First-in-man experience of the Versi Retriever in acute ischemic stroke

2018 ◽  
Vol 11 (3) ◽  
pp. 296-299 ◽  
Author(s):  
Nobuyuki Sakai ◽  
Hirotoshi Imamura ◽  
Hidemitsu Adachi ◽  
Shoichi Tani ◽  
So Tokunaga ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Mechanical Thrombectomy ◽  
Stent Retriever ◽  
Initial Experience ◽  
Related Complication ◽  
Anterior Circulation ◽  
Clinical Trial Registration ◽  
Institutional Review ◽  
Angiographic Result

ObjectiveTo describe our initial experience with the Versi Retriever for mechanical thrombectomy in patients with acute ischemic stroke.MethodsThis study is a single-center, single-arm, first-in-man registry under institutional review board control to evaluate the efficacy and safety of the new stent retriever, the Versi Retriever. Patients with acute ischemic stroke were consecutively enrolled between September and November 2017. The clinical and procedural data were retrospectively analyzed. The angiographic result after the procedure was self-graded based on the Thrombolysis in Cerebral Infarction (TICI) scale by each operator.ResultsEleven patients with a mean age of 69.4 years were treated with the Versi Retriever. Median National Institutes of Health Stroke Scale score on admission was 16 (IQR 10–34). The occluded vessel was located in the anterior circulation in 81.8%. Revascularization rates of TICI 2b–3 and TICI 3 at final angiogram were achieved in 100% and 63.6%, respectively. A favorable functional outcome (modified Rankin Scale 0–2) at 90 days was obtained in 72.7%. No symptomatic intracranial hemorrhage occurred and no procedure-related complication was observed.ConclusionsOur initial experience suggests that the Versi Retriever is a safe and effective stent retriever for mechanical thrombectomy in patients with acute ischemic stroke.Clinical trial registrationNCT03366818

scholarly journals Intra-arterial Thrombectomy with Stent Retriever for Acute Ischemic Stroke – a Retrospective, Single-centered Study from Brazil

2017 ◽  
Vol 36 (04) ◽  
pp. 213-216
Author(s):  
Luana Gatto ◽  
Viviane Zétola ◽  
Zeferino Demartini Junior ◽  
Fábio Nascimento ◽  
Gelson Koppe
Keyword(s):  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Mean Value ◽  
Posterior Circulation ◽  
Stent Retriever ◽  
National Institutes Of Health ◽  
Initial Experience ◽  
Modified Rankin Scale ◽  
Anterior Circulation ◽  
The Mean

Objective To report our initial experience with intra-arterial thrombectomy (IAT) with stent retriever for acute ischemic stroke. Methods We conducted a retrospective review of patients with acute ischemic stroke who underwent IAT from September 2010 to August 2016. Results Forty-one patients were included; mean age was 57 years (range: 29–85), and 54% were women. There were 32 anterior circulation occlusions, and 11 posterior circulation occlusions. The mean value of the National Institutes of Health Stroke Scale (NIHSS) upon admission (available in 9/41 patients) was 14 (range: 6–20). Nineteen patients had favorable outcomes (modified Rankin Scale [mRS]: 0–2 at 6 months), and 22 had unfavorable outcomes (mRS: 3–6 at 6 months). The mortality rate was 37% (15/41). Favorable outcomes were associated with revascularization within the first 360 minutes of the onset of symptoms (p = 0.000001), and satisfactory revascularization (thrombolysis in cerebral infarction [TICI] scale: 2b or 3) (p = 0.0018). Conclusion It is of paramount importance to educate stroke teams on the benefits of IAT for acute ischemic stroke and the population on identifying stroke and seeking immediate care following symptom onset.

scholarly journals TREVO stent-retriever mechanical thrombectomy for acute ischemic stroke secondary to large vessel occlusion registry

2017 ◽  
Vol 10 (6) ◽  
pp. 516-524 ◽  
Author(s):  
Osama O Zaidat ◽  
Alicia C Castonguay ◽  
Raul G Nogueira ◽  
Diogo C Haussen ◽  
Joey D English ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Clinical Practice ◽  
Acute Ischemic Stroke ◽  
Real World ◽  
Randomized Clinical Trials ◽  
Mechanical Thrombectomy ◽  
Stent Retriever ◽  
Large Vessel ◽  
Complete Revascularization ◽  
Anterior Circulation

