. Extremes of heat and
cold should be avoided. Even mild physical trauma can convert a patient from having intact skin to an ischemic
ulcer. Thus, local measures are extremely important in the overall management of these patients (see also “The
Diabetic Foot”, p. 187).

Treatment of Life-Threatening Coexisting Disease
Patients with CLI are at the highest risk for subsequent myocardial infarction, stroke, and vascular death. There-
fore, in addition to addressing the needs of their extremity, it is critical to reduce the systemic risk of mortality in
this patient population. Many of these patients have impaired cardiac and renal function, sometimes having frank
cardiac or renal failure. These coexisting conditions require active treatment by an expert in these areas. Improve-
ment of cardiac output also will inevitably improve peripheral perfusion and go some way toward treating the CLI.

Treatment of Ulcers and Gangrene
Topical therapy
Several attempts have been made to improve topical therapy for ischemic wounds in patients with CLI. This
includes the use of topical antibiotics, growth factors, and debriding agents. These treatments are attractive and
are often highly promoted by their sponsors. However, there are almost no controlled randomized trials to docu-
ment the benefits of any topical agent to augment wound healing in this patient population. There may be sub-
stantial risk to the use of this therapy, because allergic reactions leading to dermatitis can be common with topi-
cal antibiotics.1 Furthermore, reliance on topical therapy carries the risk of delaying reperfusion, and, except in
neuropathic ulcers, topical agents are unlikely to be successful as the sole therapy. These agents are also expen-
sive and often unnecessarily raise the expectation of the patient for a good result despite the absence of thera-
peutic efficacy.
Several novel dressings also have been proposed to treat these patients. These include hydrophilic dressings
and seaweed. Most of the experience with these dressings has been in venous ulcers and not arterial ischemic
ulcers. Again, there are no data to support their use. Local treatment should aim to save as much skin tissue as
possible; debridement should be avoided or kept at a minimum. Wet dressings, soaked in saline, can be used a
few times a day to eliminate pus and tissue debris. Moist dressings also may be useful in reducing pain. Only once
the ulcer has dried out should dry dressings be used. There is no indication for immobilizing a patient with an
ischemic ulcer, unless the ulcer is on a weight-bearing area. A review of a few studies with becaplermin (rhPDGF-
BB) gel suggests that ulcer healing may be improved.2 The effectiveness of current topical agents—antibiotics,
growth factors or hormones, debriding agents, or occlusive dressings—is not established.

RECOMMENDATION 83: Topical therapy for ischemic ulceration
Topical therapy for ischemic ulceration should be guided by the principles of wound care. The extrem-
ities should be kept clean, with appropriate debridement.

Systemic therapy
The use of systemic antibiotics may be indicated in patients with cellulitis. This is commonly seen in patients
with diabetes with ischemic wounds and may occur in any patient who converts from dry to wet gangrene, or who
develops an infected ulcer. Signs and symptoms include swelling, redness, and tenderness at the site of infec-
tion. Bacteriology of these wounds is often polymicrobial, particularly in patients with diabetes. Therefore, signs
of infection need to be aggressively treated. This often requires the use of systemic antibiotics to achieve ade-
quate blood levels. Additional systemic agents for treating ischemic wounds have not undergone rigorous trials.
Anticoagulation is generally not warranted except in an attempt to maintain graft patency (see “Pharmacotherapy
Other Than Prostanoids”, p. 215, and “Other Drugs”, p. 265). Antiplatelet therapy is useful as already described

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to reduce the systemic risk of cardiovascular disease (see Recommendation 28, p S83).

RECOMMENDATION 84: Systemic antibiotic therapy in patients with critical limb ischemia
Systemic antibiotics are required in patients who develop cellulitis or spreading infection in ischemic
ulcers or gangrene but should not delay more definitive treatment.

Control of Risk Factors
Patients with CLI have the same cardiovascular risk factor profile as patients with claudication. However, patients
with CLI have a more diffuse and extensive degree of atherosclerosis. Therefore, their risk of cardiovascular events
and mortality is higher than that of patients with claudication. Despite the end-stage nature of this disease, aggres-
sive systemic risk factor modification is still warranted.

Smoking cessation
The progression of peripheral arterial disease from asymptomatic to claudication to ischemic rest pain is
highly associated with cigarette smoking. In patients with severe disease, graft patencies are clearly improved
by smoking cessation. This is true for both vein as well as prosthetic graft material. Amputation rates are also
highly correlated with persistent cigarette smoking. In two series, the amputation rate was between 11% and
23% in those who continued to smoke, versus 0 to 10% in those who were smoking abstinent.3 Finally, patient
survival at 1, 3, and 5 years is also highly correlated with smoking. Therefore, in patients with severe end-stage
disease, smoking cessation is still highly beneficial (see Recommendation 22, p. 84).

Hypertension
Hypertension is a risk factor for all forms of cardiovascular disease. Although blood pressure elevations are a
risk factor for peripheral arterial disease, maintaining an adequate blood pressure is important for limb perfusion.
In patients with claudication, aggressive treatment of hypertension is associated with a modest reduction in tread-
mill exercise performance. In patients with severe chronic limb ischemia, aggressive blood pressure treatment
may decrease limb perfusion and thus result in worsening ischemic rest pain or delayed healing of ischemic ulcers.
Historically, patients with CLI have been treated by plasma volume expansion to increase blood pressure,
thereby improving distal blood flow.4 This therapy may be associated with temporary benefit but does expose
the patient to the risk of stroke, congestive heart failure, and other untoward cardiovascular events. Therefore,
inducing hypertension in this patient population is not recommended. Conversely, patients hospitalized for treat-
ment of their severe leg ischemia should not have their blood pressure acutely lowered unless there is evidence
of active coronary ischemia or congestive heart failure. Because there is the possibility of vasoconstriction with
beta-blocker antihypertensive agents, their use in CLI should be carefully considered. When such antihyper-
tensives are used, CLI patients should be monitored for worsening of ischemic ulcers.

Diabetes
Diabetes is an important risk factor for all forms of peripheral arterial disease and also greatly contributes
to CLI (see “Epidemiology, Natural History, Risk Factors”, p. 5). In addition to the risk of atherosclerotic arter-
ial occlusive disease, patients with diabetes also develop neuropathy, which increases the risk for developing
nonhealing neurotrophic ulcers. In addition to the neuropathy, hyperglycemia will inhibit white cell function, thus
predisposing the patient to infection (see also “The Diabetic Foot”, p. 187). A comprehensive approach to treat-
ing patients with diabetes would include proper footwear, with attention to areas of trauma from poorly fitting
shoes (see “Foot Care”, p. 210). Patients with nonhealing ulcers often need to be treated in the hospital to pro-

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Nilsen R. High incidence of contact dermatitis in leg-ulcer patients: implica- tions for management. Autoregulatory mechanisms in skeletal muscle beds produce dilation in response to ischemia. Clinical efficacy of becaplermin (rhPDGF-BB) gel. Activation of the microvascular defense system 212 . Cameron J. Lando HA. Larsen O. hence. The goals of therapy are to reduce the sys- temic risk of myocardial infarction and cardiovascular death. Lassen NA. p. as well as to delay the progression of peripheral ath- erosclerosis. Am J Surg 1998. Cherry G. The concept of vasodilatation has moved to vasore- active or vasorecruiting drugs and more recently to agents improving unbalanced or compromised microcircula- tion distal to an arterial obstruction. including wound care and eventually systemic antibiotics. et al. Hirsch AT. Ryan TJ. Pharmacological management of CLI must be based on an improved understanding of its pathophysiology. References 1. 3. In addition. The main components. The use of thrombolytic drugs in CLI is also to be considered. Therefore. Wieman TJ. There are no data regarding recommendations in the severe leg ischemia patient population. Another approach is to search for compounds that improve the blood rheol- ogy.1:606-609. Chronic management should attempt to normalize glycohemoglobin levels to less than 7. with an attempt to maintain fasting blood sugars below 120 mg/dL and postprandial sugars less than 180 mg/dL. Wilson CL.2:243-251. but this is often impossible or else it fails. Becaplermin Gel Studies Group. patients with CLI should have an LDL cholesterol level maintained at 100 mg/dL or less (see Recommendation 25. Vasc Med 1997.1 Break- down of the microvascular flow-regulating system is manifested in particular by abnormal vasomotion and a mald- istribution of blood flow away from the nutritive skin capillaries. p.0% (see Recommendation 23. Powell SM. 4. antiplatelet and lipid-lowering thera- pies in the treatment of peripheral arterial disease. 2. pharmaceutical and clinical research aimed at improving the morbidity of claudication has cen- tered around vasodilators. The ideal treatment for critical limb ischemia must be the elimination or bypass of the occlusions in the larger arteries. are both thought to be significantly regulated by prostacyclin. Clin Exp Dermatol 1991.176:74S- 79S. 85).vide comprehensive management. Pharmacotherapy for Critical Limb Ischemia Introduction For decades. However. Treat-Jacobson D. Hyperlipidemia The lipid risk profile for patients with peripheral arterial disease is similar between those with claudication and those with CLI. most often to be followed by endovascular or surgical treatment. How- ever. it is unlikely that any vasodilator can significantly increase blood flow distal to a physical occlusion.16:250-253. extrapolation from patients with intermittent claudication as well as from the National Cholesterol Education Program Guidelines would recommend aggressive treatment of LDL cholesterol levels and attempts to raise the HDL cholesterol and lower triglyceride levels. Lancet 1968. aggres- sive control of blood sugar is warranted in these patients. Dahn I. An alternative in these cases is to try to modify the conse- quences of the low perfusion pressure on the distal microcirculation sufficiently by some form of pharmacother- apy to reverse the rest pain and avoid amputation. HallbrookT. lack of autoregulation of the microvascular flow-regulating system and inappropriate acti- vation of the microvascular defense system. 86). Sorensen AW. Hatsukami DK. Direct-acting vasodilators can increase blood flow in normal resting skeletal muscle. vasodila- tors will increase blood flow primarily to nonischemic areas. Conservative treatment of gangrene using miner- alocorticoid-induced hypertension. The role of tobacco cessation.

with only two trials failing to reach statistical significance. p<0. platelets. Measurement of the decrease in greatest diameter of the ulcer is subject to observer variation. tissue edema.27 Although these results are impressive. Further clinical trials with prostanoids are required to show evidence of efficacy as primary medical treatment of critical limb ischemia.23 25 26 Patients who received ilo- prost were significantly less likely to have undergone a major amputation than patients in the placebo groups (23% vs 39%. where photographs were used in attempt to overcome observer variation. patients who received iloprost had a significantly greater probability of completing the follow-up period alive with both legs than patients who received placebo (35% vs 55%. Table XLI summarizes 13 subsequently performed long-term randomized open or double-blind trials comparing intraarterial or intravenous infusions of PGE1. it has to be kept in mind that this outcome measure is based on a subjective assess-ment by the individual patient. they were often of inconsistent quality. or iloprost. The prostanoid investigated in the largest number of patients with advanced chronic limb ischemia in controlled randomized studies is iloprost. p<0. 213 . or promotion of ulcer healing.05) during the treatment and follow-up period.3 Furthermore. Its use as an adjuvant to high-risk revascularization procedures is being assessed. compared with administration for 2 or 3 weeks. ciprostene. At least in regard to antiplatelet activity. All of these long-term studies administering prostanoids for more than 7 days showed a benefit in at least one of the chosen end points. both more stable prostacyclin analogs. Most importantly. intraarterial and intravenously infused PGE1 in patients with intermittent claudication caused a similar systemic inhibition of zymosan-stimulated radical production.6 there have been seven short-term (3-4 days) trials using PGE1 and PGI2 intraarterially7- 9 or intravenously10-13 showing inconclusive evidence of their efficacy in patients with unreconstructable limb ischemia. such as oxygen free radicals. There is no available technique for identifying those who will respond. in the last few years. PGE1 was mainly evaluated by intraarterial administration because of its well- known rapid pulmonary inactivation.1 This is probably the reason why prostanoids have. leukocyte activation. The clinical end points used were relief of rest pain. and the damaged vascular endothe- lium. The response seemed to be greater when prostanoids were administered for 4 weeks.14-dihydro-PGE1 is formed.results in interacting activation of white blood cells. A further bias may have been introduced by the side effects of prostanoids. it is also important to be aware of their limitations. and the damaged endothelium. analgesic consumption. allowing the observer to have an idea of the patient’s treatment group.5 Since the first report of the effects of intraarterial infusion of prostaglandin E1 in four patients with unrecon- structable leg ischemia. although the duration of treatment varied from 2 to 4 weeks.4 The clinical benefit of the intravenous administration route was later shown in a limited number of patients with PAD stage III in a single German center by Diehm et al.5 14-26 These studies all followed a similar protocol. this has been shown to display biological activity comparable with the parent compound PGE1. Prostanoids Prostanoids have been shown to have beneficial effects on most of the microcirculatory components by pre- venting the reciprocal potentiation of platelet activation. The resultant capil- lary obstruction. with placebo in patients with advanced chronic limb ischemia (Fontaine stages III and IV).05). and the liberation of activated products of leuko- cytes. and proteolytic enzymes. Furthermore. leads to a vicious cycle with further capillary obstruction. Initially. been the most widely tested group of drugs in this condition. 13. The available data support its use in patients with CLI unsuitable for any reopen- ing procedure or in whom revascularization attempts have failed.2 Intravenous studies with PGE1 were subsequently undertaken when it was shown that after a temporary inactivation of PGE1 by the lung. but its relative safety suggests that it should be tried in all such patients unless an early amputation is clearly unavoidable. platelet-activating factor. increased capillary permeability. Data on major ampu- tation at 3 or 6 months’ follow-up were available in three of the iloprost studies. With respect to pain relief. Total ulcer healing was not used because it was too uncommon an event after a few weeks of treatment.

70 PGE1 (IV) 2 x 40 µg over 6 mo rest pain reduced NS O 198920 vs pentoxifylline 2 h daily x 4 wk analg. 46 PGE1 vs 60 µg/4 h/ 1 mo pain reduced < 0.005 ulcer size reduced < 0. cons. reduced < 0.01 Guilmot et al.02 Diehm et al. may be treated with prostanoids. 113 Iloprost vs 0.05 or 0. CLI=critical limb ischemia. 214 . 57 PGE1 vs 30 20 mg over 60 3 wk analg.560 PGE1 (IV) vs 60 µg/day 6 mo CLI reduced odds 0. reduced < 0. cons.02 clinical stage improved 0.05 DB 199024 (100%) placebo (IV) x 6 h x 28 days infusion rest pain reduced < 0. cons. O=open.05 DB 199125 (31%) placebo (IV) x 6 h daily x 28 days 6 mo ulcer healing reduced < 0.05 DB 198721 (34%) placebo (IV) x 6 h x 14 days infusion Diehm et al. reduced < 0.. reduced < 0. analg cons=analgesic consumption. 34 PGE1 (IA) 10-20 µg/60 end of ulcer size reduced NS O 198716 vs ATP min x 23 days infusion rest pain reduced NS Trübestein et al.5-2 ng/kg/min end of analg.05 Balzer et al.. PGE1=prostaglandin E1. cons. DB=double-blind RECOMMENDATION 85: Use of prostanoids in critical limb ischemia Patients who have a viable limb in whom revascularization procedures are impossible...04 DB 19885 placebo (IV) day x 3 wk analg. 151 Iloprost vs up to 2 ng/kg/min 1 mo ulcer healing reduced < 0. 109 Iloprost vs 0.5-2 ng/kg/min end of ulcer size reduced < 0. PGI2=prostaglandin I2.. carry a poor chance of success or have previously failed. 101 Iloprost vs up to 2 ng/kg/ end of ulcer size reduced < 0.15 end of ulcer size reduced by 0.005 DB Group 199118 placebo (IV) x 8 h/day x 7 days by 50% ICAI Study 1.02 amputation reduced 0. 103 Iloprost vs 0.TABLE XLI.039 DB 198415 niacinate oral ng/kg/min x 24 infusion pain higher dose (200 mg continuous infusion vs..05 DB 199126 (58%) placebo (IV) x 6 hr daily x 21 days 1 mo rest pain Reduced NS NS=not statistically significant. niacinate 6 x daily) for 2-6 wk + lower dose Böhme et al.5-2 ng/kg/min 6 mo ulcer size reduced NS DB 199023 (32%) placebo (IV) x 6 h x 14 days Brock et al. and particularly when the alternative is amputation.05 DB 198922 placebo (IV) min x 6 h x 28 days infusion Norgren et al.. 128 Iloprost vs up to 2 ng/kg/min 1 mo rest pain Reduced < 0. 199819 routine x 28 days disappearance ratio 0.007 Ciprostene Study 211 PGE1 vs 120 ng/kg/min 4 mo ulcer size reduced < 0. n Trial Author (% diabetic) Drug Dosage Follow-up End points Results p design Sakaguchi 65 PGE1 (IA) 0.002 O Group.—Trials comparing long-term (7-28 days’ treatment) infusion of prostanoid with placebo or reference drug in patients with severe arterial disease (Fontaine III and IV)14.73 treatment Trübestein et al..05 UK Study Group.04 O 198717 mg ATP (IA) min daily x 3 wk ulcer size reduced < 0..

if a patient’s hematocrit remains 50% despite cessation of smoking and rehydration. 263) Hemodilution The benefit of hemodilution has not been properly evaluated in patients with chronic CLI. Meta-analysis of the Final Report of the Second Cycle of the Antiplatelet Trialistsí Collaboration shows clear evidence that these antiplatelet agents produce a 25% reduc- tion of other vascular events (stroke.33 (see also “Adjuvant Therapy after Revas- cularization”. CRITICAL ISSUE 29: Use of prostanoids in earlier stages of critical limb ischemia There is a need to test prostanoids in patients with earlier stages of critical limb ischemia and in whom intervention is predicted to have a relatively low success rate as most randomized. p. and vascular death) and also improve patency of periph- eral arteries and grafts. It should be noted that in a recent study the favorable effect of ticlopidine over 24 months has been demonstrated in patients after saphenous vein bypass grafting. hemodilution may be considered.30 However. 90). although recently an open study using low-molecular-weight heparin did show encouraging results with a decrease of rest pain and healing of ulcers previously resistant to treatment. myocardial infarction.31 Anticoagulants No clinical trials have been published on the use of unfractionated heparin for critical limb ischemia. 263). neither these trials nor the recent CAPRIE study were conducted in PAD patients with rest pain and ischemic ulcers. there is little substantive evidence to support their use on patients with critical limb ischemia. however.29 There is a strong case for treatment of all patients with PAD with long-term antiplatelet therapy such as aspirin. open or double- blind trials with intraarterial or intravenous prostanoids have been performed in patients with end- stage critical limb ischemia. CRITICAL ISSUE 30: Use of long-term oral antithrombotic therapy in terms of limb survival There is a need to determine whether long-term oral antithrombotic therapy is useful in terms of limb survival.39-44 215 .28 Whether these antiplatelet agents can prevent thrombosis in prosthetic femoropopliteal grafts is uncertain (see also “Antiplatelet Therapy”. or clopidogrel (see Recommendation 29. p. p. ticlopidine. but this single study should be confirmed.32 None of the publications on the effect of anticoag- ulation exclusively concerns such patients. Pharmacotherapy Other Than Prostanoids Antiplatelet drugs Long-term treatment with aspirin and ticlopidine is shown to reduce the progression of femoral atherosclerosis. Defibrinogenating agents Despite many open trials reporting promising results with the use of defibrinogenating agents in 50% to 80% of treated patients34-36 two recent placebo-controlled double-blind studies with ancrod failed to show any benefit in terms of healing of ischemic ulcers or in reducing subsequent amputation rate. The use of oral anticoagulants improved the long-term patency of infrainguinal bypass grafts.37 38 Other vasoactive drugs Although a few vasoactive drugs may have a beneficial effect in vasospastic diseases by increasing cutaneous capillary flow.

In the European Study Group. L-arginine induces peripheral vasodilation and inhibits platelet aggregation because of increased nitric oxide production. acting via the intracellular second-messenger cyclic guanosine monophosphate (cGMP).52 With the increase in dose of phVEGF165 to 2. improve tissue oxidative potential in the ischemic state.000 µg phVEGF165 was injected directly into the muscles of the ischemic limb.51 Using a dose-escalating design. Gene expression was documented by a transient increase in VEGF serum levels using an enzyme-linked immunosorbent assay (ELISA). Gene-Induced Therapeutic Angiogenesis Recent investigations have established the feasibility of using recombinant formulations of angiogenic growth factors to expedite or augment collateral artery development in animal models of hind limb ischemia. In the case of vascular endothe- lial growth factor (VEGF). Parenteral pentoxifylline have been investigated in patients with critical limb ischemia in two double-blind placebo-controlled multicenter trials.000 µg. Because the results are unconvincing or negative.48 RECOMMENDATION 86: Vasoactive drugs in treatment of critical limb ischemia Very few vasoactive drugs have been properly investigated in patients with critical limb ischemia.05 to 0. but unfortunately the use of analgesics was allowed and uncontrolled (intention- to-treat analysis). Gene trans- fer constitutes an alternative strategy for accomplishing therapeutic angiogenesis.48 216 . employed initially as a means of treating patients in whom vascular disease in the ischemic limb was too extensive to permit an intraarterial approach. The subsequent double-blind Norwegian study followed the same protocol but in a smaller number of patients. 93). current drugs cannot be recommended in patients with chronic critical limb ischemia.Most vasoactive drugs are said to have vasodilatory properties. treatment was initiated with 100 µg phVEGF165. the impact of the gene product is thus not limited to the transfected cells. the use of intramuscular (IM) gene transfer. the severity of rest pain was consistently and significantly lower in the pentoxifylline group. In healthy humans. or act by increasing collateral flow through a serotonergic blocking effect.33 ± 0. 600 mg pentoxifylline was administered intravenously twice daily for up to 21 days.000 µg were subse- quently shown at 1 year follow-up to have improved blood flow to the ischemic limb and remain free of rest pain. L-Arginine is the precursor of endogenous nitric oxide that is a potent vasodilator. This study confirmed a trend in the amelioration of rest pain but did not reach statistical significance between the two treatment groups.47 Treatment response was not influenced by the presence of diabetes or by eligibility for surgery. whereas some claim to alter blood rheology. A dose of 4.45 46 The clinical bene- fit of this in the treatment of CLI remains to be established.54 The IM strategy was performed in 10 limbs of nine patients with nonhealing ischemic ulcers (n = 7/10) or rest pain (n = 10/10) attributable to periph- eral arterial disease. angiographic and histological evidence of new blood vessel formation became apparent. but can be amplified considerably by paracrine effects of the gene prod- uct (VEGF protein) on endothelial cells responsible for neovascularization. this is a particularly appealing strategy because the VEGF gene encodes a signal sequence that permits the protein to be naturally secreted from intact cells50.49 No recombinant protein formulation of an angiogenic cytokine has yet been made available for human studies of CLI. resulted in marked improvement in collateral vessel development in patients with CLI.53 More recently. This novel strategy for the treatment of vascular insufficiency has been termed “therapeutic angiogenesis”. Gene therapy for therapeutic angiogenesis was performed initially in patients with CLI by arterial gene trans- fer of VEGF plasmid DNA (phVEGF165). In the two trials. p. The ankle:brachial pressure index improved significantly (from 0. Some of these drugs have been shown to be efficacious in intermittent claudication (see “Phar- macotherapy for Symptoms of Intermittent Claudication”. Three patients presenting with rest pain (but no gangrene) and treated with 1. but none have been shown to have a clinically beneficial effect in large properly controlled studies in patients with severe chronic limb ischemia.

Held K. Sakaguchi S. Ischemic ulcers healed or markedly improved in four of seven limbs. Ursprung JJ. Vasa Suppl 1987. placebo-kontrollierte Studie. Rogatti W. Friedgood A. Horsch S. Böhme H.28:196-199. for properly controlled studies of the use of gene- induced angiogenesis in treatment of patients with critical limb ischemia.130:412-421. Prostaglandin E1 in chronic arterial disease: a multicentre study. Breddin K. Lancet 1979. Mörl H. Vane JR. Trübestein G. Lowe GDO. Nizankowski R. Ott I.1111-1114. Beilatowicz J. Inactivation of prostaglandins by the lungs. Rogatti W. A controlled study showing significant short term effect of prostaglandin E1 in healing of ischaemic ulcers of the lower limb in man. Vasa 1987. Prostacyclin for ischemia ulcers in peripheral arterial disease: a random-assignment. 9. 21. Belch JJ. Szczeklik A. Heisig G. Morris PJ. Lancet 1983. 5. 1988:133-143. Diehm C. Slawinski S. Critical Leg Ischemia: Its Pathophysi- ology and Management. Prostacyclin treatment of ischemic ulcers and rest pain in unreconstructible peripheral arterial occlusive disease. Stanley JC. Diehm C. J Vasc Surg 1984. Schweer H.28:44-49. doppel-blinde Multicenterstudie zur Wirksamkeit von Iloprost bei der Behandlung ischämis- 217 . The ICAI Study Group. consistent with VEGF enhancement of vascular permeability. Bechara G. Int Angiol 1984. Wood RF. Rudofsky G.( 0. Peskar BA. Clevert HD. Holcroft JW. Second European Consensus Document on chronic critical leg ischemia. Szczeklil J.A. Irving JD.225:600-604. Flanigan DP. Prostaglandins 1991. and MRA showed qualitative evidence of improved distal flow in eight limbs. 4. Infusionen bei Peripherer Arterieller Verschlusskrankheit im Stadium III und IV. J Cardiovasc Surg 1987. et al. Successful therapy of advanced arte- riosclerosis obliterans with prostacyclin. The Ciprostene Study Group. Certain patients in this initial cohort and several others subsequently (seven limbs in six patients) satisfied diagnostic criteria for Buerger’s disease. Prostaglandins Leukot Med 1982. Schuler JJ. Piper PJ. 6. Rogatti W. European Working Group on Critical Leg Ischemia. Diehm C. Gryglewski RJ. 17. Graham LM. These findings may be cautiously interpreted to indicate that intramuscu- lar injection of naked plasmid DNA achieves constitutive overexpression of VEGF sufficient to induce therapeutic angiogenesis in selected patients with CLI. Baird RN. suggested by preliminary studies. Collin J. Gluszko P. Intravenous prostaglandin E1 versus pentoxifylline therapy in chronic arterial occlusive disease: a controlled randomised multicenter study. Stöveken HJ. Bˆhme H.71:506-508. Weiss T. Mollenhauer J.84(4):1-26. Mohrland JS. Schiffler P. 2. Telles GS. Whitehouse WM. Pathophysiology of critical limb ischemia. 19. Leiberman P. newly visible collateral blood vessels were documented by contrast angiography in seven limbs. Br J Surg 1984. 1991. Br¸lsaver M.55 CRITICAL ISSUE 31: Use of gene-induced angiogenesis in patients with critical limb ischemia There is a need. 3. Eriksson G. In: Dormandy J. Placebo-kontrollierte.100:369-375. eds.1:160-170. Trübestein G. Stock G. Pollock JG. Negus D. Gruss JD. Olsson AG. Diehm C. Eklund AE. Formation of 13. Bisler H. Nizankowski R.03. Intra-arterial prostacyclin compared to praxilen in the management of severe lower limb ischemia: A double-blind trial. Mahfoud Y. H¸bsch-M¸ller C.14-dihydro-prostaglandin E1 during intravenous infusion of prostaglamdin E1 in patients with peripheral arterial disease. Hesse WH. Kiressmann A. Intravenˆse prostaglandin E1-Therapie bei Patienten mit peripherer arterieller Ver- schlusskrankheit (AVK) im Stadium III: Eine doppelblinde. Prostaglandin E1 intra-arterial infusion therapy in patients with ischemic ulcer of the extremities. Scneider M. 18. von Bary S. Prostaglandin E1 in severe lower limb ischaemia: a dou- ble-blind controlled trial. Cronenwett JL. Surgery 1986. 16.1:315-317. Lowe GDO. Metabolism and Clinical Efficacy. The effect of ciprostene in patients with peripheral vascular disease (PVD) characterized by ischemic ulcers. Haupt HM. 7. Berlin: Springer Verlag. p = 0. Prostaglandin E1: New Aspects on Pharmacology. placebo-controlled study. Krolikowski W. Circulation 1991. 12. Zelenock GB. Wolf S. 14. McKay A. Wyllie JH. 1990:17-38.20(Suppl):206-208. Seyberth HW. Nature 1970. Mau- rin N.8:265-271. Berlin: Springer-Verlag. Gruss JD. Ann Intern Med 1999. 11. Pyke J. Szczeklik A. 13. Effect of intra-arterial and intravenous appli- cation of prostaglandin E1 on neutrophil function in peripheral arterial occlusive disease.31:81-87. J Clin Pharmacol 1991. Härtel U. Vasa Suppl 1989. Campbell WB. Heinrich H. Neumann FJ. Lindenauer SM. Balzer K. Diehm C. Complications were limited to transient lower extremity edema in six patients. controlled. In: Heinrich H. Prostaglandin E1-Wirkungen und therapeutische Wirksamheit. Epoprostenol (prostacyclin) and severe arterial disease: a double-blind trial. including successful limb salvage in three patients recommended for below-knee amputation.02).37:21-28. 15. 20. Heidelberg: Springer-Verlag.17:39-43.41:225- 228. McArdle B.3:39-42. eds. PGE. eds. Bollinger A. 8. Kontrollierte Studie zur Wirnsamkeit von I. open-label trial with prostaglandin E1. 10. Prostanoids for chronic critical leg ischaemia: a randomized. Marten M. Thromb Res 1985. Walter P. Horsch S. Maass U. In: Diehm C. Sinzinger H. Efficacy of prostaglandin E1 in the treatment of lower extremity ischemic ulcers secondary to peripheral vascular occlusive disease. Rücker G. Stammler F. References 1. Diehm C.

