scholarly journals Endovascular Treatment of Acute Ischemic Stroke With the Penumbra System in Routine Practice: COMPLETE Registry Results

Stroke ◽  
2021 ◽  
Author(s):  
Osama O. Zaidat ◽  
Johanna T. Fifi ◽  
Ashish Nanda ◽  
Benjamin Atchie ◽  
Keith Woodward ◽  
...  

Background and Purpose: The purpose of the COMPLETE (International Acute Ischemic Stroke Registry With the Penumbra System Aspiration Including the 3D Revascularization Device) registry was to evaluate the generalizability of the safety and efficacy of the Penumbra System (Penumbra, Inc, Alameda) in a real-world setting. Methods: COMPLETE was a global, prospective, postmarket, multicenter registry. Patients with large vessel occlusion–acute ischemic stroke who underwent mechanical thrombectomy using the Penumbra System with or without the 3D Revascularization Device as frontline approach were enrolled at 42 centers (29 United States, 13 Europe) from July 2018 to October 2019. Primary efficacy end points were successful postprocedure angiographic revascularization (modified Thrombolysis in Cerebral Infarction ≥2b) and 90-day functional outcome (modified Rankin Scale score 0–2). The primary safety end point was 90-day all-cause mortality. An imaging core lab determined modified Thrombolysis in Cerebral Infarction scores, Alberta Stroke Program Early CT Scores, clot location, and occurrence of intracranial hemorrhage at 24 hours. Independent medical reviewers adjudicated safety end points. Results: Six hundred fifty patients were enrolled (median age 70 years, 54.0% female, 49.2% given intravenous recombinant tissue plasminogen activator before thrombectomy). Rate of modified Thrombolysis in Cerebral Infarction 2b to 3 postprocedure was 87.8% (95% CI, 85.3%–90.4%). First pass and postprocedure rates of modified Thrombolysis in Cerebral Infarction 2c to 3 were 41.5% and 66.2%, respectively. At 90 days, 55.8% (95% CI, 51.9%–59.7%) had modified Rankin Scale score 0 to 2, and all-cause mortality was 15.5% (95% CI, 12.8%–18.3%). Conclusions: Using Penumbra System for frontline mechanical thrombectomy treatment of patients with large vessel occlusion–acute ischemic stroke in a real-world setting was associated with angiographic, clinical, and safety outcomes that were comparable to prior randomized clinical trials with stringent site and operator selection criteria. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03464565.

2019 ◽  
Vol 2 (2) ◽  
pp. 105-110
Author(s):  
Saima Ahmad ◽  
Umair Rashid Chaudhry ◽  
Ossama Yassin Mansour

Introduction: Mechanical thrombectomy has become the cornerstone and standard of care for acute stroke patients. Early reperfusion in patients experiencing acute ischemic stroke is the most important factor. The motivation behind this investigation is to display the aftereffects of mechanical thrombectomy in patients with large vessel occlusion in anterior and posterior circulation and to demonstrate that it lessens the level of handicap 3 months post stroke. Methods: A retrospective analysis was conducted of patients who presented with acute ischemic stroke at our center from 2015 to 2018 and received mechanical thrombectomy using combined manual aspiration with a stent retriever and with large bore catheters without the bridging technique. Result factors including recanalization rate and modified Rankin Scale at 90 days post procedure were assessed. An aggregate of 30 patients were included. Results: About 30 patients presented at the institute and met the inclusion criteria for the study. Successful recanalization (the Thrombolysis in Cerebral Infarction Score [TICI 2B]) was accomplished in 90% of patients, TICI 3 score was accomplished in 56% of the patients. 67% of the patients had good modified Rankin Scale score 0-2 result at 90 days. There were 3 symptomatic hemorrhages and 3 procedure and comorbidity-related deaths (10%). Conclusion: Mechanical thrombectomy using combined manual aspiration with a stent retriever and with large bore catheters alone without the bridging technique is an effective and safe procedure for endovascular revascularization of large vessel occlusion presenting with acute ischemic stroke.


2019 ◽  
Vol 11 (10) ◽  
pp. 957-963 ◽  
Author(s):  
Michael Martini ◽  
J Mocco ◽  
Aquilla Turk ◽  
Adnan H Siddiqui ◽  
David Fiorella ◽  
...  