BackgroundRecent randomized clinical trials (RCTs) demonstrated the efficacy of mechanical thrombectomy using stent-retrievers in patients with acute ischemic stroke (AIS) with large vessel occlusions; however, it remains unclear if these results translate to a real-world setting. The TREVO Stent-Retriever Acute Stroke (TRACK) multicenter Registry aimed to evaluate the use of the Trevo device in everyday clinical practice.MethodsTwenty-three centers enrolled consecutive AIS patients treated from March 2013 through August 2015 with the Trevo device. The primary outcome was defined as achieving a Thrombolysis in Cerebral Infarction (TICI) score of ≥2b. Secondary outcomes included 90-day modified Rankin Scale (mRS), mortality, and symptomatic intracranial hemorrhage (sICH).ResultsA total of 634patients were included. Mean age was 66.1±14.8 years and mean baseline NIH Stroke Scale (NIHSS) score was 17.4±6.7; 86.7% had an anterior circulation occlusion. Mean time from symptom onset to puncture and time to revascularization were 363.1±264.5 min and 78.8±49.6 min, respectively. 80.3% achieved TICI ≥2b. 90-day mRS ≤2 was achieved in 47.9%, compared with 51.4% when restricting the analysis to the anterior circulation and within 6 hours (similar to recent AHA/ASA guidelines), and 54.3% for those who achieved complete revascularization. The 90-day mortality rate was 19.8%. Independent predictors of clinical outcome included age, baseline NIHSS, use of balloon guide catheter, revascularization, and sICH.ConclusionThe TRACK Registry results demonstrate the generalizability of the recent thrombectomy RCTs in real-world clinical practice. No differences in clinical and angiographic outcomes were shown between patients treated within the AHA/ASA guidelines and those treated outside the recommendations.

scholarly journals Prospective, Multicenter, Single-Arm Study of Mechanical Thrombectomy Using Solitaire Flow Restoration in Acute Ischemic Stroke

Stroke ◽  
2013 ◽  
Vol 44 (10) ◽  
pp. 2802-2807 ◽  
Author(s):  
Vitor M. Pereira ◽  
Jan Gralla ◽  
Antoni Davalos ◽  
Alain Bonafé ◽  
Carlos Castaño ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Mechanical Thrombectomy ◽  
Hemorrhagic Transformation ◽  
Anterior Circulation ◽  
Unique Identifier ◽  
Vessel Occlusion ◽  
Clinical Trial Registration ◽  
End Point ◽  
Flow Restoration

Background and Purpose— Mechanical thrombectomy using stent retriever devices have been advocated to increase revascularization in intracranial vessel occlusion. We present the results of a large prospective study on the use of the Solitaire Flow Restoration in patients with acute ischemic stroke. Methods— Solitaire Flow Restoration Thrombectomy for Acute Revascularization was an international, multicenter, prospective, single-arm study of Solitaire Flow Restoration thrombectomy in patients with large vessel anterior circulation strokes treated within 8 hours of symptom onset. Strict criteria for site selection were applied. The primary end point was the revascularization rate (thrombolysis in cerebral infarction ≥2b) of the occluded vessel as determined by an independent core laboratory. The secondary end point was the rate of good functional outcome (defined as 90-day modified Rankin scale, 0–2). Results— A total of 202 patients were enrolled across 14 comprehensive stroke centers in Europe, Canada, and Australia. The median age was 72 years, 60% were female patients. The median National Institute of Health Stroke Scale was 17. Most proximal intracranial occlusion was the internal carotid artery in 18%, and the middle cerebral artery in 82%. Successful revascularization was achieved in 79.2% of patients. Device and procedure-related severe adverse events were found in 7.4%. Favorable neurological outcome was found in 57.9%. The mortality rate was 6.9%. Any intracranial hemorrhagic transformation was found in 18.8% of patients, 1.5% were symptomatic. Conclusions— In this single-arm study, treatment with the Solitaire Flow Restoration device in intracranial anterior circulation occlusions results in high rates of revascularization, low risk of clinically relevant procedural complications, and good clinical outcomes in combination with low mortality at 90 days. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT01327989.

