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DOI 10.1007/s00270-012-0507-9
Reimer Andresen
Received: 31 July 2012 / Accepted: 29 September 2012 / Published online: 14 November 2012
Ó Springer Science+Business Media New York and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2012
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C. Wissgott et al.: Recanalization of Bypass-Graft Occlusions 937
anesthesia [6, 7], local intra-arterial lysis has prevailed in Table 1 Risk profile and lesion characteristics of patients (n = 42)
randomized trials, at least in stages I and IIa, as the stan- Characteristics Value (%)
dard procedure [8–12].
However, even lysis therapy is associated with systemic Mean age ± SD/range (year) 65.8 ± 9.1/48–81
complications. It is complex and cost-intensive because Sex
patients must receive intensive medical care, some for Male 22 (52.4)
several days afterward the procedure [13]. Female 20 (47.6)
Currently various mechanical thrombectomy systems, Risk factors
which have the advantage of lower invasiveness, lower Smoker 26 (61.9)
complication rates, and shorter duration of treatment, are Arterial hypertension 30 (71.4)
available as an alternative treatment. Several devices are Hyperlipoproteinemia 16 (38.1)
offered and can be divided into two different physical Diabetes mellitus 21 (50.0)
action principles: (1) rotational debulking with or without Clinical classification
removal of the debris and (2) rheolytic thrombectomy Acute (\14 days) 31 (73.8)
[14–19]. Subacute (\42 days)a 11 (26.2)
The purpose of this study was to examine the results of Stage a 18 (42.9)
treatment of acute femoropopliteal bypass occlusions by Stage IIa 20 (47.6)
means of a mechanical rotational debulking and removal Stage IIb 4 (9.5)
system (Rotarex, Straub Medical AG, Switzerland) in Lesion characteristics
terms of efficacy and safety. Occlusion length/range (cm) 28.4 ± 2.9/24–34
Venous bypass 34 (80.9)
PTFE bypassb 8 (19.1)
Materials and Methods Access
Antegrade 34 (80.9)
Patients Crossover 8 (19.1)
6F 25 (59.5)
From 2008 to 2012, 42 patients with acute (start of
8F 17 (40.5)
symptoms \14 days [n = 31]) and subacute (start of
a
symptoms \42 days [n = 11]) femoropopliteal bypass Classification according to Rutherford for acute vessel occlusions
b
occlusions were consecutively treated with a rotational PTFE bypass
atherothrombectomy catheter (Rotarex). All cases were
above-knee P1 bypasses. Thirty-four (81 %) patients selected in 8 cases (19 %) because of large preponderance
underwent venous bypass, and 8 (19 %) patients underwent in these patients (Table 1). All patients were thoroughly
PTFE bypass. The mean age of the patients was informed about the treatment and gave their consent in
65.8 ± 9.1 years. writing (Figs. 1, 2, 3).
Patients were classified according to Rutherford criteria
[20] for acute ischemia. Eighteen patients (42.9 %) were Mechanical Thrombectomy
stage I; 20 patients (47.6 %) were stage IIa; and 4 patients
(9.5 %) were stage IIb. Table 1 lists the risk profiles and The system consists of three components: the Rotarex
lesions characteristics of the patients. catheter, a motor that is also used as a handle, and an
The primary inclusion criteria were as follows: (1) acute electronic control unit. The system is controlled by a
or subacute ischemia in stages I to IIb, (2) no relevant guidewire and is available in 8F and 6F sizes.
upstream lesion, (3) at least 1 peripheral outflow vessel, The Rotarex catheter is activated and, by rolling it back
and (4) safe intraluminal guidewire passage. Primary and forth between the fingers, pushed forward into the
exclusion criteria were as follows: (1) lack of a patent occlusion. The chisel-like facets on the catheter tip break
peripheral outflow vessel and (2) no intraluminal guidewire down the material. The catheter must be advanced slowly
passage possible. The decision for the percutaneous ath- to allow for the detached fragments to be hurled against the
erothrombectomy was made by a team comprised of an vessel walls by the strong vortex caused by the rotating
interventional radiologist, a vascular surgeon, and an head, where they loosen additional occlusion material on
angiologist. the walls without the rotating head of the catheter having to
The intervention was performed on 34 patients (81 %) touch them. The loosened fragments are then aspirated by
using the preferred antegrade puncture technique, and the strong suction, further broken up inside the head, and
contralateral access using the crossover technique was finally transported to a collecting bag outside of the body.