The human gene for vascular endothe- lial growth factor: multiple protein forms are encoded through alternative exon splicing. 24. Tsikas D. The European Study Group. Eur J Vasc Endovasc Surg 1995. Kearney M.127:1112-1115. 48. p 62.91:2687-2692. Dormandy JA. Mitchell R. Reid HL. a stable prostacyclin derivative in stage 4 arterial occlusive disease. London: Arnold. In: Breddin K. Analytical and Structural Data. Krolikowski W. Watt JK. A stable prostacyclin analogue (iloprost) in the treatment of ischaemic ulcers of the lower limb: a Scandina- vian-Polish placebo-controlled. Efficacy and safety of CY216 in the treatment of specific leg ulcers. Sager P.1:625. 29. Wollman Y. Effect of ticlopidine on the long term patency of saphenous vein bypass grafts in the legs.38:431-435. 1996:221-236. An evaluation of vasodilator drugs in occlusive disease by measurement. Böger RH. Bechara G. Chernichowsky T. Intermittent claudication. Blombery PA. Hangsteen V. Heinzel D. Wenzl E. Tischer E. a stable analoque of prostacyclin: results of a French Multicentre trial. A Textbook of Vascular Medicine. Lancet 1985. Bode-Böger SM. Circulation 1995. Thromb Res 1976. 35. Isner JM. Corovic D. Clinical Trials.26:1251-1256. A decade of oral anticoagulant treatment to main- tain autologous vein grafts for femoropopliteal atherosclerosis. Lowe GD. 33. Baitsch G. Siitonen O. Guilmot JL.281:794-797. Hess H. Eur J Vasc Surg 1990. Holm J. Scand J Clin Lab Invest 1978. L-arginine induces nitric oxide-dependent vasodilatation in patients with critical limb ischemia: a randomized. 39. Treatment of severe intermittent claudication by controlled defibrination. Blair R. Fareed J. Baitsch G. Oslo University Med- ical School. J Clin Invest 1994. Diehm C. Treatment of limb threatening ischemia with intravenous Iloprost: A randomised double-blind placebo controlled study. Diehm C.300:524-528. Symes JF. Eur J Vasc Surg 1991.1:415-419. Baumgartner I. Kretschmer G. Clinical evidence of angiogenesis after arterial gene transfer of phVEGF165 in patients with an ischaemic limb. Silva M. Goyle KB. Marshall M. Br Med J 1990. Creutzig A. Oberender HA. Double-blind controlled trial of ancrod for ischemic rest pain of the leg. Oslo. J Biol Chem 1991. 26.5:511-516. 28. Norgren L.97:1114-1123. Arch Surg 1992. Isner JM. Defibrination. Collaborative overview of randomised trials of antiplatelet therapy. Peer G. Drug Invest 1991. Dormandy JA. Abri O. Angiology 1982. Takolander R. Takeshita S. Pieczek A. 42. Ylitalo P. Clin Hemorheol 1984. Lowry J.9:426-436. Coffman JD. Clevert HD. Non-surgical management of peripheral vascular disease: a review. controlled study. 37. Prentice CR. Symes JF. Walsh K. 36.9:47-57. Improvement of cardiac performance by intravenous infusion of L-arginine in patients with moderate congestive heart fail- ure. In: Tooke JE. Kearney M. 27. 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because most require revascularization to avoid major amputation. Buerger’s disease in the modern era. they ultimately must be consid- ered together. The dis- ease at each level not only must be considered in terms of its own severity. it is not possible to make recommendations that cover all eventuality. results from a variety of studies are presented. Introduction to Interventional Treatment for Critical Limb Ischemia The decision to proceed with vascular intervention on a patient with CLI is relatively straightforward. The literature can provide only broad direction in the decision-making process because most series report best results in a selected patient population characterized by more favorable anatomic lesions. Porter JM. 276). there is a tendency to choose either surgical or percutaneous revascularization tech- niques exclusively in a given patient. Comorbid risk factors will modify this ideal to give priority to patient safety. Unfortunately. but a multidisciplinary approach results in better choices. Conversely. in which multilevel occlusive disease predominates and poor runoff is almost the norm. Although it is necessary to present the results of open surgical and endovascular interventions separately. In principle. Cost also should be considered. RECOMMENDATION 87: Choosing between techniques with comparable short. combined iliac dilatation with distal surgical revascularization). In such cases. however. with a number of factors requiring consideration. frail patients may be best treated with less invasive interventions. even though durability may not be optimal. It is imperative that the individual caring for the patient with CLI review the results obtained at their own institution (see also Rec- ommendation 77. In some patients. the durability of the procedure over many years is important in reducing lifetime morbidity and cost. Excellent results may be obtained when endovascular and open surgical procedures are combined (eg. In addition to the mortality and mor- bidity. Mills JL. High-risk. This is followed by a discussion of the usually preferred option for each broad category of lesion: aortoiliac or infrainguinal. The decision regarding the most appropriate interven- tion. is complex. the most appropriate treatment should be applied to each individual occlu- sive lesion. Given the multilevel nature of the disease in patients with CLI and the lack of sufficient data in the literature dealing with each of the multiple combinations of disease. Ideally. In the following sections. and combinations of treatment modalities should be considered as well as procedures that span more than one level of disease. 219 .55. This is particularly true of CLI. These and the other considerations previously mentioned should be kept in mind in the discussions that follow. p. the technique with the least morbidity and mortality must be used first. the results of open surgical and endovascular procedures are presented sepa- rately in relation to proximal and distal levels of occlusive disease: aortoiliac or infrainguinal. the patient should be treated with the least risky and least morbid but most successful and durable pro- cedure. however. but all levels of disease must be com- bined in considering the best approach to limb salvage and improved function. 190. comorbid risk factors and life expectancy must be weighed against the initial success and long-term dura- bility of the chosen intervention. revas- cularization procedures should be abandoned for primary amputation when patient factors suggest extremely high morbidity and mortality or the arterial anatomy predicts a poor outcome of intervention. Taylor LM. Am J Surg 1987.and long-term benefi When two techniques of revascularization (endovascular and open surgery) give equivalent short-term and long-term benefit.154:123-129. the tempta- tion to pursue the least invasive procedure even in the healthy individual should be resisted. p. In the following discussions. as may combining procedures. and “Vascular Registry Data”.

with 5-year patency rates ranging from 60% to 94%. The possible requirement for future aortic surgery should temper enthusiasm for this procedure except in the ideal patient. but. It avoids the risk of graft infection. and other authors have not attained similar good results. A number of alternatives to the standard approach through a vertical incision have been suggested. Aortoiliac endarterectomy The durability of aortobifemoral bypass grafting led to a decrease in the performance of this more technically challenging operation. and. it is also generally associated with greater morbidity than infrainguinal reconstruction. minimally invasive and laparoscopic approach. audited records for patients treated and their progress. which may reduce the incidence of impo- tence. mortality. However. because most patients with claudication and limited lesions are now treated by endovascular procedures. other considerations should dictate the configuration of the aortic anastomosis. in terms of degree and duration of benefit. a 10-year patency rate of 90.9 Selected results of primary patency rates for aortoiliac-femoral endarterectomies are presented in Table LXIV. ABF is in general reserved for those with extensive lesions and CLI rather than those with claudication. preservation of the hypogastric arteries. Most centers reserve endarterectomy for young patients with very localized disease. primarily because of the higher incidence of dia- betes (and thus systemic atherosclerosis) in the latter group.4% was reported. The stability of modern graft materials and the durability of benefit in those patients who have undergone ABF grafting is such that other revas- cularization procedures for aortoiliac disease must be compared with it. operations to treat each of these conditions have been addressed separately. and internal iliac flow is preserved. for the most part. and 220 .4 Overall patency rates are not different when end- to-end versus end-to-side upper anastomoses are properly compared. 190 RECOMMENDATION 77: Audit in critical limb ischemia It is recommended that all units dealing with critical limb ischemia maintain accurate. than surgical treatment of more distal lesions. However.1 Whether one is dealing with primarily unilateral (iliac artery) occlusive disease or bilateral disease (aortoiliac or bilateral iliac) has major bearing on the choice of treat- ment and particularly the choice between bypass or endovascular revascularization.2 retroperitoneal3 and more recently. and juxtarenal aortic occlusion. These include preservation of blood flow into the inferior mesen- teric and internal iliac arteries. Aortoiliac Disease—Surgical Treatment Introduction The surgical treatment of aortoiliac disease offers better results. aneurysmal changes. Bilateral Disease The aortobifemoral bypass The aortobifemoral bypass (ABF) is considered the reference standard of treatment for aortoiliac occlusive dis- ease. Most studies have a low incidence of operations for CLI. ideally. The minimum follow-up analysis should be in terms of 1-year re-interventions. amputation rates. other outcome measures. To permit the separation of bilateral (usually more diffuse) disease from more localized unilateral disease.8 Risks of infection are low. the aorta as a source of emboli. re- admissions. Repeated from p. because it produces the best and most reliable overall results (see Table XLII). recurrent urinary sepsis).5-7 Therefore. In one study. but in over half of these patients the indication for surgery was claudication. although the mortality risk is similar. and this promotes its use in patients with an ongoing increased risk of sepsis caused by infectious diseases elsewhere (eg. aortoiliac endarterectomy now competes (unfavorably) with PTA and stenting. including a transverse incision.

9 97 90 88 73 et al. 199430 where compared.. 199212 Schneider 79 59 1.. 199320 Dunn 192 36 3 96 89 86 – et al..—Primary patency results for aortobifemoral bypass ranked by percentage CLI patients and total sample size (selected reports) Primary patency (%) Operative Patients % CLI mortality (%) 1 yr 3 yrs 5 yrs 10 yrs Comments >50% patients with CLI Prendiville 134 limbs 75 3 – 94 89 – CFA anastomosis et al..6 95 92 88 78 al. 198926 van den Akker 518 23 3. The excellent patency rates for aortobifemoral bypass grafts reflect good functional results (see Table LXII).7 93 – – – et al. 199029 van der Vleit 350 19 4. 198923 Poulias 820 29 3.. most subjects were patients with intermittent claudication. patency rates are clearly better in patients treated for claudication. Tabulated Results for Aortoiliac Reconstruction Treatment comparisons of surgical and endovascular modalities are not always stratified into unilateral (iliac artery) and bilateral (aortoiliac and bilateral iliac) disease in the reported literature.3 – 85 – – et al.8 98 95 – – et al.3 – – 90 – et al..4 80.10 A study from the United Kingdom indicates that.8 – – 91 – end to side et al.. More localized endarterec- tomies also offer more favorable results than those of the entire aortofemoral segment. 199224 Martinez et 376 28 5..4 88. 197818 Ameli 105 42 5.3 – – 89 82 et al.. 199212 Prendiville 151 limbs 65 3 – 95 92 – PFA anastomosis et al. 199116 Brewster & 261 52 1.. 199113 Harris 177 59 4 – – 91 – incl 23 unilat et al. 198919 Littooy 224 37 4. 221 . Approximately 95% of patients are initially rendered asymptomatic or improved. 199522 Friedman 26 31 0 100 100 93 – Dacron graft et al. 199522 Naylor 241 29 – 94 83 81 – et al. 199215 Nevelsteen 912 53 5 – – 94 83 et al..... It should be noted that. of patients fully employed before aortobifemoral bypass..4 et al.. 198514 procedures Schneider 107 53 1 – 85 – – et al. approximately 80% to 90% remain in this cate- gory.. in many of the studies cited.TABLE LXII.9 93. 19907 Jensen & 56 21 0 96 92 – – 89% @ 4yrs Egeblad. 198025 Mason 59 25 7 92 89 – – et al. 197817 <50% patients with CLI Mulcare 114 46 8. 199227 Melliere 111 22 1.4 86.9 99 95 91 – data from 1970-77 Darling. 198221 Friedman 34 35 0 100 100 98 – PTFE graft et al. and after 5 years..

8% at 5 and 10 years.6 95 85 80 aortoiliac- femoral 92 – 1 – – 66 iliofemoral Lazaro et al.6% to 3. 198851 31 – 0 – – 75 aortoiliac 85% return to full employment an average of 4 months after surgery. Calligaro et al. but axillobifemoral bypass produces lower morbidity and mortality.0% and 86.1% to 8. such as axillofemoral bypasses. 198546 55 67 1.TABLE LXIII. they were 91. For claudication.—Results of primary patency rates from reports of aortoiliofemoral endarterectomy (selected reports)..1% (61–76) Operative mortality 3. although reporting good patencies. 199048 60 35 0 88 86 80 Oskam et al. ABF produces better patency.7 – – 60 van den Dungen et al. these are in general limited to those patients with exceptional surgical risks because of concurrent disease or to those in whom the abdominal approach is con- traindicated (eg. Patency Operative Patients % CLI mortality (%) 1 yr 3 yrs 5 yrs Comments Roder et al. LXIII). not unexpectedly have higher mortality rates. 197917 253 – 2. infection..11 It should be noted that in this table some older series. this study compared limb-based patency rates for patients with intermittent clau- dication and those with CLI.. In comparable cases. Importantly. multiple adhesions. 5-year primary patency: Limb-based 87. Although some recent studies report excellent results with extraanatomic bypass grafts. In a meta-analysis of pooled data from 1978 to 1996.. 199649 94 11 0 – 83 68 Brewster & Darling.4% (72–82) 10-year primary patency: Limb-based 81.3%. Adequate inflow for axillofemoral bypasses needs to be confirmed by duplex scan before operation. This tradeoff is more difficult to justify in good-risk patients with intermittent claudication but it is clearly valuable in those with CLI when there is a mandatory requirement for femoral inflow and the direct abdominal approach is contraindicated by a prohibitive risk. These include the use of externally supported prostheses52 53 but liberalized indications also may play a role.54 recommended inflow arteriography because they found both a higher incidence of inflow disease (25%) and the failure of noninvasive examination to detect disease in 75% of patients found to have significant stenoses 222 .5% (80-88) Patient-based 80. other intraabdominal pathological conditions).3% Systemic morbidity 8. 199147 93 39 0 94 – 83 Vitale & Inahara. respectively. and the aggregate systemic morbidity risk dropped from 13. de Vries and Hunink31 showed that after 1975 the aggre- gate mortality rate had dropped from 4. The improved recent results with 5-year primary patencies of 75% to 80% are related to technical improvements. This study confirms two previous observations of the superiority of ABF over other bypasses: (1) its remarkable dura- bility and (2) its patency is less affected by poor run-off.8% (70–85) Patient-based 72.3% TABLE LXIV.3% (Tab. typified by CLI patients. Axillofemoral bypass The axillary artery may be used as an inflow source.—Meta-analysis of primary patency in reconstructions performed after 1975 in patients with CLI31.9 98 95 94 aortoiliac 195 – 7.

In series in which the two have been compared. 199344 50 62 5 – – 79 Axillobifemoral Chang. 199052 76 – 5 93 85 @ 4yr – Axillopopliteal Ascer et al.TABLE XLV... and the issue of whether to always perform a bilateral bypass even in the face of unilateral ischemia has never been addressed by an appropriate trial. Primary patency results at 5 years (axillounifemoral. when constructing an axillofemoral bypass. 33% to 85%) are not as good as those for aortobifemoral bypass grafts. 199443 80 50 8.55-58 CRITICAL ISSUE 32: Axillobifemoral versus axillounifemoral bypass for critical limb ischemia There is a need to determine whether a bilateral procedure should always be performed.. even in the case of unilateral ischemia. 198737 27 100 13 48 19 19 Chang.. 198555 34 100 5 – – 44 Rutherford et al.. the cases may not be truly comparable.59 Special considerations in proximal surgical revascularizations 223 . Five-year patency rates of 86% have been reported. 199042 17 100 11 – – 68 Rutherford et al. 199344 29 62 5 – – 76 Harrington et al.4 90 74 74 Hepp et al. 199245 41 100 20 70 43 – with arteriography.. 198834 22 80 5 – – – El Massry et al. 198641 23 100 – – – 33 Naylor et al. 199653 108 80 3. 30% to 79%. or the mean patency rates have favored the former.— Results of aortoiliac procedures—primary patency rates for extraanatomic bypass (selected reports).. 199443 73 71 8.. Most authors find that the use of the descending thoracic aorta with a retroperitoneal tunnel provides more acceptable operative risk and acceptable patency rates. 198555 22 100 5 – – 50 Naylor et al. However. Thoracofemoral bypass The thoracic aorta may provide a suitable inflow artery in patients with reasonable pulmonary and cardiac func- tion. Results of axillounifemoral and axillobifemoral bypass grafts are presented in Table LXV.. 198555 55 100 8 58 45 40 Keller et al. 198641 26 100 – – – 75 Ascer et al.. patency rates have been statistically significantly better for axillobifemoral than for axillounifemoral bypass.3 – – – ElMassry et al...3 – – – Harris et al. 198737 15 81 11 78 62 62 Passman et al... 198834 90 80 5 – – – Harrington et al. Primary patency (%) Operative Patients CLI (%) mortality (%) 1 yr 3 yrs 5 yrs Axillounifemoral Ascer et al. axillobifemoral.59-61 The proximal anastomosis is performed through a lower thoracotomy with retroperitoneal tunneling and crossover femoral grafting to provide inflow to both legs. 199042 17 100 11 – – 50 Hepp et al...

mainly female. For this reason. The need for subsequent bypass has been estimated to be as high as 21% to 25%. have congenital markedly small aortas. either through the end of the divided infrarenal aorta (“champagne cork” operation) or through a longitudinal arteriotomy in the infrarenal position after the renal arteries have been protected from emboliza- tion. and most importantly. patients with CLI have multilevel disease. There remains controversy about the best treatment for these patients. occasionally lesions are close to the threshold between hemodynamically significant and insignificant lesions. because of obesity or intestinal gas). Complete occlusions are easy to assess angiographically. is considered to be the reference stan- dard. although in Brewster et al’s series only 4% were done simultaneously. but duplex can distinguish all but the borderline lesions with accuracy.75-79 There remains considerable 224 .65 66 One aspect of this is assessment of the hemodynamic signifi- cance of iliac stenoses. This gives acceptable results with meticulous technique. 92%. specificity.70 71 Although pressure gradient measurement can be done readily during preprocedural arteriography. if not most. Hemody- namically significant stenoses may be missed on AP projections because iliac plaques build up posteriorly. noninvasive imaging has been explored as a substitute. 74 Such borderline lesions require intraarterial pressure measurement with hyperemia at the time of arteriography. Such measurements ideally should be performed before reconstruction but also can be performed at time of surgery on the operating table. (2) there is occlusive disease in the profundageniculate collateral pathway beyond that which can be dealt with by concomitant profundaplasty. Management of the small “hypoplastic” aorta. Contrast arteriography with pressure measurements. Brewster et al. Many authors have written about the ability to predict the success of an inflow procedure alone to relieve symptoms and salvage the limb. Hyperemia can be induced either pharmacologically or mechanically.—A subset of patients. with a mean sensitivity of 92%.62 63 The additional morbidity has been reported specifically with respect to suprarenal clamping and renal fail- ure as long as the clamping time of renal arteries is less than 30 minutes and there is no embolization of throm- botic or atheromatous debris into the renal circulation.—Aortic occlusion progressing to the juxtarenal position may be treated successfully by an aortobifemoral bypass graft. The aorta must be thrombo- endarterectomized. Conventional thinking is that proximal revascularization will suffice in most cases (approximately 75%-85%).65 reported that 49% of patients undergoing aortobifemoral bypass grafts would have occlusion of the superficial femoral artery. The mean sensitivity of the clinical evaluation for aortoiliac disease has been reported to be in the range 32% to 77%.73 Although duplex scanning usually gives a clear result. and it is not possible in some patients (eg. The measurement of pressure gradients across the aortoiliac segment after the administration such as papaver- ine has been deemed a suitable assessment of aortoiliac stenosis in determining the need for an inflow versus an outflow procedure. both at rest and after vasodilatation.Management of juxtarenal aortic occlusion (aortofemoral bypass). but stenoses are difficult to gauge. which is not adequate for routine screening. 88%). (4) there is major tissue loss or infection in the foot.67 Occasionally a drop in pressure will be evident only after distal reconstruction. Even biplanar views may misjudge them. Aortoiliac endarterectomy with a patch has been advocated by some. Identifying characteristics of the remainder include (1) the proximal lesion is of modest hemodynamic significance.69 It must be stressed that it is the systolic com- ponent of the arterial pressure that most accurately reflects the underlying hemodynamic status of the arterial seg- ment being examined. It is accepted that inflow must be adequate before the performance of an outflow proce- dure. MRA is gaining recognition as an appropriate assessment of aortoiliac occlusive disease (sensitivity.64 Management of coexisting infrainguinal occlusive disease Many. but the commonly preferred alternative is to use an ABF with a wide end-to-side anastomosis. (3) the popliteal artery or two of its branches are occluded (poor runoff).72 Duplex scanning was found to be the most reliable single noninvasive test for aortoiliac disease. and there- fore these pressures should be monitored. it is less desirable as a separate procedure.68 There was no difference in infrageniculate graft patency at 4 years when the anatomic degree of proximal iliac stenosis is compared.

Most agree that major tissue loss or infection in the foot is an over- riding consideration. Presuming significant proximal disease requiring revascularization is present. (Repeated from p. In the absence of that finding. if there is doubt about the hemodynamic significance of partially occlusive aortoiliac disease. it should be determined by intraarterial pressure measurements at rest and with induced hyperemia before constructing an outflow bypass. p. However. the choice regarding profundaplasty versus distal bypass is still a matter of debate. but it is generally accepted that peak systolic differences of 5 to 10 mm Hg at rest and 10 to 15 mm Hg after vasodilatation are important (see “Aortoiliac Stents”. in the presence of a superficial femoral artery occlusion and stenosis of the origin of the profunda femoris artery. Even if profundaplasty is indicated and performed.5 were able to develop a proportion formula relating the preoperative thigh and ankle brachial indices. and.controversy over what constitutes the threshold value for hemodynamically significant pressure gradients. decisions regarding the need for concomitant bypass. 82-84 The risk of progression of occlusive disease in the contralateral iliac artery and the need for subsequent recon- struction has given rise to cautionary note by some authors who prefer to perform a bilateral reconstruction. This “predicted” (correlated with the presence or absence of) hemodynamic failure when distal recon- struction was not performed with 89% accuracy. needs to be made. Rutherford et al.80 The profunda is a durable outflow artery. 106) CRITICAL ISSUE 11: Use of pressure gradients to assess hemodynamic significance of stenoses Pressure gradient criteria with or without vasodilators for assessing hemodynamic significance in iliac lesions remain to be established.85 86 225 . the other main consideration is whether the coexisting distal disease must be dealt with by concomitant bypass or profundaplasty. The pressure index recommended for isolated profundaplasty is less useful in the face of a proximal revascularization. RECOMMENDATION 88: Intraarterial pressure measurements for assessment of multilevel disease In a patient with multilevel disease. 106). or whether a proximal revascularization alone will suffice. related to indication (3) previously discussed. This may be performed at the time of angiography. a profundaplasty should be performed at the time of ABF. The value of concomitant profundaplasty when the proximal profunda is narrowed is well estab- lished. it may be desirable to conduct a unilateral pro- cedure. CRITICAL ISSUE 33: Effect of distal disease on iliac artery pressure gradients There is a need for future studies to investigate the extent to which severe distal disease may cause an underestimation of translesion iliac artery pressure gradients.81 The iliac artery also may provide a suitable inflow artery.5 Others have successfully incorporated this approach into their practices. Several studies suggest that unilateral aorta femoral bypass grafts can be safely performed and may have higher patency rates than extraanatomic bypass grafts. and this can be aided by segmental limb pressure.44 Unilateral Iliac Disease Unilateral aorto or iliac to femoral bypass When a single iliac artery is involved in the ischemic process. attempts have been made to predict the need for concomitant distal bypass from hemodynamic data.

199239 156 34 1. 199435 165 67 4. Results of direct revascularization and crossover grafts are depicted in Table LXVI.87 88 Thus. 199689 44 50 1.4 87 79 79 Perler & Williams. 198926 39 31 0 – 89 – Ricco.89 It is recommended that donor iliac artery PTA or stenting should be reserved for the ideal lesions.5 83 71 60 Piotrowski et al. iliofemoral bypasses.. 198885 17 53 0 – 48 48 †compare with fem-fem results below† Kalman et al. 199689 26 46 1. ABF is recommended as the inflow procedure of choice. Axillounifemoral bypass The application of this bypass is limited. primarily to secondary operations for graft infections.3 – – 92 Ricco 199233 74 17 1 92 79 – ‡compare with iliofem results above‡ Farber 199040 71 – 4 – – 82 Chang 198641 53 – – – – 85 Femorofemoral bypass Comparative studies have failed to yield comparable success rates for extraanatomic bypass grafts when com- pared with the standard ABF. Operative Primary patency (%) CLI mortality ) Patients (%) (%) 1 yr 3 yr 5 yr Comments Unilateral aorto/iliaciliac/femoral bypass Piotrowski et al.2 91 81 75 Kalman et al. In addition.. Comparative studies have shown similar patency rates when donor arteries are dilated or stented before bypass in carefully selected patients.. 198834 26 80 4 100 – 80 Lorenzi et al. because of its lower patency rate.. TABLE LXVI. or endarterectomy and direct aortofemoral bypasses.. 198732 50 44 0 96 92 – van der Vleit et al.4 81 73 59 with donor artery dilatation Rutherford et al.. 223). 199338 110 44 4. 226 . unless the disease is truly localized to the uni- lateral iliac system or the patient’s condition precludes an aortic procedure. 198885 47 40 0 – 60 55 †compare with iliofem results above† Ng et al. p. Inflow may be improved with PTA before crossover femoral grafting in those with some donor iliac artery steno- sis. Controversy exists over which of the two main choices of operation is preferred. LXV.—Results of aortoiliac procedures—primary patency rates for unilateral reconstruction (selected reports). probably attribtable in part to progressive disease in the donor limb.49 CRITICAL ISSUE 34: Long-term results of crossover bypass grafts There is a need for randomized studies comparing long-term results of crossover femorofemoral bypass. 199430 184 39 2 95 88 – Mason et al.. 198737 60 45 0 79 67 67 without donor artery dilatation Criado et al. 199233 69 18 1 97 90 – ‡compare with fem-fem results below‡ Femorofemoral bypass Hepp et al. It also is used in situations in which there is a pressing need for unilateral inflow but other inflow donor arteries are not patent or accessible because of hostile anatomy or prohibitive anesthetic risk (see also Tab.. the inflow arterial system must be of an excellent quality if good results are to be obtained with crossover bypasses... 198736 82 52 0 80 6773 Perler & Williams..

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Axillopopliteal bypass for limb salvage. Harris EJ. Darling RC. femoropopliteal and femoroinfrapopliteal bypass grafting. 71. Axillofemoral bypass as a limb salvage procedure in high risk patients with aortoiliac dis- ease. Surgery 1977. Vitale GF. Moneta GL.141:252-256. 1996. J Cardiovasc Surg 1991. Hemodynamic evaluation of the aortoiliac system based on pharmacologic vasodilatation. Smith JC. Barnes RW. McConnell DB. Franco CD. 41. 58. 57. Optimal methods of aortoiliac reconstruction. Radiology 1995. Axillofemoral bypass: compromised bypass for com- promised patients. 47.15:817-822.18:495-504. J Vasc Surg 1999. Hosang M.

Aortic reconstruction vs extra-anatomic bypass and angioplasty. 88.4 5 An analysis of the results of the endovascular treatment of aortoiliac disease has already been presented (see “Aortoiliac PTA”.166:277-284. 82. interpretation. References 229 . 78% of iliac stenting for steno- sis. However. Chang BB. Interpretations and treatment deci- sions based on MR angiography versus conventional arteriography in symptomatic lower extremity ischemia. Rutherford RB. 89. that the iliac PTA and stent data primarily reflect the treatment of unilateral (iliac) disease. Simultaneous operative reapair of multilevel lower extremity occlu- sive disease. The mean systemic complication rate was 1. Cragg AH. 78. p. 77. Dalman RL. It should therefore be pointed out. 114).158(2):431-436. Harris VJ.14% for PTA and 0.76. Arch Surg 1986. Devine TJ. Unilateral iliac disease: the role of iliofemoral bypass. Cikrit DF. p. and lesion site (common vs external iliac) were found to affect patency in some studies. Berbaum KS.17:15-22. Sawchuk AP. Bunt TJ. disease severity (CLI vs claudication). lesion type (occlusion vs stenosis). 81. J Vasc Surg 1991. J Vasc Surg 1987. Scott DF. 102). 84. Yeager RA. Jones DN. respectively. with lesions amenable to these modalities. and 86% of iliac stenting for occlusion). Lalka SG.3% for stent procedures. see “Aortoiliac PTA” (p. Besso SR. Denton MJ.3%. and “Aortoiliac Stents”.7(2):213-220.116 reported patients. Johnson MS. Aortoiliac Disease—Endovascular Treatment For a detailed discussion of endovascular treatment of aortoiliac disease.24:363-370.0% for stent procedures (for detailed discussion of complications of endovascular procedures. This is because these proce- dures have been predominantly performed for claudication (proportion of patients undergoing procedures for clau- dication: 77% of PTA performed for iliac stenoses.2 Death within hospital stay (not 30-day mor- tality) averaged 0. Femorofemoral versus aortobifemoral bypass: outcome and hemodynamic results. AJR 1996. Levinson SA. Walsh DB. Cikrit DF. Aortobifemoral bypass: The operation of choice for unilateral iliac occlusion? J Vasc Surg 1988. Cronenwett JL. 80. 82% of iliac PTA for occlusions. Darling RC. J Vasc Surg 1994. Am J Roentgenol 1992 Feb. Piotrowski JJ. J Vasc Surg 1993. the local complication rate. 87. Kinney TB. Talyor LM. Ricco JB. in reviewing these data in com- parison with the surgical bypass data presented earlier (see p. J Vasc Interv Radiol 1996. Trerotola SO. 9.2 3 Analysis of variables that could potentially affect the patency results shown some heterogeneity. Williams GM. Smith TP. JVIR 1995. Bell R. Ann Vasc Surg 1992. Harris VJ.58:859-863. PTA and stents offer a lower durability of the result as compared with bifurcated graft surgery. The 30-day mortality rate averaged 0. Levinson HJ.6:209-219. Holloran G. Leather RP. Johnson MS.8:211-218.3% for PTA and 5. applications.121:1166-1171. Lloyd WE. with technical failures included. However. Perler BA. 106) and is not repeated here. 83. 79. J Vasc Surg 1996.2% for stents. Does donor iliac artery percutaneous transluminal angioplasty or stent placement influence the results of femorofemoral bypass? Analysis of 70 consecutive cases with long term follow-up. Myers KA. Walker PM. The adjusted 4-year primary patency rate for treatment of CLI. Thoughts on evolving a protocol for selection. 102. was 53% after PTA and 67% after stent placement for the treatment of stenoses. see p. and the mean rate of major complications necessitating treatment was 4. Limited indications for unilateral aortofemoral or iliofemoral vascular grafts. Shah DM. Nakagawa N. Snidow JJ.2 Endovascular procedures are generally performed on patients with less severe disease than those undergo- ing surgical treatment. Snidow JJ. Unilateral iliac artery occlusive disease: a randomized multicenter trial examining direct revascularization versus crossover bypass. Extraperitoneal unilateral iliac artery bypass for chronic lower limb ischemia. Endovas- cular techniques such as PTA and stent placement have the advantage of lower morbidity and mortality risk com- pared with open surgical revascularizations.6:139-143. Lalka SG. Cham C. Is the iliac artery a suitable inflow conduit for iliofemoral occlusive disease: an analysis of 514 Aortoiliac reconstructions.19:43-57. Porter JM. Buckwalter KA. Pearce WH. Moneta GL. The risk for endovascular technique is much lower than for surgical treatment. Comparison of the efficacy of digital subtraction and film-screen angiogra- phy of the lower limb: prospective study in 50 patients. Hosang M. 86. 85. Trerotola SO.1 The death and complication rates of aortoiliac PTA and stent place- ment were analyzed in a meta-analysis of 2. Schneider JR.13:211-221. Zwolak RM. Whitehill T. 222). Rose SC.6:595- 603. and limitations.107:791-796.6%. Kalman PG. Arch Surg 1973. Intraarterial pressure measurements during angiographic evaluation of peripheral vascular disease: techniques. Johnston KW. Iliac artery evaluation with two-dimen- sional time-of-flight MR angiography:update. Aust N Z J Surg 1988.8% for PTA and 1. Patt A.

Picot M. Introduction to Preferred Therapeutic Options The decision about what type of revascularization to recommend ideally should be made by a multidisciplinary team. J Vasc Surg 1997.4:639-648. particularly in the case of types B and C. 1. 2. Lesions are defined and then placed in four groups. J Vasc Inter Radiol 1993. bypass or angioplasty). there is no direct evidence comparing the results of endovascular or surgical treatment in a controlled. Durability of these endovascular procedures is. For most lesions. etc. ran- domized study. JVIR 1995. Bosch JL. 230 . Encarnacion CE. de Vries SO. in which no firm recommendations can be made about the preferred interventional option. The final choice of intervention.204:87-96. Laborde JC. 4. less well established. Important issues that may influence the recommended decision are: — lesion morphology. Iliac arteries: reanalysis of results of balloon angioplasty. 102). Denpree RH. such as the patient’s overall health. Radiology 1997.6:513-521. 101). will of course depend on a number of other considerations. There is insufficient solid evidence to make any firm recommendations. and it may be appropriate to use different techniques for different lesions. — patient’s life expectancy. — previous procedures (ie. Aortoiliac Disease—Preferred Therapeutic Options The following and other similarly set out recommendations merely consider the probable relative merits of sur- gical and endovascular treatment. Results of aortic bifurcation grafts for aortoiliac occlusive disease: a meta analysis. In general. Hunink MG. Palmaz JC. — risk of surgery for that particular patient.186:207-212. each group usually being treated in a similar way. Metaanalysis of the results of percutaneous transluminalangioplasty and stent placement for aor- toiliac occlusive disease. Most patients with CLI have multilevel disease. 5. In between these two groups are types B and C lesions. in which surgery is the treatment of choice. Wilson SE. The system used for preferred therapeutic options has been detailed (see “Endovascular Procedures for Intermittent Claudication”. Dougherty SP. The two extremes are type A lesions. However. Influence of anatomic distribution of athero- sclerosis on the outcome of revascularization with iliac stent placement. Principal investigators and their Associates of Veterans Administration Cooperative Study Number 199. Cross AP. particularly for category 2 and 3 lesions. Wolf GL. Stason WB. endovascular procedures are safer and require shorter hospitalization compared with surgical pro- cedures. p. and type D lesions. endovascular treatment is more commonly used in type B lesions and surgical treatment is more commonly used in type C lesions.26:558-569. 3. however. Johnston KW. Hunink MGM. Rivera FJ. Surgery or balloon angioplasty for peripheral vascular disease: a randomized clinical trial. It is therefore identical to Rec- ommendation 31 (see p. — local expertise and experience with particular surgical or endovascular procedures. Radiology 1993. prospective. the severity of the local lesion. in which endovascular approach is the treatment of choice. on the assumption that intervention is desirable.