Mechanical thrombectomy using a Solitaire stent retriever in the treatment of pediatric acute ischemic stroke

2019 ◽  
Vol 23 (3) ◽  
pp. 363-368 ◽  
Author(s):  
Bing Zhou ◽  
Xiao-Chuan Wang ◽  
Jun-Yi Xiang ◽  
Ming-Zhao Zhang ◽  
Bo Li ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Mechanical Thrombectomy ◽  
Balloon Dilation ◽  
Stent Retriever ◽  
National Institutes Of Health ◽  
Clinical Prognosis ◽  
Nihss Score ◽  
Grade 3

OBJECTIVEMechanical thrombectomy using a Solitaire stent retriever has been widely applied as a safe and effective method in adult acute ischemic stroke (AIS). However, due to the lack of data, the safety and effectiveness of mechanical thrombectomy using a Solitaire stent in pediatric AIS has not yet been verified. The purpose of this study was to explore the safety and effectiveness of mechanical thrombectomy using a Solitaire stent retriever for pediatric AIS.METHODSBetween January 2012 and December 2017, 7 cases of pediatric AIS were treated via mechanical thrombectomy using a Solitaire stent retriever. The clinical practice, imaging, and follow-up results were reviewed, and the data were summarized and analyzed.RESULTSThe ages of the 7 patients ranged from 7 to 14 years with an average age of 11.1 years. The preoperative National Institutes of Health Stroke Scale (NIHSS) scores ranged from 9 to 22 with an average of 15.4 points. A Solitaire stent retriever was used in all patients, averaging 1.7 applications of thrombectomy and combined balloon dilation in 2 cases. Grade 3 on the modified Thrombolysis In Cerebral Infarction scale of recanalization was achieved in 5 cases and grade 2b in 2 cases. Six patients improved and 1 patient died after thrombectomy. The average NIHSS score of the 6 cases was 3.67 at discharge. The average modified Rankin Scale score was 1 at the 3-month follow-up. Subarachnoid hemorrhage after thrombectomy occurred in 1 case and that patient died 3 days postoperatively.CONCLUSIONSThis study shows that mechanical thrombectomy using a Solitaire stent retriever has a high recanalization rate and excellent clinical prognosis in pediatric AIS. The safety of mechanical thrombectomy in pediatric AIS requires more clinical trials for confirmation.

scholarly journals Efficacy of Mechanical Thrombectomy using Penumbra ACETM Aspiration Catheter Compared to Stent Retriever SolitaireTM FR in Patients with Acute Ischemic Stroke

2021 ◽  
Vol 11 (4) ◽  
pp. 504
Author(s):  
Dalibor Sila ◽  
Markus Lenski ◽  
Maria Vojtková ◽  
Mustafa Elgharbawy ◽  
František Charvát ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Clinical Outcome ◽  
Acute Ischemic Stroke ◽  
Clinical Outcomes ◽  
Mechanical Thrombectomy ◽  
Binary Logistic Regression ◽  
Stent Retriever ◽  
Good Clinical Outcome ◽  
Significant Difference ◽  
Aspiration Technique

Background: Mechanical thrombectomy is the standard therapy in patients with acute ischemic stroke (AIS). The primary aim of our study was to compare the procedural efficacy of the direct aspiration technique, using Penumbra ACETM aspiration catheter, and the stent retriever technique, with a SolitaireTM FR stent. Secondarily, we investigated treatment-dependent and treatment-independent factors that predict a good clinical outcome. Methods: We analyzed our series of mechanical thrombectomies using a SolitaireTM FR stent and a Penumbra ACETM catheter. The clinical and radiographic data of 76 patients were retrospectively reviewed. Using binary logistic regression, we looked for the predictors of a good clinical outcome. Results: In the Penumbra ACETM group we achieved significantly higher rates of complete vessel recanalization with lower device passage counts, shorter recanalization times, shorter procedure times and shorter fluoroscopy times (p < 0.001) compared to the SolitaireTM FR group. We observed no significant difference in good clinical outcomes (52.4% vs. 56.4%, p = 0.756). Predictors of a good clinical outcome were lower initial NIHSS scores, pial arterial collateralization on admission head CT angiography scan, shorter recanalization times and device passage counts. Conclusions: The aspiration technique using Penumbra ACETM catheter is comparable to the stent retriever technique with SolitaireTM FR regarding clinical outcomes.