BackgroundThrombectomy for anterior large vessel occlusion less than 24 hours since last known well is now standard of care. Certain aspects of clinical trials may limit generalizability to ’real-world' practice.ObjectiveTo compare revascularization rates and outcomes for direct aspiration (ADAPT) and stent retriever thrombectomy following anterior acute ischemic stroke (AIS) in a real-life setting.MethodsData from the most recent 20 consecutive patients with AIS treated with mechanical thrombectomy between 2015 and 2016 were collected from 15 high-volume stroke centers across North America for a total of 300 cases. Patients with proximal anterior large vessel occlusions were dichotomized by primary treatment technique. Ordinal logistic regression assessed the effects of clinical variables on patient disability using 90-day modified Rankin Scale (mRS) scores.ResultsAdequate revascularization (Thrombolysis in Cerebral Infarction ≥2b) was ultimately achieved in 91.2% of first-line direct aspiration (ADAPT) cases with an average of 1.9±1.9 passes and in 87.5% of stent retriever cases with an average of 1.7±1.0 passes. Time from groin puncture to revascularization was shorter for ADAPT cases. The mean 90-day mRS score for both groups was 3.0±2.4. Number of passes using primary technique, and postintervention intracranial hemorrhage, were significant predictors of 90-day mRS scores after ADAPT, while age and preprocedure mRS score were predictive of outcomes following first-line stent retriever.ConclusionsOur data show similar adequate revascularization rates and 90-day functional outcomes for first-line direct aspiration and stent retrievers for anterior large vessel occlusion in a real-world setting. These results support the findings of other prospective trials evaluating the two techniques.


Stroke ◽  
2021 ◽  
Author(s):  
Mahmoud H. Mohammaden ◽  
Diogo C. Haussen ◽  
Leonardo Pisani ◽  
Alhamza R. Al-Bayati ◽  
Nicolas Bianchi ◽  
...  

Background and Purpose: Despite the lower rates of good outcomes and higher mortality in elderly patients, age does not modify the treatment effect of mechanical thrombectomy for large vessel occlusion strokes. We aimed to study whether racial background influences the outcome after mechanical thrombectomy in the elderly population. Methods: We reviewed a prospectively maintained database of patients with acute ischemic stroke treated with mechanical thrombectomy from October 2010 through June 2020 to identify all consecutive patients with age ≥80 years and anterior circulation large vessel occlusion strokes. The patients were categorized according to their race as Black and White. Univariable and multivariable analyses were performed to define the predictors of 90-day modified Rankin Scale and mortality in the overall population and in each race separately. Results: Among 2241 mechanical thrombectomy, a total of 344 patients (median [interquartile range]; age 85 [82–88] years, baseline National Institutes of Health Stroke Scale score of 19 [15–23], Alberta Stroke Program Early CT Score 9 [7–9], 69.5% females) were eligible for the analysis. White patients (n=251; 73%) had significantly lower median body mass index (25.37 versus 26.89, P =0.04) and less frequent hypertension (78.9% versus 90.3%, P =0.01) but more atrial fibrillation (64.5% versus 44.1%, P =0.001) compared with African Americans (n=93; 27%). Other clinical, imaging, and procedural characteristics were comparable between groups. The rates of symptomatic intracerebral hemorrhage, 90-day modified Rankin Scale score of 0 to 2, and mortality were comparable among both groups. On multivariable analysis, race was neither a predictor of 90-day modified Rankin Scale score of 0 to 2 (White race: odds ratio, 0.899 [95% CI, 0.409–1.974], P =0.79) nor 90-day mortality (White race: odds ratio, 1.368; [95% CI, 0.715–2.618], P =0.34). Conclusions: In elderly patients undergoing mechanical thrombectomy for acute ischemic stroke, there was no racial difference in terms of outcome.


Stroke ◽  
2021 ◽  
Vol 52 (1) ◽  
pp. 232-240
Author(s):  
Jean-Marc Olivot ◽  
Jean-François Albucher ◽  
Adrien Guenego ◽  
Claire Thalamas ◽  
Michael Mlynash ◽  
...  