CFA. type C lesions of iliac and femoral arteries can be treated by endovascular means with a reasonable technical success rate (for references. EIA. CIRSE believes that in clinical practice these lesions are more commonly treated by endovasular tech- niques. 102) CRITICAL ISSUE 10: Treatment of TASC type B and C lesions More evidence is needed to make any firm recommendations about the best treatment for TASC types B and C lesions. and CFA (usually >10cm) — Unilateral occlusion involving both the CIA and EIA — Bilateral EIA occlusions — Diffuse disease involving the aorta and both iliac arteries — Iliac stenoses in a patient with an abdominal aortic aneurysm or other lesion requiring aortic or iliac surgery Abbreviations: CIA. Reason for dissenting opinion: Due to technical developments. not extending into the CFA — Unilateral EIA occlusion not extending into the CFA — Unilateral EIA stenosis extending into the CFA — Bilateral CIA occlusion TASC Type D iliac lesions: — Diffuse. multiple unilateral stenoses involving the CIA.* *CIRSE dissenting opinion: Currently endovascular treatment is more commonly used for type B and C lesions. common iliac artery. but more evidence is needed to make any firm recommendations about best treatment. 102) RECOMMENDATION 31: Morphological stratification of iliac lesions TASC Type A iliac lesions: — Single stenosis <3 cm of the CIA or EIA (unilateral/bilateral) TASC Type B iliac lesions: — Single stenosis 3–10 cm in length. (Repeated from p. see B 4. There- fore. (Repeated from p. although scientific evidence of any superiority over vascular surgery is lacking. 102) RECOMMENDATION 32: Treatment of choice for TASC type A and D aortoiliac lesions Endovascular procedure is the treatment of choice for type A lesions and surgery is the procedure of choice for type D lesions. 231 . common femoral artery. not extending into the common femoral artery (CFA) — Total of two stenoses <5cm long in the CIA and/or EIA and not extending into the CFA — Unilateral CIA occlusion TASC Type C iliac lesions: — Bilateral 5–10-cm-long stenoses of the CIA and/or EIA. external iliac artery.3). (Repeated from p. EIA.

Perler BA. For suitable lesions. Combined percutaneous transluminal angioplasty and extraanatomic bypass for symptomatic unilateral iliac artery occlusion with contralateral iliac artery stenosis. balloon angioplasty may remove a dis- crete lesion distally. performed either intraoperatively or preoperatively.Combined Surgical and Endovascular Procedures This discussion primarily concerns the choice between open surgical reconstruction and endovascular proce- dures and is directed toward proximal revascularization. Harris JP. However. in the absence of sufficient length of ideal conduit for a distal bypass. balloon angioplasty. Combined endovascu- lar/surgical procedures have had some success in this regard. combinations of endovascular and surgical procedures are increasingly being employed. Walker PJ. Does donor iliac artery percutaneous transluminal angioplasty or stent placement influence the results of femorofemoral bypass? Analysis of 70 consecutive cases with long term follow-up. J Vasc Surg 1996. The determination of com- bining or performing the procedures sequentially will be determined by local circumstances. Williams GM. Ann Vasc Surg 1991. permitting longer-term patency of an otherwise compromised graft. provides adequate inflow to maintain the distal reconstruction. each lesion must be considered on its own merit.1 2 Those patients with pressure gradients across aortoiliac stenoses should have these corrected before construction of a distal bypass graft. Also. 2. May J. 232 . The common occurrence of multilevel disease in CLI patients has already been alluded to and discussed in terms of the need for concomitant distal bypass. In considering the approach to a combined proce- dure. either concurrently in the operating room or sequentially in the angiography suite with early subsequent bypass.5:209-216. References 1. The quality of the endovascular and surgical components of the tech- nique must not be compromised by skills and training of the individual performing either part of the procedure. Iliac artery dilatation to improve inflow for a cross-femoral graft has been reported to be successful in carefully selected patients.24:363-370.

RECOMMENDATION 89: Inflow artery for femorodistal bypass Any artery. p. popliteal) and have found that in appropriately chosen indi- viduals there is no compromise to the bypass. may serve as a suitable outflow tract with acceptable expected patency rates. SFA. distal origin bypass grafts should be undertaken only when inflow to that level is uncompromised. Infrainguinal Disease—Surgical Treatment The main guiding principles behind surgical reconstruction are to bypass into the best available outflow vessel possible regardless of the anatomic level and to construct the bypass graft with autogenous vein. because this will give the best long-term patency rates. p. RECOMMENDATION 90: Femorofemoral distal bypass outflow vessel In a femoral crural bypass. 117). This issue is of some importance when alternative (and presumably shorter) segments of vein must be used for bypass grafts. Further expla- nation and exceptions to these principles are discussed in the following sections. The common femoral artery or an inflow graft is the usually accepted origin of a femoral distal bypass graft. not only the common femoral artery). the surgeon must ensure adequate inflow to the groin level or site of proximal anastomosis (see also Recommendation 88. 225).4 5 The results of femoro–below-knee popliteal grafting are similar to femoral distal bypass grafting. Any distal artery. Distal Bypass Grafts The same principles as outlined in the previous section on femoral-popliteal lesions apply to more distal bypass grafts. a stenosis of 20% or more in the native superficial femoral artery proximal to a graft origin has been correlated with eventual graft failure. 233 . the least diseased distal artery with the best continuous run-off to the ankle/foot should be used for outflow regardless of location. may serve as an inflow artery for a distal bypass provided that flow to that artery and the origin of the graft is uncompromised.1-3 For example. including the pedal arteries. A number of authors have reviewed experience with more distal take-off of bypass grafts (profunda. When a bypass graft is constructed to an outflow artery below the knee. The increased length of the required conduit introduces some special problems in the absence of long saphenous vein. provided there is adequate length of suit- able vein. autogenous tissue is accepted as the preferred conduit. and these are discussed in the following sections.1 Because atherosclerosis is a generalized and in many cases progressive disease. The main exceptions to this relate to the lack of adequate length of suitable vein. Outflow (Run-off) Arteries The guiding principle here is to choose the distal outflow artery that allows the best perfusion of the foot. The issue of above-knee femoropopliteal bypass grafting has been addressed earlier (see “Surgery for Intermittent Claudication”. The best dis- tal artery should be selected. The choice of the site of the distal anastomosis should be based on the quality of the distal artery and its runoff and not the length of the bypass. There should be no effort to compromise the length of bypass just to have the distal anastomosis in the popliteal artery rather than a distal artery. Inflow Before reconstruction of infrainguinal PAD. regardless of level (ie.

Choice of Conduit (See “Surgical Procedures”. is an exception to the previously discussed guiding principle.4% reversed).12 Such randomized comparisons also reflect problems in comparing the two approaches. Five-year patency rates for bypasses to an isolated popliteal segment were reported as PTFE. Large perigeniculate collateral arteries have been used successfully as outflow vessels in some patients.11 12 On the contrary.7 Suggested requirements for a successful bypass to the blind popliteal artery were a segment of artery of at least 7 cm and at least one major collateral vessel draining the segment. If this is not available. 239). 56%. Basic science and clinical investigations continue into the development of alternative bypass conduits when autogenous vein is not available. the secondary patency rate was comparable in the two groups (71. This demonstrates the need for meticulous follow-up of vein bypass grafts. An adequate segment of popliteal artery with collateral outflow to the foot is required to ensure ongoing patency. because of shortage of vein). saphenous vein. p. the techniques are considered equivalent. The quality of the vein can affect the outcome.10 Initial good results with improved techniques for in situ bypass grafts led to claims of better long-term patency rates.8 RECOMMENDATION 91: Bypass to an isolated popliteal artery Bypass to an isolated popliteal artery should be considered as an alternative when no crural or pedal bypass is possible or realistic (eg. 79%. provided expected patency is sufficiently high to justify patient risk. In general. antegrade use of dislocated vein after valve disruption holds the same advantage and can be used to overcome diameter mismatch. Good results have been achieved by a variety of techniques. A randomized control trial comparing PTFE with autogenous vein found significantly improved results in bypass grafts distal to the knee when vein was used in the reconstruction. 74%. autogenous tissue is far superior to any other conduit. this “isolated popliteal artery” may be used as an outflow tract.8% for reversed bypasses (p < 0.2%.6% in situ vs 79. showing diminishing results as less favorable bypass grafts are used. For bypasses below the knee. at 5 years the primary patency rate for in situ bypasses was 46. the preferred alternatives in order of preference are single-segment venous bypass (contralateral greater saphenous vein.Isolated Popliteal Artery Segment When there is no direct communication between the popliteal artery and the tibial vessels. However. a number of random- ized trials failed to support this statement. compared with 68.05). such as greater (learning curve) experience needed for in situ bypass and greater need for secondary procedures to deal with residual arteriovenous fistulas (graft stenoses being equivalent). which usually arises when there is a shortage of vein.) followed by spliced veins from any source. and saphenous vein. How- ever. p. The length and estimate of the diameter of available veins is frequently 234 . A saphenous vein is optimal if the vessel wall is thin. and the diameter at least 4 mm. the preferred reconstruction is with ipsilateral long saphenous vein (either in situ or reversed). Results from a variety of conduits are shown in Table XLVII. 118) For infrageniculate reconstruction.9 This is confirmed in a meta-analysis by Hunink (see Table XLIX. with tapering vein creating a diameter mismatch in infrageniculate bypass being the solitary advantage to in situ bypass. These include arterial and venous homografts.6 This situation. but addi- tional study is required to determine their efficacy. Direct comparison studies (in addition to those already shown) are shown in Table XLVIII. there is general agreement that the con- duit should be constructed of autogenous vein. The indication for such an operation would be CLI and the absence of sufficient length of suitable vein for bypass into a more appropriate vessel. when this technique was compared with reversed saphenous vein graft. etc. and limb sal- vage rates as PTFE. composite or prosthetic grafts with adjunct procedures (vein cuff. Although some claim that reversed vein has the advantage that it can be moved to the required location. the endothe- lium intact. Finally. distal AV fistula) may be considered. arm vein. How- ever. 55%.

TABLE XLVII.—Selected results of infrainguinal bypass with various conduits.
Operative Primary patency (%) Secondary Patency (%)
CLI Mortality
Patients (%) (%) 1 yr 2 yrs 3 yrs 5 yrs 1 yr 2 yrs 3 yrs 5 yrs Comments

Reversed greater saphenous vein
Rutherford 100 – 75 – 63 – – – – – –
et al., 198827
Taylor et al., 1990 22 100 – 75 – 63 – – – – –
Gentile et al., 199618 268 – 2 98 – 83 74 – – – – ipsilateral
Hall et al., 198561 52 23 – 85 – 68 – – – – –
In situ

Belkin et al., 1996 386 100 2 – – – 68 – – – 80
Feinberg et al., 199032 57 97 – 82 64 – – – – – –
Alexander et al., 1996 119 92 1 – – 81 – – – – –
Londrey et al., 199133 61 92 4 – –ó – 72 83 74 74 74

LS Vother

Belkin et al., 199662 168 100 1 – – – 66 – – – 75 Nonreversed
Londrey et al., 199133 93 92 4 – –ó – 59 76 68 61 59 Reversed vein
Londrey et al., 199417 169 88 2 – – – – 78 67 59 52 Single length,
any vein
Myers et al., 199364 537 43 – 80 – – 73 – – – – Reversed vein

Arm Vein
Chalmers et al., 199465 42 95 0 – 46 – – – 85 – – 64% infrapopliteal
Harward et al., 199266 43 93 0 67 – 49 – – – 64 – 34% infrapopliteal
Harris et al., 198467 70 83 0 85 – 72 68 – – – – 56% infrapopliteal
Myers et al., 199364 49 43 – 63 – – – – – – –
Spliced Vein
Harris et al., 198668 54 100 6 58 – – – 74 – – – 78% tibial
Chang et al., 199520 114 95 4.4 72 – 69 – 80 – 77 – Part in situ
Londrey et al., 199417 88 88 2 – – – – 56 53 39 29
Taylor et al., 198769 140 81 1.5 95 – 83 – – – – – Other vein
Taylor et al., 198769 189 69 1.5 89 – 84 – – – – – Partial ipsilateral
vein
Ankle/distal, all vein
Panayiotopoulos et al., 199670 109 100 7 – – 27 – – – 45 – Crural/pedal
Davidson & Callis, 199371 75 100 6 89 79 68 – 93 – 82 70 All vein to foot
Quinones- 46 100 0 72 – 72 – – – – – Distal ankle
Baldrich et al., 199372
Shah et al., 199659 487 91 3.5 83 – – 70 89 – – 77
Composite partial prosthesis
Fichelle et al., 199573 145 100 3.3 – – 41 35 – – – –
McCarthy et al., 199274 67 100 0 72 64 48 – – 64 – 40 Sequential 100%
infrapopliteal
DeMasi & Snyder, 199575 85 99 1 – – 22 – – – 47 – 85% infrapopliteal
Feinberg et al., 199032 108 97 – 35 30 – – – –ó – –
Londrey et al., 199133 45 92 4 – – – 26 55 50 44 28
Alexander et al., 199663 35 92 – – 35 – – – 50 – –
Distal prosthesis
Schweiger et al., 199341 211 100 3.3 – 37 – 23 45 – 25 – 100% infrapop-
liteal
Londrey et al., 199133 33 92 4 – – – 7 63 38 26 7

assessed preoperatively with duplex scanning, in the order of choice (ipsilateral greater saphenous, contralateral
greater saphenous, lesser saphenous, and arm veins). This practice and the abandonment of unnecessary dis-
qualification of patients with coronary disease (ie, “saving” veins for the heart) has greatly increased vein utiliza-
tion. It has been found that even those with previous partial greater saphenous removal for vein stripping, or har-

235

TABLE XLVIII.—Selected results of comparative studies of infrainguinal bypass grafts.
Primary patency (%)
Operative
Patients CLI (%) mortality (%) 1 yr 3 yrs 4 yrs 5 yrs Comments

>90% Infrapopliteal comparisons—all studies
Vein type
Taylor et al., 199060 285 80 1 89 84 – 80 GSV
231 80 1 84 71 – 68 other vein
Gentile et al., 199618 268 – 2 98 83 – 74 ipsilateral GSV
58 – 2 85 82 – 82 contralateral GSV
133 – 1 83 75 – 72 other vein
Distal anastomosis
Donaldson et al., 199176 440 68 – 87 84 – 83 all grafts
299 100 2 83 81 – 81 CLI only
240 – – 91 86 – 86 popliteal
anastomosis
200 – – 82 81 – 78 distal anastomosis
Graft type
Veith et al., 19869 106 86 6 – – 49 – any vein
98 88 4 – – 12 – PTFE
Cranley & Hafner, 198277 40 100 2 59 – – – any vein
13 100 – 33 – – – HUV
Edwards & Mulherin, 198078 57 88 – 82 – – – any vein
29 93 – 21 – – – PTFE
15 93 – 7 – – – HUV
Rutherford et al., 198827 50 98 – 88 88 – – in situ GSV
22 100 – 75 63 – – reversed GSV
14 71 – 25 17 – – PTFE
21 95 – 7 7 – – HUV
Hall et al., 198561 52 23 – 85 68 – – RSV
27 48 – 63 49 – – Composite
47 62 – 54 34 – – PTFE

vest for CABG or other bypasses, commonly have sufficient vein left in the same leg for an infrainguinal bypass.
13 Those veins that require modification for disease at the time of the original procedure are more apt to require

further modification to maintain patency.14 Arm vein is easily accessible and can provide excellent results over the
long term.15 The configuration of the arm vein may be a total segment of basilic or cephalic vein, which is either
reversed or undergoes valve destruction. An alternative is to use a basilic-cephalic loop with one segment requir-
ing valve lysis.16
Composite vein grafts composed entirely of vein but constructed from a number of different segments or
sources have proved adequate conduits. Sources of vein may include remnants of long saphenous vein, short
saphenous vein, and arm vein.17 Some studies report results as good as single-segment long saphenous vein
bypass grafts,18 and others suggest that, although good, the results are not comparable.19 The results of spliced
vein grafts to the popliteal and distal vessels at 4 years are: primary, 45%, and secondary, 61%. These results
are improved if at least some of the graft is in situ long saphenous vein.20 Although direct comparison trials
have not been performed, this approach would seem better than other alternatives, that is, the other adjunc-
tive procedures discussed in this section. However, the revision rate to maintain patency is approximately 20%,
and a careful program of surveillance is required to achieve optimum results.
Superficial femoral vein has been suggested as a suitable conduit with very acceptable patency rates. The
removal of the superficial femoral vein may be complicated by limb edema, but this generally settles with time and
elastic support.21 Size discrepancy may pose a problem in some patients. However, patency rates equivalent to
those for long saphenous vein bypass grafts have been reported.22 23

RECOMMENDATION 92: Femoral below-knee popliteal and distal bypass
An adequate long saphenous vein is the optimal conduit in femoral below-knee popliteal and distal
ypass. In its absence, other good-quality vein should be used.

236

Other Conduits
Available conduits for femoral popliteal bypass grafts include PTFE, HUV, and Dacron. Results are varied, and
reports tend to be selected case studies. A randomized trial comparing PTFE and Dacron at the popliteal level
gave similar results.24 25 Although some randomized trials have reported superiority of HUV over PTFE or Dacron
with respect to patency, this has not been a consistent finding26-28 and late degenerative changes in HUV with
aneurysm formation offset any potential patency advantage.29 The major determinant of graft patency is the type
of graft used, and vein is superior to any prosthesis.30 31

Composite grafts (prosthetic vein)
When insufficient autologous vein is available for distal bypass grafting, there is a question of whether there is
an advantage to constructing some of the bypass graft with vein (composite bypass graft) rather than use pros-
thesis entirely. Most studies show a difference or at least a trend toward improved patency with composite grafts32
33 but no randomized trial data are available comparing all prosthetic (with or without vein cuff) with composite

grafts. Studies are difficult to compare because there is usually minimal information regarding the percentage of
the graft that is composed of vein.

Role of the Profundaplasty Alone
The role for profundaplasty is well accepted as an adjunct to inflow procedures to maintain graft patency and
reduce the need for subsequent or simultaneous distal reconstruction (see also “Management of Coexisting Infrain-
guinal Occlusive Disease”, p. 224). The role of isolated profundaplasty is more controversial. Clinical success with
such a procedure has been achieved in 49% of patients at 3 years.34 A review of the literature has suggested that
requirements for success include (1) excellent inflow, (2) a greater than 50% stenosis in the proximal third of the
profunda, and (3) the presence of excellent collateral flow to the tibial vessels in continuity with a foot with no tis-
sue loss.35 In an attempt to evaluate collateral flow distal to the profundaplasty as a predictor of success, a high
segmental limb pressure gradient across the knee (AK-BK pressure/AK pressure >0.5) has been found to predict
clinical failure.36 There are no other successful objective predictors of success of isolated profundaplasty.

Assessing Run-off
In a large, nonrandomized, retrospective study, Darling et al.37 reviewed bypass grafts to the peroneal (n =
888) and dorsalis pedis artery (n = 291). No difference was found in patency or limb salvage at 1 and 5 years
between the two groups (5-year secondary patency peroneal, 76%; dorsalis pedis, 68%). These findings are con-
firmed by other authors.38 39 Even in the presence of pedal gangrene, the peroneal artery may be an appropriate
outflow tract.40
When performing a bypass for CLI, the outflow vessel must be widely patent, with adequate run-off, and this
principle must not be compromised to shorten the length of the bypass. At least one study has shown that long-
term patency may be predicted by the adequacy of the pedal arch.41 Three-year pedal artery graft patencies
were compared with more proximal crural bypass grafts and yielded comparable results (82% pedal vs 79% tib-
ial, secondary patency) as well as yielding comparable limb salvage rates (92% pedal vs 87% tibial).42
A variety of methods exist for the intraoperative assessment of graft flow and run-off resistance/impedance.
Variable results have been reported from a variety of sophisticated methods of assessment.43-45 Although these
methods have been shown to predict patency, they have not gained widespread acceptance because they
require completion of the bypass graft before predicting success. The SVS/ISCVS reporting standards for eval-
uating run-off resistance, taking into account a number of factors, has been modified and validated by Peterkin
et al.46 based on angiography and multiple linear regression analysis. However, it tends to be less predictive
of vein than prosthetic graft patency, the former faring much better in the face of poor run-off.

237

Adjuvant Procedures to Improve Patency
At times there is insufficient available autogenous tissue with which to construct a bypass graft. The results of
reinforced PTFE to arteries distal to the popliteal have been reported as 45% and 25% at 2 and 5 years, respec-
tively, but are generally lower. Patency rates were reduced if the bypass was a secondary procedure or if the pedal
arch was not intact. Many other surgeons are unable to match these results when performing prosthetic distal
bypass grafts. The following sections review adjuvant procedures to improve patency of the disadvantaged (espe-
cially prosthetic) bypass graft.

Arteriovenous fistula
This procedure has been advocated by some when distal bypass graft is constructed with PTFE. The princi-
ple is to decrease vascular resistance and thereby increase flow in the graft while not creating a hemodynamically
significant steal phenomenon. The two most common types are (1) the“common ostia,” where the artery and vein
are sutured in such a fashion that an arteriovenous fistula is created at the site of the distal anastomosis47 and
(2) a separate remote arteriovenous fistula constructed distal to the artery-prosthesis anastomosis.48 49
There is a lack of good data to support the use of arteriovenous fistula on a routine basis. Anecdotal reports
of graft patency of 71% and limb salvage of 83% have been published.50 In a prospective, randomized study,
Hamsho et al.51 compared graft patency and limb salvage after femoro-infrapopliteal bypass using ePTFE with
and without addition of adjuvant arteriovenous fistula. The differences in cumulative rates of primary patency and
limb salvage at 1 year after operation were not statistically significant (55.2% and 54.1% for patients with arteri-
ovenous fistula compared with 53.4% and 43.2%, respectively, for the control group).50 Follow-up with duplex
scanning suggests that ongoing venous patency is important to the continued function of the graft.52 Arteriove-
nous fistula, if used at all, should be reserved for tibial or peroneal bypasses in those situations with poor run-off
or a “disadvantaged graft.”

Vein interposition/cuff
Among the adjunct techniques, creating a venous patch or cuff at the distal anastomosis of a prosthetic graft
has been described by a number of authors. Miller53 has described a “silo” configuration, whereas Taylor inserts
a patch over just the distal toe of the anastomosis. Tyrrell and Wolfe54 have shaped the cuff to improve its con-
figuration (the so-called St Mary’s boot). In 1995, Raptis and Miller55 reported the results of primary femoropopliteal
PTFE grafting with and without an interposition vein cuff. There was no difference in the patency rates between
cuffed and direct suture for above-knee popliteal bypass grafts (69% and 68% for cuffed and direct suture, respec-
tively, at 36 months).56 There was, however, an appreciable difference for the below-knee bypass grafts (57% vs
29%, respectively, at 36 months).55 These figures were later confirmed by Stonebridge et al.56 in a randomized
trial. The results supported the use of an interposition vein cuff when PTFE grafts were anastomosed to the popliteal
artery below the knee, with 2-year patency rates for cuffed and uncuffed grafts of 52% and 29%, respectively (p
= 0.03). A more recent randomized study from Belgium did not support the initial positive results with the use of
vein interposition cuffs.57 A comparison of a current series with historical controls suggests that venous cuffs
increase patency for prosthetic grafts carried to crural vessels.58 Further studies are needed to establish the role
of adjuvant procedures in femoropopliteal or femoral crural prosthetic bypass grafts (see Critical Issue 35).

CRITICAL ISSUE 35: Adjunctive procedures with prosthetic infrainguinal bypass grafts
There is a need to determine whether an adjuvant procedure (such as arteriovenous fistula or vein
cuff) significantly improves patency when it is necessary to use a prosthetic conduit for a
femoropopliteal or femoral crural bypass.

238

Is long vein bypass from groin to ankle a durable procedure? An analysis of a ten year experience. 234).—Summary of results of a meta-analysis of femoropopliteal bypass grafts (critical limb ischemia only)10. Papers published between 1983 and 1995 were included if they were original reports not duplicating previous data. Schuler JJ.10:440-444. Chant A. p. outflow artery. LoGerfo FW. Barros DíSa A. Durham JR. Shah DJ. Darling RC. The reanalysis of 2. and reported the distribution of covariates. Elliott BM. 6. they have confirmed the superiority of autogenous tissue in infrain- guinal bypass. Robinson JG. analysis techniques. References 1. J Vasc Surg 1992. Meyer JP.21:375-384. Schwarcz TH. defined patency as hemodynamic improvement. Rosenbloom MS. Brothers TE. Harris P. 72%. and length of bypass59 (see Tab. Kaufman JL. Pomposellei FB. Conduit Primary patency at 4 years Reverse saphenous vein 77% In situ vein bypass 68% Human Umbilical Vein 60% Polytetrafluoroethylene (PTFE) 40% 239 . Clyne C.274 bypass grafts reports primary patency of in situ grafts as: 1 year. Fitzgerald KM. Flanigan DP. Miller A.Results of Infrainguinal Bypass Grafts In large studies. 4. Conduit Primary patency at 5 years Vein (any level) 66% Above-knee PTFE 47% Below-knee PTFE 33% TABLE L. Eur J Vasc Endovasc Surg 1995. J Vasc Surg 1988. Overall results of femoral distal bypass reports for CLI are depicted in Table XLIX. Leather RP. Lamont P.79 Although limited information is given about inclusion cri- teria.060 patients surgically treated allowed for the assessment of 1. Shah DM. 3. Walsh JJ. Chang BB. Freeman DV. et al. showing a clear advantage for vein bypass grafts. Bock DE. with no difference in patency detected when strat- ified for inflow artery. 5 years. the major determinant of long-term graft patency is the type of graft material used as well as the continued use of tobacco. Results of Femoropopliteal Bypass Grafts A meta-analysis performed by Hunink and colleagues10 involved strict entry criteria.27 One review of a personal series of 2. included the numeric data for the Kaplan-Meier analy- sis. or the raw data.9:172-178. Arens C. which permitted pooling of data with reanalysis of stratified categories of patients. The previous comments comparing in situ and reversed vein should be considered before accept- ing the superiority of one over the other (see “Choice of Conduit”. J Vasc Surg 1995. XLVII and XLVIII). 5.10 A review of reports of the results of infrainguinal revascularization procedures published between 1981 and 1990 was performed by Dalman and Taylor (Table L). Darling RC. Burgess AM.15:402-407. 2. Darke S.—Summary: below-knee femoropopliteal grafts79. Gibbons GW. Average results are shown in Figure 25 on page 250. Is infrapopliteal bypass compromised by distal origin of the proximal anas- tomosis? Ann Vasc Surg 1995. 55%. Long-term results of infragenicular bypasses with autologous vein originating from the distal superficial femoral and popliteal arteries. Leather RP. Marcaccio EJ. Dorsalis pedis arterial bypass: durable limb salvage for foot ischemia in patients with diabetes mellitus. Campbell DR.7:691-696. 84%. Eldrup-Jorgensen J. Femoro-popliteal versus femoro-distal bypass grafting TABLE XLIX. Durability of short bypasses to infragenicular arteries.572 patients with CLI. 10 years. Chang BB.

24.23:272-280. Astelford P. Edwards PR. Fallon KT. 17. Harrington DP. Hunink MG. 28. Bonier P. J Vasc Surg 1995. 14.7:173-177. Stoneburner FD. Mannick JA. Towne JB. Jones DN. Leather RP. Shah DM. Arch Surg 1988. Whittemore AD. Schulman ML. Testart J. nonvelour Dacron versus expanded polytetrafluoroethylene. Brewster DC. Ann Vasc Surg 1997. McIntyre K. 1995. randomized clinical trial comparing polytetrafluoroethylene and modified human umbilical vein for below-knee femoropopiteal bypass. Brown PW. 10.23:130- 140. Watelet J. 23. Green RM. The use of spliced vein bypasses for infrainguinal arterial recon- struction. Mural degeneration in the glutaraldehyde- tanned umbilical vein graft: incidence and implications.20:451-457. LíItalien GJ. Seabrook GR. J Vasc Surg 1987. 8. Kram HB. J Surg Res 1993. Matsumoto T. Barral X. and remnants of greater saphenous vein: a report of 257 cases. J Vasc Surg 1986. Superficial femoral-popliteal veins and reversed saphenous veins as primary femoropopliteal bypass grafts: a randomized comparative study. Flinn WR. 29. J Vasc Surg 1988. Andros G. Salari GR. J Vasc Surg 1987. Sladen JG. Gournier JP. Polytetrafluoroethylene versus human umbilical vein in above-knee femoropopliteal bypass: six year results of a randomized clinical trial. Donaldson MC. White-Flores S. Hasson JE. randomized trial. for limb salvage in patients with an ëisolatedí popliteal segment. et al. Wong JB. Darling RC. Comerota AJ. Darling RC. Comparative evaluation of prosthetic. Lestrat JP. Bergan JJ. 19. Semin Vasc Surg 1995. Shah DM. Taylor LM. Veith FJ.3:104-114. Holzenbein TJ. 11. Leather RP. 25. Yao JST. Towne JB.25:255-270. Campbell DR. Infrainguinal reconstruction with arm vein.16:816-823. Ascer E. J Vasc Surg 1997. Pomposelli FB. Autogenous aortoiliac/femoral reconstruction from superficial femoral-popliteal veins: feasibility and durability. Superficial femoral vein. Fac- tors affecting the patency of infrainguinal bypass. Br J Surg 1992. et al. Finding autogenous veins for reoperative lower extremity bypass: limitations of veins other than the greater saphenous. Mouritzen C et al. Eickhoff JH.6(5):506-511. Four years’ results of a prospective. Belkin M. Veterans Cooperative Study Group. Eur J Vasc Surg 1989. J Vasc Surg 1986. Bernhard VM. Pevec WC. Clagett GP. Gupta SK. Semin Vasc Surg 1994.4:243-250. Moody AP. Wheeler JR. Rutherford RB. 18. Panetta TF. Bosher LP. Suggs WD. Porter JM. Semin Vasc Surg. Jones DN. 30. Moneta GL. and in situ vein bypass grafts in distal popliteal and tibial-peroneal revascu- larization.12:422- 428. Contreraras MA. Flinn WH. Berqvist D. In situ versus reversed femoropopliteal vein grafts: long term follow-up of a prospective. Abbott WM. Late results of two hundred seventeen femoropopliteal bypasses to isolated popliteal artery segments. Pancoast JW. van Vroonhoven TJ. J Vasc Surg 1996. Wengerter KR. 21. Donaldson MC. Samson RH. Menard JF. Bergentz SE. Soury P. J Vasc Surg 1995. Miller N. 27.16:60-65. 9. Harris PL. Darling RC. Ericsson BF. Results of a policy with arm veins used as first alternative to an unavailable ipsilateral greater saphenous vein for infrainguinal bypass. Durability of the in situ bypass following modification of abnormal vein segment. J Vasc Surg 1998. et al. 16.11(5):510-519. J Vasc Surg 1996. 13. Chang BB. Valentine RJ. Gupta SK. J Vasc Surg 1992. J Vasc Surg 1991.79:750-752. Conte MS. J Vasc Surg 1997. Edwards JM.123:434-438. Richardson JD.14:386-390. 12. 31. A useful technique for limb salvage: preliminary report on 22 patients. 15. Newton WD. Bergamini TM. Abbott WM. Kordt KF. J Vasc Surg 1992. Bandyk DF. Londrey GL. Scher LA.25:19-28. J Vasc Surg 1990. Moore WS.6:1-10. 7. Prosthetic above-knee femoropopliteal bypass grafting: results of a multicenter randomized prospective trial: Above-Knee Femoropopliteal Study Group. Davis RK. 240 .21:403-412. Chang BB. Dardik H. Sawyer JD. Techniques and strategies using arm vein. Lee RW. Downs AR. Bock DE.8:236-246. Rutherford RB. Preferred strategies for secondary infrainguinal bypass: lessons learned from 300 consecutives reoperations. Favre JP. Veith FJ. Darling RC. Nwosis C.27:928-935.8:179-187. Yatco R. Plissonnier D. Meyerovitz MF. The fate of saphenous vein after partial removal or ligation. Bypass to perigeniculate collateral vessels. Broome A. Miller A. Toursarkissian B. Results of bypass to the popliteal and tibial arteries with alternative sources of autogenous vein. Hagino RT. Fry WJ.8:209-215 22. J Vasc Surg 1994. Femoropopliteal reconstruction with knitted. Waltman AC. Gentile AT. Peillon C.3(3):203-207.21:282-293. Badhey MR. Patency results of percutaneous and surgical revas- cularization for femoropopliteal arterial disease. reversed. Gibbons GW. 26. Femoropopliteal bypass: in situ or reversed vein grafts? Ten year results of a randomized prospective study. Reny P. 20. Veith FJ. Aalders GJ. Buchardt Hansen HJ.14:71-81. Med Decis Making 1994. Six-year prospective multicentre randomized comparison of autologous saphenous vein and expanded polytetrafluoroethylene grafts in infrainguinal arterial reconstructions. lesser saphenous vein.54:196-201.

