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Cardiovasc Intervent Radiol (2013) 36:936–942

DOI 10.1007/s00270-012-0507-9

CLINICAL INVESTIGATION ARTERIAL INTERVENTIONS

Recanalization of Acute and Subacute Venous and Synthetic


Bypass-Graft Occlusions With a Mechanical Rotational Catheter
Christian Wissgott • Peter Kamusella •

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

Abstract Conclusion PMT with the Rotarex atherothrombectomy


Purpose Percutaneous mechanical thrombectomy (PMT) catheter represents a safe and effective option in the
is now established as an alternative treatment of acute treatment of acute and subacute femoropopliteal bypass
arterial occlusions in addition to fibrinolysis and surgical occlusions because it can quickly restore blood flow.
thrombectomy. The objective of this retrospective study
was the investigation of a rotational atherothrombectomy Keywords Mechanical thrombectomy  Bypass
catheter in terms of safety and efficacy in the treatment of recanalisation  Atherothrombectomy  Acute occlusion
acute and subacute femoropopliteal bypass occlusions.
Materials and Methods Forty-two patients (average age
65.8 ± 9.1 years) with acute (\14 days [n = 31]) and Introduction
subacute (14–42 days [n = 11]) femoropopliteal bypass
occlusions were treated consecutively with a rotational Acute and subacute ischemia of the limbs is caused by a
debulking and removal catheter (Straub Rotarex). The decrease in arterial perfusion to a limb. In addition to the
average occlusion length was 28.4 ± 2.9 (24–34) cm. risk of damage to or loss of a limb, this can give rise to life-
Thirty-four (81 %) patients underwent venous bypass, and threatening complications for the patient due to anaerobic
8 (19 %) patients underwent polytetrafluoroethylene local and ultimately systemic metabolic conditions.
bypass. Therefore, in additional to general intensive medical
Results The technical success rate was 97.6 % (41 of 42). measures, therapeutic management will include making a
In 1 patient, blood flow could not be restored despite the decision regarding the most rapid, suitable revasculariza-
use of the atherothrombectomy system. The average cath- tion measure [1]. The situation is similar in patients with
eter intervention time was 6.9 ± 2.1 (4–9) min. Ankle- femoropopliteal bypasses, especially P1 bypasses where it
brachial index increased from 0.39 ± 0.13 to 0.83 ± 0.11 makes no difference whether the bypasses are venous or
at discharge and to 0.82 ± 0.17 after 1 month (p \ 0.05). polytetrafluoroethylene (PTFE) [2–4].
There were a total of 2 (4.8 %) peri-interventional com- Acute occlusions are divided into three stages according
plications: One patient developed a distal embolism, which to the criteria of the TASC Working Group, but so far,
was successfully treated with local lysis, and another there are no clear therapy recommendations [5]. Local lysis
patient had a small perforation at the distal anastomosis, is indirectly recommended in stages I and IIa with
which was successfully treated with a stent. mechanical thrombectomy as an alternative. In cases of
acute, limb-endangering ischemia (stages IIb and III),
immediate recanalization is necessary, usually by vascular
C. Wissgott (&)  P. Kamusella  R. Andresen surgery, but mechanical thrombectomy also provides an
Institute of Diagnostic and Interventional Radiology/ alternative in this case in particular.
Neuroradiology, Westküstenklinikum Heide—Academic
Because the results of vascular surgery are often not
Teaching Hospital of the Universities of Kiel, Lübeck
and Hamburg, Esmarchstrasse 50, 25746 Heide, Germany completely satisfactory and are also associated with
e-mail: cwissgott@wkk-hei.de increased morbidity and mortality due to the necessary

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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.

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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

Fig. 3 A–C Final result after recanalization with 8F Rotarex system


Fig. 2 A, B Documentation of recanalization of the bypass occlusion without any relevant residual stenosis. No additional treatment was
with an 8F-Rotarex-System necessary. No distal embolization was noted in the runoff vessels

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C. Wissgott et al.: Recanalization of Bypass-Graft Occlusions 939