Abstract WP372: Hydration Status and Clinical Outcomes in Acute Ischemic Stroke Patients Undergoing Mechanical Thrombectomy

Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Mona N Bahouth ◽  
Rebecca Gottesman
Keyword(s):  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Clinical Outcomes ◽  
Blood Urea Nitrogen ◽  
Mechanical Thrombectomy ◽  
Large Vessel ◽  
Hydration Status ◽  
Creatinine Ratio ◽  
Stroke Patients ◽  
Anterior Circulation

Introduction: Impaired hydration measured by elevated blood urea nitrogen (BUN) to creatinine ratio has been associated with worsened outcome after acute ischemic stroke. Whether hydration status is relevant for patients with acute ischemic stroke treated with mechanical thrombectomy remains unknown. Materials and Methods: We conducted a retrospective review of consecutive acute ischemic stroke patients who underwent endovascular procedures for anterior circulation large artery occlusion at Johns Hopkins Comprehensive Stroke Centers between 2012 and 2017. A volume contracted state (VCS), was determined based on surrogate lab markers and defined as blood urea nitrogen (BUN) to creatinine ratio greater than 15. Endpoints were achievement of successful revascularization (TICI 2b or 3), early re-occlusion, and short term clinical outcomes including development of early neurological worsening and functional outcome at 3 months. Results: Of the 158 patients who underwent an endovascular procedure, 102 patients had a final diagnosis of anterior circulation large vessel occlusion and met the inclusion criteria for analysis. Volume contracted state was present in 62/102 (61%) of patients. Successful revascularization was achieved in 75/102 (74%) of the cohort. There was no relationship between VCS and successful revascularization, but there was a 1.13 increased adjusted odds (95% CI 1.01, 1.27) of re-occlusion within 24 hours for every point higher BUN/creatinine ratio in the subset of patients who underwent radiological testing for pre-procedure planning (n=57). There was no relationship between VCS and clinical outcomes including early neurological worsening and 3 month outcome. Conclusions: Patients with VCS and large vessel anterior circulation stroke may have a higher odds of early re-occlusion after mechanical thrombectomy than their non-VCS counterparts, but no differences in successful revascularization nor clinical outcomes were present in this cohort. These results may suggest an opportunity for the exploration of pre-procedure hydration to improve outcomes.

Abstract WP1: Thrombectomy Outcomes in Acute Ischemic Stroke due to Middle Cerebral Artery M2 Occlusion with Stent-Retriever, Aspiration, MERCI: Multi-Center Experience

Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
Kunakorn Atchaneeyasakul ◽  
Amer M Malik ◽  
Dileep R Yavagal ◽  
Mehdi Bouslama ◽  
Diogo C Haussen ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Middle Cerebral Artery ◽  
Acute Ischemic Stroke ◽  
Cerebral Artery ◽  
Tertiary Care ◽  
Stent Retriever ◽  
Anterior Circulation ◽  
Vessel Occlusion ◽  
Symptomatic Intracerebral Hemorrhage ◽  
Significant Difference