The role of composite sequential bypass in the treatment of multilevel infrainguinal arterial occlusive disease. Hall RG. Ascer E. Schneider JR. 48. Arch Surg 1996. 34. Craig DM. J Vasc Surg 1991.17(3):197-201. Serial duplex scans elucidate the evolving hemodynamics of distal arteriovenous fistulas. Adv Surg 1996. Lane R. Darling RC. Ann Vasc Surg 1993. Walker PM. composite. Jamil Z. Klein P. Dardik A. Eur J Vasc Endovasc Surg 1999. New prosthetic venous collar anastomotic technique: combining the best of other procedures. Ascer EE. Components of outflow resistance and their correlation with graft patency in lower extremity arterial reconstruction. Belkin M. Sept 1998.15:612-618. J Vasc Surg 1988. 35. Aust NZ J Surg. Moneta GL. 59. Infrapopliteal bypass for severe ischemia: Comparison of autogenous vein. Nevelsteen A. and prosthetic grafts. Johnston KW. Paris. Abou-Zamzam AM.5:820-827. Randomized trial comparing infrainguinal polytetrafluoroethylene bypass grafting with and without vein interposition cuff at the distal anastomosis. Raftery KB. Tibial bypass grafting for limb salvage with ringed polytetrafluoroethylene prostheses: results of primary and secondary procedures.26:543-550. Miller E.115:1366-1372. 45. Peterkin GA. Raptis S. Sumner DS. Piotrowski JJ. Kaufman JL. Lang W.24:957-962. Leather RP. Lesser ML. McCann RL. Hodgson KJ. Taylor LM.32. Veith FJ. Stonebridge PA.11:193-206.12:257-263. Tyrrell MR. Gregoric ID. Smith PK. Hamsho A. Synn AY.11:171-178. O’Donnell TF. Lee RW. Prescott RJ. Barkmeier LD. Adjunctive arteriovenous fistula with tibial and peroneal reconstruction for limb salvage. 51. 47. Pedal or peroneal bypass: which is better when both are patent? J Vasc Surg 1994. J Vasc Surg 1997.30:123-140. Saifi J. Bernhard VM. Ibrahim IM. Henke PK.6:19-26. Kahn M. Moawad J. 50. Infrapopliteal prosthetic graft patency by use of the dis- tal adjunctive arteriovenous fistula. Shah DM. White-Flores SA. Myers KA. Donaldson MC. Morin L. Porter JM. 37. Are peroneal artery bypass grafts hemodynamically inferior to other tibial artery bypass grafts? J Vasc Surg 1994. 58. Nott D. 61. Gupta SK. Paty PS. Parent FN. Veith FJ. Lloyd WB. 65. J Vasc Surg 1984. 53. Chang BB. Ramsey DE. Massey HT. et al. Edwards JM. Pappas PJ. 49. Miller JH.31:107-110. et al. Prosthetic graft placement and creation of a distal arteriovenous fistula for secondary vas- cular reconstruction in patients with severe limb ischemia. Alexander JB. Prospective. Kresowik TF. 56. LaMorte WW. Walsh DB. Towne JB. Hobson RW. Cardio- vasc Surg abstract V5. Kenny M. Schwartz LB. 38. Arch Surg 1980. Profundapopliteal collateral index: a guide to successful profundaplasty. 43. Berry SM.13:631-636. Hoballah JJ. 36. Mackey WC.5:176-181. 60. 1984. J Vasc Surg 1990. Choice of peroneal or dorsalis pedis artery bypass for limb salvage.161:308-312. Semin Vasc Surg 1995. Present status of reversed vein bypass grafting: five-year results of modern series. Infrainguinal arterial reconstruction with nonreversed greater saphenous vein.10:17-22. Israel M. Appleberg M. 46. Ann Vasc Surg 1991. Factors influencing patency of infrainguinal bypasses with polytetrafluoroethylene. Silva MB. Wheeler JR. Coupland GA. Kalman PG. Chan A.172:118-122. 41. Am J Surg 1996. Zwolak RM. Miller JH.7:379- 385. J Vasc Surg 1991. Ibrahim IM. Chang BB.19:279-288. The use of composite grafts for femorocrural bypasses performed for limb salvage: a review of 108 consecutive cases and comparison with 57 in situ saphenous vein bypasses. 42. Cardiovasc Surg 1998. Knox J. White-Flores SA. 57. Dardik I. Intraoperative outflow resistance as a predictor of late patency of femoropopliteal and infrapopliteal arterial bypasses. 55.1:817-828. Interposition vein cuff for anastomosis of prosthesis to small artery. Lambert GE. Schweiger H. Morin L. 54. 40. Sallas-Cunha S. Tovar-Pardo AE.131:894-899. Feustel PJ. J Vasc Surg 1990.20:347-356. Adcock GD. J Cardiovasc Surg 1990. Measurement of vascular input impedance in infrain- guinal vein grafts. J Vasc Surg 1996.7:262-269. Devine TJ. Shah DM. J Vasc Surg 1992. Suy R. 62. Vein.19:964-969. Gregory RT. J Vasc Surg 1987. Laroix H. Cronenwett JL. Paty PSK. Wolfe JHN. Feinberg RL. Faris I. Surg Gynecol 1985.8:225-235. Porter JM. Wolodiger F. Whittemore AD. Yuhas JP. Klamer TW. Taylor LM. Menzoian JO. Chalmers RT. Am J Surg 1980. Mannick JA. Semin Vasc Surg 1997. Belkin M. Gupta SK. Alexander JJ. Fuller JA. Dardik H. Peroneal bypass is equivalent to inframalleolar bypass for ischemic pedal gangrene. Darling RC. Gore-Tex or composite graft for femoropoliteal bypass. Br J Surg 1991. Denton MJ. J Vasc Surg 1993. Reul GJ. 64. Long term results of using insitu saphenous vein bypass.140:246-251. Foreman RK. Spence RK. Besso SR. Pedal bypass versus tibial bypass with auto- genous vein: a comparison of outcome and hemodynamic results. Gayle RG.17:1029-1038. 33. Delbridge L. Snyder SO. Boren CH. The impact of color duplex surveillance on the outcome of lower limb bypass with segments of arm vein. Multivariate Cox regression analysis of covariates for patency rates after femorodistal vein bypass grafting. J Vasc Surg 1990. Evaluation of a proposed standard reporting system for preoperative angiograms in infrainguinal bypass procedures: angiographic correlates of measured runoff resistance. randomised trial of distal arteriovenous fistula as an adjunct to femoro-infrapopliteal PTFE bypass. Manabe S.6. Shah DM. Pecoraro J.18:867-874. Harris PL. Where the profunda femoris artery fits in the spectrum of lower limb revascularization. McDaniel MD. Camishion RC. 44.11:35-43. Londrey GL. Leather RP. Nehler MR.13:685-691. Purut CM. Wells KE. Jacobs MJ. Corson JD.82:487-491. Br J Surg 1995. J Vasc Surg 1993. Lesser ML. Influence of a vein cuff on polytetrafluoroethylene grafts for primary femoropopliteal bypass. Chang BB. Scott DF. The current role of isolated profundaplasty. Lee BC. Patency of infrainguinal polytetrafluoroethylene bypass grafts with distal interposition vein cuffs. Winter RP. J Vasc Surg 1994. George SM. Remote distal arteriovenous fistula to improve infrapopliteal bypass patency. Bernhard VM. Ferguson L. Sharp WJ. Bergaminin TM. 63. 52. Meyers MG.54:283-285. 39. Ann Vasc Surg 1997. Sussman B.78:1016-1017. 241 . Ruckley CV.

Seeger JM. Apyan R. The use of arm vein conduits during infrageniculate arterial bypass.117:1543-1550. 71. This is because most patients with rest pain and tissue loss will have multisegment occlusive disease. Autogenous reversed vein bypass for lower extremity ischemia in patients with absent or inadequate greater saphenous vein. 74. 76.121:1128-1132. McCarthy WJ.75:741-752. Brant B.11 Many reported studies suffer from grouping of claudication and limb salvage patients. Arch Surg 1986. 79. Taylor LM. The current status of prosthetic-vein composite grafts for lower extremity revascularization. Hafner CD. because often the report- ing of indications and results has not been standardized. Varying the reporting criteria has been shown to result in as much as a twofold difference in reported 5-year patency. Infrapopliteal polytetrafluoroethylene and composite bypass: factors influencing patency. Flynn TC. Gelabert HA.8-10 However. 77. Sallea-Cunha SX. Late restenosis or occlu- sion after PTA may result in recurrent ulceration in some patients. long term results using the Mills valvulotome. Sallea-Cunha SX. Gigou F. 78.217:699-710. PTA can spare saphenous vein for later use in the ipsilateral limb. Reidy JF. Br J Surg 1997.153:505-510. Oblath RW. and umbil- ical vein grafts. p. Ann Surg 1991. Pearce WH.9:187-186. Snyder SO.1 but it rarely precludes subsequent surgery or compromises additional vascular segments. effective restoration of tibioperoneal artery blood flow is believed by some to increase the durability of femoropopliteal artery angioplasty.4:309-312.84:207-212. 73. Cormier JM. Edwards WH. Colacchio G. Owen SE. 70.4 Unfortunately. Am J Surg 1987. Edwards JM. Successful long-term limb salvage using cephalic vein bypass grafts. based on clinical symptoms. Tyrrell MR. the purpose of PTA is to salvage a functioning foot. Donaldson MC. Ann Surg 1980. few series have analyzed PTA of the femoropopliteal and tibial segments together. 75. Phinney ES. 68. Infrainguinal Disease—Endovascular Treatment As with other interventions for CLI. Flinn WR. Ann Vasc Surg 1990. Oblath RW.15:761-770. Confusion and controversy still exist concerning outcomes. Quinones-Baldrich WJ. Dulawa LB. Ann Surg 1984. polytetrafluoroethylene.191:721-726. For limb salvage indications. Colburn MD. Outcome and cost analysis after femorocrural and femorope- dal grafting for critical limb ischemia. others from failure to stratify results. J Vasc Surg 1992. 67. Salavage of the almost irretrievable extremity. Whittemore AD.5-7 Angioplasty techniques have improved with time.13 14 242 . Very distal bypass for salvage of the severely ischemic extremity. Taylor LM.166:117-123. Marzelle J. Davidson JT.16:420-427. Arch Surg 1982. Long-term evaluation of composite sequential bypass for limb-threatening ischemia. 69. Femoral-distal bypass with in situ greater saphenous vein. Surg Clin North Am 1995. McGee GS. or the coronary circulation. Dulawa LB. Ann Surg 1993. 108). Andros G. Callis JT. include patients in the grade I (severe claudication) grade II (rest pain). and effective treatment of both segments may be necessary to alleviate signs and symptoms. allowing for technically successful percutaneous recanalization of virtually all short lesions.Harris RW. Mulherin JL. Haward TR. Yao JST.66. Andros G. The role of graft material in femorotibial bypass grafts. Cormier F.200:785-792. The categorical indications for endovascular treatment. 72. Totally autogenous venovenous composite bypass grafts. and grade III (tissue loss) of the Rutherford classification. Apyan R. Coe D. Revascularization of femoropoliteal arteries using saphenous vein. Ahn SS. DeMasi RJ. soft-tipped guidewires. Harris RW. Panayiotopoulos YP. Mannick JA. and statistical analysis has not been optimal. the effectiveness of transluminal angioplasty of the femoropopliteal arteries and the tibioperoneal arteries should be considered together rather than separately. Am J Surg 1993. Moore WS. Arterial reconstruction of vessels in the foot and ankle. Taylor PR. Fichelle JM. Wang R.213:457-465. Cranley JJ. appropriate selection of anatomically suitable lesions remains the key to achieving acceptable results in patients with infrainguinal occlusive disease and chronic limb-threatening ischemia (see Recommendation 34. J Vasc Surg 1992. the contralateral limb. 12 and still others from describing early experiences that antedate the latest developments in low-profile balloon catheters and steerable. Porter JM. Basic data related to Infrainguinal revascularization procedures. Ann Vasc Surg 1995. Factors Affecting the Outcome of Femoropopliteal Angioplasty Percutaneous transluminal angioplasty has been applied to the superficial femoral and popliteal artery seg- ments for almost 35 years. Dalman RL.2 3 Furthermore.

virtually all short femoropopliteal artery stenoses and occlusions can be percutaneously recanalized. Importantly. if all other factors are equal (ie.29 Patient factors Patient factors widely believed to adversely influence femoropopliteal artery PTA success are the presence of diabetes mellitus and presentation for PTA with CLI rather than claudication. Patients with two. it generally exhibits the same expected patency as that of a stenosis of equivalent length.1921 28 30 However. it is likely that the effects of diabetes and CLI are statistically confounded by run-off status and the extent of occlusive disease.15 16 Post-angioplasty residual stenosis predicts limited durability.15 16 23 24 This means that occlusion is a confounding variable that lowers the initial technical success but that has no other established impact on long-term patency. and 32% and 27%. respectively. relative to stenoses.25-27 Runoff status One of the most powerful predictors of long-term success that has great relevance in patients with chronic CLI is the status of the runoff circulation. because of a combination of vas- 243 . approximately up to 90% of lesions up to 10 cm in length can be successfully traversed and dilated8 22 and even a higher percentage success rate with longer lesions has been achieved. for occlusion and good runoff.to one-vessel run-off at 2 to 3 years (71% to 78% vs 25% to 37%.15 21 Stenosis versus occlusion This variable was previously considered to be one of the most important determinants of both technical suc- cess and durability of femoropopliteal PTA.to three-vessel run-off have as much as two to three times greater femoropoliteal PTA patency than those with 0. respectively)1721 and at 5 years (36% to 53% vs 16% to 31%. long lesion length is considered one of the factors detracting from both technical success and durability of femoropopliteal PTA. usually result from failure to cross the lesion with a guidewire and occur almost exclusively in cases of occlusion. for stenosis and poor run-off. and whether duplex ultrasonography is a modality useful for making this determination is controversial. analysis of subsets from these studies allows the clinical effectiveness of the method to be estimated in patients with chronic CLI.31 Diabetic patients in whom continuous run-off can be restored by tibioperoneal PTA also fare well.32 It is also likely that patients with end-stage renal disease fare worse than the angioplasty population as a whole. 49% and 43%. Still. Technical failures.5 18-20 PTA of lesions longer than 7 to 10 cm offers limited potency.Claudication versus chronic critical limb ischemia Despite the grouping of claudication and limb salvage patients in most femoropopliteal PTA series. respectively. Still. most symptomatic patients with femoropopliteal disease presenting for angiography have occlusions rather than stenoses. 16 18 whereas those 3cm in length or smaller fare well with PTA. Dia- betic patients with good run-off fare better than those with poor run-off after femoropopliteal PTA. once an occlusion is crossed with a guidewire and successfully dilated.18 Nevertheless.28 A retrospective analysis of the literature with attention to run-off status indicated 3. 53% and 48%.and 5-year patency results of 67% and 62%. Other target lesion morphological determinants Concentric lesions respond better than eccentric lesions to PTA initially.15-18 Although recent analyses often include a preponderance of patients with longer lesions. for occlusion and poor run-off. respectively. respectively. However. the life-table curves are parallel). and heavy lesion calcification appears to exert a negative effect on success. for femoropopliteal stenosis and good run-off. though uncommon. respectively). there is a difference in technical success that lowers the starting point of the life-table patency curve for occlu- sions. Lesion length Currently.

77% vs. 109) (see “Femoropopliteal PTA”. these patients have been inadequately stratified in the PTA lit- erature and may constitute up to 8% to 10% of the limb salvage population in some institutions.21 found that stenoses smaller than 1 cm fared significantly better than lesions larger than 1 cm at 5 years (pri- mary patency. 37% vs 71% at 2 years). Nevertheless.cular anatomic factors and local metabolic factors. Unfortunately. Jeans et al. at 6 months. For patients with CLI. it is likely that some nonsignifi- cant differences were due to small sample size. Table 24. Capek et al. and although technical success is high. p < 0. 10 of 17 short occlusions or stenoses were patent (59%).44 In comparing 0.15 stratified results on durability and found that stenoses smaller than 2 cm fared better at 5 years than stenoses longer than 2 cm (primary patency. occlusions with poor runoff showed a 25% patency rate.007. whereas only 1 of 23 long lesions were patent (4%).16 Murray et al. Femoropopliteal Angioplasty Results The results of several large studies are summarized in Table XXI.44 defined lesions with a 5-cm cut- off. by analyzing subsets of patients described in these studies and others.28 36-43 There is no body of published data on the use of laser-assisted PTA and rotoblator atherectomy in infrapopliteal lesions. p=0.17 Currie et al.32 Laser-assisted angioplasty and rotablator atherectomy of crural arteries does not improve the technical and clinical results as compared with PTA alone. 54%). Endovascular Procedures for Intermittent Claudication (p.21 Durability of femoropopliteal PTA in a subgroup of 37 patients with stenoses and two.015).06). there was a 22% technical failure rate in this series. They are presented in the intermittent claudication section because this indication dominates the data (72% of subjects in the studies cited were patients with intermittent claudication). p. Restenosis rates appear to be higher 244 .to 5-cm lesions with those larger than 10 cm. 111). Capek et al. because infrain- guinal angioplasty depends heavily on patient selection factors. 107.to 10-cm lesions (p=0. to a lesser extent.to three-vessel runoff (primary patency.10.05). Reported mean steno- sis rates are 30% at 1 year (range. it is likely that only a minority—perhaps 5% to 35%—are candidates for PTA if selected for favorable anatomy.to 2-cm lesions were compared with 2. its efficacy is highly dependent on anatomic selection and.to three-vessel run-off was 78% at 3 years (SE±9.4%). p=0. one can estimate the clinical effectiveness of infrainguinal PTA performed in patients with chronic CLI.16 found highly sig- nificant differences in success (p=0. 111) shows the results from selected studies by lesion length cut-off point. versus only 50% in occlusions larger than 3 cm15 Gallino et al. 50%. whereas 1-year patency rates with occlusions smaller than 3 cm was 93%. Krepel et al. restenosis rates are considerable. There were also strong statistical trends when 0. p. Table XXII (p.17 found that patients with occlusions larger than 3 cm and poor distal run-off had elevated reocclusion rates compared with those who had focal stenoses or occlusions smaller than 3 cm and two. 76% vs. 113).to 5-cm and 5. were unable to utilize Cox multivariate regression because of sample size so they were unable to simultaneously analyze any run-off effect on these stratified groups. patient selection. found that only 23% of long femoropopliteal artery PTA were patent at 6 months. Adjunctive use of stents in femoropopliteal lesions The preponderance of patients in published series of femoropopliteal stents have been patients with intermit- tent claudication. “Femoropopliteal Stents”. by contrast. although some have attempted to place a single value or range of values on the results of femoropopliteal PTA.2 10 33-35 PTA of proximal popliteocrural obstructions to improve flow to collateral vessels in the absence of straight-line flow to the foot will not help patients. and the authors did not assess the effect of run-off on patency. 28% to 82%) (see Table 23. dividing his patients at 7 cm.to 2-cm and 2. 111. p. This series does not stratify durability by clinical indication. 19% to 53%) and 40% at 3 years (range.3 Summary of factors affecting the outcome of femoropopliteal angioplasty Thus.18 Because power estimates were not given. Again these results are presented in the intermittent claudication section because this indication dominates the data. These listed results must be viewed with caution. p.

32 Five-year survival in patients with limb salvage indica- tions for surgical or percutaneous intervention is only approximately 50%.2 The procedure-related mortality is lower with PTA than with bypass surgery.47 48 Because limb salvage indications are associated with poor run-off and more diffuse disease.3 53 Cardiovascular comorbidity The median age of patients undergoing tibial angioplasty in published series is approximately 69 years. However. elastic recoil. (Repeated from p. chronic renal insufficiency. but it has not been accounted for in published angioplasty series.63 A number of published reports have shown increased durability of femoropopliteal PTA in patients with good distal run-off. with good run-off distally. and surgery is the procedure of choice for type D lesions. and they would be expected to fare worse than the aggregate published stent population.45 46 Poor outflow and long occlusions appear to increase the frequency of stent thrombosis. Although most of these patients present with three-vessel calf occlusive disease. and history of TIA or stroke are common. The presence of end-stage renal disease (ESRD) probably has a negative prognostic effect on the durability of tibial and femoropopliteal PTA. or thrombosis. These high-risk patients almost always have associated cardiac or cerebrovascular disease: hypertension. anatomy favorable for tibial PTA. Only approximately 20% to 30% of patients with tibial disease have anatomy favorable for PTA. Some reported series have comprised a significant proportion of claudicators. 245 .3 10 Severe three-vessel disease is nearly universal in limb salvage patients. Infrapopliteal Angioplasty Clinical class The universally accepted indication for infrapopliteal artery PTA is limb salvage.in distal femoropopliteal segments or when lesions require multiple stents.200 patients are reported in the literature. 49-51 There is little published evidence regarding the efficacy of tibial artery stents. thus. some authors have recommended tibial angio- plasty as an adjunct to femoropopliteal PTA performed for either claudication or limb salvage when calf run-off is poor. there is accumulating evidence that stents can play an impor- tant role in rescuing failed femoropopliteal PTA attributable to PTA-induced dissection. Patients with end-stage renal disease (who are often diabetic) appear to be the most difficult group to treat because they have very diffuse disease with more involvement of the distal and pedal vessels. 108) RECOMMENDATION 35: Treatment of choice for TASC type A and D femoropopliteal lesions Endovascular procedure is the treatment of choice for type A lesions. femoropopliteal stents probably do worse in CLI patients than in intermittent claudication. there is usually reconstitution of at least one pedal artery. mortality is usually attributable to coro- nary artery disease or stroke. Stenoses appear to have a better technical success rate than occlusions. More than 1.4 Diabetes and end-stage renal disease Diabetes is present in 63% to 91% of patients undergoing tibial angioplasty for limb salvage indications. and because there is heavier arterial calcification.52 Lesion length and run-off status The ideal tibial lesion is focal.4 52 64 Infrapopliteal PTA can be used to salvage failing distal bypass grafts by restoring tibial artery outflow.

in rare cases.. 199359 14 100 38 100 85 (8 mo) Durham et al. 199465 24 71 43 86* NA Wagner et al. if present. 19946 41 53 13 96 NA Varty et al. Crural disease in patients with long-standing diabetes may.... 199552 40 50 45 98 77 (12 mo) Horvath et al.. Restoration of straight-line flow to the pedal arch by PTA in one or more tibial arteries is necessary for clinical success. 199066 151 53 46 90 NA Sivanathan et al. Results of endovascular treatment of infrapopliteal lesions Recent published technical success rates of infrapopliteal artery PTA using small vessel balloons have been excellent. more diffuse disease in patients with poor surgical options had a 1-year primary patency as low as 15%. CLI Diabetes Technical % Limb salvage Author Limbs (%) (%) success (%) (follow-up period) Schwarten & Cutcliff. A small subset of these patients may be suitable for PTA. be the sole determinant of CLI. 199264 168 76 52 100 85 (24 mo) Bolia et al.... confirming the need for careful anatomic selection. 198437 46 67 NA 76 NA Dorros et al.. 199460 14 100 100 100 77 (17 mo) Brown et al. For example. between 86% and 100%.32 In a later group of patients at the same institution. 198861 11 100= 91 82 73 (8 mo) Bakal et al.32 63 64 This finding has since been corroborated by others.. thus. 19937 158 68 46 95 88 (17 mo) Starck et al.—Results of PTA in infrapopliteal lesions (from a review by Wagner & Rager 55). Bakal et al. A concomitant procedure. Only technical success and limb salvage figures are given.52 In recent years. usually femoropopliteal artery PTA.. 199762 87 93 64 92 71 (12 mo) Brown et al.32 found an 80% limb salvage rate in patients with “straight line flow” to the foot in at least one tibial vessel after PTA. infrainguinal PTA performed for long-seg- ment.. 198810 114 100 60 97 86 (24 mo) Löfberg et al. is usually seen in one or two vessels. 19904 71 42 35 96 NA *Subintimal angioplasty. Careful patient selec- tion is thus important for both technical and clinical success. is necessary in most patients undergoing tibial angioplasty because of the predominance of multilevel occlusive dis- ease. 199363 55 84 64 95 53 (24 mo) Bull et al. Appropriate post-PTA surveillance with secondary inter- vention appears to significantly prolong the patency of tibial PTA. despite the absence of aortoiliac or femoropopliteal disease. 19935 84 100 77 83 52 (24 mo) Hauser et al. Limb salvage has been reported to be between 60% and 86% at 2 years and appears to be depen- dent on anatomic factors. most fre- quently puncture site hematomas and vessel occlusions. Iatrogenic vascular occlusion usually responds to local thrombolysis. 199656 86 100 74 88 75 (24 mo) Matsi et al. the results of femoropopliteal PTA and tibial PTA are closely associated. several reports with sufficient long-term follow-up of PTA in infrapopliteal lesions have appeared in the literature (Table LI)... dilatation of a proxi- mal lesion when the distal artery is severely diseased will not yield lasting clinical benefit in limb salvage patients. 246 .TABLE LI. whereas limb salvage fell to 0% when distal outflow was obstructed.. 199032 57 98 85 78 NA Wagner & Klose. It is probable that the status of the pedal arch—never looked at in infrainguinal angioplasty studies—also affects the outcome of distal angioplasty.. 199657 47 100 93 80 77 (24 mo) Saab et al. 199258 14 100 69 100 79 (19 mo) Buckenham et al. because patency of one of three crural vessels is impossible to determine by ABPI or other indirect measurements. especially because prox- imal revascularization procedures may have been done concomitantly.. Major complications have been reported in 2% to 6% of cases.

10. van Erp WF. Circulation 1984. 26. Waslker PM. Arterial occlusive disease below the knee: treatment with percutaneous transluminal angioplasty performed with low-profile catheters and steerable guide wires. 8. Capek P. Sprayregen S.81:1282-1285. Becker GJ. 16. Mitchell SE. Gupta SK. Johnston KW.177:559-564. Yucel EK. Andros G. 11. Radiology 1990. a consensus about its effectiveness can be obtained by critical analysis of the existing reports. Jones AM. Meyerovitz MF. and with appropriate patient selection. Hunink MG. 23. 14. Mahler F. Bakal CW. J Intervent Radiol 1993. Seabrook GR. The role of duplex scanning versus angiography in predicting outcome after balloon angioplasty in the femoropopliteal artery. J Vasc Surg 1993:17:183-194. Ann Surg 1987. Radiology 1996. Cynamon J. Risks and benefits of femoropopliteal percutaneous balloon PTA. 25. 162:473-476.6:159-163. Dormandy JA. 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Percutaneous transluminal angioplasty (PTA) of isolated crural arterial stenoses in critical arterial occlusive disease. Bertuch H. Marty A. Johnston KW. 40. Veith FJ. Rosenfield K. Killeen JD. Hagen B. Kohl C. Radiology 1982. Cardiovasc Intervent Radiol 1992. Vorwerk D. The Combined Rotablator Atherectomy Group (CRAG). Varty K. Klein GE. Wagner HJ. Horrocks M. Eur J Vasc Surg 1991. Decrinis M. Tylen U. Veith FJ. Goldsmith J. Parsons RE. et al. Strecker EP. Donaldson MC. Iliac and femoropoliteal occlusive disease treated with flexible tantalum stents.168:115-119. et al. Rager G. Med Decis Making 1994.5:517-522. Scott DJ. Summers TA. Radiology 1992. 50.

Hold M. In their 1995 study. Lewin RF. the potential covariates of lesion length and calf runoff were not analyzed. Subintimal and intraluminal recanalisation of occluded crural arteries by per- cutaneous ballon angioplasty. Denck H. Schoenberg NY. conduit type. 249 . Nevertheless. Mendel H. Percutaneous transluminal angioplasty of infrapopliteal vessels: prelim- inary results and technical considerations. Eur J Vasc Surg 1994. Below-the knee-angioplasty: tibioperoneal vessels.511 surgi- cal bypasses. Moore ED. Saddekni S. and the results were not stratified by pre- senting indication. Bull PG. 64. JVIR 1992. Bolia A. and distal anastomosis site (AK/BK). This group concluded that for femoropopliteal stenosis and CLI. (The authors noted that because there was a statistically significant association between poor runoff and CLI in an earlier paper. but for femoropopliteal occlusions and CLI. The pooled 5- year PTA patency results were calculated for subgroups by lesion type (stenosis vs occlusion) and indication (disabling claudication vs chronic critical limb ischemia). 62.) Stenting or other adjunctive techniques were not considered. Moore ED. the predomi- nant presenting symptom in this study was intermittent claudication.4:139-144. surgical bypass is preferable. 65. The following recommendations apply to the choice between endovascular and open surgical intervention for CLI. 66. Quality-adjusted life-years (QALY) were used as the main effectiveness measure.19:170-178. Brown KT. Thompson MM. Saddekni S. Getrajdman GI. Bell PR.1 2 performed key decision and cost-effectiveness studies on femoropopliteal disease. Furthermore. and the use of prosthetic conduit in many patients.3 found that for 100 femoropopliteal artery lesions. JVIR 1993.3:45-53.2 either model could be used.61. in part because of the inadequate data descriptors provided in the original reports. Cathet Cardiovasc Diagn 1990. data were included from 26 selected studies published after 1985. it did suggest that PTA and surgery do have comparable results for a minority subset selected for anatomic criteria suitable for PTA. Pertinent to the recommendation to attempt PTA first in anatomically favorable lesions. involving 4. high initial PTA technical failure rate. the acute outcome. Klose KJ. The mortality rate was 2. by using a range of values found in the literature and performing multiway sensitivity analyses. Radiology 1988. Jamnadas P. They basically identify categorical lev- els of increasing lesion severity in which the choice of intervention shifts progressively from endovascular to open surgical intervention.8 (Suppl):247 63. J Vasc Interv Radiol 1997. surgical bypass subgroups were based on indication. Infrainguinal Disease—Preferred Therapeutic Options Hunink et al. However. and the same system will be used for making recommendations.1 Notably. Dorros G. Infrapopliteal angioplasty: long-term follow up.8:214-219. Mathiak LM. Schlegl A. The same general considerations apply as were discussed in the overall strategy of the treatment of aortoiliac lesions. PTA should be the first treatment modality.169:75-78. this study has been criticized because of its high degree of selectivity. Sayers RD.800 PTA procedures and 4. Brown KT. Wilson et al. a failed PTA did not place the patient at higher risk for limb loss or sur- gical failure. Wagner HJ. Distal popliteal and tibioperoneal transluminal angioplasty: long-term fol- low-up. Infrapopliteal angioplasty for limb-salvage: a 4-year experience.4% in the surgical group and 0% in the PTA group.

However.35 36 Studies comparing PTA with bypass surgery in femoropopliteal lesions 4-10 cm long do not exist. not involving the distal popliteal artery Type C femoropopliteal lesions: 6.—Average results for surgical treatment. (Repeated from p. Fig. with or without heavy calcification TASC Type D femoropopliteal lesions: — Complete common femoral artery or superficial femoral artery occlusions or complete popliteal and proximal tri- furcation occlusions. not involving the distal popliteal artery* — Heavily calcified stenoses up to 3 cm in length — Multiple lesions. 25. Single stenoses or occlusion >10 cm long Reason for dissenting opinion: The lower long-term clinical success rate of long stenoses and occlusions in earlier studies was due to a low technical success rate. each 3-5 cm. *CIRSE agrees except for the following changes: Type B femoropopliteal lesions: 2. to be followed by higher patency rates. Single stenoses occlusions 3-10 cm long. each less than 3 cm (stenoses or occlusions) — Single or multiple lesions in the absence of continuous tibial runoff to improve inflow for distal surgical bypass TASC Type C femoropopliteal lesions: — Single stenosis or occlusion longer than 5 cm* — Multiple stenoses or occlusions. 108) RECOMMENDATION 34: Morphological stratification of femoropopliteal lesions TASC Type A iliac lesions: — Single stenosis <3 cm of the CIA or EIA (unilateral/bilateral) TASC Type B iliac lesions: — Single stenosis 3–10 cm in length. 250 . developments of catheters and wires have improved the technical success rate.

Tibial or peroneal occlusions longer than 2 cm. 3. Short tibial or peroneal stenosis in conjunction with femoropopliteal PTA. One or two focal stenoses. Diffusely diseased tibial or peroneal vessels. each less than 1 cm long. However. Extensive stenoses of the tibial trifurcation. 7. (Repeated from p. CIRSE believes that in clinical practice these lesions are more commonly treated by endovascular tech- niques. Reason for dissenting opinion: Due to technical developments. 101). Multiple focal stenoses of the tibial or peroneal vessel. at the tibial trifurcation. type C lesions of iliac and femoral arteries can be treated by endovascular means with a reasonable technical success rate (for references. 112) RECOMMENDATION 36: Femoropopliteal stenting in PAD Femoropopliteal stenting as a primary approach to the interventional treatment of intermittent claudication or CLI is not indicated. each less than 1 cm in length. TASC Type B infrapopliteal lesions: 2. TASC Type D infrapopliteal lesions: 8. see p. 108) RECOMMENDATION 35: Treatment of choice for TASC type A and D femoropopliteal lesions Endovascular procedure is the treatment of choice for type A lesions. 102) CRITICAL ISSUE 10: Treatment of TASC type B and C lesions More evidence is needed to make any firm recommendations about the best treatment for types B and C lesions. TASC Type C infrapopliteal lesions: 5. stents may have a limited role in salvage of acute PTA failures or complica- tions. and surgery is the procedure of choice for type D lesions. 251 . 4. (Repeated from p. Occlusions 1-2 cm in length of the tibial or peroneal vessels. although scientific evidence of any superiority over vascular surgery is lacking.* *CIRSE dissenting opinion: Currently endovascular treatment is more commonly used for type B and C lesions. 6. Single stenoses shorter than 1 cm in the tibial or peroneal vessels. There- fore. Stenoses 1-4 cm in length. RECOMMENDATION 93: Morphological stratification of infrapopliteal lesions TASC Type A infrapopliteal lesions: 1. but more evidence is needed to make any firm recommendations about best treatment. 9. (Repeated from p.

