Key words mechanical thrombectomy - obstruction/occlusion - vascular - rotarex - interventional
procedures - arteries
Introduction
Peripheral artery disease (PAD) is a broad spread disease and manifests as impaired
blood flow to the extremities due to gradual arterial stenosis or complete occlusion
[1 ]
[2 ]
[3 ]. Along with medical management and surgical therapy, endovascular interventional
therapy is a mainstay of treatment for PAD, particularly for patients with advanced
disease and comorbidities predictive of poor surgical outcomes. Advancements in traditional
percutaneous procedures include mechanical thrombectomy, which detaches the occluding
material, aspirates it without additional suction, fragments it, and drains it into
a collection bag [4 ]
[5 ]. Mechanical thrombectomy excels in this regard, mainly as it may not require pharmacologic
lysis and, therefore, can be used in patients with contraindications to thrombolytics,
including recent stroke, one of several pathologies for which patients with PAD are
at increased risk [6 ]
[7 ]. It has been hypothesized, but not yet scientifically proven, that debulking of
vessels in high-grade stenosis or chronic total occlusion (CTO) allows the removal
of both superimposed acute and better-organized chronic thrombotic material, resulting
in less stress on vessel walls than either balloon angioplasty alone (POBA) or drug-coated
balloon angioplasty (DCB) as a therapeutic approach. Vessel preparation via rotational
thrombectomy (RT) is expected to reduce the risk of flow-limiting dissection and mural
recoil and improve drug uptake into the vessel wall [8 ]
[9 ].
The existing data for RT are convincing. However, these studies often do not assess
outcomes in more complex real-world settings where RT is used in combined procedures
with additional thrombolysis to treat native vessels or occluded limb bypasses [10 ]
[11 ]
[12 ]. However, real-world data are lacking, and most studies are based on selected cohorts,
which often have a particularly favorable distribution pattern of arterial occlusions,
or on small retrospective cohorts.
The aim of this study is to evaluate the safety and efficacy of RT in a real-word
cohort that included all patients treated with RT at our institution. This included
patients with acute, subacute, and chronic infrarenal arterial occlusions of native
vessels, in-stent occlusions, and bypass grafts.
Materials and methods
Patient cohort
The retrospective study received institutional review board approval with a waiver
of informed consent (No.XXX). A retrospective search of the clinical data system since
the introduction of RT (Rotarex, BD) at a single institution in December 2010 through
January 2020 yielded 405 RT procedures in 300 patients. The final study cohort comprised
397 RT procedures in 293 patients with all kinds of stages of PAD (peripheral arterial
disease), since procedures in visceral arteries, occluded TIPS, and incomplete datasets
were excluded, see [Fig. 1 ]. The mean age of the subjects was 69.8 ± 12.0 years, and 64.8 % (n = 190) were male.
Acute (intervention < 3 days after symptom onset) events accounted for 47.5 % of cases
(n = 182), subacute (intervention 3–14 days after symptom onset) and acute-on-chronic
(clinically relevant chronic stenosis with additional acute occlusion) events for
22.2 % of cases (n = 85), and chronic (intervention > 14 days after symptom onset)
events for 30.3 % of cases (n = 116). For 3.5 % of patients (n = 14), the age of occlusion
could not be definitively determined. Rutherford categories 3 (23.5 %, n = 69) and
4 (32.1 %, n = 94) were most prevalent. Cardiovascular risk factors were frequently
present, as summarized in [Table 1 ]. The median diameter of the reference vessels as measured via DSA (n = 373) was
6 mm (range: 2.5 to 12 mm). Further characteristics of the target lesions are summarized
in [Table 2 ]. The median procedure duration was 78 minutes (interquartile range 55 and 106.25).
Cross-over vascular access was performed in 55.3 % of cases (n = 219) and antegrade
access was performed in 41.9 % (n = 166). 2.8 % of accesses (n = 11) were performed
retrograde from the popliteal or tibial-pedal arteries, retrograde from the brachial
artery, or both cross-over from the contralateral common femoral artery and retrograde
from the ipsilateral popliteal or tibial-pedal arteries. A 6F RT catheter was used
in 92.2 % of cases (n = 365); an 8F catheter was used for the remaining cases. Additional
catheter-directed thrombolysis was performed in 32.0 % of procedures (n = 127). The
timing of thrombolysis was available for 123 procedures. Among these cases, thrombolysis
was performed before RT in 8.9 % (n = 11), peri-interventionally in 13.0 % (n = 16),
after RT in 58.5 % (n = 72), or before and after RT in 19.5 % of cases (n = 24). The
thrombolytic was available in 120 cases: urokinase was used in 65.0 % of cases (n = 78),
alteplase in 32.5 % (n = 39), and abciximab or argatroban in 2.5 % (n = 3). Patients
underwent thrombolysis for a median of 18.3 hours (interquartile range: 8.3 to 21.3 hours).
