scholarly journals Safety and Effectiveness of the New Generation APERIO® Hybrid Stent-retriever Device in Large Vessel Occlusion Stroke

Author(s):  
Marius L. Vogt ◽  
Alexander M. Kollikowski ◽  
Franziska Weidner ◽  
Marc Strinitz ◽  
Jörn Feick ◽  
...  

Abstract Background It is unknown whether technological advancement of stent-retriever devices influences typical observational indicators of safety or effectiveness. Methods Observational retrospective study of APERIO® (AP) vs. new generation APERIO® Hybrid (APH) (Acandis®, Pforzheim, Germany) stent-retriever device (01/2019–09/2020) for mechanical thrombectomy (MT) in large vessel occlusion (LVO) stroke. Primary effectiveness endpoint was successful recanalization eTICI (expanded Thrombolysis In Cerebral Ischemia) ≥ 2b67, primary safety endpoint was occurrence of hemorrhagic complications after MT. Secondary outcome measures were time from groin puncture to first pass and successful reperfusion, and the total number of passes needed to achieve the final recanalization result. Results A total of 298 patients with LVO stroke who were treated by MT matched the inclusion criteria: 148 patients (49.7%) treated with AP vs. 150 patients (50.3%) treated with new generation APH. Successful recanalization was not statistically different between both groups: 75.7% for AP vs. 79.3% for APH; p = 0.450. Postinterventional hemorrhagic complications and particularly subarachnoid hemorrhage as the entity possibly associated with stent-retriever device type was significantly less frequent in the group treated with the APH: 29.7% for AP and 16.0% for APH; p = 0.005; however, rates of symptomatic hemorrhage with clinical deterioration and in domo mortality were not statistically different. Neither the median number of stent-retriever passages needed to achieve final recanalization, time from groin puncture to first pass, time from groin puncture to final recanalization nor the number of cases in which successful recanalization could only be achieved by using a different stent-retriever as bail-out device differed between both groups. Conclusion In the specific example of the APERIO® stent-retriever device, we observed that further technological developments of the new generation device were not associated with disadvantages with respect to typical observational indicators of safety or effectiveness.

2017 ◽  
Vol 10 (6) ◽  
pp. 525-529 ◽  
Author(s):  
Amélie Carolina Hesse ◽  
Daniel Behme ◽  
André Kemmling ◽  
Antonia Zapf ◽  
Nils Große Hokamp ◽  
...  

Background and purposeThrombectomy has become the standard of care for acute ischaemic stroke due to large vessel occlusion. Aim of this study was to compare the radiological outcomes and time metrics of the various thrombectomy techniques.MethodsIn this retrospective, multicenter study we analysed the data of 450 patients with occlusion of the anterior circulation, treated in five high-volume center from 2013 to 2016. The treatment techniques were divided in three categories: first-pass use of a large-bore aspiration-catheter; first-pass use of a stent-retriever; and primary combined approach (PCA) of an aspiration-catheter and stent-retriever. Primary endpoints were successful reperfusion and groin to reperfusion time. Secondary endpoints were the number of attempts and occurrence of emboli in new territory (ENT). The primary analysis was based on the intention to treat groups (ITT).ResultsThe ITT-analysis showed significantly higher reperfusion rates, with 86% of successful reperfusion in the PCA-group compared with 73% in the aspiration group and 65% in the stent-retriever group. There was no significant difference in groin to reperfusion time regarding the used technique. The secondary analysis showed an impact of the technique on the number of attempts and the occurrence of ENTs. Lowest ENT rates and attempts were reported with the combined approach.ConclusionsThe combined first-pass deployment of a stent-retriever and an aspiration-catheter was the most effective technique for reperfusion of anterior circulation large vessel occlusion. Our results correlate with the latest single-centrere studies, reporting very high reperfusion rates with PCA variations.


2021 ◽  
pp. neurintsurg-2020-017042
Author(s):  
Waleed Brinjikji ◽  
Eytan Raz ◽  
Reade De Leacy ◽  
Dan Meila ◽  
Maxim Mokin ◽  
...  

