Safety and Efficacy of a 3-Dimensional Stent Retriever With Aspiration-Based Thrombectomy vs Aspiration-Based Thrombectomy Alone in Acute Ischemic Stroke Intervention: A Randomized Clinical Trial.
Nogueira Raul G,Frei Donald,Kirmani Jawad F,Zaidat Osama,Lopes Demetrius,Turk Aquilla S,Heck Donald,Mason Brian,Haussen Diogo C,Levy Elad I,Mehta Siddhart,Lazzaro Marc,Chen Michael,Dörfler Arnd,Yoo Albert J,Derdeyn Colin P,Schwamm Lee,Langer David,Siddiqui Adnan,
Importance:The treatment effects of individual mechanical thrombectomy devices in large-vessel acute ischemic stroke (AIS) remain unclear. Objective:To determine whether the novel 3-dimensional (3-D) stent retriever used in conjunction with an aspiration-based mechanical thrombectomy device (Penumbra System; Penumbra) is noninferior to aspiration-based thrombectomy alone in AIS. Design, Setting, and Participants:This randomized, noninferiority clinical trial enrolled patients at 25 North American centers from May 19, 2012, through November 19, 2015, with follow-up for 90 days. Adjudicators of the primary end points were masked to treatment allocation. Patients with large-vessel intracranial occlusion AIS presenting with a National Institutes of Health Stroke Scale (NIHSS) score of at least 8 within 8 hours of onset underwent 1:1 randomization to 3-D stent retriever with aspiration or aspiration alone. The primary analyses were conducted in the intention-to-treat population. Interventions:Mechanical thrombectomy using intracranial aspiration with or without the 3-D stent retriever. Main Outcomes and Measures:The primary effectiveness end point was the rate of a modified Thrombolysis in Cerebral Infarction (mTICI) grade of 2 to 3 with a 15% noninferiority margin. Device- and procedure-related serious adverse events at 24 hours were the primary safety end points. Results:Of 8082 patients screened, 198 patients were enrolled (111 women [56.1%] and 87 men [43.9%]; mean [SD] age, 66.9 [13.0] years) and randomized, including 98 in the 3-D stent retriever with aspiration group and 100 in the aspiration alone group; an additional 238 patients were eligible but not enrolled. The median baseline NIHSS score was 18.0 (interquartile range, 14.0-23.0). Eighty-two of 94 patients in the 3-D stent retriever and aspiration group (87.2%) had an mTICI grade of 2 to 3 compared with 79 of 96 in the aspiration alone group (82.3%; difference, 4.9%; 90% CI, -3.6% to 13.5%). None of the other measures were significantly different between the 2 groups. Device-related serious adverse events were reported by 4 of 98 patients in the 3-D stent retriever with aspiration group (4.1%) vs 5 of 100 patients in the aspiration only group (5.0%); procedure-related serious adverse events, 10 of 98 (10.2%) vs 14 of 100 (14.0%). A 90-day modified Rankin Scale score of 0 to 2 was reported by 39 of 86 patients in the 3-D stent retriever with aspiration group (45.3%) vs 44 of 96 patients in the aspiration only group (45.8%). Conclusions and Relevance:The present study provides class 1 evidence for the noninferiority of the 3-D stent retriever with aspiration vs aspiration alone in AIS. Future trials should evaluate whether these results can be generalized to other stent retrievers. Trial Registration:clinicaltrials.gov Identifier: NCT01584609.
Mechanical Thrombectomy for Acute Ischemic Stroke: A Meta-Analysis of Randomized Trials.
Elgendy Islam Y,Kumbhani Dharam J,Mahmoud Ahmed,Bhatt Deepak L,Bavry Anthony A
Journal of the American College of Cardiology
BACKGROUND:Acute ischemic stroke is a leading cause of serious disability and death worldwide. Individual randomized trials have shown possible benefits of mechanical thrombectomy after usual care compared with usual care alone (i.e., intravenous thrombolysis) in the management of acute ischemic stroke patients. OBJECTIVES:This study systematically determined if mechanical thrombectomy after usual care would be associated with better outcomes in patients with acute ischemic stroke caused by large artery occlusion. METHODS:The authors included randomized trials that compared mechanical thrombectomy after usual care versus usual care alone for acute ischemic stroke. Random effects summary risk ratios (RR) were constructed using a DerSimonian and Laird model. RESULTS:Nine trials with 2,410 patients were available for analysis. Compared with usual care alone, mechanical thrombectomy was associated with a higher incidence of achieving good functional outcome, defined as a modified Rankin scale (mRS) of 0 to 2 (RR: 1.45; 95% confidence interval [CI]: 1.22 to 1.72; p < 0.0001) and excellent functional outcome defined as mRS 0 to 1 (RR: 1.67; 95% CI: 1.27 to 2.19; p < 0.0001) at 90 days. There was a trend toward reduced all-cause mortality with mechanical thrombectomy (RR: 0.86; 95% CI: 0.72 to 1.02; p = 0.09). The risk of symptomatic intracranial hemorrhage was similar with either treatment modality (RR 1.06: 95% CI: 0.73 to 1.55; p = 0.76). CONCLUSIONS:In acute ischemic stroke due to large artery occlusion, mechanical thrombectomy after usual care was associated with improved functional outcomes compared with usual care alone, and was found to be relatively safe, with no excess in intracranial hemorrhage. There was a trend for reduction in all-cause mortality with mechanical thrombectomy.