6 7 The same principles of sterile techniques must apply to endovascular procedures with stent implantation. References 1. the need for and effectiveness of antibiotic prophylaxis with other endovas- cular techniques is unknown. Covered stents should be treated as prosthetic grafts in terms of use of prophylactic antibiotics. Spinal or epidural anesthesia has no direct effect on the myocardium but may increase myocardial oxygen consumption because they may be associated with hyper- tension and bradycardia resulting from sympathetic blockade. often weigh- ing risks to life and limb against each other in an attempt to save both. Hunink MG. large doses of narcotics may be necessary to avoid hypertension during intraabdominal procedures. between open surgery and an endovascular procedure. 276). All inhalation anesthetics are myocardial depressants. Prospective studies that have compared general and epidural anesthesia have found no advantage to either technique in reducing perioperative cardiac complica- tions in patients undergoing aortic surgery or infrainguinal procedures. The assessment of chances of success in an individual case would be better based on the audited results obtained in the relevant institution rather than published results from other centers (see p. The choice of intervention. Patency results of percutaneous and surgical revas- cularizations for femoropopliteal arterial disease. Meyerovitz MF. However. Cross AP. General Issues Relating to Surgical TreatmentAnesthesia Either general or regional anesthesia may be used for lower-extremity bypass grafts.9:1-9. Some centers advocate the use of a combination of both techniques for aortic surgery for optimal patient comfort and minimal respiratory depression.2 3 Systemic anticoagulation is not a con- traindication for epidural anesthesia if begun after catheter placement. can be difficult. and its perioperative use is now well accepted. However. Accurately pre- dicting the result of a particular revascularization in an individual is difficult based on available literature. Wong JB. J Vasc Surg 1989. It is important to develop guidelines regarding the likelihood of success below which a reconstruction should not attempted. Revascularization for femoropopliteal dis- ease: a decision and cost-effectiveness analysis. and amputation has the same risk. Meyerovitz MF. de Vries J. Harrington DP. This emphasizes the importance of a meticulous sterile technique with avoidance of skin contact by the use of adherent plastic drapes. but patients with CLI have complex lesions not suitable for endovascular treatment. evidence that the same principles should apply to stents. JAMA 1995.1 The choice and conduct of the anesthetic technique is more important in the transabdominal aortoiliac recon- structions.5 6 There is evidence that antibiotic prophylaxis should continue until drains and invasive monitoring lines are removed. Donaldson MC.8-11 252 . and as a consequence may produce ventilatory depression. Harrington DP. Several randomized studies have now demonstrated the efficacy of antibiotic prophylaxis in reducing the incidence of vascular graft infection.4 Antibiotic Prophylaxis for Vascular Procedures It is generally believed that graft contamination occurs most commonly at the time of the original operation. 3. Donaldson MC.14:71-81.274:165-171. 2. There are risks to limb and life involved in any attempted revascularization procedure. intravenous narcotic analgesics such as fentanyl are often used as an alternative to inhalation anesthetics because they produce minimal myocardial depression. However. particularly in some difficult surgical bypasses. Hunink MG. Wolf GL. operation for peripheral arteriosclerosis: report of a prospective randomized trial in a selected group of patients. There have been reports of increased distal graft patency when epidural/spinal anesthesia are used. Wong JB. Wilson SE. the results of a recent randomized control trial failed to show any effect of the type of anesthesia on the 30-day patency rate of infrainguinal bypass grafts. although it is uncertain how long a delay is necessary after catheter placement before anticoagulation can be instituted. Percutaneous transluminal angioplasty vs. Med Decis Making 1994.

This may involve the switch from oral agents to insulin in some patients. Although urgent thrombectomy may be required for immediate limb threat. alternative means of restoring graft function that also provides the oppor- tunity to unmask stenotic lesions responsible for the occlusive event and to clear the run-off vessels. four major trials have failed to show an overall advantage for thrombolysis on an intent-to-treat basis. with the latter giving best results. thrombolysis holds the advantages in terms of mortality and amputation for less than 14 days’ occlusion. 162). respectively. Perioperative Care of the Diabetic Patient Ideally. Open surgical procedures have been the traditional approach for bypass graft occlusion. RECOMMENDATION 94: Use of prophylactic antibiotics with prosthetic grafts Patients undergoing prosthetic grafts should have prophylactic antibiotic therapy perioperatively. Such patients can be hemo- dynamically unstable during anesthesia because of dehydration and osmotic shifts. Graft surveillance is necessary to detect a failing graft at this preocclusive stage. 269). and may have increased free fatty acids. Graft stenoses can be managed by either interposition or jump graft segmental bypass or patch angioplasty. depending on the length of the lesion. and revision or replacement of the existing graft. the choice depending on the characteristics of the lesion (eg. CRITICAL ISSUE 36: Duration of prophylactic antibiotics with prosthetic grafts There is a need for more data to determine how long antibiotic prophylaxis is required when prosthetic grafts are implanted. The most appropriate treatment for a valve cusp stenosis is operative patching or resec- 253 . that is. Treatment of Graft Thrombosis: The Failed Graft The choice between thrombolysis and thrombectomy for graft occlusion is complicated by the fact that these tend to be linked with PTA and surgical revascularization. and surgical reconstruction is preferred in delayed occlusions (>14 days’ duration). directing procedures at thrombectomy. because investigations such as angiography may lead to deterioration.14-17 However. neointimal hyperplasia or diffuse or local athero- sclerotic involvement).21 22 The unmasked lesion is then addressed with an endovascular or operative approach after successful thrombolysis. The details are dealt with in “Surveillance after Revascularization” (see p. Grafts may fail on the basis of intrinsic graft pathology or pathology in the inflow or outflow segments. The control of sepsis in the diabetic foot may help control hyperglycemia and ketoacidosis. have decreased wound healing. such patients are more prone to infection. As a result of this and also of a significant technical failure rate. in trials. but current opinion favors segmental bypass or patch angioplasty rather than percutaneous balloon angioplasty for most lesions. its obvious potential advantages (stated previously) and the relative ease of the procedure probably can be achieved only by selective application.12 13 Treatment of the Failing Graft The concept of the “failing graft” has been emphasized by several series documenting improved results when intervention is directed at the time when the graft is still patent.18-20 Thrombolysis has been advocated as a less invasive.14 17 This complex subject is dealt with in more detail in “Contraindications to Thrombolysis” (see p. The rationale for striving to achieve near- normal glucose has been established. Particular attention to the renal function is needed in patients with diabetes. Inflow and outflow lesions should be managed according to the principles outlined elsewhere in this document. Furthermore. Debate continues. but other factors must be considered in patients with diabetes who must undergo surgery with less than optimal control of metabolism in an acute situation. blood sugar should be normalized in the diabetic patient before surgical intervention. failing rather than failed. the metab- olism of which increases myocardial oxygen consumption.

23). Perioperative mortality rates are well under 3% in many centers. Thrombolysis may be considered as a treatment option in patients who present early after their bypass graft occlusion where the limb is not immediately threatened. For instance. good success rates have been achieved with the use of alternative vein sources. then graft replacement of this disadvantaged conduit is indicated. Deep vein thrombosis A randomized prospective trial of deep venous thrombosis (DVT) prophylaxis in aortic surgery failed to show any increased incidence after aortic surgery in the control group compared with the prophylaxis group. extensive arterial disease. Acute complications. there may be a need to extend the bypass graft. General Complications of Surgical Intervention Cardiac mortality and morbidity The most common source of morbidity and mortality after revascularization for PAD is myocardial ischemia.27 All patients in this study had received DVT prophylaxis. the para- meters that are important in determining appropriate therapy include the severity of the patients’ symptoms. The results for open repair are believed to be superior to dilatation and yield excellent secondary patency rates. Therefore. Complications of Aortoiliac Reconstruction Currently.24 RECOMMENDATION 95: Treatment of chronic critical leg ischemia due to bypass graft occlusion In patients with chronic critical leg ischemia. the duration of the occlusion.28 29 Though somewhat dated. In addition to the characteristics of the underlying lesion. surgical revision or graft replacement is the preferred treatment for bypass graft occlusion. although pharmacotherapy to avoid arterial thrombosis after revascularization also frequently reduces the risk of DVT. this risk cannot be neglected entirely. Patients with CLI. long-term survival of these patients continues to be compro- mised.tion and reconstruction. and the nature of occluded conduit (autogenous or prosthetic). Whatever method is used. The cumulative long-term survival is 40% to 50% at 10 years.8% in patients undergoing either aortic or distal revascularization (with the highest incidence following amputation).26 A second study reported a DVT incidence of 9. or diabetes have a less favorable long-term prognosis than patients with localized disease and claudication. Although operative mortality is decreasing steadily. excellent early and late results of direct aortoiliofemoral reconstructions for occlusive disease can be anticipated. limb ischemia Acute limb ischemia occurring shortly after aortic operation for occlusive disease is generally attributable to acute thrombosis of the graft or one of its limbs and occurs in 1% to 3% of patients. in patients with occluded lower-limb grafts who present with sudden-onset claudication. Most late deaths are also attributed to atherosclerotic heart disease. Other specific complications are outlined in the following paragraphs.23 If the distal anastomosis is involved or should there be progression of disease. The main causes are twist- 254 . a list of complications of aortoiliac reconstruction other than graft failure are summarized in Table LII. the clinician will need to consider the original indications for the graft and possible future surgical options if no attempt is made to rescue the graft. and patency rates of close to 85% at 5 years and 75% at 10 years are expected.23 If an established bypass graft fails less than 6 months after construc- tion. The treatment strategy for bypass graft occlusion must be tailored to the clinical setting and the risks and ben- efits associated with the therapeutic options.25 (see “Fate of Patients With CLI”. p.

45 46 0. These anastomotic aortic aneurysms are more common after lateral anastomosis than after end-to-end anastomosis. kinking of the graft limb.56 The true incidence of proximal aortic anastomotic aneurysm may be higher than previously thought after aor- tic surgery for PAD.3 Usually myocardial Intestinal ischemia39 1. lack of reperitonealization. aortic false aneurysms Lymph fistula49 1. Intestinal ischemia Intestinal ischemia is more likely after aortic surgery for aneurysmal disease than after that for PAD but may occur after the latter. of mostly asymptomatic anastomotic aneurysms. a study by Edwards et al. Erectile impotence The incidence of iatrogenic erectile impotence after aortic reconstruction may approach 25%.. Complication Incidence (%) Etiology/Comments Myocardial Infarction30 31 0.8–5. Infection may be a contributing cause and always needs to be considered as a possible causative factor.25 Atheroemboli.—Complication of aorto-iliac bypass grafts.57 reported a 10% incidence. impo- tence implies inadequate preservation of the hypogastric artery and pelvic circulation. or technical problems at the distal femoral anastomosis site. prosthetic suture material may fracture. at a mean interval of 12 years after initial revascularization.55 Previously these were related to the use of silk sutures and. that is.5–3. This suggests that CT scans should be a routine part of the late follow-up of patients with an aortic graft. As described by De Palma et al.3 Higher incidence involving groin anastomosis Aortoenteric fistula 47 48 0. beginning at 3 years postintervention. A large or meandering inferior mesenteric artery (IMA) with upward flow warns of concomi- tant celiac or superior mesenteric artery (SMA) disease deserving attention and mandates IMA preservation.6 Frequent association with graft complication Spinal cord ischemia.5 Division of lymphatics False aneurysm47 48 50-52 3–5 Infection. and preservation of the hypogastric artery flow by a variety of techniques is also essential.5 Erosion. occlusion vascular supply Graft infection41 47 48 0. preservation of hypogastric internal iliac artery outflow is the key to avoiding intestinal ischemia. native artery degeneration Altered sexual function53 20 ing.2 Concurrent cardiac disease Death32-38 0–3.1 Ligation IMA—colonic Preexisting SMA disease Renal failure40-43 0 –4.1–1. 255 . all related to technique and all preventable. Retrograde ejaculation is also a frequent occurrence and is attributable to disturbance of autonomic nerve fibers that course along the left wall of the aorta and cross the common iliac arteries. Oth- erwise. this may dictate the choice between proximal end-to-side and end-to-end anastomosis.TABLE LII. Most often. Degenerative changes within the host arterial wall leading to weakness and dehiscence of the intact suture line appear to be the most common cause.54 a nerve-sparing approach to the infrarenal aorta is helpful. Anastomotic false aneurysms The incidence of anastomotic false aneurysm formation after aortoiliac reconstruction varies from 1% to 5% and is by far most common at the femoral anastomosis. rarely.1–0. or paraplegia (see next paragraph).39 As discussed earlier. Acute limb ischemia also can occur as a result of intraoperative thromboembolic events. impo- tence.6 Preexisting renal dysfunction increases risk Ureteral injury44 1.

and this technique is not practiced widely.60 Autogenous vein grafts provide an alternative to prosthetic material for in situ reconstruction.67 256 . Staphylococcus. and streptococcus species. because of its sig- nificant mortality and morbidity. However. whether graft infection is likely. Graft conservation with local debridement of infected tissue followed by local irrigation with antibiotics has been advocated by some authors. many authors believe that most graft infections involve the whole length of the prosthesis. the likelihood of infection must be balanced against the general condition of the patient. aortofemoral graft infection The incidence of graft infection is between 1% and 5% after aortic surgery.64 Cryopreserved homografts to reconstruct the aortoiliac anatomy have recently been advocated for replacement of infected aortic prosthetic grafts.Aortoiliac. recently good experiences have been reported with the use of the superficial femoral vein for this purpose. Graft excision has been recommended by most authors. It may be difficult to prove unequiv- ocally that a graft is infected.58 However. Computed tomography scanning and magnetic resonance imaging are very helpful in demonstrating fluid collections around a suspect aortic graft. it is reserved for situations in which life or limb loss would probably result without revascularization. Treatment of aortic graft infection is challenging.63-66 Some experience has been achieved using in situ allograft replacement. and. The organisms most commonly isolated from blood or from wounds are Pseudomonas. Despite this. whenever possible. Concern regarding long-term dilatation remain. Once this has been deter- mined. Labeled white cell scans also can be useful if per- formed more than 4 weeks after surgery.65 When complete graft excision with extraanatomic reconstruction using bilateral axillounifemoral bypasses is not feasible because of extensive groin/thigh sepsis or previous extraanatomic bypass failure.62 63 The consequences of harvesting this vein have been surprisingly mild. A number of recent reports have advocated direct in situ replacement with a rifampin-soaked Dacron or PTFE graft. the patient’s condition needs to be optimized before surgery. Placement of a graft in a site that is potentially infected might result in higher risk of future reinfection. and the necessity for immediate intervention. This decision should be made carefully. and which infecting organisms are involved. However. these selected excep- tions to the generally accepted policy of complete graft excision and extraanatomic bypass primarily involve late indolent infections with Staphylococcus epidermidis with little associated systemic sepsis. in situ reconstruc- tion using (superficial femoral or popliteal) veins may be the only remaining option. the extent of revi- sion surgery. even though presentation or imaging may suggest a local sepsis. because size mismatch is less of a prob- lem. but sufficient vein is difficult to obtain. all efforts should be made to determine whether a perigraft collection is present. although they seem resistant to reinfection.59 After excision. extensive retroperitoneal debridement must be done.61 However.

74. the cause was intrinsic to the graft or anastomosis.—Complications of infrainguinal bypass. The overall early graft occlusion rate can be reduced by good technique. Complication Incidence (%) Etiology/comments Death68. A randomized trial reported the benefit of Dextran 40 in preventing early graft thrombosis of “difficult” distal bypasses.56 — HUV71 1.69 1. failed to confirm this difference in wound complications seen in situ (15%) and reversed vein (17%) graft reconstructions. however.75 10–30 — Prosthetic71 18 — Exposure/blowout69 9. missed valve cusp. Doppler assessment) but occasionally become apparent after the operation.9% (0% in vein grafts) in the Dextran 40 group. Arteriovenous fistulae may be treated by ligation or embolization under local anes- thetic.TABLE LIII. 263. p.48 Leg edema72 50–100 Resolution usually by 4 months Lymph leak49.78 Early graft thrombo- sis is usually attributed to technical error. A continuous incision was also associated with higher rates of wound complications.84 1.3%). hypercoagulable state. A retrospective comparative study showed that the in situ technique was associated with a higher rate of wound complications than nonreversed or reversed subcutaneously placed long saphenous vein grafts (23% vs. and adjuvant therapy (see “Adjuvant Therapy After Revascularization” p.36 — PTFE/Dacron71 3. anastomotic error). with most problems occurring in the distal wound or the mid thigh. LIII) Wound complications The in situ technique has a recorded wound complication rate of 10% to 30%. Leg swelling Leg swelling after revascularization is an accepted complication of any infrainguinal bypass. twist.5–1.69 Arteriovenous fistula These are avoided by on table graft assessment (angiogram.6 Infection: — Vein71 1. 257 .8 Lower with femoral distal than with aortofemoral Acute limb ischemia 1–2 Complications of Infrainguinal Vein Bypass Grafting (Tab. The origin of the swelling has been investigated and found to be related to the lymphatic disruption and interruption in the groin along the path of vein harvest and increased lymph production during postoperative reactive hyperemia.74 75 Meticulous dissection without creation of flaps and tension-free closure are emphasized to reduce this complication. 9. 269). “Surveillance after Revascularization”.9–3. or periods of hypotension or hypoperfusion.76 77 Early graft occlusion Early failure rates have been reported to be as high as 17% for grafts to the popliteal artery and 24% for grafts to more distal arteries and is related to technical failure (eg.78-81 In 63% of the graft failures in one study. intraoperative monitoring of the com- pleted bypass.5% in the control group and 6.70 A prospective randomized trial.73 0.3–6 Usually cardiac Myocardial infarction68. 82 The 1-week occlusion rate was 20.5/1.4 Wound: — Vein69.

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J Vasc Surg 1993. J Cardiovasc Surg 1988. Hannon RJ. van den Akker PJ. Stewart MT. 57. Aortic prosthetic infection: 50 patients treated by radical or local surgery.6(1):53-61. Criado E. 69. Brewster DC. Davidson J. Intestinal ischemia complicating abdom- inal aortic surgery. Levine SB. Clagett GP.11:629-634. Gupta SK. Edmiston CE. Surg Gynecol Obstet 1981. J Vasc Surg 1999. Teefey SA. Ann Surg 1983.20:88-95. Aortic reconstruction vs. Direct surgery on the aorto-iliac area: prosthe- ses-endarterectomy? Int Surg 1988. Kieffer E. 56. Ernst CB. di Marzo L. Hajo van Bockel J. Perdue GD. Torsello G. 65. Hagino RT. 66. Paris E. Becquemin JP. Shepard AD. Terpstra JL. Shanik G. Jackson MR.19(1):43-55. 51. Pairolero PC. Wright DJ. Hagino RT.134:615-620. Doundoulakis N. Spier LN. Valentine RJ. Ruotolo C.11:193-206. 40. 37. J Vasc Surg 1990. Papaioannou K. Quick CR. Anastomotic aneurysms after vascular reconstruction: prob- lems of incidence. Jensen BV. Moore D. Franke S. Bunt TJ. Dall’Omo CA. Proximal anastomosis in aortobifemoral bypass: end-to-end or end-to-side? J Cardiovasc Surg 1990.12:272-281. Ischemic injury to the spinal cord or lumbosacral plexus after aorto-iliac reconstruction. Salam A. Cali RF. Reddy DJ. Ischemic damage to the spinal cord following end-to-side aortobifemoral bypass. et al.17:768-773. Wilczewski JM.31(1):77-80. J Vasc Surg 1992. Ligush J. Duchateau J. Diehl JT. Tyndall SH. 67. Complex aortofemoral prosthetic infections: the role of autogenous superficial femoropopliteal vein reconstruction. and treatment. Edwards JM. Plissonier D. 58. Cronenwett JL. Reddy DJ. 46. 44. Evans JR. Hageman JH.29:315-317. van Schilfgaarde R. In situ replacement of infected vascular prosthesis with rifampicin soaked vascular graft. Wells J. J Vasc Surg 1990. 61.121:1166-71. Eur J Vasc Endovasc Surg 1996. Beven EG. Kakish HB.33(6):664-678. Ameli FM.109:447-454. The superficial femoral vein as arterial substitute in infections of the aortoiliac region. J Vasc Surg 1993. Friedman SG. Arch Surg 1999. Vasallo DJ. Towne JB. Voit R. Aorto-femoral bypass and determinants of early success and late favourable outcome: experience with 1000 consecutive cases. Koskas F. 50. 54.83:654-658. Jungblut R. Valentine RJ. Ann Vasc Surg 1993. Franklin DP. Gordon LL. 35. Elliott JP. Mulherin JL Jr.197:714720. 36. Edwards WH. extra-antomic bypass and angioplasty: thoughts on an evolving protocol for selection Arch Surg 1986. etiology. Melliere D. Sandmann W. Ann Vasc Surg 1997. Morris GE. Cherry Kj. Lamuraglia GM. Moccio C. 53. Friend PJ. In situ allograft replacement of infected infrarenal aor- tic prosthetic grafts: results in forty-three patients. Autogenous aortoiliac/femoral reconstruction from superficial femoral-popliteal veins: feasility and durability. Groin lymphatic complications after arterial recon- struction. 42. Ernst CB. Surgery 1995. Stanson AW. Lymberiades D. Wengerter KR. 68. Aorto-iliac arteriosclerotic disease in young human adults. Haddad H. J Cardiovasc Surg 1992. The role of graft material in aortic reconstructive surgery. J Vasc Surg 1996. Smith RF.197:49-56.29(2):282-291. Besso SR. Ann Surg 1987. Aorto-femoral reconstruction and sexual function: a prospective study.162:131-136. Br J Surg 1996. Veith FJ. J Vasc Surg 1997. Gesto R. Venous morbidity after superficial femoral- popliteal vein harvest. Schellack J. Callow AD. 60. Fernandez Valderrama Fonseca JL.206:168-172. Zierler RE. Valentine RJ. Claggett CP. Krepel CJ. 49. Nevelsteen A. Le Blevec D. 39. Surgery 1975. Complications of abdominal aortic reconstruction. Beyens G.7:569-576. 52. False aneurysms following arterial reconstruction: collective review. Management and outcome of chronic atherosclerotic infrarenal aor- tic occlusion. Mansfield AO. Arch Surg 1978. Bandyk DF.117(1):7-10. Am J Surg 1991. Jackson MR. Strandness EL. 59. Femoral anastomotic aneurysms: a continuing chal- lenge. Gorecki JP. Suy R. Farrell E. Feldman S. Prombonas E. A prospective randomized comparison of Dacron and polyte- trafluoroethylene aortic bifurcation grafts. Long-term patency of the aortofemoral Dacron graft: a graft limb related study over a 25- years period. Zwolak RM. Cross SA. Taylor LM. Bahnini A. Schultz RD. J Vasc Surg 1987. Schneider JR. Femorofemoral versus aortobifemoral bypass: outcome and hemodynamic results. Kassab M. Long-term results of prosthetic and non- prosthetic reconstruction for obstructive aorto-iliac disease. Lazzaro RS. Carmichael SW. Keagy BA. 48. J Vasc Surg 1994. Moncure AC. Porter JM. Hagino RT. Nevelsteen A.11:406-412. Feldhaus RJ. Gloviczki P. Porto J.17:349-356.11:29-37.78:800-816. Suy R. Edwards JM.33.25:255-270. Farrington M. De Palma RG.73:213-217. Bower TC. Autogenous venous reconstruction in the treatment of aortobifemoral prosthetic infection. Szilagyi DE. Suy R. Brand R. Lazaro T. Hallet JW. Shepard AD. Eur J Vasc Surg 1990. Antibiotic irrigation and conservative surgery for major aortic graft infection. Present status of reversed vein bypass grafting: five year results of a modern series. 34. Tortolani AJ. Prospective randomized multi- 259 . J Cardiovasc Surg (Torino) 1991. Ureteral complications and aortoiliac recon- struction.4:247-251.24:394-405.113:958- 962. Abouzeid MA. 63. Eur J Vasc Surg 1992. Elliott JP.19:858-864.6:308-317. Modrall JG. Toomey BJ. Preservation of erectile function after aortoiliac reconstruction.152:357-363. Surgery 1991. 62. Elliot JP. J Vasc Surg 1994. Smith RB. Smith RF.15:344-350. J Vasc Surg 1994. Poulias GE. Darling RC. Labastie J. J Vasc Surg 1990. Wouters L. 41. Leapman S. Arterial homografts. 55. Satiani B. Anastomotic femoral pseudoaneurysm: an inves- tigation of occult infection as an etiologic factor. Lozano P. Seabrook GR. 38.32:174-180. Eur J Vasc Surg 1990. Wolfe JH. Gehrt A. 47. Bargmann KM. Ann Surg 1983. Reoperation for femoral anastomotic false aneurysm: a fifteen year experience. Goldsmith J. Intraabdominal paraanastomotic aneurysms after aortic bypass grafting. 64. et al. Schmitt DD. Kohler TR. Benckart D. Egeblad K. 43. Walsh DB. Hertzer NR. Cambria RP. Burnham SJ. Johnson G. Harris PL. Nevelsteen A.4(6):583-586. 45.

Wound complications after in situ bypass. Palmaz. et al. Donaldson MC. patency can be improved. Wengrovitz M. 78.5. whereas Capek et al. Bergentz SE. Yao JST. Porter JM. Qvarfordt P. For example. used surveillance and re- intervention as needed with 57% primary 6-month patency and 82% assisted primary 6-month patency.9 found that duplex ultrasound is sensitive in detecting restenosis and.10:316-322. primary and assisted primary patency rates approximate each other because re-intervention is attempted in a relatively small proportion of PTA patients. 74. Bergqvist D. 82. J Vasc Surg 1990. Marin ML. J Vasc Surg 1990. 79. Berstein JM. The self- 260 . 75.114:1416-1418. General Issues Relating to Endovascular Treatment Need for Surveillance As with surgical bypass grafts. 1986:311. 83. Distal wound complications following pedal bypass: analysis of risk factors. Veith FJ. Management of lymph fistula in the groin after arterial reconstruction. 70. In: Bergan JJ. Schwartz ME. Thorne J. Panetta TF. Schanzer H. The incidence of perioperative myocardial infarction in gen- eral vascular surgery. The use of composite grafts in femorocrural bypasses performed for limb salvage: a review of 108 consecutive cases and comparison with 57 in situ saphenous vein bypasses. Porter JM. eds. 71. Atnip RG.15:52-61. Orlando: Grune and Startton. 76. 77. Arch Surg 1972:105:883- 888. Immediate occlusion of in situ saphenous vein bypass grafts: a survey of 329 reconstructions. 81.12:257-263. Johnsen H. In Angiol 1988. Schubart PJ. Vroegindewij et al. et al. 72. Ann Vasc Surg 1995. Ross JP. McConnell DB. Brothers TE. Dardik H. et al. Ernst C. Jones DN.26:517-538. Harrington EB. Whittemore AD. J Vasc Surg 1991. J Vasc Surg 1988. Saether OD. In infrainguinal PTA. when repeat PTA is performed in a higher percentage of patients. Technical aspects and early results.13:189-199. Winter RP. J Vasc Surg 1992. Leg edema following femoraldistal bypass. J Vasc Surg 1992. Unsuspected preexisting saphenous vein dis- ease: an unrecognised cause of vein bypass failure. Robison JG.1:765-773. Haaverstad R. Myhre HO. The ideal stent and delivery system should have the following character- istics10-12 (see Table LIV). Snyder SO. Alback A. Eur J Surg 1998. 73. Taylor LM. J Vasc Surg 1997. Lymphatic drainage and the development of post-reconstruction leg edema is not influenced by the type of inguinal incision: a prospective randomized study in patients undergoing femoropopliteal bypass surgery Eur J Endovasc Surg 1995. Thiele BL. Heitjan DF. Rutherford RB. Lepantalo M. Gayle RG. Comparison of Available Stents Currently all intravascular stents in clinical use are permanent and metallic. The efficacy of dextran 40 in preventing early postoperative thrombosis following difficult lower extremity bypass. Reoperative Arterial Surgery. J Vasc Surg 1991.4 However.15(1):102-110. Although the ability of periprocedural duplex to predict ultimate PTA durability is controversial.6-8 duplex ultra- sound may be useful in an appropriate longitudinal postprocedure surveillance program. Gregory RT. Feinberg RL. Stents are generally stratified into balloon-expandable (eg. Ribbe E. Johnston KW. Neumyer MM. Rutherford RB. Mannick JA.1-4 For example. Gordon RE.4 repeated PTA on only 14% of failed or failing femoropoliteal PTA. Lindell TD. center comparison of in situ and reversed vein infrapopliteal bypasses. Elliott BM. along with clinical and other noninvasive follow-up. Strecker) and self-expandable. Wheeler JR. it could be very useful in augmenting the durability of femoropopliteal PTA. Harris et al. Gifford RR.7:802-807. Porter JM. Jones AM. Arch Surg 1979.3 reported a re-inter- vention rate of only 8%. Gallino et al. Wound complications of autogenous subcuta- neous infrainguinal arterial bypass surgery: predisposing factors and management. J Vasc Surg 1984. 80. Kwaan JHM. Yeager RA. Leg edema following femoropopliteal autogenous vein bypass. Conolly JE. Moneta GL. The availability of and approved indica- tions for specific stents vary by country. Baker JD. Causes of primary graft failure after in situ saphenous vein bypass grafting. it is likely that surveillance and repeat intervention would improve the assisted primary patency of PTA. Stent designs and technologies used for managing peripheral vascular disease are continually evolving. Lakin PC.7:2-6. Karmody AM. Jones DN: Recommended standards for reports deal- ing with lower extremity ischemia: Revised version.164(10):745-750.11:156-63. Ahn S. Distal bypass with the saphenous vein in situ.9:53-59. 84. Porter JM.15:113-120. in a series of PTA performed by surgeons. Goldsmith J.

in “Factors Affecting the Outcome of Femoropopliteal Angioplasty” (see p. Nitinol stents). Currently thermal stents are constructed of Nitinol (nickel-titanium alloy). including the relative incidence of complications such as hemorrhage and distal embolization. as an adjunct to PTA for treating occlusive flaps or eccentric calcified plaque. This choice of a particular stent type tends to be most related to anatomy and ease of placement (eg. or dissection flap Be thromboresistant Resist restenosis Resist compression. such as poten- tial for development of new intimal hyperplasia. and self-expandable spring and balloon-expand- able stents are generally constructed from stainless steel.—Ideal characteristics of stents and delivery systems Characteristics Allow for efficiency in and ease of deployment Use percutaneous technique — have a low-profile delivery system — have a high expansion ratio Be available in a wide range of diameters and lengths Have longitudinal flexibility Ability to be optimally and precisely positioned — have high radio-opacity — have minimal foreshortening — ability to be retrieved or repositioned — no slippage of stent on balloons. 261 .24 25 28 CRITICAL ISSUE 37: Role of thrombolysis in chronic iliac lesions There is a need for studies to determine whether preliminary catheter-directed thrombolytic therapy enhances the efficacy or safety of angioplasty and stenting of chronic iliac occlusions.27 Data on comparative costs and morbidity. Wallstent) or (2) thermal memory expansion at body temperature (eg. or fracture Be biologically compatible.18 20 Similarly. The long-term effects of stent design.TABLE LIV. are incompletely understood. are lacking. Some authors favor lysis before stent placement24-26 and others favor stenting alone. Memotherm. flexibility) and cost considerations (eg. techniques. and ultrasound. to resist infection and minimize inflammatory reaction Be incorporated into vessel wall with thin neointima/functional endothelium Do not embolize or migrate Be inexpensive Allow for noninvasive imaging and follow-up with CT. the use of lasers for crossing or debulking occlusive lesions generally has not been accepted as cost effective. deformation. laser and atherectomy do not appear to be broadly applicable to the infrapopliteal arteries. These devices do not appear to offer improved clinical and hemodynamic outcomes or superior durability compared with PTA. minimiz- ing the number of stents needed to treat the target lesions).10-17 Role of Endovascular Procedures Other Than Angioplasty and Stenting The role of directional and rotational atherectomy for treating atheromatous occlusions or stenoses remains circumscribed. expandable stents are generally based on one of two designs: (1) spring-open expansion after removal of restraint (eg. and reporting have hindered com- parison of these two approaches. stenosis. rupture-resistant balloon (for stent/balloon delivery system) Yield durable clinical results Reliably oppose elastic recoil. MRA.9 18 19 Percutaneous atherectomy may have utility as a niche device in highly selected patients. As noted ear- lier.21-23 Role of Thrombolysis in CLI The role of thrombolysis for treating chronic iliac and femoropoliteal artery occlusions in patients with chronic CLI is controversial. Differences in patient selection. 242).