BackgroundOver the past several years there has been increased interest in the use of the Sofia aspiration system (MicroVention, Tustin, California) as a primary aspiration catheter.ObjectiveTo perform a multicenter retrospective study examining the efficacy of the Sofia aspiration catheter as a standalone aspiration treatment for large vessel occlusion.MethodsConsecutive cases in which the Sofia catheter was used for aspiration thrombectomy for large vessel occlusion were included. Exclusion criteria were the following: (1) Sofia not used for first pass, and (2) a stent retriever used as an adjunct on the first pass. The primary outcome of the study was first pass recanalization (Thrombolysis in Cerebral Infarction (TICI) 2c/3). Secondary outcomes included first pass TICI 2b/3, crossover to other thrombectomy devices, number of passes, time from puncture to recanalization, and complications.Results323 patients were included. First pass TICI 2c/3 was achieved in 49.8% of cases (161/323). First pass TICI 2b/3 was achieved in 69.7% (225/323) of cases. 74.8% had TICI 2b/3 with the Sofia alone. Crossover to other thrombectomy devices occurred in 29.1% of cases (94/323). The median number of passes was 1 (IQR=1–3). Median time from puncture to recanalization was 26 min (IQR=17–45). Procedure related complications occurred in 3.1% (10/323) of cases.ConclusionOur study highlights the potential advantage of the Sofia aspiration catheter for primary aspiration thrombectomy in acute ischemic stroke. High rates of first pass recanalization with low crossover rates to other thrombectomy devices were achieved. Median procedure time was low, as were procedural complications.


Author(s):  
Mais N Al‐Kawaz ◽  
Satvros Matsoukas ◽  
Christopher P Kellner ◽  
J Mocco ◽  
Johanna T Fifi ◽  
...  

Introduction : Rescue treatment for failed thrombectomy in patients with acute ischemic stroke (AIS) from large vessel occlusion (LVO) remains controversial. We report our institutional experience with using intracranial stenting of occlusion refractory to aspiration and stent retriever thrombectomy. Methods : We performed a retrospective review of our prospectively maintained thrombectomy database to identify the LVO AIS patients who underwent intracranial stenting during endovascular thrombectomy at our comprehensive stroke center between January 2015 and July 2021. Modified Rankin scale (mRS) at 90 days was used as primary outcome. A good neurologic outcome was defined as mRS 0–3, and a poor neurologic outcome is defined as mRS score between 4–6. Secondary outcomes included symptomatic intracerebral hemorrhage (sICH) based on ECASS criteria, and in‐hospital mortality. Results : We identified 52 acute ischemic stroke patients who underwent intracranial stenting acutely. Thirty‐three patient (63.4%) are males. Median age was 64 years (Interquartile range (IQR 57–74), median baseline mRS was 0 (IQR 0–1), median NIHSS score was 13 (IQR 7–18), and median ASPECTS was 9 (IQR 8–10). Thirty six percent of the patients had a vertebrobasilar occlusion, 34% had a middle cerebral occlusion (M1 segment), and 14% had an M2 segment occlusion. The median number of thrombectomy passes prior to stenting was 3 (IQR 2–4). In 48% of patients, a combination of aspiration and stent retriever techniques were used prior to intracranial stenting. The Enterprise stent was the most commonly used stent (51.9%), followed by Wingspan stent (25%), and Neuroform Atlas stent (21.5%). Majority of the patients (93%) were loaded with anti‐thrombotics intraoperatively, with rectal Aspirin and intravenous Integrilin being the most commonly used agents. Successful recanalization (TICI 2 B or better) was achieved in 96% of the patients, while the remaining 2 patients were graded as TICI 2A recanalization. Fifty percent of the patients had good outcome at 90 days. A total of 4 patients (8%) developed a sICH, with a 90 day mortality of rate of 15.4% (8/52). Conclusions : Rescue intracranial stenting appears to be a safe and effective approach in patients with emergent large vessel occlusion refractory to thrombectomy. Larger studies are warranted to further establish the safety and efficacy of this approach.


2020 ◽  
Vol 132 (4) ◽  
pp. 1202-1208 ◽  
Author(s):  
Dong-Hun Kang ◽  
Woong Yoon ◽  
Byung Hyun Baek ◽  
Seul Kee Kim ◽  
Yun Young Lee ◽  
...  