Cerebral Hemodynamic Evaluation After Cerebral Recanalization Therapy for Acute Ischemic Stroke.
Zhang Zhe,Pu Yuehua,Mi Donghua,Liu Liping
Frontiers in neurology
Cerebral recanalization therapy, either intravenous thrombolysis or mechanical thrombectomy, improves the outcomes in patients with acute ischemic stroke (AIS) by restoring the cerebral perfusion of the ischemic penumbra. Cerebral hemodynamic evaluation after recanalization therapy, can help identify patients with high risks of reperfusion-associated complications. Among the various hemodynamic modalities, magnetic resonance imaging (MRI), computed tomography perfusion, and transcranial Doppler sonography (TCD) are the most commonly used. Poststroke hypoperfusion is associated with infarct expansion, while hyperperfusion, which once was considered the hallmark of successful recanalization, is associated with hemorrhagic transformation. Either the hypo- or the hyperperfusion may result in poor clinical outcomes. Individual blood pressure target based on cerebral hemodynamic evaluation was crucial to improve the prognosis. This review summarizes literature on cerebral hemodynamic evaluation and management after recanalization therapy to guide clinical decision making.
Early hemodynamic predictors of good outcome and reperfusion injury after endovascular treatment.
Baracchini Claudio,Farina Filippo,Palmieri Anna,Kulyk Caterina,Pieroni Alessio,Viaro Federica,Cester Giacomo,Causin Francesco,Manara Renzo
OBJECTIVE:To find early hemodynamic predictors of outcome and reperfusion injury in patients with acute ischemic stroke due to anterior circulation large artery occlusion (LAO) after endovascular treatment (EVT). METHODS:Serial transcranial color-coded sonography examinations assessed the vessel status and cerebral hemodynamics of 185 (109 [58.9%] men, mean age 69.5 ± 12.3 years) consecutive patients with acute anterior circulation LAO soon after, at 48 hours after, and 1 week after EVT. RESULTS:Successful recanalization (odds ratio [OR] 0.25, 95% confidence interval [CI] 0.11-0.61) and normal peak systolic velocity (PSV) ratio (PSV of recanalized middle cerebral artery/PSV of contralateral middle cerebral artery) at 48 hours (OR 0.22, 95% CI 0.15-0.64) and after 1 week (OR 0.11, 95% CI 0.07-0.31) from EVT were independent predictors of good outcome at 3 months. Thrombectomy failure (OR 10.22, 95% CI 1.47-45.53) and pathologic PSV ratio at 1 week from EVT (OR 15.23, 95% CI 4.54-46.72) were associated with a worse 90-day outcome. Patients who subsequently developed postinterventional intracranial hemorrhage (ICH) showed a higher mean PSV ratio (3.5 ± 0.2 vs 2.4 ± 0.1, < 0.0001) soon after successful recanalization. In multivariate analysis, early PSV ratio was independently associated with postprocedural ICH (OR 8.474, 95% CI 3.066-45.122, < 0.01]. At 1 week from EVT, 15 of 21 (71.4%) patients with ICH who resumed normal PSV values had a better 90-day outcome (modified Rankin Scale score 0-2: 40% vs 0%). CONCLUSION:Post-EVT ultrasound monitoring of stroke patients might be an effective bedside method for assessing treatment efficacy, shedding light on outcome variability and identifying patients at increased risk of ICH.
Risk Factors for Acute Ischemic Stroke Caused by Anterior Large Vessel Occlusion.