RT was followed by POBA in 68.0 % of cases (n = 270), DCB angioplasty in 37.5 % (n = 149),
and stenting in 41.1 % (n = 163).
Fig. 1 Subject enrollment data. All subjects were enrolled beginning December 2010 (initiation
of rotational thrombectomy at study institution) through January 2020. RT: rotational
thrombectomy; TIPS: transjugular intrahepatic portosystemic shunt.
Table 1
Demographic data. SD: standard deviation.
n (%), 293 total subjects
Age in years (mean ± SD)
69.8 ± 12.0
Gender
Male
190 (64.8)
Female
103 (35.3)
Rutherford category
0
0 (0)
1
4 (1.3)
2
37 (12.6)
3
69 (23.5)
4
94 (32.1)
5
27 (9.2)
Cardiovascular risk factor
Arterial hypertension
241 (82.3)
History of nicotine abuse
151 (51.5)
Dyslipidemia
144 (49.1)
Adiposity (BMI > 30 kg/m2 )
65 (22.2)
Coronary artery disease
100 (34.1)
Diabetes mellitus
95 (32.4)
Chronic renal insufficiency
66 (22.5)
Table 2
Features of target lesions. *TASC score was assessed in native vessels only. ** Only digital subtraction angiography images were saved during the procedure. Hence,
the characterization of calcification required concurrent CT angiography, since calcifications
were evaluated for 194 of 397 total lesions. TASC: Trans-Atlantic Inter-Society Consensus
Document on Management of Peripheral Arterial Disease (version TASC II); ISR: in-stent-restenosis
(ISR).
Angiographic details of target lesions
n/total (%)
Lesion length:
153/397 (38.5)
244/397 (61.5)
Vessel type:
338 /397 (85.1)
148/397 (37.3)
190/397 (47.9)
59/397 (14.9)
45/397 (11.3)
14/397 (3.5)
TASC score:
*338/397 (85.1)
10/338 (3.0)
87/338 (25.7)
144/338 (42.6)
97/338 (28.7)
Degree of associated calcification:
**194/397 (48.9)
44/194 (22.7)
57/194 (29.4)
76/194 (39.2)
17/194 (8.8)
Location of target lesion:
28/397 (7.1)
20/397 (5.0)
107/397 (27.0)
236/397 (59.4)
6/397 (1.5)
Data Collection
Clinical data and risk factors, clinical stage of disease at the time of intervention,
procedural data, and technical and clinical success rates were recorded. The stage
of PAD was determined according to the Rutherford classification and further stratified
into acute, subacute and acute-on-chronic, and chronic. Angiographic images of the
index procedure were reviewed, and lesion length, vessel diameter, and the presence
or absence of vascular calcifications were assessed by consensus of two experienced
interventional radiologists with nine and ten years of experience (*blinded to review*)
and one resident with three years of specialty training (*blinded to review*). Calcifications
of the target lesion were visually graded on CT angiography images on a four-point
scale (none, minimal, medium, severe). In the case of minimal, no more than one-third,
in the case of medium, one-third to two-thirds, and in the case of severe, more than
two-thirds of the vessel’s cross-sectional area was calcified. Treatments and procedures
in addition to RT (e. g., POBA, DCB, or stent placement) were recorded. Procedures
were deemed clinically successful if sufficient blood flow was achieved to the limb
at the interventionist’s discretion at the end of the procedure or additional catheter-directed
thrombolysis. As an outcome, primary patency, as clinically driven target lesion revascularization
(CDTLR) free patency, and freedom from amputations were recorded through July 2020.
Adverse events were recorded for the index procedure and during the hospital stay
through discharge and were classified according to the CIRSE classification system
[13 ].
Interventional procedure
Target lesions were identified and characterized via digital subtraction angiography
(DSA). A guidewire was used to cross the target lesion. Rotational thrombectomy was
performed using a 6F or 8F RT catheter with four or more catheter passes across the
occlusion. DSA was performed again, and the procedure was repeated selectively as
needed to achieve angiographically apparent vessel patency. In the case of persistent
thrombi or emboli in the infra-popliteal arteries, additional lysis therapy was administered.