et al. AJR 1993. JVS 1988. Castellani L. 15. Bodenhagen K. Strecker E. 17. Yucel EK. Haas RA. et al. Berg G. Richter GM. Palmaz stent placement in iliac and femoropopliteal arteries: primary and secondary patency in 310 patients with 2-4 year follow-up. Percutaneous iliac artery stent: angio- graphic long-term follow-up. Wolf HR.183(3):773-778. Seabrook GR. Schlegl A. Lipchik EO. et al. Katzen BT. Chatellier G. J Vasc Interv Radiol 1995. AJR 1994. Marcade JP. Distal popliteal and tibioperoneal transluminal angioplasty: long-term follow up. JVIR 1996. Sapoval MR.70:619-623.180:771-778. et al. 12. Liermann D. Henry M. 262 . Pagny JY. Hreudenberg N. Pfeiffer KP. References 1. 11. Vroegindewij D. Decrinis M. Dornberg W. Femoropopliteal angioplasty: can we predict success with duplex sonography? AJR 1994. controlled. 14. Expandable tubular stents for treatment of arte- rial occlusive diseases: experimental and clinical results. Oertl M. Robinson ML. Surg Clin North Am 1992. Ann Vasc Surg 1991. Stark G. Long AL. Webb MS. Removal of focal atheromatous lesions by angioscopically guided high speed rotary atherectomy. three year experience. Tielbeck AV. Moore WS. Placement of balloon-expandable intraluminal stents in iliac arteries: first 171 procedures. 24. Rovani C. et al. Radiology 1990. Lossef SV. Recanalization of occluded superficial femoral artery using the rotational transluminal angioplasty catheter system (ROTACS). Bertuch H.7:292-300. Mahler F. Probst P. 541-546. AJR 1996. Capek P.189:536-540. Palmaz JC. Giraud C. Batt M. Decrinus M. Palmaz JC. Bandyk DF. Radiology 1990:174:969-975. 20. 4. Landman GH.175:97-102. Kent KC. van Kints MJ. Salles-Cunha SX. Berkowitz HD. et al. et al. J Vasc Surg 1992:15:860-866. 8. Amor M. Lutz RJ. Sacks D. Cardiovasc Intervent Radiol 1992. randomized trial. Nachbur B. Amicabile C.6:66S-72S. Redecker M. The role of duplex scanning versus angiography in predicting outcome after balloon angioplasty in the femoropopliteal artery. Motarjeme A.83:141-147. 6. 28. Quehenberger F. Page PE. Intravascular stents:tissue-stent interactions and design considerations. Carciovasc Surg 1993:1. 7. Beron R. Blum U. 18.19:509-515. Gianturco LE. Andros G. Murphy TP. Mundorf J. J Vasc Surg 1994. Pilger E. Noldge G. and is not repeated here. et al. color duplex US. Marcus DR. Orron DE. Gordon GI. Ahn SS. Apyan RL. 83(2 Suppl):I122-1136. Percutaneous transluminal angioplasty of the lower extremities by the vascular surgeon. Recanalization of femoropopliteal occlusive lesions: a comparison of long term clinical.166:1173-1179.177:565-569. Becker GJ. Rees CR. Garcia OJ. Harris RW. Schatz RA. Peripheral atherectomy with the rotablator: a multicenter report. Stark G. Barth KH. Kim D. 9.5:345-353. Marinelli DL. The value of duplex sonography after peripheral artery angioplasty in predicting subacute restenosis. Kinney EV. Self-expandable stents for the treatment of iliac artery obstructive lesions: long-term success and prognostic factors. Summers TA. 25. Raynaud AC. et al. 3. Lammer J. Gabelmann A. Reifsnyder T. Thrombolysis and angioplasty of chronic iliac artery occlusions. Beyssen BM. et al. Circulation 1991 Feb.Incidence and Management of Complications The incidence and management of complications after endovascular intervention is detailed in “Complications of Endovascular Procedures” (see p. Radiology 1995. Haidinger D. Palmaz JC. 22. Hold M. Percutaneous recanalization of iliac artery occlusions: results of a prospective study. Dulawa LB. Klein GE. Circulation 1984. Percutaneous transluminal angioplasty of crural arteries. Lambiase RE.340:1183-1188. Raynaud AC. et al.3:45-53. Pilger E.7:21-27. Reix T.160:613-618. Carney WI. 16.72:941- 957. Oblath RW. Dorfman GS. 5. Coulbois PM. The Combined Rotablator Atherectomy Group (CRAG).5:341-349. Circulation 1991. Bull PG. Lammer J. JVIR 1992. Intravascular stenting: from basic research to clinical application. McLean GK. Ducimetiere P. JVIR 1995. Fiessinger JN. Auth D. Radiology 1992 Jun. Radiology 1991. Circulation 1991. Lancet 1992. Mewissen MW. Denck H. Radiology 1993. Porter DH. Roeren T. 10.197:167-174. 23. Intravascular stents: general principles and status of lower-extremity arterial applications. Pulsed excimer laser versus continuous wave Nd:YAG laser versus conventional angioplasty of peripheral arterial occlusions: prospective. Femoropopliteal angioplasty: factors influencing long term success. Gallino A. Kuntz RE. Intravascular stents status of development and clinical application. Peripheral directional atherectomy: 4-year experience. 19. 2. 26.162:179-183. Barth KH. Nd:YAG laser with sapphire tip combined with bal- loon angioplasty in peripheral arterial occlusions: long term results. Horvath W. Mali WP.162:184-186. et al. 27. Long AL. 21. Buth S. Henry I. Grosser G. Becker GJ.6:331-337. Mendel H. and arteriographic follow-up. Percutaneous transluminal angioplasty of the arteries of the lower limbs: a 5 year follow-up. 114). Ethevenet G.83(suppl I) I-70-I-80. 15:279- 284 13. J Vasc Intervent Radiol 1994. Comparison of mechanical deformation properties of metallic stents with use of stress-strain analysis. Percutaneous revascularization of complex iliac artery stenoses and occlusions with use of Wallstents. Radiology 1990.

Regarding open vascular procedures. Recently also. occlusive lesions in the inflow or outflow vessels. which means that less knowledge exists on the incidence and magnitude of the problems. ASA alone. In a 1982 report. Current adjuvant pharmacological treatment aims to reduce either early failures due to thrombosis. The two most important categories are antiplatelet therapy and anticoagulation. an aortobifemoral graft with a perfect outflow carries at least a 90% 1-year patency. the Antiplatelet Trialists in their meta-analy- sis found that not only survival but also graft patency could be improved using ASA. patients with PTFE grafts for either above-knee or below- knee femoropopliteal bypass procedures were randomized to either placebo. or late. In combined series with autologous veins and PTFE grafts. whereas the corresponding figure for a pros- thetic femorodistal bypass with restricted run-off might be 30% or even less. and the location of the procedure.2 3 In a large series.5 263 .1 For below-knee grafts. Adjuvant Therapy After Revascularization Introduction Vascular and endovascular procedures suffer a risk of failure. no difference was found between the groups. no patency differences were seen with placebo versus ASA or ASA plus dipyridamole treatment given postoperatively in two series. This also relates to differences in the caliber of the recipient arteries. all with a femoropopliteal autologous vein bypass. starting preoperatively. either alone or in combination with dipyridamole. also greatly influence the immediate outcome of the procedure. these compounds are discussed separately from antiplatelet therapy. Antiplatelet Therapy Acetylsalicylic acid Acetylsalicylic acid (ASA) has been recommended on its own merits for reducing thrombotic events in all patients with PAD (see Recommendation 28. Even though vein grafts are at much less risk of developing occlusions than synthetic grafts. endarterectomy versus bypass procedures. 87). Progression of disease and risk factors such as smoking and blood lipids have a major implication on patency. it is reasonable to discuss them together because most of the expected problems are of the same kind. and the capacity of the collateral circulation. p. and there were no dif- ferences in patency rates recorded between the groups. factors that affect failure are the use of autogenous versus synthetic vas- cular conduits. prostanoids and nitric oxide have been tried clinically. The main causes of failure can be categorized as (1) early: technical flaws or low flow or increased thrombogenicity.4 Patients were followed-up for 3 years. Several fac- tors affect this risk. either early. Acetylsalicylic acid has been investigated in randomized clinical trials. Bypass patency also depends on the caliber and length of graft to be used. This discussion focuses on the use of ASA to assist the patency of revascularization procedures. though not of the same magnitude. Conversely. intermedi- ate graft occlusions due to intimal hyperplasia. At one extreme. some of these procedures have only come into use recently. or further progression of atherosclerosis. (2) intermedi- ate (6-24 months): intimal hyperplasia. encountered dur- ing surgery or caused by surgery. Technical problems. were randomized to treat- ment with either ASA plus dipyridamole or placebo. an aor- tic procedure compared with a distal reconstruction. Various phar- macological agents are in use to prevent thrombosis. Although exerting antiplatelet effects. and (3) late: progression of atheromatous disease. However. whereas those patients on placebo undergoing an above-knee reconstruction had a significantly worse outcome than those receiving ASA or ASA plus dipyridamole. for example. 549 patients. and the incidence differs considerably between various types of procedures. The same kind of factors presumably influence the outcome of endovascular procedures. intermediate. or ASA plus dipyridamole.

Both primary graft patency and limb salvage were significantly increased. Caution should be used in patients in whom use of anticoagulants is proposed.12 Anticoagulants The use of unfractionated heparin (UFH) during vascular surgery is a widespread routine. Ticlopidine Ticlopidine. It has been suggested that the conclusions are less valid because only one fourth of the grafts were vein. and studies have pointed at beneficial effects of LMWH in the postoperative management of infrainguinal bypass. multicenter study has shown that ticlopidine compared with placebo after femoropopliteal or femorotibial saphe- nous vein bypass procedures in 143 patients increased both survival and 2-year patency of saphenous vein bypass grafts in the legs. this should be contin- ued indefinitely. In this study. such as thrombocytopenia. the remaining were various synthetic materials. after which the randomized scheme started. it was shown that LMWH was superior and as safe as unfractionated heparin in prevention of early graft thrombosis. has proved effective in preventing vascular complications. 264 . but controversies exist as to whether graft patency could be influenced. A randomized controlled study comparing LMWH with ASA and dipyridamole14 showed significantly better patency in the LMWH group. The development of LMWH has changed this perspective considerably.11 do not appear to be pre- sent with newer ADP inhibitors such as clopidogrel. it has been shown that graft patency is improved in patients with saphe- nous vein grafts receiving oral anticoagulation.. Based on current knowledge.13 Conversely. this effect was restricted to patients operated on for CLI.10 Some of the side effects of ticlopidine. randomized. including patients receiving either vein grafts or synthetic grafts. ASA is recommended for those undergoing interventions. A Danish review recently concluded that there is evidence for lifelong treatment with ASA after infrainguinal vascular reconstructions.8 A reduced platelet uptake on aortobifemoral grafts has been shown. it was shown that low-molecular-weight heparin (LMWH) is as effective an anticoagulant as UFH during infrainguinal bypass surgery. Recently. 215). In two studies from Austria. Unless subsequently contraindicated. A theoretical explanation for an early benefit of ASA is given in a study by Goldman et al. UFH has been used more selectively during the postoperative course. In another randomized controlled trial comparing LMWH and unfrac- tionated heparin. as a more recent antiplatelet drug. but restricted to patients with CLI.16 17 In the first of these two studies. a Swedish study. did not indicate any better outcome in patients receiving oral anticoagulation during a 3-year follow-up.9 A recently published prospective.7 The authors also recommended a rather high dose (300–500 mg ASA daily).6 finding a lower thrombogenicity index with ASA and dipyridamole treatment using 111Indium-labeled platelets. p. 12% of patients randomized to coumarin were withdrawn for bleeding complications. and all patients received LMWH for the first week postoperatively.18 The place for coumarin as adjuvant therapy after revascularization procedures remains to be determined (see Critical Issue 30. This study combined results achieved with both synthetic grafts and vein grafts.15 Oral coumarin seems to increase patient survival. Contrary to these findings. RECOMMENDATION 96: Antiplatelets as adjuvant pharmacotherapy after revascularization Antiplatelet therapy should be started preoperatively and continued as adjuvant pharmacotherapy after an endovascular or surgical procedure. The main reason might be a risk of postoperative bleeding and a need for careful monitoring of coagulation parameters.

On this basis. when patients were treated with iloprost. Abciximab exchanges between and binds to platelets for as long as 2 weeks. other complications such as wound bleeding and vascular overload are not uncommon unless a strict protocol is followed and certain categorical exclusions observed such as recent myocardial infarction. whereas synthetic GPIIb/IIIa inhibitors block ex vivo platelet aggregation only a few hours after the end of an infusion but have the advantage of also being orally active.26-28 Adjuvant Therapy After Endovascular Procedures For endovascular procedures. tissue factor pathway inhibitors. but there are few published studies that compare dextran with other forms of treatment. Results on patency have not yet been presented. 25 New Approaches Activation of the glycoprotein (GP)IIb/IIIa on the platelet surface is the final pathway of platelet aggregation. congestive heart failure. resulting in an aug- mented graft flow and inhibition of depleted plasma antioxidants. Inhibitors of GPIIb/IIIa receptors include monoclonal antibodies and peptidic as well as nonpeptidic synthetic specific receptor blockers. significant benefit lasted up to 32 months. synthetic grafts performed better during the first month.5% in the control group and 6. including oral anticoagula- 265 . Other approaches are synthetic inhibitors of factors VIII. nitric oxide has been administered during infrainguinal bypass surgery. no significant improvement could be shown with respect to the 1-year patency. By the end of the trial. Prostanoids Prostanoids such as the prostacyclin analog iloprost have antiplatelet effects but also have effects on white cell aggregation and adhesion as well as on vasoconstriction. regardless of the initiating stimulus.21 Dextran has been used extensively in Sweden. Interestingly. there was no advantage in vein graft bypasses unless they were carried to crural arteries.9% (0% in vein grafts ) in the dextran 40 group. Recently.22 Although ana- phylactic reactions have been mitigated by pretreatment with the hapten. and renal insufficiency. is uncer- tain but may be a possibility. IX or X. Nitric oxide In a small series.24 Whether this failure could be attributed to the short time of drug administration. Direct inhibitors of thrombin is one of the recent pharmacological approaches being evaluated in clinical trials. non-autogenous reconstructions or crural bypasses) and no contraindications. However.Other Drugs Dextran Dextran is able to reduce platelet uptake on graft surfaces19 and was shown to be beneficial during follow-up of “difficult lower extremity revascularizations” utilizing either veins or synthetic grafts. especially PTCA. the overall advantage of dextran 40 was statistically significant at all times up to and including 1 month and in the subgroup with umbilical vein or prosthetic grafts. Flow increases in vein grafts during distal vascular reconstructions after iloprost injection have been shown. only during the day of surgery and 2 subsequent days. except considerably more side effects with dextran. dextran 70 cannot be recommended as a routine measure and should only be used in those distal bypasses in which there is a predictably high risk of early thrombosis (eg. anticoagulation has been advised. par- ticularly in patients with diabetes. or inactivated factor VIII. dextran 70 was compared with LMWH for distal vascular reconstruc- tions.20 The graft occlusion rate at 1 week was 20.23 In a large European multicenter study on patients with CLI comparing iloprost and placebo in distal vascular reconstructions using either vein grafts or synthetic grafts.20 The latter has been confirmed in a recent single-center prospective randomized trial. New data indicate few differences. New ways to interfere with the complex coagulation system abound.

14 This conclusion is not entirely evident. and a regimen with ASA is advised (see Recommendation 96. A major question is whether drugs that may reduce thrombogenicity are usable for this purpose as well. p. intending to compare aspirin and LMWH. and reasonably acceptable early and intermediate patency rates have been obtained. in which case an effect on thrombogenicity might be as important as an effect on intimal hyperplasia. Intimal Hyperplasia Proliferation of smooth muscle cells causing hyperplastic growth. with a short-term follow-up. Aspirin is the therapy most used. although the low-dose/high-dose debate is not settled. or together with. In most of the trials suggest- ing protected patency.30 although other authors have routinely used coumarin.40 41 Another proposal is that very high doses of heparin are needed. the higher dose of aspirin was used. an effect on intimal hyperplasia has been evident. claimed a beneficial effect of LMWH on intimal hyperplasia. the need for oral anticoagulation has been questioned.43 44 TABLE LV. Whether LMWH should replace aspirin. for infrainguinal bypass.30-35 In a Swedish multicenter study. radiation and drug delivery from. administered in a dose of 75 or 160 mg daily. Compound Experimental setting Effect Naroparcil45 arterial injury + Scavengers46 vein grafts - L-arginine47 48 vein grafts + Angiotensin-converting enzyme inhibition49 PTA + Cholesterol reduction50 vein grafts + Ketanserin51vein grafts + FGF saporin52 PTFE grafts + VEGF53 vein grafts + Cyclosporin54 aortic transplant + Lazaroids55 vein grafts + 266 . Drugs to be discussed are aspirin and heparin. measures to prevent this hyperplastic growth have to be found. however. 264). in recent studies. patients were treated with ASA and dipyridamole or placebo after PTA of iliac and infrainguinal vessels.29 Vascular stents in the femoropopliteal region have been used without long-term anticoagulation. because the effect was seen mostly in patients with severe ischemia. is not estab- lished. Some of them are listed in Table LV. but most importantly.42 The study reported above. any clinical benefit in humans has not been proved.38 In animal models. No differences were recorded between the groups with respect to the 1-year patency rate. this only proves an effect on thrombus formation. In addition.1-3 Conversely. 36 Summary of Adjuvant Therapy Even though randomized controlled studies are not entirely convincing. Clinical effects of aspirin and dipyridamole were seen after peripheral vas- cular surgery. especially in the distal anastomosis of a syn- thetic graft or in the anastomoses or body of a vein graft. UFH or LMWH. there seems to be consensus that adju- vant pharmacotherapy is needed to prevent graft thrombosis. Strict programs for graft surveillance give an opportunity to treat the lesion before any deleterious clinical effect. is the main cause of graft failure during a mid-term fol- low-up. implanted stents are under evaluation. compliance may be a problem with the higher dose over time.37 Heparin (UFH) has been shown to inhibit proliferation and migration of smooth muscle cells even in vivo. for example.39 It has been suggested that a continuous heparin infusion has to be used and also that LMWH has a greater effect on native arteries than on vein grafts. It seems reasonable to use the same policy for endovascular procedures as for surgical procedures. It seems important to start the treatment preoperatively. Several experimental models have been tried to reduce intimal hyperplasia. however. However.—Compounds used in animal model experimental settings to reduce intimal hyperplasia.tion.

102:453-459. Kaufman JL.11(1):59-64. Satiani B.227:301-308.127:1112-1115.36:608-616. Universitaire de Recherche en Chirurgie.64:363- 369. et al. Effect of aspirin and dipyridamole on the patency of lower extremity bypass grafts. The influence of anticoagulant treatment on the prob- ability of function in femoropopliteal vein bypass surgery: analysis of a clinical series (1970-85) and interim evaluation of a controlled clinical trial. Collaborative overview of randomised trials of antiplatelet therapy. Low molecular mass heparin instead of unfractionated heparin during infrainguinal bypass surgery. Drott C. Lundgren F. Whether this kind of treatment will also affect intimal hyperplastic growth has still to be proved. Angiology 1985.159:556-560. Herbst F. Maybe there is a future in drugs acting in different ways to reduce platelet activity.344:914-918. Vasehus Madsen P. Becquemin JP. 5.13:150-162. Egberg N. Franks PJ. Roedersheimer LR. et al. Nydahl S. McCollum CN. Goldman MD. lipid-lowering drugs. Simpson D. cholesterol reduction is an interesting possibility. Poltrauer P. Samama CM. Hensler M. A decade of oral anticoagulant treatment to maintain autologous vein grafts for femoropopliteal atherosclerosis. Incidence and clinical course of thrombotic thrombocytopenic purpura due to ticlopidine following coronary stenting. Lancet 1994. 9. Kohler TR.and cAMP-elevating and cyclooxygenase-inhibiting drugs may be useful. Scherstein T. Ann Surg 1983. Kelly E. platelets. DeWeese JA. Both early thrombosis and late hyperplastic growth are multifactorial events. the Swedish Ticlopidine Multicentre Study. 3. Prevention of myocardial infarction and stroke in patients with intermittent claudication. are crucial. Merckx E. Am J Surg 1990. A randomized. 18. Norcott HC. 2. Most certainly. Influence of coumarin treatment on patency and limb salvage after peripheral arterial reconstructive surgery. Etude de la ticlo- pidine apres pontage femoro-poplite and the Assoc. research aimed at its prevention is of critical importance. Effects of aspirin and dipyridamole on expanded polytetrafluoroethylene graft patency.96:462-466. N Engl J Med 1997. Because intimal hyperplasia is a major cause of failure of both percutaneous and open surgical revascularization procedures. Effect of ticlopidine on the long term patency of saphenous vein bypass grafts in the legs. Ill P. Janzon L. Hawker RJ. Greenhalgh R. Lindgarde F. J Intern Med 1990. Donaldson M. Sautner T.348:1329-1339. Nevelsteen A. 13. and treatment of hypertension are all associated with reduced progression of atherosclerosis. and a combination of cGMP. References 1.308:159-168. effects of ticlopidine: results from STIMS. J Vasc Surg 1991. Foody JM. Arch Surg 1992. Wagner MB. 11. Boberg J. et al. Surgery 1984. Kakkar VV. Tan WA. et al. Effect of ticlopidine on blood loss. A prospective randomized trial of aspirin in femoral popliteal and tibial bypass grafts. Berlakovich GA. there will also be techniques to inhibit the effects of activated white cells participating in the inflammatory response. Alexander C. Gigou F. Acetylsalicylic acid treatment after peripheral vascular surgery. Eur J Vasc Endovasc Surg 1996. Wenzl E. 12. 16. especially if combined with smoking cessation and exer- cise. II: Maintenance of vascular graft or arterial patency by antiplatelet therapy. 14. Bergqvist D. Antiplatelet drugs in femoropopliteal vein bypasses: a multicenter trial. Synergistic effects have been shown with drugs acting on different pathways. Piza F.198:713-716. Interestingly. Ugeskr Læger 1994. Apparently. JAMA 1999. 8. Surgery 1987. Kretschmer G. Kretschmer G. Wenzl E. because it promises to reduce atherosclerosis. Green RM. Lancet 1996. Ehringer H. Edmondson RA. Verhaeghe R. Arfvidsson B. Enoxart Study Group. Aspirin and dipyridamole reduce platelet deposition on prosthetic femoro-popliteal grafts in man. and it therefore would be most astonishing if one single drug could prevent them all. and to a lesser degree. Van de Cruys A. BMJ 1994.9(Suppl):S45-S53. 7. Kenchington G.92:1016-1026. 17. Surgery 1982. Low-molecular weight heparin vs unfractionated heparin in femorodistal reconstructive surgery: a multicenter open randomized study. Calcium channel antagonists. Prager M. 6. Topol EJ. Kacoyanis G. Thromb Res 1991. white cells. Minar E.156:1278- 1285. Lundholm K. Ann Vasc Surg 1995. Clowes A. Mortelmans L. Concerning the cells involved. CRITICAL ISSUE 38: Agents to inhibit intimal hyperplasia There is a need to determine the clinical efficacy of agents reported to inhibit intimal hyperplasia in animal models. 267 . McCollum C.337:1726- 1731. platelet turnover and platelet deposition on prosthetic surfaces in patients undergoing aorto-femoral bypass grafting. but apparently also hyperplastic growth. Low-molecular weight heparin versus aspirin and dipyridamole after femoropopliteal bypass grafting. Eriksson I. Boberg M. Antiplatelet Trialists’ Collaboration. 10. blinded trial of clopidogrel versus aspirin in patients at risk of ischaemic events (CAPRIE). 15. 4. Swedenborg J.281:806-810. Das SK. almost all drugs reported in Table LV exert a positive effect in the respective experimental model. Whether any of these findings will be possible to transfer to the human situation is too early to predict. Cohen AT. Steinhubl SR. CAPRIE Steering Committee.

Robert C. 27. Davies MG. Kidd J. Auditing surgical outcome: Ten years with the Swedish Vascular Registry—Swedvasc. Stirnemann P. Golomb G. 51. Henry M.8:174-178. Morice MC.54:530-538. Walpoth BH. Radiology 1992. Bourdonnec C. 25. Levy RJ.1:765-773. Intimal hyperplasia and graft failure. Cooper GG. et al. Br J Surg 1987. Reduction of intimal hyperplasia by naroparcil. after arterial injury in the hypercholesterolemic rabbit. Kakkar VV. et al. 53.130:976-980. Rasey JS. The influence of low molecular weight heparin on neointimal proliferation in cultured human saphenous vein. Cardiovasc Intervent Radiol 1992. Zemour G. 23. Muller DW.89:770-776.7:88-94. Eur J Vasc Endovasc Surg 1996. Reduction of experimental vein graft inti- mal hyperplasia by ketanserin. Luo Z. Circ Res 1995. Clowes AW. A comparison study of self-expandable stents vs balloon angio- plasty alone in femoropopliteal artery occlusions. Gordon D. Clyne CA. Eur J Vasc Surg 1994. Svendsen E. p 126 (abstract).7:266-269.197:167-174. Bergqvist D. Long AL. Clowes MM. Does dextran 40 improve the patency of autogenous infrainguinal bypass grafts. Radiology 1997. 33. Van Belle E. Tahlil O. Radiology 1995. Contrasting effects of the intermittent and continuous administration of heparin in experimental restenosis.28(1):23- 26. Atuhaire LK. IV: Heparin inhibits rat smooth muscle mitoge- nesis and migration. Davies MG.142:212-220.6:843-849. 21. Davies MG. Strecker EP. Klyachkin ML. Naylor AR.74:246-248. Edelman ER. Jones L. London S. Symes JF.8:60-64. Kinetics of cellular proliferation after arterial injury. 42. Platelet inhibition with ASA/Dipyridamole after percutaneous balloon angioplasty in patients with symptomatic lower limb arte- rial disease: a prospective double-blind trial. Ziol M. The efficacy of dextran 40 in preventing early postoperative thrombosis following difficult lower extremity bypass. 36.205(2):375-383. Allen KE. J Surg Res 1993. Gajdusek C. Am Heart J 1996. Engeset J. Bergentz SE. Dalen H. Klyachkin ML. Surgery 1994. Kaiser B. Beron R. Int Angiol 1988. Tsang GMK. In: M Verstraete. Cathet Cardiovasc Diagn 1995. EJ Topol. 39. JVIR 1995. Faivre R. Triller J. 43. Random control trial of a short course of aspirin and dipyridamole (Persantin) for femorodistal grafts. Webster JH. Waugh RC. 34. Harris JP. Thromb Haemost 1997. Isner JM. Eur J Surg Suppl 1998. Dardik H.60:339-344. Barber L. et al. Ratliff DA.78:357- 363. Al-Huneidi W. 38. Sustained release local hirulog therapy decreases early thrombosis but not neointimal thickening after arterial stenting. Biron Y.19. Fiessinger JN. Gottmann D. Macaulay EM. Schwartz LB. J Vasc Surg 1995. 52. Massey MF. Jones DN. Archer TJ. 20. Diethrich EB. Paterson IS. Smith FCT.116:557-568. 26. Hanson SR.108:556-566. J Surg Res 1995. V Fuster. Amor M. Thomson IA. Direct thrombin inhibitors: appraisal of the antithrombotic/hemorrhagic balance.8:83- 88. Pierce GF. Femoropopliteal stent placement: long-term results. The effect of low molecular weight heparin on intimal hyperplasia in vein grafts. J Hypertens 1995. Mattar SG. Amicabile C. 50. Clowes AW. Bell PR. 45. Study group on pharmacological treatment after PTA. 22. Beysson BM. Svendsen E. Kim JH. ESVS 96. 28. 268 . et al. Hedberg B. Eur J Vasc Surg 1994. McFadden EP. Raynaud AC. Do-dai-do. Chen C. Katz SG. Car- diovascular Thrombosis. J Vasc Surg 1998. Liew SC. Whiting PH. Sapoval MR. Boos IB.12:363-371. 46. Ann Vasc Surg 1993. J Vasc Surg 1984. EJ Topol. Walenga JM. Makhoul RG. et al. The effect of low molecular weight dextran on early platelet deposition onto vascular grafts. Gaux JC. et al. Kohl RD. Shearman CP.184:844-840. 37. 47. 35.27:167-173. V Fuster. Circulation 1994. a 4-methy- lumbelliferyl beta-D-xyloside analogue. 49. Mahler F. Stephen MS. eds. Radiation inhibition of intimal hyperplasia after arterial injury. Davies MG. Wilson NV. Karnovsky MJ.131:211-218. Circ Res 1986. Beneficial effects of administration of nitric oxide during infrain- guinal bypass. et al. Wernert N. 29. Topol EJ.15:306-312. Reduction of experimental vein graft intimal hyperpla- sia and preservation of nitric oxide-mediated relaxation by the nitric oxide precursor L-arginine. Verstraete M. Samama MM.59:35-42. Katzen BT. Angiotensin converting enzyme inhibition prevents proto-oncogene expression in the vascular wall after injury. Karnovsky MJ. Henry I. Delcayre C. Reduction of vein graft intimal hyperplasia and preservation of endothe- lial-dependent relaxation by topical vascular endothelial growth factor. Martin EC. Owunwanne A. Mayberg MR. Svendsen E. Barber L. Christenson JT. 31. Rutherford RB. Bauters C. Steg PG. Verstraete M. et al.581:3-8. Chant AD. eds. Radiat Res 1995. 41. Adjuvant prostanoid treatment during femorodistal reconstruction. Postoperative reduction of high serum cholesterol concentrations and experimental vein bypass grafts: effect on the development of intimal hyperplasia and abnormal vaso- motor function. et al. 32. Tsurumi Y.2:179S-186S. Kim JH. Cardiovasc Pathol 1993. Dupuis B. Philadelphia: Lip- pincott-Raven. 30. Kim JH. White GH. Benveniste E. Asahara T. In: M Verstraete. Elfstrom J. 48. Hagen PO.77:919-926. Cook JE. 44. 24. Local infusion of FGF-saporin reduces intimal hyper- plasia. J Vasc Surg 1998. J Surg Res 1996. J Thorac Cardiovasc Surg 1994. Varty K. Philadelphia: Lippincott-Raven 1998:173-188 . Hagen PO. Cardiovascular Thrombosis. Svendsen E. Bergqvist D. 40.13:105-112. 1998:173-188. Dalen H. et al. Femoropopliteal artery stent placement: evaluation of long-term success. Barber L. Palmaz stent placement in iliac and femoropopliteal arteries: primary and secondary patency in 310 patients with 2-4 year follow-up.21:270-279. Hickey NC. Hirsch GM. Effects of peri-operative iloprost on patency of femorodistal bypass grafts.35:1-7.58:839-845. Ljungström K-G. et al. Suppressors of oxygen metabolites fail to reduce vein graft intimal hyperplasia. Hughes JD. Multicenter trial of the Wallstent in iliac and femoral arteries. Early outcome and intermediate follow-up of vascular stents in the femoral and popliteal arteries without long-term anticoagulation. Other antithrombotics. Specific factor Xa inhibitors. Norgren L. London NJ. Dorros G. Intracoronary stenting without coumadin: one month results of a French multicenter study. Control of accelerated vein graft atheroma with the nitric oxide precursor L-arginine. Eur J Vasc Surg 1994. Gates JD. Karmody AM. Sayers RD. The Iloprost Bypass International Study Group. Graor RA. Arch Surg 1995. Benanti JF. Masson P. Fareed J. Luo Z. Salisbury JR. Pruneau D. Ethevenot G. Simms MH. Dalen H. Troeng T.