Hendrix Philipp,Sofoluke Nelson,Adams Matthew D,Kunaprayoon Saran,Zand Ramin,Kolinovsky Amy N,Person Thomas N,Gupta Mudit,Goren Oded,Schirmer Clemens M,Rost Natalia S,Faber James E,Griessenauer Christoph J
Background and Purpose- Accurate prediction of acute ischemic stroke (AIS) caused by anterior large vessel occlusion (LVO) that is amendable to mechanical thrombectomy remains a challenge. We developed and validated a prediction model for anterior circulation LVO stroke using past medical history elements present on admission and neurological examination. Methods- We retrospectively reviewed AIS patients admitted between 2009 and 2017 to 3 hospitals within a large healthcare system in the United States. Patients with occlusions of the internal carotid artery or M1 or M2 segments of the middle cerebral artery were randomly split into 2/3 derivation and 1/3 validation cohorts for development of an anterior circulation LVO prediction model and score that was further curtailed for potential use in the prehospital setting. Results- A total of 1654 AIS were reviewed, including 248 (15%) with proximal anterior circulation LVO AIS. In the derivation cohort, National Institutes of Health Stroke Scale score at the time of cerebrovascular imaging, current smoking status, type 2 diabetes mellitus, extracranial carotid, and intracranial atherosclerotic stenosis was significantly associated with anterior circulation LVO stroke. The prehospital score was curtailed to National Institutes of Health Stroke Scale score, current smoking status, and type 2 diabetes mellitus. The areas under the curve for the prediction model, prehospital score, and National Institutes of Health Stroke Scale score alone were 0.796, 0.757, and 0.725 for the derivation cohort and 0.770, 0.689, and 0.665 for the validation cohort, respectively. The Youden index J was 0.46 for a score of >6 with 84.7% sensitivity and 62.0% specificity for the prediction model. Conclusions- Previously reported LVO stroke prediction scores focus solely on elements of the neurological examination. In addition to stroke severity, smoking, diabetes mellitus, extracranial carotid, and intracranial atherosclerotic stenosis were associated with anterior circulation LVO AIS. Although atherosclerotic stenosis may not be known until imaging is obtained, smoking and diabetes mellitus history can be readily obtained in the field and represent important elements of the prehospital score supplementing National Institutes of Health Stroke Scale score.
Day 1 Extracranial Internal Carotid Artery Patency Is Associated With Good Outcome After Mechanical Thrombectomy for Tandem Occlusion.
Bricout Nicolas,Personnic Thomas,Ferrigno Marc,Labreuche Julien,Estrade Laurent,Bretzner Martin,Leclerc Xavier,Cordonnier Charlotte,Boulouis Grégoire,Henon Hilde
Background and Purpose- Optimal management of the extracranial occlusive component remains controversial in patients with acute ischemic stroke by tandem occlusion treated with mechanical thrombectomy. We investigated the association between extracranial internal carotid artery (ICA) patency at day 1 and the clinical outcome after mechanical thrombectomy. Methods- Consecutive patients with acute ischemic stroke with tandem occlusion were identified from a hospital-based prospective registry from 2011 to 2017. Baseline characteristics, angiographic outcomes, and day 1 ICA patency assessed by MR angiography were analyzed with regard to their associations with 3-month modified Rankin Scale scores. Favorable outcome was defined as a modified Rankin Scale score of 0 to 2 at 3 months. Results- Of 594 patients with acute ischemic stroke treated with mechanical thrombectomy during the study period, 83 met inclusion criteria. Successful recanalization (modified Thrombolysis in Cerebral Infarction, 2b/3) was achieved in 61.5%. Extracranial ICA was patent in 37 of 83 patients (44.6%) at day 1, more frequently in those with prior intravenous thrombolysis ( P=0.035) or with cervical revascularization procedure (balloon angioplasty or stenting, P=0.034). Favorable 3-month functional outcome was more frequent in patients with patent extracranial ICA at day 1 (adjusted odds ratio, 4.72; 95% CI, 1.76-13.34; P=0.003) independent of intracranial recanalization success. Conclusions- Day 1 stable extracranial ICA patency is associated with better clinical outcome in patients with acute ischemic stroke with tandem occlusions. Randomized studies are needed.
Impact of Periprocedural and Technical Factors and Patient Characteristics on Revascularization and Outcome in the DAWN Trial.