These cases were classified as “not fully treatable” with RT. Persistent underlying
chronic stenoses were treated with POBA, DCB, or stent angioplasty. Covered stents
were used in cases of vascular perforation. Periinterventional medications included
anticoagulation with 5000 international units (IU) of unfractionated heparin with
an additional 2500 IU of heparin administered for long procedures or severely obese
patients at the discretion of the interventionist. Patients with confirmed HIT received
argatroban at a flow rate of 2 μg/kg body weight/min as a continuous infusion. In
cases of persistent smaller thrombi, or linear non-flow-limiting dissections, perfusor-assisted
full heparinization was performed for 48 hours. All patients received a loading dose
of dual antiplatelet therapy with 500 mg acetylsalicylic acid (ASA) and 300 mg clopidogrel.
This was followed by sustained administration of 100 mg ASA and 75 mg clopidogrel
for 4 weeks and, if DCB angioplasty was performed, for 12 weeks.
Statistical analysis
Statistical analyses were evaluated using Jmp (version 15. SAS Institute Inc.) and
Spss (IBM Spss statistics for Windows, version 26.0). An alpha error of less than
0.05 was regarded as statistically significant. Normally distributed continuous values
were compared via Student’s T-test. Nonparametric procedures (Mann–Whitney U-test)
were used for nonnormally distributed data. Pearson’s chi-squared test was used to
determine the relationship between nominal and ordinally scaled variables. Two-sided
Monte Carlo significance tests were performed with 10 000 sample tables. The effect
size was expressed as Cramér’s V. Primary patency was assessed using Kaplan-Meier
estimates.
Results
A guidewire was passed across the target lesion in 100 % of cases. 90.4 % of procedures
were deemed clinically successful (n = 359), defined as sufficient blood flow to the
limb at the interventionist’s discretion at the end of the procedure or additional
catheter-directed thrombolysis. Insufficient or no flow was present after RT in 9.1 %
of cases (n = 36). RT catheter technical failure was observed in 1.8 % of cases (n = 7).
Overall, 6.5 % of patients (n = 26) required minor amputation post-RT during the entire
follow-up period. In 38.5 % of these patients (n = 10), amputation was planned prior
to the index RT procedure, and the intervention was considered clinically successful
in enabling wound healing by revascularization of the amputation stump. The pre-procedural
mean ABI was 0.33 ± 0.29 (n = 176), corresponding to severe PAD. The mean post-procedural
ABI increased to 0.81 ± 0.25 (n = 198; p < 0.0001). Walking distance was available
in 147 cases before RT and after in 48 cases. Of these 48 cases, the proportion of
patients with a walking distance of fewer than 200 m decreased from 93.9 % to 22.9 %
(p < 0.0001) during the hospital stay of the index procedure.
The overall primary patency was 93.2 %, 88.8 %, 79.1 %, and 72.4 % after 1, 3, 6 and
12 months, respectively. Subacute occlusions treated via RT maintained the highest
primary patency rate after one year at 81.2 %. Patency rates are described in further
detail in [Table 3 ] and [Fig. 2 ], [3 ]. CDTLR was required in 141 subjects (35.5 %) during the entire follow-up period.
8.3 % (n = 33) required CDTLR within 30 days of the index intervention. When subdivided
into acute, subacute, and chronic subgroups, no significant difference in primary
patency was observed between groups over the entirety of the follow-up period (log-rank
test p = 0.052, see [Fig. 2 ]). When subdivided according to the use of a DCB during the index procedure, no significant
difference in primary patency was observed over the follow-up period (log-rank test
of p = 0.135, see [Fig. 3 ]). An exemplary case of a treated patient is shown in [Fig. 4 ].
Table 3
Primary patency. Primary patency is defined as clinically driven target lesion revascularization
[CDTLR] free patency and freedom from amputations). The table shows primary patency
rates for acute (intervention < 3 days after symptom onset) events (47.5 % of cases
(n = 182)), subacute (intervention 3–14 days after symptom onset) and acute-on-chronic
(clinically relevant chronic stenosis with additional acute occlusion) events (22.2 %
of cases (n = 85)), and chronic (intervention > 14 days after symptom onset) events
(30.3 % of cases (n = 116)). In addition, primary patency with or without the use
of a DCB in the setting of adjuvant therapy is presented. DCB: drug-coated balloon.