OBJECTIVEThe optimal front-line thrombectomy choice for primary recanalization of a target artery remains unknown for patients with acute large-vessel occlusion (LVO) and an underlying intracranial atherosclerotic stenosis (ICAS). The authors aimed to compare procedural characteristics and outcomes between patients who received a stent-retriever thrombectomy (SRT) and patients who received a contact aspiration thrombectomy (CAT), as the front-line approach for treating LVO due to severe underlying ICAS.METHODSOne hundred thirty patients who presented with acute LVO and underlying severe ICAS at the occlusion site were included. Procedural characteristics and treatment outcomes were compared between patients treated with front-line SRT (n = 70) and those treated with front-line CAT (n = 60). The primary outcomes were the rate of switching to an alternative thrombectomy technique, time from groin puncture to initial reperfusion, and duration of the procedure. Initial reperfusion was defined as revealing the underlying culprit stenosis with an antegrade flow after thrombectomy.RESULTSThe rate of switching to an alternative thrombectomy after failure of the front-line technique was significantly higher in the CAT group than in the SRT group (40% vs 4.3%; OR 2.543, 95% CI 1.893–3.417, p < 0.001). The median time from puncture to initial reperfusion (17 vs 31 minutes, p < 0.001) and procedure duration (39 vs 75.5 minutes, p < 0.001) were significantly shorter in the SRT group than in the CAT group. In the binary logistic regression analysis, a longer time from puncture to initial reperfusion was an independent predictor of a 90-day poor (modified Rankin Scale score 3–6) functional outcome (per 1-minute increase; OR 1.029, 95% CI 1.008–1.050, p = 0.006).CONCLUSIONSThe authors’ results suggest that SRT may be more effective than CAT for identifying underlying culprit stenosis and therefore considered the optimal front-line thrombectomy technique in acute stroke patients with LVO and severe underlying ICAS.


2021 ◽  
Vol 14 ◽  
pp. 175628642199901
Author(s):  
Meredeth Zotter ◽  
Eike I. Piechowiak ◽  
Rupashani Balasubramaniam ◽  
Rascha Von Martial ◽  
Kotryna Genceviciute ◽  
...  

Background and aims: To investigate whether stroke aetiology affects outcome in patients with acute ischaemic stroke who undergo endovascular therapy. Methods: We retrospectively analysed patients from the Bernese Stroke Centre Registry (January 2010–September 2018), with acute large vessel occlusion in the anterior circulation due to cardioembolism or large-artery atherosclerosis, treated with endovascular therapy (±intravenous thrombolysis). Results: The study included 850 patients (median age 77.4 years, 49.3% female, 80.1% with cardioembolism). Compared with those with large-artery atherosclerosis, patients with cardioembolism were older, more often female, and more likely to have a history of hypercholesterolaemia, atrial fibrillation, current smoking (each p < 0.0001) and higher median National Institutes of Health Stroke Scale (NIHSS) scores on admission ( p = 0.030). They were more frequently treated with stent retrievers ( p = 0.007), but the median number of stent retriever attempts was lower ( p = 0.016) and fewer had permanent stent placements ( p ⩽ 0.004). Univariable analysis showed that patients with cardioembolism had worse 3-month survival [72.7% versus 84%, odds ratio (OR) = 0.51; p = 0.004] and modified Rankin scale (mRS) score shift ( p = 0.043) and higher rates of post-interventional heart failure (33.5% versus 18.5%, OR = 2.22; p < 0.0001), but better modified thrombolysis in cerebral infarction (mTICI) score shift ( p = 0.025). Excellent (mRS = 0–1) 3-month outcome, successful reperfusion (mTICI = 2b–3), symptomatic intracranial haemorrhage and Updated Charlson Comorbidity Index were similar between groups. Propensity-matched analysis found no statistically significant difference in outcome between stroke aetiology groups. Stroke aetiology was not an independent predictor of favourable mRS score shift, but lower admission NIHSS score, younger age and independence pre-stroke were (each p < 0.0001). Stroke aetiology was not an independent predictor of heart failure, but older age, admission antithrombotics and dependence pre-stroke were (each ⩽0.027). Stroke aetiology was not an independent predictor of favourable mTICI score shift, but application of stent retriever and no permanent intracranial stent placement were (each ⩽0.044). Conclusion: We suggest prospective studies to further elucidate differences in reperfusion and outcome between patients with cardioembolism and large-artery atherosclerosis.