Introduction: Recent trials demonstrated that mechanical thrombectomy improve functional outcome in anterior circulation acute ischemic stroke (AIS) due to emergent large vessel occlusion (ELVO) of the middle cerebral artery (MCA) M1 segment. However, such data regarding AIS due to MCA M2 segment ELVO is limited. Analysis of the STAR, SWIFT, and SWIFT-PRIME trials found thrombectomy in MCA M2 occlusion to be feasible in achieving successful reperfusion. The most optimal technique and/or device used for such reperfusion is not clearly defined. We aim to compare the outcome for the contemporary techniques and devices used for thrombectomy of AIS patients due to MCA M2 ELVO. Methods: A retrospective review of AIS patients with MCA M2 ELVO receiving thrombectomy from three tertiary care academic medical centers was conducted. Thrombectomy technique and thrombectomy device utilized were recorded. Outcomes were successful angiographic reperfusion (TICI ≥2b), favorable modified Rankin Scale (mRS≤2) at discharge and at 90 days, and rate of symptomatic intracerebral hemorrhage (sICH). Results: From October 1999 through June 2016, 253 AIS patients underwent thrombectomy for MCA M2 ELVO. Thrombectomy methods utilized were Stent-retriever (n=118), Aspiration only [manual or Penumbra device] (n=83), and MERCI retriever (n=52). Table 1 shows rate of outcomes measured. There was no difference in baseline NIHSS or in stroke onset to groin puncture time. Stent-retriever group showed a significantly higher recanalization rate, lower sICH rate, and favorable 90-day mRS versus Aspiration group or MERCI group, respectively. No significant difference was seen in discharge mRS between the groups. Conclusions: Thrombectomy for AIS patients with MCA M2 ELVO with Stent-retriever appears to be feasible with a significantly higher rate of recanalization, lower sICH rate, and favorable 90-day mRS when compared to Aspiration and MERCI.

scholarly journals Mechanical Thrombectomy Using a Solitaire Stent in Acute Ischemic Stroke; Initial Experience in 40 Patients

2012 ◽  
Vol 14 (3) ◽  
pp. 164 ◽  
Author(s):  
Gyu-Seong Bae ◽  
Hyon-Jo Kwon ◽  
Chang-Woo Kang ◽  
Seung-Won Choi ◽  
Seon-Hwan Kim ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Mechanical Thrombectomy ◽  
Initial Experience

Real-world stent retriever thrombectomy for acute ischemic stroke beyond 6 hours of onset: analysis of the NASA and TRACK registries

2018 ◽  
Vol 11 (4) ◽  
pp. 334-337 ◽  
Author(s):  
Maxim Mokin ◽  
Alex Abou-Chebl ◽  
Alicia C Castonguay ◽  
Raul G Nogueira ◽  
Joey D English ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Acute Stroke ◽  
Acute Ischemic Stroke ◽  
Real World ◽  
Symptom Onset ◽  
Individual Patient Data ◽  
Patient Data ◽  
Stent Retriever ◽  
Anterior Circulation ◽  
Stroke Symptom

BackgroundThe DEFUSE 3 and DAWN trials have shown the benefit of thrombectomy beyond 6 hours of stroke symptom onset in carefully selected patients.ObjectiveTo evaluate the real-world outcomes of stent retriever thrombectomy beyond 6 hours of stroke onset using combined individual patient data from the North American Solitaire Stent Retriever Acute Stroke (NASA) and Trevo Stent-Retriever Acute Stroke (TRACK) registries.MethodsPooled analysis of individual patient data of all cases of anterior circulation acute ischemic stroke (AIS) from NASA and TRACK was performed to compare outcomes of patients presenting within the first hours 6 or beyond 6 hours of stroke symptom onset.ResultsOf 830 patients with anterior circulation AIS from the NASA and TRACK registries, 32.7% (271 patients) underwent thrombectomy beyond the first 6 hours of symptom onset. The rates of good clinical outcome (modified Rankin scale score of 0–2 at 90 days), mortality, and symptomatic intracranial hemorrhage were similar: 48.1%, 20.6%, and 8.0% within 0–6 hours, 46.2%, 21.6%, and 10.9% within 6–16 hours, and 38.9%, 33.3%, and 5% within 16–24 hours (p=0.8, 0.6, and 0.5, respectively). The rates of successful recanalization (Thrombolysis in Cerebral Infarction 2b/3) were 79.4% in patients with stroke within 0–6 hours, 72.6% within 6–16 hours, and 85.0% within 16–24 hours (p=0.04).ConclusionsReal-world experience with patients with anterior circulation AIS treated with the Solitaire and Trevo thrombectomy devices beyond the first 6 hours of symptom onset proved to be equally safe and effective as for patients with symptom onset within the first 6 hours.

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