123
938 C. Wissgott et al.: Recanalization of Bypass-Graft Occlusions
Fig. 1 Preinterventional
angiogram of 74-year-old
woman with an acute occlusion
of a femoropopliteal bypass-
graft. The proximal and distal
anastomes were previously
stented
123
C. Wissgott et al.: Recanalization of Bypass-Graft Occlusions 939
123
940 C. Wissgott et al.: Recanalization of Bypass-Graft Occlusions
Table 2 Results after Rotarex thrombectomy et al. [21] and with those of further studies of the treatment
Results Value (%)
of acute and subacute occlusions with the Rotarex System
[22–24]. For cross-over procedures, we used a special
Technical success rate 41 (97.6) introducer (Balkin Up; Cook). This made successful con-
Rotarex (stand alone) 26 (61.9) tralateral application of the rotational catheter possible in
Additional procedures all cases. In an earlier study with the system, breakage of
PTA 16 (38.1) the driving and conveying screw during cross-over appli-
Stent (self-expandable)a 5 (11.9) cation had been reported [21], but we did not experience
Complications any breakage of the driving and conveying screw in any of
Distal embolism 1 (2.4) our cases, and this result is also confirmed by further
Perforation 1 (2.4) studies [24–26]. The technical success rate with the Rota-
a
Nitinol stents (Maris [Invatec] or Absolute Pro [Abbott])
rex system is also better than that after conventional local
lysis [8, 9].
insertion to final removal was 6.9 ± 2.1 (range 4–9) min After successful removal of the occlusion material, a
with 2.1 ± 0.4 (range 1–3) passages being conducted. balloon dilatation was necessary in 38.1 % of cases. All
There was a significant clinical improvement in ABI cases of additional treatment were located in the area of the
from before the intervention (0.39 ± 0.13) to 0.83 ± 0.11 proximal and/or distal anastomosis. The bypass itself was
at discharge and 0.82 ± 0.17 after 1 month (p \ 0.05). recanalized without residual thrombi in all technically
The average length of hospital stay was 2.2 ± 0.71 successful cases. In addition, stent implantation was nec-
(1–4) days. During the follow-up observation period, no essary in 11.9 % of patients due to residual stenoses. In the
reinterventions on the affected limbs were necessary. studies already cited previously [21–23], the rate of addi-
tive therapies was higher, but these studies did not deal
Complications with treatments of femoropopliteal bypasses exclusively.
Only Duc et al. [27] reported in a study on 38 patients of
There were a total of two (4.8 %) complications. One whom only 2 patients required additional PTA and 5
patient developed a distal embolism in the area of the distal patients stent implantation. The overall low rate of additive
anterior tibial artery, which was successfully treated with therapy compared with local lysis confirms the potential of
local short-term lysis (10 mg Alteplase for 20 min). At the the Rotarex catheter to also function as an ‘‘atherectomy
time, there was no critical ischemia because the posterior system’’ and treat the underlying stenosis, the ‘‘culprit
tibial artery was properly perfused after recanalization of lesion,’’ at the same time. Some studies have already
the bypass. The other patient developed a small perforation shown the effectiveness of the Rotarex catheter in the
with mild contrast medium leakage in the area of the distal treatment of chronic lesions with a technical success rate of
anastomosis, which was successfully treated with pro- well over 90 % [25, 26, 28]. The system has proven to
longed balloon dilatation and stabilization of the vessel safely and effectively debulk and remove occlusion mate-
wall with a bare metal stent (6 9 60-mm Maris, Invatec rial from acute to chronic occlusions while unmasking and,
Medtronic). There was no pseudoaneurysm or arteriove- at least partially, treating the culprit lesion. Hence, we have
nous fistula. There were no amputations or deaths during started to refer to this device as an ‘‘atherothrombectomy’’
the follow-up observation period (Table 2). system.
No reintervention was necessary during the observation
period. There were no amputations or deaths. These values
Discussion are significantly better than those after conventional lysis
therapy or even after vascular surgery, where reinterven-
In this article, we report on the results of the treatment of tion rates have been reported as 35 % [2, 3, 8, 9]. Our
acute and subacute occlusions of femoropopliteal bypasses amputation-free survival rate (100 %) is comparable with
using a mechanical rotational debulking-and-removal sys- the results of Zeller et al. and Duc et al. [21, 27].
tem for PMT. Treatment time with the Rotarex atherothrombectomy
PMT was primarily conducted with a 6F system because system is approximately 52.7 ± 13.2 min and is therefore
the majority of the bypasses treated were venous femoro- significantly faster than conventional local lysis, which
popliteal bypasses with a lumen of approximately 5 mm. takes 24 h on average [8, 9], Surgical thrombectomy also
The venous bypasses and the PTFE bypasses with a lumen requires, on average, more time than Rotarex treatment, is
[5 mm were treated with an 8F system. Overall, we were significantly more invasive, and is also associated with
able to achieve a technical success rate in our cohort of increased complication rates, among other things, due to
97.6 %, which is comparable with the results of Zeller the necessary anesthesia [8].
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C. Wissgott et al.: Recanalization of Bypass-Graft Occlusions 941
The complication rate of 4.8 % observed by us is sig- safe and effective alternative to conventional lysis or vas-
nificantly lower than that seen with conventional lysis and cular surgery. The advantages of the Rotarex atheroh-
vascular surgical therapy [7–9, 12], and is also less than the rombectomy catheter are (1) no relative or absolute
19 % rate reported by Zeller et al. [21]. Both complications contraindications are known and (2) treatment time is
that occurred were successfully treated during the inter- significantly shorter. Therefore, this method also offers a
vention and did not lead to a longer in-hospital stay for the good treatment choice for patients for whom local lysis is
patients. contraindicated or who have an increased surgical risk.
One advantage of this mechanical debulking-and-removal
system compared with lysis therapy is the lack of systemic Conflict of interest None.
complications, such as bleeding in the brain and kidneys, etc.,
which have been reported in the large lysis studies [8, 9].
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