with assisted primary patencies of 82% to 92% at 5 years. Inhibition of intimal hyperplasia in rat aortic allografts with cyclosporine. 269 . Therefore. Transplantation 1995. Hagen PO. Methods of Surveillance A number of methods of posttreatment surveillance of patients undergoing lower extremity revascularization have been practiced over the past several decades. thrombectomy and revi- sion yields a poorer secondary patency of only 43% to 76% at 5 years. Because not all peripheral interventions are easily evaluated. Lazaroid therapy (methylaminochroman: U83836E) reduces vein graft intimal hyperplasia. for example. and yields a less durable result. These include clinical examination. however. Davies MG.12 Unfortunately. Hullett DA. duplex imaging. results in excellent long-term graft function. few of these patients develop slowly progressive symptomatology during the development of flow-limiting or graft-threatening lesions.63:128-136.54. represent a potentially valuable adjunct to every type of vascular intervention performed for the preservation of lower extremity perfusion. the treatment of complete re- occlusions of angioplasty sites has a lower likelihood of technical success. essential components of any surveil- lance program.7-9 Similarly. although patient history is an essential and valuable source of information. Physical examination also lacks sufficient sensitivity for the detection of failing grafts or angioplasty sites. a higher incidence of complications. Therefore. 55. It is now well recognized that patency of the treated arterial segment is most effectively preserved through surveillance programs that are capable of identifying flow-limiting lesions before complete occlusion of the conduit or vessel. Kennedy E. p. the identification and treatment of flow-limiting lesions within the treated arterial segment before throm- bosis of the segment provides a more durable result. ankle:brachial indices. all lower-extremity revascularization procedures have a sig- nificant rate of failure over time (see also “Surgery for Intermittent Claudication”. Patient history and physical examination remain.10 11 Clearly. Stoltenberg RL. Steele DM. therefore. Geraghty J.16 Graft occlusion occurs in many patients before the onset of symptoms or alteration in the quality and character of peripheral pulses. and arteriography. Patient history and clinical examination Most patients (66%) who have undergone femoropopliteal or femorotibial bypass procedures experience a return of preoperative symptoms immediately on graft occlusion. Surveillance programs. Barber L. such as segmental pressures and plethysmography.5 6 Once complete occlusion has occurred. Additional study methods have been used. J Surg Res 1996.1-4 Revision of fail- ing reversed saphenous vein bypass grafts. clinical history and physical examination are inadequate as the sole components for graft surveillance and the reliable detection of failing femoropopliteal or femorotibial bypass grafts. alone it is of lit- tle value in detecting the development and evolution of luminal lesions capable of causing graft thrombosis. Sollinger HW. pulse examination of the patient at rest and the appearance of the foot may not be changed by the presence of a sig- nificant isolated stenosis.13 This is especially true of those patients who do not participate in a postoperative exercise therapy program and remain sedentary. Similarly. but little information exists regarding the utility of these technologies.60:993-998. Dalen H. Surveillance After Revascularization Introduction Despite a high likelihood of immediate success. 117).14 15 Iso- lated stenoses of inflow or outflow vessels or of a graft infrequently alter physical examination. the methods that provide the most cost-effective sur- veillance in a given setting remain controversial. Svendsen E.

whereas those to the tibial vessels had a mean peak flow velocity of 64 cm/s. The flow surface contours of a normal vein graft should be smooth and parallel on longitudinal scan. Individual recordings of ABPI in a patient may vary by as much as 0. A well-recognized method for enhancing the detection of subcritical stenoses in native vessels.2) and those with stable ABPI.0 across a stenosis.2 did not distinguish between patients who proceeded to graft occlusion and those who did not. resting ABPI may be falsely elevated in patients with calcified distal arteries and may be of limited value in patients who did not normalize their ABPI in the immediate postoperative period. the post-exercise ABPI may be helpful in the detection of suprainguinal reconstructions or lower extremity angioplasty procedures.18 Similarly.22 Thus. there are general guidelines for detection of the fail- ing distal graft.18 19 Addi- tionally. Although criteria for graft failure vary among laboratories. Duplex surveillance of lower extremity vein grafts is more easily accomplished than prosthetic grafts because of the abil- ity to completely scan the graft and identify areas of stenosis and altered flow rates.25 As the peak systolic velocity increases. although they may be subject to measurement variability and study limitations.21 A recent application of this form of ABPI assessment showed that a significant number of patients with significant graft stenoses experienced a reduction in post-exer- cise ABPI despite an unchanged resting ABPI.20 The measurement of post-exercise ABPI may improve the detection of flow-limiting stenoses.Ankle-brachial pressure indices (ABPI) The use of resting ABPI for the detection of hemodynamically significant arterial occlusive disease has been uniformly accepted. These factors limit the use- fulness of the resting ABPI for the detection of failing lower extremity revascularizations. One group of investigators has documented equivalent graft failure rates in patients with hemodynamically sig- nificant drops in resting ABPI (>0.19 For these reasons. a peak systolic veloc- ity ratio of greater than 2. A decrease in index of 0. 270 . another group has shown that a decrease in resting ABPI of 0.17 These high-grade stenoses are more likely to undergo sudden thrombotic occlusion. The inability to identify mild or moderate flow-reducing lesions prevents the recording of slowly falling ABPI in patients with an evolving graft-related stenosis. A recent study has shown that baseline graft peak flow velocities vary with the site of distal anastomosis (popliteal vs tibial) and quality of outflow tract. A graft can be evaluated at each anastomosis and throughout its length.5 cm/s.24 A peak systolic velocity of 180 cm/s or greater suggests a critical diameter reduction of 80% or more. compressive hematoma. requires the development of a hemodynamically significant stenosis of at least 50%. has made rapid scanning of the entire graft length in the lower extremity feasible. and a reduction in peak systolic velocity to less than 45 cm/s. the resting ABPI cannot reliably provide the physician with information regard- ing the development of stenoses and the probability of a thrombotic episode within angioplasty sites or bypass grafts. end-diastolic velocity may also begin to rise. the parameter most widely used as representative of a significant reduction in blood flow.15. therefore. Color flow duplex scanning Color flow duplex scanning has been widely used in surveillance programs because of its simplified ability to identify stenoses in native arteries and vein grafts. and pseudoaneurysms. post-exercise ankle-brachial indices have been shown to be of greater value than resting ABPI for the identification of failing lower extremity angioplasty. kinks or other forms of graft malpositioning. These include an increase in peak systolic velocity to greater than 150 cm/s. Because luminal diameter is narrowed within a native artery or autogenous graft. Scans can be performed longitudinally and can detect a variety of conditions that may impact on graft function. Toe:brachial indices provide no better discrimination. peak systolic velocities within the lesion increase. Areas of concern can be reexamined at frequent intervals if clinically indicated to identify the extent and rate of development of stenotic lesions.23 Vein grafts to the popliteal artery had a mean peak flow velocity of 89.1 without a fixed reduction in peripheral blood flow. including persistent arteriovenous fistulae. A peak systolic velocity of 150 to 170 cm/s correlates with a greater than 50% diameter reduction. Color guidance has reduced the amount of time required to locate significant lesions within autogenous grafts and.

and peak systolic velocity ratios can be calculated.25 A reduction of peak systolic velocity to less than 45 cm/s at the site of the smaller of the anastomoses (proximal in reversed vein grafts. however. Angiography Angiography is well accepted as the “gold standard” for anatomic diagnostic studies. when corrected. duplex imaging has been applied to the surveillance of transluminal angioplasty of the lower extremity. More recently. or if other reasons exist for ABPI being inade- quate. moderate.27 28 An elevated peak systolic velocity ratio in con- junction with elevated peak velocities and the identification of an anatomic lesion on duplex image are strongly suggestive of a significant. Unlike the noninvasive studies. distal in situ) suggests a proximal flow-limiting lesion but is less specific than either peak systolic or end-diastolic velocity measurements. duplex imaging permits frequent assess- ment of luminal irregularities and the detection of hemodynamically significant stenoses that. though quite low. It might be that MRA should be advised if patients have heavily calcified vessels.30 31 Its role as an adjunctive diagnostic modality to confirm nonin- vasive duplex findings.32 Postoperatively.33 As an easily repeated diagnostic test with excellent patient compliance. These values are capable of detecting the presence of restenosis of the angioplasty site or the worsening of occlusive disease in adjacent segments. and the mobility of newer imaging systems permits a wide variety of views capable of providing significant anatomic information. help 271 . End-diastolic velocities of greater than 50 cm/s in conjunction with high peak systolic velocities indicate a greater than 70% loss of luminal diameter.10 29 The use of peak systolic velocities and velocity ratios enhance the ability of color flow duplex imaging to detect mild. make this an unacceptable routine method of surveillance. graft-threatening stenosis. This surveillance modality is capable of detecting stenoses of less than 50%. Appropriate Use of Graft Surveillance Overall. The retrograde measurement of pres- sure gradients across iliac lesions can contribute valuable hemodynamic information about inflow vessels.0 suggests the presence of a 50% diameter-reducing lesion. the benefit of duplex imaging is limited to the evaluation of the anastomoses and the inflow and outflow vessels. peak systolic flow velocities across the site can be determined. loca- tion. if untreated. and 20% were at the anastomoses. velocity ratios have been used to detect the presence of significant stenoses. or if good quality color duplex scanning either is not available or cannot be performed adequately because of patient habitus. The use of duplex imaging for the evaluation of prosthetic bypass grafts is more limited. would result in graft occlusion. and severity of occlusive lesion within the segment of arterial tree imaged.26 Because peak velocities within a vein graft may vary from the established baseline. or to provide additional anatomic detail about a specific stenotic lesion is. Optimal results with color duplex imag- ing for surveillance requires an experienced technologist who can not only identify the presence of a stenotic lesion by velocity criteria but also provide information about the location and characteristics of the lesion. Because clear luminal images frequently cannot be obtained within synthetic grafts. Appropriately performed. The peak systolic velocity ratio is calculated by dividing the peak systolic velocity at the site of the stenosis by that obtained in the normal segment. this diagnostic test can identify the presence. The morbidity and mortality of angiography. The value of performing a truncated scan such as this remains controversial. especially ePTFE. and severe stenoses. the development of lesions that threaten graft patency of saphenous vein bypasses occur most often within the body of the graft. Although the presence of significant amounts of calcium in the arterial wall may prevent clear visual- ization of the specific angioplasty site. A ratio greater than 2. image clarity does not decrease above the inguinal ligament. impor- tant. In a study of occluded and fail- ing saphenous vein grafts. permitting physicians to follow the evolution of these lesions and plan appropriate therapy. Biplanar arteriography is associated with high positive and negative predictive values for the detection of stenoses within native arteries and autogenous and prosthetic grafts. surveillance programs have shown the benefit of duplex imaging for the detection of vein graft stenoses that. plus patient discomfort and cost. The greatest lim- itation to this technique of patient evaluation is its operator dependency. 63% of the lesions were located within the graft.

however. and outflow vessels. — duplex scanning of the entire length of the graft. CRITICAL ISSUE 40: Frequency and duration of surveillance in vein and prosthetic grafts There is a need to establish optimal frequency and duration of surveillance testing in vein and pros- thetic grafts.34 Treatment of hemodynamically sig- nificant lesions in nonoccluded but failing saphenous vein grafts results in primary assisted patency rates greater than 80% at 5 years. and outflow vessel pulses. 18 and 24 months. and intervention. The detection of luminal pathology not discovered in the operating room at the time of graft placement has been reported to occur in as many as 37% of patients. — vascular examination of the leg with palpation of proximal. definitive evaluation of the entire graft. and then yearly thereafter. the value of a surveillance program lies in its ability to identify for the vascular specialist the graft threatened by flow-limiting lesions. 3. Surveillance programs should be performed in the immediate postoperative period and at regular inter- vals for at least 2 years. It has been suggested that surveillance may be restricted to the first 6 months after operation in those patients who have a normal bypass during that period. Nonetheless. anastomotic pseudoa- neurysms. 12.3 36 The cost-effective- ness of Duplex scanning during the first year has also been questioned.40 Prompt. The cost-effectiveness of frequent surveillance beyond 2 years is controversial because of the reduced incidence of graft failure after this period. graft surveillance studies are performed at 1. CRITICAL ISSUE 39: Cost-effectiveness of duplex imaging surveillance for vein grafts There is a need for documenting the cost-effectiveness of using duplex imaging for vein graft sur- veillance at all periods. the identification of such lesions should lead the vascular specialist to consider treatment.35 Subsequent surveillance studies have been performed on a wide variety of sched- ules. as well as retained valves. The initial scan may detect a wide variety of graft conditions that might impact on graft survival. and luminal flaps. Most.preserve vein graft function. with angiography if necessary. obtain the first postoperative scan at 1 week or before discharge. The impact of such lesions on long-term graft function has been well recognized and defined. 6.1-6 The time of initiation of duplex imaging surveillance programs varies among practicing centers. compressive hematoma. — periodic measurement of resting and. This program should consist of: — interval history (new symptoms).38 39 Because stenotic lesions causing a greater than 50% diameter reduction are at greater risk for acute thrombosis. with calculation of peak systolic velocities and the velocity ratios across all identified lesions. if indicated. Delay in the evalua- tion and treatment of grafts at risk may result in graft failure and a poorer prognosis for the patient. should be undertaken. large arteri- ovenous fistulae that may divert distal flow in in situ bypasses. Most commonly for patients with autogenous lower extremity bypass.35 These include the identification of persistent. inflow. with 32% of these compromised grafts ultimately requiring revision of the identified lesion. adherent thrombus.41 272 . graft. Numerous variables impact on graft function and limb salvage. The indications for treatment of an identified lesion must be individualized for each specific patient. post-exercise ankle:brachial indices.37 RECOMMENDATION 97: Surveillance program for vein bypass grafts Patients undergoing vein bypass graft placement in the lower extremity for the treatment of claudica- tion or limb-threatening ischemia should be entered into a surveillance program. if possible.

post-exercise ABPI recording.42 43 Sur- veillance of prosthetic bypasses with duplex imaging may not detect impending graft failure secondary to lesions within the graft. or transluminal angioplasty. 273 . The benefit of surveillance programs for patients who have been treated with proximal vascular reconstruction. only 10 stenoses (8%) were located within the graft. Surveillance programs should be performed in the immediate post-PTA period and at intervals for at least 2 years. The benefit of surveillance in patient with prosthetic grafts lies in the likelihood that the graft-threatening lesion usually does not occur within the body of the graft. and outflow vessel pulses — ankle-brachial indices at rest and.45 Other studies have shown a benefit of duplex image surveillance for prosthetic grafts. such as aortoiliac or iliofemoral bypass. frequently yield suboptimal images. Some studies have demonstrated a benefit to surveillance with duplex imaging. The remainder were located within the inflow vessel (30%). has not been uniformly effective for the detection of failing prosthetic grafts. if possible.46 47 Though the benefit of duplex imaging alone appears to be limited. especially those prosthetics with exter- nal support. however.21 RECOMMENDATION 99: Surveillance program for aortoiliac transluminal angioplasty Patients undergoing aortoiliac vascular reconstruction or transluminal angioplasty for lower extrem- ity revascularization should be entered into a surveillance program consisting of: — interval history (new symptoms). Duplex imaging. which consists of: — interval history (new symptoms) — vascular examination of the leg with palpation of proximal. — resting and. outflow vessel (57%). — vascular examination of the leg with palpation of proximal and outflow vessel pulses. Of 144 graft- threatening lesions identified in 91 failing PTFE bypass grafts. A recent study of duplex sonography surveillance initiated within 48 hours of infrainguinal angioplasty and con- tinued for more than 2 years failed to detect a difference in patency of angioplasty sites between those patients who had abnormal results of duplex examinations and those whose examination results were normal.10 29 48 Few studies have been rigorously performed to determine the impact of a surveillance program on the long-term outcome of angioplasty. a surveillance program for patients who have undergone placement of a synthetic bypass graft is indicated. remains controversial. or at an anastomosis (6%). after exercise testing Surveillance programs should be performed in the immediate postoperative period and at regular inter- vals for at least 2 years. CRITICAL ISSUE 41: Surveillance program for angioplasty and other endovascular procedures There is a need for confirmation that the surveillance program suggested for vein bypass grafts is also beneficial after endovascular procedures. Post-exercise ABPI measurement is more likely to show the presence of hemodynamically significant lesions. if possible.44 Technical difficulties associated with scanning of the graft. RECOMMENDATION 98: Surveillance program for prosthetic grafts Patients undergoing prosthetic femoropopliteal or femorotibial bypass for claudication or limb-threat- ening ischemia should be entered into a graft surveillance program.49 Similarly. investigators have shown that resting ABPI does not identify patients with significant restenosis. graft.

Arch Surg 1991.126:743-747. van de Pavoordt ED. 11. Lanza D.121:758-759.5:170-179. The point at which a graft stenosis becomes critical. Cohen JR. Many techniques have been used successfully to treat these lesions. Lindblad B. Ricotta JJ. Bandyk DF. 10. Donaldson MC. Darling RC. Schmidtke I.21:26-33. J Vasc Surg 1994. Adams MB. Surgical treatment of threatened reversed infrain- guinal vein grafts. Stenoses within the body of the prosthetic graft are best treated by direct surgical revision. Taylor LM.9:284-296.100:646-653. Long-term surveillance by duplex scanning of nonrevised infra- genicular graft stenosis. Moll FL. Ouriel K. Yeager RA. Int Angiol 1985. Mannick JA. and segmental vein resection and interposition vein graft. 3. et al. Bergqvist D. Fox AD. Ho GH. et al. the point beyond which thrombosis is very likely to occur.4:87-91. Polak JF. including balloon angioplasty. Patients who have had rapid restenosis of an angioplasty site or who have required multiple repeat angioplasties should be considered for surgical intervention. Strayhorn EC. Only then can appropriate intervention be planned. Bergan JJ.11:289-294. primary results. Because duplex imaging fails to adequately image the flow surface of prosthetic grafts. Flinn WR. The reoperative potential of infrainguinal bypass: long-term limb and patient survival. Lundell A. J Vasc Surg 1990. McCarthy WJ. Monitoring functional patency of percuta- neous transluminal angioplasty. There appears to be a transition from a low to high risk between a 50% and 75% stenosis. prosthetic. 12.15:130- 142. that is. Bartlett ST. et al. has not been determined. Olinde AJ. Towne JB. intervention requires a complete and detailed evaluation of the inflow. LaSalle AJ. CRITICAL ISSUE 42: Intervention during surveillance program There is a need for further information to identify what degree of lesion(s) restenosis. Femoropopliteal graft failures: clinical consequances and 274 . Surgery 1986.9:547-553. Kuipers MM. Kinney EV. Couch NP. Arch Surg 1986. A decrease in the resting or post-exercise ABPI in patients who were treated by transluminal angioplasty should be studied by angiography to determine the feasibility of performing a redilation of the lesion. More research is needed to settle this important issue. Whittemore AD. Seabrook GR. Porter JM. Monitoring functional patency of in situ saphenous vein bypasses: the impact of a surveillance protocol and elective revision. Moneta GL. Duplex imaging of lower-extremity angioplasty sites may be of value for the assessment of lesions in patients who do not clearly war- rant intervention. Harrington DP. DeWeese JA. Green RM. Recognition and management of impending graft failure: importance for long-term patency. as detected by surveillance studies. Whittemore AD. Repeated percutaneous transluminal catheter-treatment. Deaton DH. Robison JG. 4. Grassi DF. 7. Fahey VA. Roth FJ. Patients with stenoses within the native inflow or outflow arteries may be treated by conventional angioplasty or surgical techniques. This is especially true of in situ saphenous vein bypass grafts.1-6 The presence of hemodynamically significant stenoses within the graft or the progression of a mild lesion to one of hemodynamic significance should indicate the need for intervention. 2. Reversed vein graft stenosis: early diagnosis and management. and outflow vessels. J Vasc Surg 1995. Femoropopliteal-crural graft patency is improved by an intensive surveillance program: a prospective randomized study. The detection of a decreasing resting or post-exercise ABPI in a patient with a prosthetic infrainguinal bypass should lead to angiographic assessment of the patient. 6. Edwards JM. 9.20:558-563. Belkin M. must be corrected. Brewster DC. Algra A. Berkowitz HD. Schmitt DD. patch angioplasty. 5. J Vasc Surg 1992. Bandyk DF. Hansen F. The interposition of a prosthetic segment into a vein graft is of dubious value. Lipchik EO. Angioplasty has not been of demonstrated ben- efit in the treatment of these lesions. J Vasc Surg 1989. Revision of failed infrainguinal bypass graft: principles of management.Management of a Failing Lower Extremity Revascularization The identification of a failing lower extremity autogenous bypass by duplex imaging surveillance frequently pro- vides the physician with sufficient information to plan intervention. Mewisson MW. Observations on the use of thrombolytic agents for thrombotic occlusion of infrainguinal vein grafts. Ann Vasc Surg 1995. 8. Nehler MR. whether velocity cri- teria from Duplex scanning or anatomic criteria from angiography best identify the critical risk point is debated. References 1.25 50 In addition. Bergamini TM. J Vasc Surg 1987.

Londrey GL. Stark G. The effect of a surveillance programme on the patency of synthetic infrainguinal bypass grafts.3:389-392. Veith FJ.17:195-206. 13. Ramsey DE. Arch Surg 1983. Surgery 1996. Dunlop P. Leiberman DP. Musser DJ. Davies AH. Nicolaides AN. Nix ML.11:441-445. Radiology 1981. Aust N Z J Surg 1994. Sharp WJ. A prospective study of the deter- minants of vein graft flow velocity: implications for graft surveillance. 22. Eur J Vasc Endovasc Surg 1998. Allan PL. 31. Eur J Vasc Endovasc Surg 1997. Asymptomatic strictures in femoropopliteal vein grafts. Buth J. 46. Szilagyi DE. Sommeling C. Wilson YG. J Vasc Surg 1994. J Royal Coll Surg (Edinb) 1994. Dormandy JA. Nix AD. McLaughlin RL.64:684-687. Golledge J. Whittemore AD. J Vasc Surg 1993. Hodgson KJ. Bandyk DF. Machleder HI. A prospective comparison of ankle/brachial indices and color duplex imaging in surveillance of the in situ saphenous vein bypass. Dougherty MJ. Kunkemueller A. Variability of Doppler ankle pressure with arterial occlusive disease: an evaluation of ankle index and brachial- ankle pressure gradient. 25. et al.6:159-163. Raftery KB. Cuypers P. Kupinski AM. Wengerter KR. Tong Y.15:113-120.20:637-641. and histopathologic observations in femoropopliteal operations for atherosclerosis. McAfee-Bennett S. Noninvasive methods in the early detection of restenosis after percutaneous transluminal angioplasty in peripheral arteries. Thompson BW. 41. Ann Surg 1973. Buth J.14:125-133. Tong Y. The value of pre-discharge duplex scanning in infrainguinal graft surveillance. Duplex ultrasonography to diagnose failing arterial prosthetic grafts. angiographic.123:477-482.118:1043-1047. Cardiovasc Surg 1994. A low flow velocity predicts failure of femoropopliteal and femorotibial bypass grafts. Prognosis of the failed infrainguinal vascular graft. J Cardiovasc Surg 1992. Somjen G. Pilger E. Smith RF. Naylor AR. Greenhalgh RM. Impact of different patency criteria on the long-term results of femoropopliteal angioplasty: analysis of 106 consecutive patients with claudication.138:273-281. Morgan M. Kaebnick HW. J Vasc Interv Radiol 1995. Hageman JH. van den Bosch HC. Complications of arteriography. Br J Surg 1995. Synn AY. Vos LD. Luther M. Moody P. Bower TR. Causes of primary graft failure after in situ saphenous vein bypass grafting. and duplex ultrasonography after recanal- 275 . Murtagh A. Towne JB.82:1217-1221. success of secondary reconstructions. Idu MM. Arch Surg 1988. Landgraf H.18:981-989. Mali WPM. Economising vein-graft surveillance programs. 19. Currie IC. Detection and grading of femoro-distal vein graft stenoses: duplex velocity measure- ments compared with angiography. A prospective evaluation of sensitivity and specificity of the ankle/brachial index in the follow-up of superficial femoral artery occlusions treated by angioplasty. et al. Lambeth A. Manninen HI. Taylor SM. Moldenhauer P. Eur J Vasc Endovasc Surg 1998.12:596-600. Barnes RW. Minty I.84:25-32.11:388-392. Hessel SJ.8:661-666. 17. Abrams HL. J Vasc Surg 1992. van de Pavoordt ED. 42. Reid AW. Sacharias N. Cardiology 1994.16:19-27. 36. 39. Laborde AL. Kaufman JL.19:259-265. Taylor RS. Bell PR. Buckenham TM. 24. Buth J.182:243-246. Grigg MJ. Spadone DP. Winter-Warnars HAO. Cardiovasc Intervent Radiol 1997. Liermann D. 14. Dormandy JA. Duplex scan surveillance of infrainguinal prosthetic bypass grafts. Baker JD. Buckenham TM. Gilmour DG. Calligaro KD. Ray SA. Ann Surg 1989. et al. Duplex ultrasound surveillance of infrainguinal bypass grafts: auditing the process.12:284-290. Morgan A. McGrath C. Patterns of recurrent disease after recanalization of femoropopliteal artery occlusions. Matsi PJ.3:43-48. Bandyk DF. Tierala E.120:455-459. 33. Hanel KC.14:716-728. Ihlberg L. Semin Vasc Surg 1990. 45. J Vasc Surg 1990. 23. Belli AM. J Vasc Surg 1993. Woodburn KR. Sayers RD. Belkin M. et al. et al. J Vasc Surg 1991. Mannick JA. Br J Surg 1995. 30. Donaldson MC. Insonation and impedance analysis in graft surveillance. Fujitani RM. Marin ML. Clin Invest 1994. Panetta TF. Taylor T. Barkmeier LD. J Vasc Surg 1994.82:1222-1225. Teeuwsen W. Clinical outcome and restenosis following per- cutaneous transluminal angioplasty for ischaemic rest pain or ulceration. 15. Surgery 1981. Umphrey SE. 43. Disselhoff B. Hop WC. Cato RF. Bergamini TM. Color-flow duplex criteria for grading stenosis in infrainguinal vein grafts. Chen AY. Arteriographic complications in the DSA era. Davies AH. Ray SA. 37. J Vasc Surg 1988. Vroegindeweij D. Andrade B. Serial non-invasive studies do not herald postoperative failure of femoropopliteal or femorotibial bypass grafts. 16. Leather RP. 34. Eur J Vasc Surg 1989. Hemodynamic characteristics of failing infrain- guinal in situ vein bypass. Tordoir JM. The value of duplex scanning in the surveillance of infra-inguinal vein and synthetic grafts. 47. Mackey WC. Davies MJ. Taylor RS. Chang BB. 29. J Vasc Surg 1990. The characteristics and anatomic distribution of lesions that cause reversed vein graft fail- ure: a five-year prospective study. Percutaneous transluminal angioplasty: follow-up with treadmill exercise testing.39:297-300. Dix D.33:420-425. Surgery 1985. Waugh JR. Shah DM.15:432-438. Elliot JP. Harris PL. Decrinis M.178:232-246. The utility of duplex scanning in infrainguinal vein graft surveillance: results from a randomised controlled study. Biologic fate of autogenous vein implants as arterial substitutes: clinical. Sumner DS. The nature and importance of changes in toe-brachial pres- sure indices following percutaneous transluminal angioplasty for leg ischaemia. Hoballah JJ. Leopold PW. Eur J Vasc Endovasc Surg 1995. Hemodynamics of in situ saphenous vein arterial bypass. Belli AM. Lalak NJ. Initial experience with color-flow duplex scanning of infrainguinal bypass grafts. et al.10:237-242. Beattie DK. Royle J.20:257-262. Wolfe JH. Stam L. angiography. Worsey MJ.98:799-809. Kollath D. et al. Mills JL. Is surveillance to detect failing polytetrafluoroeth- ylene bypasses worthwhile? a twelve-year experience with ninety-one grafts.2:503-507. London NJ. Dall’olmo CA. Lepäntalo M. 27.89:134-137. Breslin P. Stonebridge PA. 26. Doer KJ. Eur J Vasc Endovasc Surg 1996. Hunt J. Doder S. 20. Radiology 1992. et al. 35. 28. TielBeek V.72:592-597. 44. Suggs WD. 32. 48. Baird RN. Ankle-arm index. van der Graaf Y. Vallbracht C. Gehring A. Royle JP. Hartmann A. 38. 40. Adams DF. MacDonald CM. Kelman J. Douglas HM. Sanchez LA.210:486-494. Have the results of infrainguinal bypass improved with the widespread utilisation of postoperative surveillance? Eur J Vasc Endovasc Surg 1996. 21. de Cossart LM. Towne JB. et al. 18.

This has been used in stud- ies based on outcome in the SWEDVASC registry. 12% were lost to follow-up. Compromise. One example is the accumulation of data from treatment of ALI. this was accomplished from early 1994 after a successive increase of the number of hospitals from its initiation in 1987. a Danish follow-up has con- vincingly shown that patients lost to follow-up had a significantly increased rate of graft thrombosis. initiate professional debate. and the study of time trends have an even higher impact and should be even more reliable. In a study of femoral distal bypass procedures. 50. whereas endovascular procedures are less frequently reported. Besides specific registries. Another drawback is that if all operative details are considered impor- tant.17(1):42-52. those lost to follow-up had mortality rates of 29% versus 19% and patency rates of 43% versus 68%. and this can be cumbersome. in countries in which it is possible to connect a national reg- istry to a population registry. it is undoubtedly true for all kinds of vascular and endovascular procedures.”1 Although this quotation comes from an editorial regarding carotid surgery. experiences have been presented from a New Zealand vascular registry.11 Also.14-16 Advantages of Vascular Registries Advantages of vascular registries include that surgeons frequently receive feedback. Buth J. such as the Vietnam Vascular Registry. Robinson ML. and the Norwegian NORKAR.3 More recent registries have been reported from the Society for Clinical Vascular Surgery4 and the Upstate New York Vascular Society. Impact of a color-flow duplex surveillance program on infrainguinal vein graft patency: a five-year experience. ization of occlusions in femoropopliteal arteries: comparison of long-term results. Regarding SWEDVASC. The value of duplex sonography after peripheral artery angioplasty in predicting subacute restenosis. J Vasc Surg 1993. limb amputa- tion. Summers TA. Problems With Vascular Registry Data Limitations may be that long-term results are not easily obtained. p. Marinelli DL. Conversely. long-term mortality rates would at least be achievable. Idu MM. followed by the FINN-VASC. An important difference between the Scandinavian and North American registries reported above is that the former are intended to cover entire countries. for instance using Reporting Standards. There is an apparent risk that patients not followed-up are worse than those who are followed-up. (See also Recommendation 77. Both FINNVASC and the Danish registry have found data after 30 days difficult to retrieve. Sacks D.6 Recently. Only those surgeons with accept- able results are ultimately qualified. and develop better decision making. Blankenstein JD. because nonintervention cases and amputa- tions are not recorded in current registries. but larger registries enabling comparisons between centers. has not yet been possible. which has expedited a change from hazardous thrombectomies to more reasonable thromboly- 276 .. Vascular Registry Data “It is the responsibility of every surgeon. 49. has to be the solution. Carefully performed single-center audits are obviously of value.. a registry protocol has to be extensive. which means that uniformity. Cardiovasc Intervent Radiol 1996. 190). de Gier P. and death. Compared with followed-up patients. from Northern Ireland and from The Netherlands (personal com- munication). therefore. reporting a large-scale computerized registration.19:234- 238.2 a very early experience came from the Cleveland Vascular Society.7-10 The Swedish Vascular Registry has a 1-year follow-up rate after surgery for chronic limb ischemia of 92%.162:179-183. Am J Roentgenol 1994.5 More recent experiences come from Scandinavia with the Swedish Vascular Registry (SWEDVASC) starting in 1987. improve self-assessment. Truyen E.to monitor his experience with care.13 One problem is that epidemiology data are not easily retrieved. between treatments. the Danish KARBASE. Longer-term follow-up would be beneficial but is not realistic.12 On average the 1-year follow-up rate in SWEDVASC now exceeds 90%.

17 A reason- able explanation may be that single centers may have different case mixes or that patients are lost to follow-up. corresponding increases are from 25% to 50%. compared with those who underwent an amputation. CRITICAL ISSUE 43: Influence of vascular registries on patient management There is a need to establish how vascular registries benefit the management of patients with periph- eral arterial disease on a population basis.4:313-314. The 30-day amputation and mortality rates range between 7% and 11% without significant differences between the various locations of lesions for surgical procedures. unfavorable results are reported less frequently than favorable results. As described.000 inhabitants are performed annually for CLI and reported to SWED- VASC—a figure lower than expected given that the proportion of new CLI patients ranges from 500 to 1. whether all patients are followed-up. and quality improvement measures then may be initiated. 277 . For CLI. Surgery 1969. which is a drawback. the late survival rate was cal- culated. The quotient IC/CLI varies between health care regions from 0. For the distal (femoropopliteal) above-knee region.18 It is therefore assumed that risk factors are of great importance in a full audit. 2. Important questions have been raised concerning the validity and reliability aspects of a registry. Whether all data need to be included is a matter of debate.000 per 100. whether a distal bypass procedure is of any lasting benefit for the patient or whether severe complications to carotid surgery might reduce the value of carotid endarterectomy. provided that they are involved in the process. 47% of interventional procedures registered in the SWEDVASC between 1987 and 1996 were performed using endovascular techniques.6 A registry may be a good guide to identify accumulation of “sentinel events” that need further investigation. for instance.23. the risk of this or amputation is higher after other kinds of vascular surgery.0 procedures per 100. This has been discussed after the 10-year experiences of the SWEDVASC. endovascular procedures now constitute 73% of cases.6 The concern is primarily whether all procedures have been included in the registry. Vietnam vascular registry: a preliminary report. References 1. Hughes CW. The 6-year cumulative survival rate was significantly higher for patients with a patent reconstruction after 1 year and also for those who did not have amputations. On average. From 11. In a follow- up of almost 5. For example. it is helpful to find out whether treatments are of value for a particular patient category. From the Swedish Vascular Registry.13 National vascular registries have a great impact on the attitude of vascular surgeons.7 to 37. Endovascular procedures are used increasingly. A vascular registry may allow deviations from standards to be detected more quickly. although there is a risk of myocardial infarction after surgery for intermittent claudication. It was recently shown that smoking increased the risk for both reoperation in ALI and elective aortic aneurysm surgery. Moore WS. and whether the data included are cor- rect and complete. Rich NM. fully audited study of more than 500 patients.65:218-226. In a recent. compared with 30% in 1987. Carotid endarterectomy: is it safe in the community? J Vasc Surg 1986.000 population annually. This was particularly true after surgery.000 surgical and endovascular procedures below the groin for CLI. In the proximal (aor- toiliofemoral) region. One of the difficult issues is to have risk factors reported. Hypertension had the same effect in emergency aortic aneurysm surgery. infrainguinal procedures constitute 88% of all procedures.sis. whereas after PTA only a patent segment indicated a better cumulative survival rate.62 to 1. Discussions and debates regarding the outcome of the registry variables might help to understand drawbacks of treatments or variations in outcomes. despite an occluded reconstruction. At the very least. but a larger propor- tion than expected is performed for IC. the true patency rate was less than 60%. Registries are of value to study time trends and differences between geographical areas. it is evident that as much as 49% of all procedures are performed for CLI. for example. patency rates of 70% to 90% have been reported for femoral distal bypass after 1 year.