A driving and conveying screw similar to an ‘‘Archimedes Medication


screw’’ operates the catheter head, produces the suction
power, and evacuates the loosened material. This helix All patients received 100 mg acetylsalicylic acid (ASA)/d
running along the inside of the catheter rotates at before the intervention if long-term medication was not
40,000–60,000 rpm and transfers this rotation to the already being given. During the intervention, as already
working head. The helix is driven by a magnetic coupling mentioned previously, 5,000 IU heparin were given, and
between the motor and the catheter. The rotation of the long-term medication with ASA 100 mg/day was given
screw drives the rotational head and at the same time postintervention. In the case of a stent implantation, 75 mg
creates a permanent partial vacuum inside the catheter, clopidogrel (Sanofi Aventis, Germany) was also given for
which aspirates thrombotic material into the cutting win- 6 weeks after a saturation dose of 300 mg was reached.
dow, where it is broken up, and finally transports it through
the conveyor screw into a collecting bag. The aspiration Follow-Up
performance is approximately 1.25 ml/s with the 8F system
or 0.75 ml/s with the 6F system. All patients were routinely followed-up up before dis-
charge and after 1 month with clinical examination and
determination of the ankle-brachial index (ABI) as well as
Intervention
optional color-coded duplex sonography. The follow-up
examinations were performed either by an interventional
All interventions were performed by two interventional
radiologist or a vascular surgeon.
radiologists. After performing an angiogram using standard
technique, the nominal diameter of the vessel in the target
Statistics
lesion was estimated, and it was decided which rotational
catheter caliber to use to perform the procedure. Target
All values are given as means ± SD or number (percent)
lesions with a maximum nominal vessel diameter of 5 mm
of patients. Significance was determined by means of
must be treated, according to the manufacturer’s instruc-
Student t test. The statistical analysis were performed by
tions, with the Rotarex 6F. Those with a minimum nominal
the investigators.
vessel diameter of 5–8 mm must be treated with the Rotarex
8F. The smallest treatable vessel diameter is currently 3 mm
(with the Rotarex 6F), whereas the upper limit is 8 mm Results
(Rotarex 8F). A 6F or 8F sheath was used depending on the
caliber of rotational catheter to be used. Finally, the occlu- After Rotarex atherothrombectomy, the technical success
sion was passed with a 0.035-inch hydrophilic coated rate was 97.6 % (41 of 42 patients). In the 1 remaining
guidewire (Terumo stiff) using road-map imaging. This was patient, no blood flow could be restored using Rotarex
then exchanged for the 0.018-inch hydrophilic, Teflon- atherothrombectomy despite successful wire probing.
coated guidewire (Angiotech [Denmark] or Straub Medical Therefore, 24-hour local lysis was also performed with
AG) included with the Rotarex intervention set through a 4F alteplase (Actilyse; Boehringer Ingelheim, Germany). The
straight catheter (Boston Scientific). After this, 5,000 IU residual stenosis was seen after lysis was [95 %.
heparin (UFH) were given. The Rotarex catheter was After percutaneous mechanical thrombectomy (PMT)
introduced and activated shortly above the occlusion. Then alone, a good recanalization result without relevant residual
the occlusion was passed, under fluoroscopy, with small stenosis was achieved in 26 patients (61.9 %); balloon
forward and backward movements at an advancement speed dilatation was ultimately performed in 16 patients (38.1 %);
of 5 mm/s. After complete passage, the catheter was pulled and 5 patients (11.9 %) also underwent stent implantation
back, and a control angiogram was performed. Depending on (Absolute Pro, Abbott Vascular [n = 2] or Maris, Invatec
the result, as many as three Rotarex passes were conducted. Medtronic [n = 3]). PTA or stent implantation was neces-
Finally, any remaining stenosis[30 % was treated by means sary either on the proximal or distal anastomosis of the
of percutaneous transluminal angioplasty (PTA) or, if nec- bypass. No residual thrombosis of the bypass was detectable
essary, additional stent implantation (self-expanding nitinol after rotational atherothrombectomy in any of the patients
stents) (Figs. 1–3). experiencing technical success (Table 2). The average
Technical success was defined as recanalization with occlusion length was 28.4 ± 2.9 (range 24–34) cm.
residual stenosis \50 % on angiographic control. After The total treatment time with the Rotarex athero-
completing the intervention, the puncture was closed using thrombectomy catheter, from puncture start to full hemos-
a percutaneous closure system (StarClose or Perclose- tasis of the puncture site, was 52.7 ± 13.2 (range
Proglide [both from Abbott, IL, USA]). 35–75) min. The average catheter application time from first

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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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