Background and Purpose: Mechanical thrombectomy (MT) is the recommended treatment for acute ischemic stroke caused by anterior circulation large vessel occlusion. However, despite a high rate of reperfusion, the clinical response to successful MT remains highly variable in the early time window where optimal imaging selection criteria have not been established. We hypothesize that the baseline perfusion imaging profile may help forecast the clinical response to MT in this setting. Methods: We conducted a prospective multicenter cohort study of patients with large vessel occlusion–related acute ischemic stroke treated by MT within 6 hours. Treatment decisions and the modified Rankin Scale evaluation at 3 months were performed blinded to the results of baseline perfusion imaging. Study groups were defined a posteriori based on predefined imaging profiles: target mismatch (TMM; core volume <70 mL/mismatch ratio >1.2 and mismatch volume >10 mL) versus no TMM or mismatch (MM; mismatch ratio >1.2 and volume >10 mL) versus no MM. Functional recovery (modified Rankin Scale, 0–2) at 3 months was compared based on imaging profile at baseline and whether reperfusion (modified Thrombolysis in Cerebral Infarction 2bc3) was achieved. Results: Two hundred eighteen patients (mean age, 71±15 years; median National Institutes of Health Stroke Scale score, 17 [interquartile range, 12–21]) were enrolled. Perfusion imaging profiles were 71% TMM and 82% MM. The rate of functional recovery was 54% overall. Both TMM and MM profiles were independently associated with a higher rate on functional recovery at 3 months Adjusted odds ratios were 3.3 (95% CI, 1.4–7.9) for TMM and 5.9 (95% CI, 1.8–19.6) for MM. Reperfusion (modified Thrombolysis in Cerebral Infarction 2bc3) was achieved in 86% and was more frequent in TMM and MM patients. Reperfusion was associated with a higher rate of functional recovery in MM and TMM patients but not among those with no MM. Conclusions: In this cohort study, about 80% of the patients with a large vessel occlusion–related acute ischemic stroke had evidence of penumbra, regardless of infarction volume. Perfusion imaging profiles predict the clinical response to MT.


2021 ◽  
pp. 159101992110394
Author(s):  
Ameer E Hassan ◽  
Victor M Ringheanu ◽  
Laurie Preston ◽  
Wondwossen G Tekle ◽  
Adnan I Qureshi

Objective To investigate whether significant differences exist in recanalization rates and primary outcomes between patients who undergo mechanical thrombectomy alone versus those who undergo mechanical thrombectomy with acute intracranial stenting. Methods Through the utilization of a prospectively collected endovascular database at a comprehensive stroke center between 2012 and 2020, variables such as demographics, co-morbid conditions, symptomatic intracerebral hemorrhage, mortality rate at discharge, and good/poor outcomes in regard to modified thrombolysis in cerebral infarction score and modified Rankin Scale were examined. The outcomes between patients receiving acute intracranial stenting + mechanical thrombectomy and patients that underwent mechanical thrombectomy alone were compared. Results There were a total of 420 acute ischemic stroke patients who met criteria for the study (average age 70.6 ± 13.01 years; 46.9% were women). Analysis of 46 patients from the acute stenting + mechanical thrombectomy group (average age 70.34 ± 13.75 years; 37.0% were women), and 374 patients from the mechanical thrombectomy alone group (average age 70.64 ± 12.92 years; 48.1% were women). Four patients (8.7%) in the acute stenting + mechanical thrombectomy group experienced intracerebral hemorrhage versus 45 patients (12.0%) in the mechanical thrombectomy alone group ( p = 0.506); no significant increases were noted in the median length of stay (7 vs 8 days; p = 0.208), rates of modified thrombolysis in cerebral infarction 2B-3 recanalization ( p = 0.758), or good modified Rankin Scale scores ( p = 0.806). Conclusion Acute intracranial stenting in addition to mechanical thrombectomy was not associated with an increase in overall length of stay, intracerebral hemorrhage rates, or any change in discharge modified Rankin Scale. Further research is required to determine whether mechanical thrombectomy and acute intracranial stenting in acute ischemic stroke patients is unsafe.


2020 ◽  
Vol 9 (23) ◽  
Author(s):  
Kazutaka Uchida ◽  
Shinichi Yoshimura ◽  
Hirotoshi Imamura ◽  
Nobuyuki Ohara ◽  
Nobuyuki Sakai ◽  
...  

Background Statins have been associated with reduced recurrence and better functional outcomes in patients with acute ischemic stroke. However, the effect of statins in patients with acute large vessel occlusion (LVO) is not well scrutinized. Methods and Results RESCUE (Recovery by Endovascular Salvage for Cerebral Ultra‐Acute Embolism)‐Japan Registry 2, a physician‐initiated registry, enrolled 2420 consecutive patients with acute LVO who were admitted to 46 centers across Japan within 24 hours of onset. We compared patients with and without statin use after acute LVO onset (statin group and nonstatin group, respectively) in terms of the modified Rankin scale at 90 days. We estimated that the odds ratios for the primary outcome was modified Rankin scale and we estimated the odds ratios for a 1‐scale lower modified Rankin scale adjusting for confounders. After excluding 12 patients without LVO and 9 patients without follow‐up, the mean age of 2399 patients was 75.9 years; men accounted for 55% of patients. Statins were administered to 447 (19%) patients after acute LVO onset. Patients in the statin group had more atherothrombotic cerebral infarctions (34.2% versus 12.1%, P <0.0001), younger age (73.4 years versus 76.5 years, P <0.0001), and lower median National Institutes of Health Stroke Scale on admission (14 versus 17, P <0.0001) than the nonstatin group. The adjusted common OR of the statin group for lower modified Rankin scale was 1.29 (95% CI, 1.04–1.37; P =0.02). The mortality at 90 days was lower in the statin group (4.7%) than the nonstatin group (12.5%; P <0.0001). The adjusted OR of the statin group relative to the nonstatin group for mortality was 0.36 (95% CI, 0.21–0.62; P =0.02). Conclusions Statin administration after acute LVO onset is significantly associated with better functional outcome and mortality at 90 days.