2021 ◽  
pp. 1-9
Author(s):  
Jong-Hoon Kim ◽  
Young-Jin Jung ◽  
Chul-Hoon Chang

OBJECTIVEThe optimal treatment for underlying intracranial atherosclerosis (ICAS) in patients with emergent large-vessel occlusion (ELVO) remains unclear. Reocclusion during endovascular treatment (EVT) occurs frequently (57.1%–77.3%) after initial recanalization with stent retriever (SR) thrombectomy in ICAS-related ELVO. This study aimed to compare treatment outcomes of the strategy of first stenting without retrieval (FRESH) using the Solitaire FR versus SR thrombectomy in patients with ICAS-related ELVO.METHODSThe authors retrospectively reviewed consecutive patients with acute ischemic stroke and intracranial ELVO of the anterior circulation who underwent EVT between January 2017 and December 2019 at Yeungnam University Medical Center. Large-vessel occlusion (LVO) of the anterior circulation was classified by etiology as follows: 1) no significant stenosis after recanalization (embolic group) and 2) remnant stenosis > 70% or lesser degree of stenosis with a tendency toward reocclusion and/or flow impairment during EVT (ICAS group). The ICAS group was divided into the SR thrombectomy group (SR thrombectomy) and the FRESH group.RESULTSA total of 105 patients (62 men and 43 women; median age 71 years, IQR 62.5–79 years) were included. The embolic, SR thrombectomy, and FRESH groups comprised 66 (62.9%), 26 (24.7%), and 13 (12.4%) patients, respectively. There were no significant differences between the SR thrombectomy and FRESH groups in symptom onset–to-door time, but puncture-to-recanalization time was significantly shorter in the latter group (39 vs 54 minutes, p = 0.032). There were fewer stent retrieval passes but more first-pass recanalizations in the FRESH group (p < 0.001). Favorable functional outcomes were significantly more frequent in the FRESH group (84.6% vs 42.3%, p = 0.017).CONCLUSIONSThis study’s findings suggest that FRESH, rather than rescue stenting, could be a treatment option for ICAS-related ELVO.


Stroke ◽  
2021 ◽  
Vol 52 (Suppl_1) ◽  
Author(s):  
Shadi Yaghi ◽  
Eytan Raz ◽  
Seena Dehkharghani ◽  
Howard Riina ◽  
Ryan McTaggart ◽  
...  

Introduction: In patients with acute large vessel occlusion, the definition of penumbral tissue based on T max delay perfusion imaging is not well established in relation to late-window endovascular thrombectomy (EVT). In this study, we sought to evaluate penumbra consumption rates for T max delays in patients treated between 6 and 16 hours from last known normal. Methods: This is a secondary analysis of the DEFUSE-3 trial, which included patients with an acute ischemic stroke due to anterior circulation occlusion within 6-16 hours of last known normal. The primary outcome is percentage penumbra consumption defined as (24 hour infarct volume-core infarct volume)/(Tmax volume-baseline core volume). We stratified the cohort into 4 categories (untreated, TICI 0-2a, TICI 2b, and TICI3) and calculated penumbral consumption rates. Results: We included 143 patients, of which 66 were untreated, 16 had TICI 0-2a, 46 had TICI 2b, and 15 had TICI 3. In untreated patients, a median (IQR) of 48% (21% - 85%) of penumbral tissue was consumed based on Tmax6 as opposed to 160.6% (51% - 455.2%) of penumbral tissue based on Tmax10. On the contrary, in patients achieving TICI 3 reperfusion, a median (IQR) of 5.3% (1.1% - 14.6%) of penumbral tissue was consumed based on Tmax6 and 25.7% (3.2% - 72.1%) of penumbral tissue based on Tmax10. Conclusion: Contrary to prior studies, we show that at least 75% of penumbral tissue with Tmax > 10 sec delay can be salvaged with successful reperfusion and new generation devices. In untreated patients, since infarct expansion can occur beyond 24 hours, future studies with delayed brain imaging are needed to determine the optimal T max delay threshold that defines penumbral tissue in patients with proximal anterior circulation large vessel occlusion.


Stroke ◽  
2016 ◽  
Vol 47 (suppl_1) ◽  
Author(s):  
Amrou Sarraj ◽  
Navdeep Sangha ◽  
Muhammad Shazam Hussain ◽  
Dolora Wisco ◽  
Nirav Vora ◽  
...  