The Iloprost Bypass International Study Group. Reoperations. Society for Vascular Surgery/North American Chapter.162:279-285. Troeng T. Eur J Vasc Endovasc Surg 1996. 7. Lepäntalo M. Ann Chir Gynaecol 1992. Ann Chir Gynecol 1996. Jensen LP. Salenius JP. Patients not included in medical audit have a worse outcome than those included. Jensen LP. Eur J Vasc Endovasc Surg 1998. Troeng T. Eur J Surg 1996. 16. Trends in vascular surgery: an evaluation of operative activity in Finland 1976-1992. 17.4:80-94. Swedish Vascular Registry (SWEDVASC). Semin Vasc Surg 1986. 278 . Zdanowski Z. J Vasc Surg 1984. Beven EG. Int J of Quality Health Care 1996. Gupta SK. Fitzgerald K. Avellone JC. Salenius JP. Lepäntalo M. The importance of complete follow-up for results after femoro-infrapopliteal vascular surgery. Frequency of repeated vascular surgery. A computerized vascular registry: experience of the Cleve- land Vascular Society.12:282-286. Salenius JP. Outcome and influence of age after infrainguinal revascularization in critcal limb ischemia. A survey of 7616 surgi- cal and endovascular Finnvasc procedures. Development of a computerized vascular registry for large scale use. 9.4:80-94. Eur J Vasc Endovasc Surg 1997. 14. Wall CA. Am J Surg 1983. National vascular registry in Finland-Finnvasc. Ann Chir Gynaecol 1992. Acute limb ischaemia: clinical assessment and standards for reporting. Reporting standards for endovascular surgery: should existing standards be modified for newer procedures? Semin Vasc Surg 1997.8:153-157. Nielsen OM.86:826-835.14:244- 251. Madsen PV. DePalma RG. 18.10:197-205. Finnvasc Study Group. Hertzer NR. Luther M.164(suppl)581. Albäck A. Vascular registers in Denmark based on personal computers. 15. Blumenberg RM. Leather RP. 3.1:594-600.81:253-256. 4. 8. Finnvasc STUDY GROUP.146:162- 163. Rutherford RB. Flanigan PD. 12. Stubberöd A. 13. Harjola PT. Lorentzen JE. Rutherford RB. Branagh M.85:225-229. Plecha FR. Rutherford RB. Suggested standards for reports dealing with lower extremity ischemia. 10. et al. 11. The Swedish Society for Vascular Surgery. 6. Schroeder TV. Schroeder TV. Effects of perioperative iloprost on patency of femorodistal bypass grafts.12:363-371. Elfström J. Pre- pared by the Ad Hoc Committee on Reporting Standards. Eur J Vasc Endovasc Surg 1996. Eur J Surg 1998. 5. Auditing Surgical Outcome: 10 years with the Swedish Vascular Registry (SWEDVASC). A study from Swed- vasc (the Swedish Vascular Registry). International Society for Cardiovascular Surgery. redo surgery and other site interventions constitute more than one third of vascular surgery. J Vasc Surg 1986. Karmody AM.81:257-260.16:137-141. Surgery 1979. Preliminary experience with a large scale vascular registry. Norgren L. Ylönen K. Karmody AM.

but all made at least a fair response. because relief of pain was obtained and amputations could be postponed.16 17 These and similar approaches may be of benefit in the management of patients with PAD. Transfusion of Ultraviolet Irradiated Autologous Blood This technique is widely used in patients with PAD in all stages. negative pressure application in peripheral arterial disease There is a need for properly designed studies to determine the benefit of limited walking. calf. 18% of diabetic patients with ulcers refractory to conventional treatment had complete heal- ing.2 3 In an uncontrolled study.4 The longest and largest expe- rience was reported by Fredenucci.11 12 Similarly. Other Treatment Modalities The treatment modalities considered here are not necessarily confined to CLI patients but are sometimes also used in claudicants. CRITICAL ISSUE 44: Limited walking.000 patients treated in over 70.1 Hyperbaric Oxygen The initial reports on the use of hyperbaric oxygen in patients with early gangrene of the legs were encourag- ing. Photohemotherapy consists of ultraviolet radiation of autologous blood. spinal cord stimulation (SCS) has been used since the late 1960s in 279 . The therapy is cumbersome. and negative pressure application in treatment of peripheral arterial disease.15 There is some evidence that increased blood flow in response to walking or intermittent venous compression may be contributed to further in some cases by the inhibition of veno-arteriolar reflex vasoconstric- tion or by endothelium-mediated mechanisms.000 ses- sions between 1966 and 1983.8-13 Limited walking in patients with chronic CLI was suggested in the Second European Consensus Document on Chronic Critical Limb Ischemia. intermittent pneumatic compression. Negative Pressure Application Limited walking and intermittent compression of the foot. including heparin infusion.14 and Foley reported on the treatment of gan- grene by walking. but their value needs to be assessed by properly designed clinical trials. even for several years. its use for treatment of ulcers due to CLI or for stump healing problems. application of external negative pressure to the leg increased skin blood flow in the foot of patients with PAD and increased walking distance in patients with IC. intermittent pneumatic compression. especially when inter- ventional treatment is not indicated. All of the reported studies were uncontrolled. Relief of rest pain and healing of limiting ulcers was observed in one third of patients after 4 to 6 weeks of treatment. Although a few uncontrolled studies showed an improvement of rheological properties of the blood. Seventy-five percent of atherosclerotic ulcers in nondiabetic patients improved sufficiently to allow patients to return home and resume daily activities. Epidural Spinal Cord Stimulation In some vascular centers in Europe. This treatment cannot be recommended until prospective controlled trials have shown it to be beneficial. Intermittent Venous Compression. and it is also unclear to what extent the clinical results can be attributed to concomitant therapy. Local treatment with hyperbaric oxygen Although local hyperbaric oxygen with topical hyperbaric oxygen chamber technique has undergone real waves of enthusiasm. or both have been shown to increase blood flow and foot TCPO2 in limbs with PAD. there is no controlled prospective study in patients with IC or CLI showing a clear clinical benefit for the treated patients.5 who collected data on more than 2. mostly in eastern countries of Europe and Rus- sia. Ambulation.6 7 remains to be more clearly demonstrated by randomized clinical trials.

p. healing of ischemic ulcers occurred. There was no difference in mortality between the two groups.22 Long-term pain relief was observed only in the SCS group. no evidence 280 . Chelation Therapy Chelation therapy has been promoted as a means to treat atherosclerosis and relieve symptoms of cardio- vascular disease. Sympathectomy in the Management of Critical Limb Ischemia Among patients with atherosclerotic arterial occlusion or thromboangiitis obliterans. Two controlled studies have been published on the efficacy of SCS in patients with inoperable severe CLI. However.47). patients with inoperable severe CLI were randomized to either SCS plus best med- ical treatment or best medical treatment only.18 In another uncontrolled study. although tissue loss was significantly less in the SCS group. RECOMMENDATION 101: Chelation therapy in peripheral arterial disease There is no scientific basis for the use of chelation therapy in the treatment of peripheral arterial dis- ease. p = 0. 244–1. and the appropriate place for this form of therapy remains to be determined. Four randomized. 94% of the 38 patients treated with SCS experienced pain relief. Prospective studies are needed to show the value of SCS20 21 (see also “Control of Pain”. 12 patients had continued pain relief and healing of ischemic ulcers.771).22 23 In the first study.3. patients with inoperable severe CLI were randomized to either SCS or analgesic treatment only with 18 months’ follow-up. double-blind. multicenter trials of ethylenediaminetetra-acetic acid (EDTA) in patients with PAD have been recently reviewed. there is no scientific basis to support these claims. This method is used not only to relieve leg pain but also as a means of maintaining circulation in the leg. RECOMMENDATION 100: Spinal cord stimulation in critical limb ischemia On current evidence.25 The best results were obtained by Persson26 among 37 patients who had an ABPI greater than 0. and the major amputation rate was insignificantly lower in the SCS plus medical treatment group (42% vs 48%. 209).24 The drug was not shown to be effective in treating the symptoms of claudication in any of these studies. In one uncontrolled study. Of these. immediate relief of rest pain was seen in 18 of 20 CLI patients. with improved microcirculatory flow suggested by capil- laroscopy. lumbar sympathec- tomy has been limited to patients with inoperable disease complicated by rest pain and tissue loss. and a subgroup analysis showed that patients without arterial hypertension had a lower amputation rate if treated with SCS. the real mechanism of action of SCS is unknown. Sympathectomy to treat ischemic rest pain Symptom relief has been reported in 47% to 71% of unselected patients.19 Nevertheless. frequent infusions of EDTA may produce severe hypocalcemia and therefore actually may be dangerous.22 In the second study. with limb salvage in 60% to 94%.patients with intractable pain caused by CLI. as an alternative to amputation. and in half of the patients. The technique involves implantation of an electrode at the level of L3–L4 and a pulse generator subcutaneously. Furthermore.23 Median follow-up was 605 days (interquartile range. Limb salvage rates did not differ at the end of the follow-up period. nor in improving the ABPI. spinal cord stimulation cannot be recommended in the treatment of critical limb ischemia.

and 11% required amputation. with only 6% obtaining relief. and (5) acceptable surgical risk for a retroperitoneal approach. (4) symp- tom relief after lumbar sympathetic blockade. 30 However. (3) absent neuropathy (diabetes). amputation rates were higher than in the rest pain group.of neuropathy. Disappointing results therefore can be expected when limb-threatening ischemia is unselectively treated by sympathectomy. The most common complications of lumbar sympathectomy are temporary neuralgia and inadequate clinical improve- ment. Sympathectomy as an adjunct for lower-extremity revascularization Because lumbar sympathectomy increases lower-extremity blood flow at least temporarily. In rare cases in which such revascularization procedures are not feasible because of inadequate run-off. (2) superficial tissue necrosis limited to digits. this technique is no longer practiced. 78% of patients had long-term relief of ischemic pain.26 again reported the best results in 22 patients who had adequate inflow. How- ever.3.26 RECOMMENDATION 102: Lumbar sympathectomy in critical limb ischemia There is currently insufficient scientific evidence for the selection of patients likely to benefit from lum- bar sympathectomy for the treatment of critical limb ischemia. Current indications for lumbar sympathectomy Primary indications for lumbar sympathectomy are limited to selected patients with inoperable distal arterial occlusive disease secondary to arteriosclerosis or thromboangiitis obliterans. it has been sug- gested as an adjunct during aortoiliac reconstruction in an attempt to improve outflow and graft patency. 281 . There have not been trials of the effect of sympathectomy on infrainguinal bypass patency or efficacy.25 Persson et al. with 35% to 62% of patients showing complete initial healing of the ischemic lesions. A benefit of temporary chemical sympathectomy provided by epidural anesthesia was suggested in one randomized trial that showed improved early infrainguinal graft patency. there is no established role for adju- vant surgical sympathectomy to improve bypass graft patency or efficacy. Current determination of inoperability differs with expertise and availability of saphenous vein. no neuropathy. Sympathectomy to treat tissue loss Less impressive results than for rest pain are generally noted.31 32 Currently. In this series. 77% had ulcer healing. lumbar sympathectomy may be considered in the patients with (1) ABPI greater than 0.28 29 Thus. and very limited tissue necrosis. two subsequent trials failed to show this effect. with a range of 27 to 38%. and no evidence of infection. but the requirement for a separate incision discourages this approach. whereas 70% required early amputation. In addition. subsequent randomized trials failed to show any difference in clinical outcome or graft patency when sym- pathectomy was added during aortofemoral bypass. and only 22% required amputation. The worst results were noted by Fulton and Blakely27 in 17 unselected patients undergoing sympathectomy.

Petukhov EB. Jivegard L. Surg Gynaecol Obstet 1978.353:1040-1044. 3. Stanley GD. Gardner AM. Cisek PL.96. 11. Linhart J. 6. Circulation 1957.37:451-4. 17. 2.8:335-337. Holm J. Barkmeier LD. J Vasc Surg 1990. Skinner JA.146:583-592.61(9):784-789. Am J Surg 1968. 13.19:1052-1058. Fischer BH. discussion 232-233. P312-314. 27. J Am Podiatry Assoc 1982. Liapis CD. Anderson LA. Clin Physiol 1996. J Vasc Surg 1997. 12. Woodcock JP. Amputation for premature peripheral atherosclerosis: do young patients do better? Lancet 1996. In: Smith G.2:1272.202:104-110. Holland BS. Evans WE. Risberg B. Slaf DW. The influence of hyperbaric oxygen in chronic arterial obstruction of the peripheral arteries. 30.155(2):76-78. Value of concomitant sympathectomy in aortoil- iac reconstruction: results of a prospective. Hyperbaric Medicine. Christopherson R. Foley WT. Shanik G. Strauss MB. ESES Study Group. Foot salvage and improvement of microvas- cular blood flow as a result of epidural spinal cord electrical stimulation. Engell HC.Am Surg 1995. 10. 21.143(6):755-760. randomised. J Cardiovasc Surg 1967. Veeramasuneni R.1:55-58. 20. Am J Surg 1982 Jun. Jivegard LE. Treatment of ulcers on the legs with hyperbaric oxygen. 23. Jacobs M. et al. Padberg FT. Illingworth CFW. Steyerberg EW. Hayes JP. Cohen AT.10(Suppl A):166-172. The effect of slow walking on the subcutaneous blood flow in the leg in patients with ischemic disease of lower limbs. Surgery 1980. Kerr RP.172:130-134. Anesthesia type does not influence early graft patency or limb salvage rates of lower extremity arterial bypass. 19. Norris EJ. The effect of hyperbaric oxygen on lower extremity ulcerations. Lancet 1999. increased blood flow and a possible limb-saving effect. Effects of ambulation on foot oxygen tension in limbs with peripheral atherosclerosis.44:16-20.25(2):226-232. et al. Fulton RL. Intermittent calf and foot compression increases lower extremity blood flow. Arch Surg 1977 Nov. 8. Karandashov VI. Diamond E. Pain relief. Persson AV. Parrott JC. Spincemaille GH. Fredenucci P. O’Hara PJ. J Mal Vasc 1985.5:323-328. J Dermatol Surg 1975. Faught WE. Br Med J 1962. Vasa 1976. Circulation 1997. European Working Group on Critical Leg Ischaemia. Satiani B. Epidural electric stimulation in severe limb ischemia. 22. Carlson CA. Augustinson LE. Lumbar sympathectomy: a procedure of questionable value in the treatment of arteriosclerosis oblit- erans of the legs. Sullivan TM. Miles J.6(Suppl A):1-32. Johnston KW: Predicting the success of a sympathectomy†: a prospective study using discriminant function and multiple regression analysis. Treatment of arterial occlusion under oxygen at two atmospheres pressure. Rosenfeld BA. Chelation therapy for peripheral arterial occlusive disease: a systematic review. Himmelstrup B. Effects of spinal cord stimulation (SCS) in patients with inop- erable severe lower limb ischemia: a prospective. ed. Augustinsson LE. Epidural versus general anesthesia: does anes- thetic management influence early infrainguinal graft thrombosis? Ann Vasc Surg 1998. Dan Med Bull 1990. Agerskov K. Jensen FB. Baker WH. Selection of patients for lumbar sympathectomy.6:101-105.12:354-360. controlled study. Forst MB.16:199- 208. for the ESES Study. randomized study. 32. The effect of a mechanical venous pump on the circulation of the feet in the presence of arterial obstruc- tions.Jan 12(1):65-69. Am J Surg 1996. 4. 16. Hlavova A. Augmentation of blood flow in limbs with occlusive arterial disease by intermittent calf compression. Ortenwall P. Second European Consensus Document on Chronic Critical Leg Ischaemia. 7. Koomen AR. Frank S. Karalkin AV. External negative thigh pressure: effect upon blood flow and pressure in the foot in patients with occlusive arterial disease. Jorning PJ.116:735-744.87:216-221. Kimmins S. Surg Clin North Am 1985. The regional hemodynamics in patients with chronic arterial insufficiency of the lower extremities after the transfusion of UV-irradiated autologous blood. Beven EG. Treatment of gangrene of the feet and legs by walking. Spinal-cord stimulation in critical limb ischaemia: a randomised trial. Eze AR. Angiology 1993. Pierce ET. Pomposelli FB.65:393- 403. et al. van Kleef M. et al. 15. Prerovsky I. 29. Trap-Jensen J. Beneficial effects of intermittent suction and pressure treatment in intermittent claudication. Tofft HP. Comerota AJ. Krajewski LP. Lin R. Eur J Vasc Endovasc Surg 1995. Carolan G. J Vasc Surg 1994.9(4)421- 425. Mansour MA. Blakeley WR. Gaskell P. Clarke W. Holm J. et al. 5. Spinal cord stimulation in peripheral vascular disease. 25. Walker PM. Rand SA. 14. Arterial flow enhancement by impulse compression. Ubbink DT.1031-1033. Barnes RW.348:1396.15:689-700. Aberdeen: Aberdeen University Press.Feb. Lewis KP. Eur J Vasc Surg 1992. Hertzer NR. Cass JL. van Bemmelen PS. Fox RH. Jacobs MJ. Habbema JD. The influence of anesthetic method on infrainguinal bypass graft patency: a closer look. Hyman SA. Oxygenotherapie hyperbare et arteropathies. 282 . 9. Hayes AC. Prospective randomized study of concomitant lumbar sympathec- tomy with aortoiliac reconstruction. LoGerfo FW. Morgan RH. Ann Surg 1985. Mattos MA. Vasc Surg 1991. 28. Mehlsen J.112(11):1325-1330. Himmelstrup H. Hodgson KJ. Beckers RCY. Winther K.25:8-15. Schunn CD. Ernst E. 31. Br J Neurosurg 1992. References 1. Hart GB. 24. Vestn Khir Im II Grek 1996. Spacil J. 26. Perler BA. Psaila JV.72:180-185. Responses of ischemic conditions to OHP. van Urk H. Tallis R. Beattie C. Carter SA. 18. Maixner W.

respectively. duplex ultrasonography. 26). Unreconstructable arterial disease is generally due to the progressive nature of the underlying atherosclerotic occlusive disease. Peripheral arterial occlusive disease is often severe and associated with rest pain and tissue loss. 283 .5 Loss of the heel renders revascularization useless for preservation of ambulation. Newer imaging techniques. These patients frequently have flexion contractures which form from the prolonged withdrawal response to the pain.6 The use of myocuta- neous free flaps for the replacement of necrotic muscle and skin has been reported as a technique for extend- ing limb salvage in selected patients. primary amputation provides optimal therapy. Most remain non-ambulatory after amputation.1 The complete absence of detectable distal vessels. In a recent study of more than 200 patients requiring amputation loss of the foot pads at the level of the digits.4 12 Finally. metatarsophalangeal joints and the heel was the indication for amputation in more than 75% of cases. their operative risk is significantly elevated. These patients require only a stable. especially in the setting of advanced distal ischemia associated with a low ABPI (<0.2 3 These patients are best served by primary amputation. Relief of pain and the removal of necrotic tissue and the creation of a stable limb can be most expeditiously achieved through primary amputation.4 Ulceration and necrosis of the weight-bearing surface of the foot are frequent causes of amputation.7 This aggressive vascular reconstructive effort. high-resolution digital angiography. p. pain-free limb that can be used for positioning in bed or wheelchair. Nonambulatory elderly patients represent a particularly challenging group. however. may be associ- ated with multiple procedures. have improved the ability of physicians to pre-operatively detect patent distal vessels that might serve as suitable recipient sites for the construction of a bypass. Aggressive vascular reconstruction does not pro- vide these patients with a stable and useful limb. regardless of the level. Amputation is considered as primary therapy for lower limb ischemia only in selected cases. Therefore the indications for amputa- tion.8-11 As vascular reconstruction in these patients does not result in a functional extremity. The surgical endeavor is significantly complicated by the pres- ence of the flexion contraction as well as the frequent presence of decubitus ulcers in the region of the greater trochanters. a recuperative period of more than 6 months and yields flap survival in the range of 50% to 62% and a functional foot in 50% to 86%. These patients require relief from pain of all etiologies. cere- brovascular and renal disease.30). Amputation Because patients with severe lower extremity ischemia have a high incidence of coexisting myocardial. PAD patients with terminal or near terminal comorbid conditions often have physical as well as ethical contraindications to aggressive lower-extremity arterial reconstructive surgery. Indications for Amputation Primary amputation Primary amputation is defined as amputation of the ischemic lower extremity without an antecedent attempt at revascularization. selection of the appropriate level and surgical management of these patients must clearly be established prior to the procedure to avoid the need for revision or re-amputation (see “Risk Factors for Major Amputation”. such as magnetic resonance angiography. suggests that vascular reconstruction is not possible and that major amputation is inevitable. using modern imaging techniques. Amputation affords these individuals expeditious relief of pain and a reduced hospital stay for definitive treat- ment of their ischemia. and more recently.

Unreconstructable vascular disease has become the most common indication for secondary amputation. The energy expenditure of ambulation increases as the level of amputation rises from calf to thigh. and enables older or more frail patients to walk independently. in many patients. unremediable flexion contracture of the leg.13-16 Re-do vascular reconstructive procedures are also of benefit for limb salvage and the preservation of ambulatory ability. initial attempts at vascular reconstruction of the lower extremity are indicated. minimizes the energy of ambulation.22 Although the presence of a palpable pulse in the major artery immediately above the level of amputation selected strongly suggests a high likelihood of primary healing. The appearance of ischemic or necrotic tissue or the absence of bleeding along the margins of transection 284 . Sec- ondary amputation is indicated when vascular intervention is no longer possible or when the limb continues to deteriorate despite the presence of a patent reconstruction. the complete removal of all diseased. palpably normal muscle and the absence of infection at the site selected for amputation. CRITICAL ISSUE 45: Selection of patients for primary major amputation There is a need for data to determine predictors for which patients are best treated with primary major amputation rather than bypass therapy for limb salvage. — a terminal illness or very limited life expectancy because of comorbid conditions. Attempts have been made to quantify skin temperature by objective measurement but this has been of little proven value.17 Unfortunately. the absence of a palpa- ble pulse does not in itself significantly reduce the likelihood of primary healing.21 Therefore. the lowest level of amputation that will heal is the ideal site for limb transection. — fixed.18 The goals of secondary amputation are the relief of ischemic pain. Historically. Numerous methods have been used to iden- tify this most distal site. Secondary amputation Revascularization of the lower extremity remains the treatment of choice for most patients with significant arte- rial occlusive disease. eliminating the possibility of further reconstruction. capillary refill. — necrosis of significant areas of weight-bearing portion of the foot.23 24 The selected site is usually further evaluated in the operating room by the surgeon who observes the appear- ance of the subcutaneous tissue and muscle and the presence or absence of bleeding from the transected tis- sues. Failure of a lower-extremity vascular reconstruction does not predispose the patient to a higher level of amputation. Factors that are most frequently considered include the warmth and integrity of the skin. the most distal level of amputation that will heal has been determined by clinical examination of the leg by the surgeon immediately before surgery.6 Persistent infection despite aggressive vascular reconstruction is the second most common diagnosis. the achievement of complete healing and the construction of a stump suitable for ambulation with a prosthesis. The antecedent surgical procedures do not worsen the overall condition of the leg. Preser- vation of the knee joint and a significant length of the tibia permits the use of lightweight prostheses. account- ing for nearly 60% of patients. the continued progression of atherosclerosis obliterates all major distal vessels. RECOMMENDATION 103: Indications for primary major amputation of the lower extremity Primary major amputation for critical limb ischemia is indicated in advanced distal ischemia with uncon- trollable pain or infection in the setting of: — unreconstructable arterial occlusive disease. infected and necrotic tissue.19 20 Therefore. Selection of Amputation Level It is the implicit goal of amputation to obtain primary healing of the lower extremity at the most distal level pos- sible.

several investigators reported primary heal- ing in nearly 100% of patients. Using a discriminatory arterial pressure of greater than 50 mm Hg at the level of amputation. Doppler pressure measurement As Doppler pressure measurements became standardized for the assessment of PAD.33 Selection of the appropriate level of foot amputation is not enhanced by determination of the ABPI. Eneroth and colleagues noted that an ankle pressure greater than 80 mm Hg and a toe pressure of greater than 45 mm Hg are associated with primary heal- ing of forefoot and toe amputations.22 37 39 40 Because skin perfusion may not be uniform. In a study of 161 consecutive diabetic patients who presented with foot lesions. most vascular specialists routinely obtain Doppler arterial assessments of patients with significant lower extremity ischemia and this diagnostic modality continues to be widely used as a supportive study for the determination of the site of amputation. several measurements across the site of amputation may be of benefit to determine areas of persistent ischemia.41 42 Overall.22 30 31 Patients with severe lower-extrem- ity arterial occlusive disease often have diffuse calcified atherosclerosis resulting in falsely elevated arterial pres- sures.22 Determination of ankle and toe blood pressures may provide information about the likelihood of healing of infra- malleolar amputations. 26). These investigators found no healing of a foot amputation with an ankle pressure of less than 50 mm Hg and no healing of a toe amputation with a toe pressure less than 15 mm Hg. sitting. Those with long-standing rest pain frequently have significant edema preventing accurate pressure mea- surement. In a study of 233 consecutive diabetic patients with foot infection.30 However. may not be measurable in patients with toe or foot lesions requiring excision therapy because of calcification of the distal vessels or the presence of ulceration or gangrene at the site of measurement. These pressures. is frequently used to standardize the result. Initial results reported more than a decade ago suggested that this non-invasive diagnostic study could identify the appropriate level of amputation. Modifications of this diagnostic study include the continuous recording of TCPO2 before and during the inhalation of oxygen34-36 and with the patient in the supine.38 Using a higher discriminatory pressure at the site of amputation may improve the chances for primary heal- ing. transcutaneous oxygen pressure measurements may improve the surgeon’s clinical ability to determine the lowest amputation site that will heal primarily. With a TCPO2 pressure of greater than 35 mm Hg. unfortunately. A reference electrode. usually on the chest. This electrode heats the under- lying skin slightly to induce a hyperemia.are used as indications to attempt amputation at a higher level. several surgical groups have reported healing in more than 95% of patients. When made by experienced surgeons. Lars- son and colleagues32 noted that ankle and toe pressures could not be obtained in 24% and 27%. Wagner and colleagues. 285 .36 37 The ability of the transcutaneous measurement of capillary skin oxygen pressure to predict the likelihood of healing of a major amputation is dependent upon the discriminatory value chosen. p. clinical determination of the amputation level results in uninterrupted primary healing of the below-knee stump in 75% to 85% and the above-knee stump in 85% to 93% of cases25-27 (see also “Risk Factors for Major Amputation”. Transcutaneous oxygen measurement Transcutaneous oxygen determination by a small electrode attached to the skin has been used for the detec- tion of viable skin and appropriate level of amputation for more than two decades. respectively.24 28 29 Despite these optimistic early reports. It then records the increase in oxygen delivery as pressure. in a study of 109 amputations. respectively. A TCPO2 value of greater than 20 mm Hg at the site of amputation indicates an 80% likelihood of primary heal- ing. found that Doppler pressure measurements were unreliable for the selection of amputation level. and leg elevated positions. they were applied to the evaluation of the extremity requiring amputation. others have reported little benefit from the pre-operative Doppler assessment of patients requiring amputation.

The Lisfranc.54 A return to independent ambulation is the ultimate challenge for patients undergoing major amputation of the lower extremity. 26). but can occasionally be useful in avoiding a below knee amputation. a through-knee ampu- tation has the advantage of a long lever for mobility and balance in bed in patients who are unlikely to be able to use a prosthesis. p.52 Overall. These include laser Doppler velocimetry which measures the velocity of skin capillary blood flow.22 Each of these tests have had proponents. The air is then slowly released from the cuff and the pressure at which capillary flow resumes is detected by the photoelectric cell is considered the skin perfusion pressure. 194). With a discriminatory skin pressure of greater than 20 mm Hg as determined by photoelectric cell. 28) and relatively high risk of re-amputation is detailed earlier (see “Major Amputation”. Of these. but.49-51 A major amputation. Major amputations are usually performed at the below-knee or above-knee level.46 47 and fluoroscein dye assessment of skin perfusion.Skin perfusion pressure measurement Photoplethysmographic skin perfusion pressure measurement is a simple test performed by fixing a photo- electrode on the patientís skin at the proposed site of amputation and then surrounding it with a blood pressure cuff. Armstrong and colleagues reviewed the outcome of 1043 patients who had foot amputations. p. nearly 40% required a more proximal foot amputation to treat a non-healing distal amputation. 17% sub- sequently had a below-knee amputation.44 Other diagnostic tests Numerous other diagnostic tests designed to improve the rate of primary healing of a major amputation have been reported. It is essential that antibiotic cover is provided for all patients undergoing amputations for ischemia to prevent gas gangrene.45 isotopic measurement of skin perfusion with xenon-133. 60% required a second amputation. will require a prosthesis and meticulous technique is essential to ensure a well-formed and well-perfused stump with soft tissue covering the transected end of the bone. or cost. Technical Principles of Amputation Ray amputation48 and transmetatarsal amputation are the standard procedure distal to the ankle.43 A variant of this test uses a laser Doppler to detect the presence of flow in the skin.23 43 For laser Doppler pressure determination. healing in more than 90% of patients can be expected. p. In a study of 90 diabetic patients who had a great toe amputation. that is above the foot. 21% had a third. Outcome The outcome of major amputation (see “Fate of the Amputee”. because of technical difficulty. The cuff is inflated beyond systolic pressure eliminating all cutaneous skin flow and reducing skin perfusion pressure to zero. and 7% had a fourth.53 Distal ischemia is a frequent cause of non-healing transmetatarsal ampu- tations requiring re-treatment by major amputation in patients with diabetes. and available information is limited (see “Microcirculatory Investigations”.44 This measurement has been used to select the appropriate site of amputation. p. Chopart and Syme amputations are now rarely used. they have not been widely used. significant variability of the test result. The same discussion applies to forefoot and toe amputations. and “Summary: Major Amputation”. Patients with a well-healed below-knee amputation stump have a 66% to 81% likelihood of inde- 286 . 27. a skin perfusion pressure of greater than 30 mm Hg correlated with primary healing of the major amputation in all patients. CRITICAL ISSUE 46: Diagnostic tests for selection of amputation level There is a need for prospective studies to demonstrate that diagnostic tests improve selection of ampu- tation level over clinical judgment. It is possibly also indicated in extremely ill patients in whom a quick and less traumatic proce- dure crucial. However. Similarly.

Karanfilian RG. 26). Surgery for limb threatening ischaemia: a reappraisal of the costs and benefits. Cronenwett JL.74:130-133. J Vasc Interv Radiol 1995. Reifsnyder T. Goldberg JA. el Ferzli G. Plast Reconstr Surg 1993.66 67 Phan- tom limb pain. Bloom RJ.102:1999-2005. Watkin G. In: Yao JST. Seeger RW. eds.12:65-69. Tukiainen E. Susak Z. Results of revascularization and amputation in severe lower extremity ischemia: a five-year clinical review.to 6-month intervals with physical examination and ABPI to identify and correct worsening ischemia.57-62 Independent ambulation with a prosthesis has been reported in 44% to 57%. Relationship of severity of lower limb peripheral vascular dis- ease to mortality and morbidity: a 6 year follow-up study. 2.92:904-911. Evans L. Relative risks of limb revascularization and amputation in the modern era. Leers SA. Padberg FT. Eur J Vasc Endovasc Surg 1995. Jagger C. 4. Fine NA. Jacobsen SJ. 8. 6. 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Management algorithm for patients with CLI 290 .