Stroke ◽  
2021 ◽  
Vol 52 (4) ◽  
pp. 1192-1202
Author(s):  
Vanessa H.E. Chen ◽  
Grace K.H. Lee ◽  
Choon-Han Tan ◽  
Aloysius S.T. Leow ◽  
Ying-Kiat Tan ◽  
...  

Background and Purpose: In patients with acute ischemic stroke with large vessel occlusion, the role of intra-arterial adjunctive medications (IAMs), such as urokinase, tPA (tissue-type plasminogen activator), or glycoprotein IIb/IIIa inhibitors, during mechanical thrombectomy (MT) has not been clearly established. We aim to evaluate the efficacy and safety of concomitant or rescue IAM for acute ischemic stroke with large vessel occlusion patients undergoing MT. Methods: We searched Medline, Embase, and Cochrane Stroke Group Trials Register databases from inception until March 13, 2020. We analyzed all studies with patients diagnosed with acute ischemic stroke with large vessel occlusion in the anterior or posterior circulation that provided data for the two treatment arms, (1) MT+IAM and (2) MT only, and also reported on at least one of the following efficacy outcomes, recanalization and 90-day modified Rankin Scale, or safety outcomes, symptomatic intracranial hemorrhage and 90-day mortality. Data were collated in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Results: Sixteen nonrandomized observational studies with a total of 4581 patients were analyzed. MT only was performed in 3233 (70.6%) patients, while 1348 (29.4%) patients were treated with both MT and IAM. As compared with patients treated with MT alone, patients treated with combination therapy (MT+IAM) had a higher likelihood of achieving good functional outcome (risk ratio, 1.13 [95% CI, 1.03–1.24]) and a lower risk of 90-day mortality (risk ratio, 0.82 [95% CI, 0.72–0.94]). There was no significant difference in successful recanalization (risk ratio, 1.02 [95% CI, 0.99–1.06]) and symptomatic intracranial hemorrhage between the two groups (risk ratio, 1.13 [95% CI, 0.87–1.46]). Conclusions: In acute ischemic stroke with large vessel occlusion, the use of IAM together with MT may achieve better functional outcomes and lower mortality rates. Randomized controlled trials are warranted to establish the safety and efficacy of IAM as adjunctive treatment to MT.


Author(s):  
Uday Bhanu Kovilapu ◽  
Narendra Jain ◽  
Atul Mishra ◽  
Virender Malik

Abstract Background: The data pertaining to selecting an optimal first-line strategy (stent retriever [SR] vs. contact aspiration [CA]) based on noncontrast computed tomography (NCCT) in cases of acute ischemic stroke consequent to large vessel occlusion (LVO) is lacking. Aims: This article studies the influence of hyperdense vessel sign (HVS) in selecting optimal first-line strategy, with intention of increasing first-pass recanalization (FPR). Methods: Upfront approach at our center is SR technique with rescue therapy (CA) adoption consequent to three failed SR attempts to achieve successful recanalization. Data of patients with acute LVO who underwent mechanical thrombectomy from June 2017 to May 2020 was retrospectively analyzed. Patients were classified into HVS (+) and HVS (–) cohort. Rate of successful recanalization (first pass, early, and final) and efficacy of rescue therapy was assessed between the two cohorts. Results: Of 52 patients included, 28 and 24 were assigned to the HVS (+) and HVS (–) cohort, respectively. FPR was observed in 50% of HVS (+) and 20.9% of HVS (–) (p = 0.029). Early recanalization was documented in 64.2% of HVS (+) and 37.5% of HVS (–) (p = 0.054). Rescue therapy need was higher in patients not demonstrating HVS (p = 0.062). Successful recanalization was achieved with rescue therapy in 50% of HVS (–) group. Conclusion: A higher FPR is achievable following individualized first-pass strategy (based on NCCT appearance of clot), instead of a generalized SR first-pass approach. This CT imaging-based strategy is a step closer to achieving primary angiographic goal of FPR.


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