Time
Acute (% [n])
Subacute (%[n]))
Chronic (% [n]))
DCB (% [n]))
No DCB (% [n]))
Overall (%)
1 month
90.1 (163)
95.3 (81)
97.4 (113)
95.1 (142)
91.1 (226)
93.2
3 months
85.0 (152)
91.8 (78)
92.2 (107)
93.2 (139)
85.5 (210)
88.8
6 months
77.2 (137)
84.7 (72)
80.2 (93)
85.8 (127)
75.3 (184)
79.1
1 year
69.7 (111)
81.2 (63)
70.5 (77)
78.2 (107)
68.6 (151)
72.4
Fig. 2 Primary patency illustrated using Kaplan-Meier curves subdivided according to lesion
age. Because cases were included between 12/2010 and 01/2020 and data collection of
clinically determined target lesion revascularization (CDTLR) was 07/2020, cases were
censored if they had primary patency at the time of data collection but were shorter
in follow-up.
Fig. 3 Primary patency illustrated using Kaplan-Meier curves with or without the use of
drug-coated balloon during the index procedure. Because cases were included between
12/2010 and 01/2020 and data collection of clinically determined target lesion revascularization
(CDTLR) was 07/2020, cases were censored if they had primary patency at the time of
data collection but were shorter in follow-up.
Fig. 4 Case report of an 80-year-old patient who underwent femoropopliteal bypass surgery
one year ago. Due to a stroke, the existing therapy with phenprocoumon was paused
and an acute occlusion of the bypass with rest pain (Rutherford IV) occurred A . Because of the existing contraindication to lysis therapy, an 8-French rotational
thrombectomy was performed for recanalization B . With this procedure, the patient’s symptoms resolved completely.
Complications
46.1 % of procedures were associated with complications (n = 183 of 397). Distal embolism
was the most common complication at 22.4 % (n = 89 of 397). Of these, 65.2 % of cases
(n = 58 of 89) required further treatment by aspiration thrombectomy in 14.3 % of
cases (n = 8 of 56), aspiration with periprocedural administration of lysis in 37.5 %
of cases (n = 21 of 56), more extended use of RT in 5.4 % of cases (n = 3 of 56) or
subsequent thrombolysis in 27 % of cases (n = 24 of 56), 27.0 % (n = 24) received
therapeutic-dose heparin over 48 hours, and seven minor embolizations did not require
additional treatment. 98.9 % (n = 88 of 89) of distal embolizations were CIRSE complication
grade 1 to 3 without post-procedure sequelae, 1.1 % (n = 1 of 89) developed intracerebral
bleeding during subsequent thrombolysis (CIRSE complication grade 5). RT was directly
associated with complications in 7.1 % of cases (n = 28), which consisted of perforations
2.8 % (n = 11), arteriovenous fistula 1.3 % (n = 5), dissections 2.0 % (n = 8) and
guidewire fractures 0.5 % (n = 2). The data analysis by location of the target lesion
revealed significantly more RT-associated iliac artery complications compared to femoropopliteal
or below the knee vessels (χ²(2) = 7.365, p = .025, Cramér’s V = 0.140, Monte Carlo
significance p = .022). Severe complications (CIRSE grades 5 and 6) occurred in 7
patients, with not a single complication being directly related to RT. A detailed
overview of observed complications is provided in [Table 4 ], [5 ].
Table 4
Complications. Complication category by cause in absolute number and percentage of
final study cohort (n = 397 total interventions). Cases were classified as “unknown”
if assignment to the categories RT, adjuvant therapy, and underlying disease was not
possible from the retrospective data. The two fatal complications occurred in the
setting of intracerebral hemorrhage during adjuvant therapy with lysis. RT: rotational
thrombectomy.
Complication category
RT
n (%)
Adjuvant therapy
n (%)
Underlying disease
n (%)
Unknown
n (%)
Total
Dissection
8 (2.0)
30 (7.6)
0 (0)
3 (0.8)
41 (10.3)
Perforation
11 (2.8)
6 (1.5)
0 (0)
0 (0)
17 (4.3)
Pain
0 (0)
1 (0.3)
0 (0)
0 (0)
1 (0.3)
Arteriovenous fistula
5 (1.3)
1 (0.3)
0 (0)
1 (0.3)
7 (1.8)
Guidewire fracture
2 (0.5)
0 (0)
0 (0)
0 (0)
2 (0.5)
Compartment syndrome
0 (0)
0 (0)
7 (1.8)
0 (0)
7 (1.8)
Miscellaneous
2 (0.5)
4 (1.0)
5 (1.3)
0 (0)
11 (2.8)
Secondary hemorrhage
0 (0)
0 (0)
5 (1.3)
0 (0)
5 (1.3)
Death during hospital stay
0 (0)
2 (0.5)
1 (0.3)
0 (0)
3 (0.8)
Total
28 (7.1)
44 (11.1)
18 (4.5)
4 (1.0)
94 (23.7)
Table 5
CIRSE classification of adverse events. Distribution of observed complications according
to the CIRSE classification system in absolute number and percentage. CIRSE: Cardiovascular
and Interventional Radiological Society of Europe.