Introduction: Five RCTs demonstrated the superiority of endovascular therapy (EVT) over best medical management (MM) for acute ischemic strokes (AIS) with large vessel occlusion (LVO) in the anterior circulation. Patients with M2 occlusions, however, were underrepresented (95 randomized; 51 EVT treated). Evidence from RCTs of the benefit of EVT for M2 occlusions is lacking, as reflected in the recent AHA guidelines. Methods: A retrospective cohort was pooled from 10 academic centers from 1/12 to 4/15 of AIS patients with LVO isolated to M2 presenting within 8 hours from last known normal (LKN). Patients were divided into EVT and MM groups. Primary outcome was 90 day mRS (good outcome 0-2); secondary outcome was sICH. Logistic regression compared the 2 groups. Univariate and multivariate analyses evaluated predictors of good outcome in the EVT group. Results: Figure 1 shows participating centers, 522 patients (288 EVT and 234 MM) were identified. Table (1) shows baseline characteristics. MM treated patients were older and had higher IV tPA treatment rates, otherwise the 2 groups were balanced. 62.7 % EVT patients had mRS 0-2 at 90 days compared to 35.4 % MM (figure 2). EVT patients had 3 times the odds of good outcome as compared to MM patients (OR: 3.1, 95% CI:2.1-4.4, P <0.001) even after adjustment for age, NIHSS, ASPECTS, IV tPA and LKN to door time (OR: 3.2, 95%CI: 2-5.2, P<0.001). sICH rate was 5.6 %, which was not statistically different than the MM group (table 1, P=0.1). Age, NIHSS, good ASPECTS, LKN to reperfusion time and successful reperfusion mTICI ≥ 2b were independent predictors of good outcome in EVT patients. There was a linear relationship between good outcome and time LKN to reperfusion (Figure 3). Conclusion: Despite inherent limitations of its retrospective design, our study suggests that EVT may be effective and safe for distal LVO (M2) relative to best MM. A trial randomizing M2 occlusions to EVT vs. MM is warranted to confirm these findings.


Stroke ◽  
2021 ◽  
Vol 52 (Suppl_1) ◽  
Author(s):  
Luis Savastano ◽  
Yang Liu ◽  
Daniel Gebrezgiabhier ◽  
Adithya Reddy ◽  
Evan Davis ◽  
...  

Introduction: Suction catheters and stent retrievers are based on the classical paradigm of “en bloc” removal of emboli by generation of tensile forces by vacuum or device withdrawal. However, in this process emboli elongate and fracture leading to fragmentation. Fragments can migrate downstream or remain impacted in the arterial wall resulting in a residual occlusion. Hypothesis: Clot ingestion is biomechanically superior to “en bloc” removal and leads to higher recanalization rates with less complications. Methods: To test this hypothesis, we present a hybrid test bed consisting of pressurized human brains which was developed and validated for large vessel occlusion (LVO) and revascularization. We fabricated 3 types of representative embolus analogs (EAs) (elastic, fragment-prone and stiff) and recreated 105 LVO in twenty-four fresh human brains with the vasculature connected to an hydraulic system to mimic physiological flow and pressures. Recanalization was attempted in 61 LVO cases by Direct Aspiration (DA) using an 068 catheter and in 44 LVO cases combining Stent Retriever with Aspiration (SR+A). Rates of successful recanalization (SR, Grade 2b or higher) and complete recanalization (CR, Grade 2c or higher) were measured. Up to 4 attempts were done before declaring a failure (Grade 2a or lower). Results: DA resulted in 90% of SR, 79% of CR, 61% of first pass SR and 49% of first pass CR. SR+A resulted in 34% of SR, 34% of CR, 23% of first pass SR and 14% of first pass CR. Elastic EA were associated with 88% of SR, 85% of CR, 61% of first pass SR and 52% of first pass CR. Stiff EAs were associated with 64% of SR, 64% of CR, 36% of first pass SR and 36% of first pass CR. Fragment-prone EAs were associated with 64% of SR, 40% of CR, 38% of first pass SR and 21% of first pass CR. Conclusion: Clot ingestion is biomechanically superior to “en bloc” removal and leads to the highest rates of SR, CR and first pass recanalization. DA achieves higher recanalization rates than SR+A. Elastic clots are associated with the highest rates or recanalization, followed by stiff clots and finally by fragment-prone clots.


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