CIRSE
n/94 (%)
1
71 (75.5)
2
1 (1.1)
3
12 (12.8)
4
1 (1.1)
5
6 (6.4)
6
3 (3.2)
Discussion
This study demonstrated a technical and clinical success rate of revascularization
in 90 % of procedures with significant improvement in ABI and pain-free walking distance
in a large retrospectively evaluated patient population of 293 patients and 397 procedures,
demonstrating RT as a safe and effective treatment option. With approximately 50 %
acute and 30 % chronic occlusions of the iliac or femoropopliteal vessels and more
than 60 % of patients with CLI, the patient population represents a challenging cohort
that is grossly representative of real-world daily vascular practice. Complex TASC-C
and TASC-D lesions with lengths greater than 20 cm comprised most of the study cohort.
Our evaluation demonstrated clinical success and a significant improvement of the
ABI and the pain-free walking distance. However, as the patient population was challenging,
a relatively high risk of reintervention was observed, which occurred in approximately
one-third during the follow-up period, but in only 8.5 % within the first 30 days
after the index procedure. Overall, we documented 183 adverse events, with distal
embolism being the most commonly observed in 22.4 % of cases. Of these, 65.2 % required
further treatment by aspiration thrombectomy or subsequent thrombolysis, and 27.0 %
received therapeutic-dose heparin over 48 hours. In our opinion, this is because we
included a larger proportion of patients after bypass surgery in our study [12 ]. The bypass diameter often exceeds the diameter of the native vessels and cannot
be completely thrombectomized, which carries the risk of peripheral embolization after
balloon PTA, for example.
To date, our study represents one of the largest and most comprehensive patient populations
for evaluating rotational thrombectomy without excluding subgroups from the analysis.
Such a mixed cohort has only been studied previously by Lagana et al., but only in
a comparatively small cohort of 22 patients [14 ]. Previous studies that had enrolled similar numbers of subjects excluded important
subgroups encountered in daily vascular practice, including chronic occlusions, in-stent
lesions, and bypass occlusion [10 ]
[15 ]
[16 ], thus limiting their general applicability in daily practice. It should be noted
that the treatment of our cohort in which 71.3 % of cases were classified as TASC-C
or TASC-D lesions, resulted in technical and clinical success rates above 90 %, which
is in line with the German S3 guideline on the diagnosis, treatment, and follow-up
of peripheral arterial occlusive disease [17 ].
Furthermore, lesion length was not a predictor of clinical success, as most lesions
exceeded 20 cm in length. The results align with a recently published study for RT
in long lesions [18 ]. Because 89.5 % of occluded vessels had underlying residual stenosis exposed by
RT, adjunctive therapy was frequently employed, most commonly POBA, followed by DCB
angioplasty, a combination of POBA and DCB angioplasty, and least commonly stenting.
These results are similar to prior studies focusing on populations with underlying
chronic stenotic/occlusive mechanisms rather than acute embolic events in otherwise
healthy arteries [19 ].
Additional thrombolytic therapy was used in 32.0 % of cases (n = 127). 64.6 % (n = 82)
of cases utilizing thrombolytic therapy in addition to RT were in the setting of occluded
bypass grafts, a slightly higher but comparable rate of adjunctive thrombolysis therapy
as compared to a previous study [10 ]. As the majority of RT catheters used in this study were 6-F in diameter, we surmise
that this caliber catheter is relatively undersized for use in occluded bypass grafts,
leading to insufficient initial debulking during RT and necessitating additional thrombolytic
treatment. Consequently, the use of an 8-F catheter should be considered for vessels
with a luminal diameter of 5 to 8 mm. It should be noted that patients with bypass
grafts often have complex preoperative conditions that may inhibit the use of an 8-F
sheath or increase the lysis-associated bleeding risk connected with 8-F access, necessitating
a careful, patient-specific appraisal of the risks and benefits of both the choice
of RT catheter size and additional employment of thrombolytics.
In this retrospective evaluation, primary patency was indirectly determined using
CDTLR as a surrogate parameter over the entire observation period. Furthermore, the
subjects in this study were found to continue the vast majority of their follow-up
at the index institution, and there was no documented external intervention in any
subject during follow-up visits or visits for other indications. Consequently, we
surmise that CDTLR represents a robust and relevant alternate measure of primary patency.
CDTLR within the first year after the index procedure was necessary for 30.3 % of
the entire cohort, as further described in [Table 3 ] and [Fig. 2 ]. For the entire follow-up period, no significant difference was observed between
the subgroups.
When subdivided according to the use of a DCB during the index procedure, no significant
difference in primary patency was observed, as further described in [Table 3 ] and [Fig. 3 ]. These results are in contrast to a previous prospective trial by Latacz et al.,
who observed a reduction of restenosis rates from 45.5 % to 12.5 % [20 ] when combing RT and DCB. However, the cohorts differ regarding target vessels, lesion
length, and patient demographics. The amputation rate during the observation period
was 6.5 %, which is consistent with previously published literature [21 ].
Regarding complications, the observed peripheral embolization rate was relatively
high at 22.4 % (n = 89 %), with approximately two-thirds requiring further treatment
via aspiration or thrombolysis. Our data cannot distinguish whether peripheral embolization
was caused directly by RT or incomplete thrombectomy followed by balloon angioplasty.
Dissections occurred in 10.3 % of cases (n = 30), but only 26.7 % of dissections (n = 8)
were directly attributable to RT, which is similar to data observed by Freitas et
al. [10 ]. It has been argued that reopening of chronically occluded vessels is often associated
with dissections, but a recent in vitro study demonstrated the superior safety of
RT in terms of rates of significant macroembolism, dissection, and microscopic vessel
injury as compared to alternative techniques [22 ]. Overall, the most common directly RT-associated complication in our cohort was
vessel perforation, which occurred in 2.8 % of cases (n = 11), followed by iatrogenic
AV fistulas in 1.3 % of cases (n = 5), which is similar to a previous study [16 ]. No correlation was observed between the degree of calcification and the risk of
perforation in our study cohort, as has been hypothesized in the past [16 ]
[23 ]. What was observed, however, was an increased rate of complications using RT in
the iliac vessels. All perforations were successfully treated by the intraprocedural
deployment of covered stents, and no surgical repair was required.
This study is limited by its retrospective design, which made systematic follow-up
of patients difficult and did not allow direct determination of restenosis rates at
one or two years. However, this was compensated for by using CDTLR as a surrogate
parameter of primary patency with clinically meaningful impact. Another limitation
arises from the disproportionately frequent use of a 6-F RT catheter versus an 8-F
catheter, particularly at the beginning of the study period. We hypothesize that the
employment of 8-F catheters more frequently, particular for occluded bypass grafts,
would likely have reduced the need for additional thrombolysis. This hypothesis will
be the focus of future work. Finally, this study did not directly compare RT with
alternative procedures, as RT had become the mainstay of therapy at the study institution
during the retrospective period evaluated. In this study, only patients who received
RT in the context of a CTO of the lower extremity were included. Of course, it is
debatable to what extent, especially in the subgroup of acute occlusions, the primary
use of adjuvant therapies and specifically lysis could have provided similar results.
In the cohort of patients we investigated, there were numerous patients who had contraindications
to classic lysis therapy (for example, condition after surgery, condition after insult
or hemorrhage) or relative contraindications (advanced age). Furthermore, rotational
thrombectomy has been widely implemented in the clinical routine in our institution
to reduce the rate of serious complications of lysis therapy. Also, in the patient
population considered here, intracerebral hemorrhage occurred in three patients during
adjuvant lysis therapy, which corresponds to the severe bleeding complication rates
of 1–2 % known from the literature [24 ]. Furthermore, RT allowed completion of therapy or a single-stage approach in 301
of the 397.
Conclusion
Rotational thrombectomy is a safe and efficacious method for treating arterial occlusions
of the lower extremity, with a clinical success rate of 90.0 %. Distal embolization
was observed in 22.4 % of cases. However, complications directly associated with RT
were rare, with perforation (2.8 %) and iatrogenic AV fistulas (1.3 %) being the most
frequent. It should be noted that occluded bypass grafts were observed to have a higher
probability of residual thrombi requiring additional lysis therapy. We hypothesize
that employing a larger-caliber RT catheter may reduce this rate at the risk of an
increased rate of pseudoaneurysm or hemorrhage at the access site.