Tekle Wondwossen G,Hassan Ameer E,Jadhav Ashutosh P,Haussen Diogo C,Budzik Ronald F,Bonafe Alain,Bhuva Parita,Yavagal Dileep R,Hanel Ricardo A,Ribo Marc,Cognard Christophe,Sila Cathy A,Smith Wade S,Saver Jeffrey L,Liebeskind David S,Shields Ryan,Nogueira Raul G,Jovin Tudor G,
Background and Purpose- Because of unique attributes of mechanical thrombectomy performed between 6 and 24 hours after symptom onset in acute ischemic stroke patients, it is not known if predictors of angiographic recanalization and favorable outcome in patients treated with thrombectomy in the late (6-24 hour) time window are similar to those treated in the early time window. Methods- We analyzed data from the DAWN trial (DWI or CTP Assessment With Clinical Mismatch in the Triage of Wake-Up and Late Presenting Strokes Undergoing Neurointervention With Trevo) which enrolled patients with symptom onset 6 to 24hours after last known well and occlusion of the intracranial internal carotid artery or proximal middle cerebral artery with a mismatch between severity of clinical deficit and infarct core volume as identified by computed tomography-perfusion or diffusion magnetic resonance imaging. We evaluated the effect of tandem occlusions, periprocedural heparin use, procedural speed (from puncture to procedure completion), general anesthesia, balloon-guide catheters, thrombectomy device size, and number of passes on substantial reperfusion (modified Thrombolysis in Cerebral Infarction 2b/3) and on likelihood of obtaining a modified Rankin Scale at 3 months indicating functional independence. Results- Of 107 patients who underwent MT in the interventional arm of DAWN, substantial reperfusion and modified Rankin Scale score 0 to 2 at 3 months was seen in 90 (84%) and 52 (49%), respectively. In univariate analysis, general anesthesia (odds ratio [OR] 0.27; =0.042) and ≥3 passes with stent retriever (OR, 0.17; =0.002) were inversely associated with substantial reperfusion. In multivariate analyses, only ≥3 passes were associated with lack of revascularization (OR, 0.17; =0.002). in univariate analysis ≥3 passes (OR, 0.24; =0.003) and baseline National Institutes of Health Stroke Scale score >17 (OR, 0.19; <0.001) were inversely associated with functional independence at 3 months. In multivariate analyses, ≥3 passes (OR, 0.24; =0.003) and National Institutes of Health Stroke Scale score >17 (OR, 0.19; <0.001) remained inversely associated with favorable outcome at 3 months. Conclusions- Patients requiring ≥3 thrombectomy passes had reduced substantial reperfusion and favorable outcome at 3 months in DAWN. Whether or not additional thrombectomy techniques beyond ≥3 thrombectomy passes with the Trevo stent retriever are beneficial for patient outcomes in this patient population remains to be clarified by future studies. Clinical Trial Registration- URL: https://www.clinicaltrials.gov. Unique identifier: NCT02142283.
Twenty-Four-Hour Reocclusion After Successful Mechanical Thrombectomy: Associated Factors and Long-Term Prognosis.
Marto João Pedro,Strambo Davide,Hajdu Steven D,Eskandari Ashraf,Nannoni Stefania,Sirimarco Gaia,Bartolini Bruno,Puccinelli Francesco,Maeder Philippe,Saliou Guillaume,Michel Patrik
Background and Purpose- Early arterial recanalization is a strong determinant of prognosis in acute ischemic stroke. Nevertheless, reocclusion can occur after initial recanalization. We assessed associated factors and long-term prognosis of reocclusion after successful mechanical thrombectomy (MT). Methods- From the prospectively constructed Acute Stroke Registry and Analysis of Lausanne cohort, we included consecutive patients with anterior and posterior circulation strokes treated by successful MT (modified treatment in cerebral infarction 2b-3) and with 24-hour vascular imaging available. Reocclusion at this time-point was defined as new intracranial occlusion within an arterial segment recanalized at the end of MT. Through multivariate logistic regression, we investigated associated factors and 3-months outcome. In a 4:1 matched-cohort, we also assessed the role of residual thrombus or stenosis on post-recanalization angiographic images as potential predictor of reocclusion. Results- Among 473 patients with successful recanalization, 423 (89%) were included. Of these, 28 (6.6%) had 24-hour reocclusion. Preadmission statin therapy (aOR [adjusted odds ratio], 0.27; 95% CI, 0.08-0.94), intracranial internal carotid artery occlusion (aOR, 3.53; 95% CI, 1.50-8.32), number of passes (aOR, 1.31; 95% CI, 1.06-1.62), transient reocclusion during MT (aOR, 8.55; 95% CI, 2.14-34.09), and atherosclerotic cause (aOR, 3.14; 95% CI, 1.34-7.37) were independently associated with reocclusion. In the matched-cohort analysis, residual thrombus or stenosis was associated with reocclusion (aOR, 15.6; 95% CI, 4.6-52.8). Patients experiencing reocclusion had worse outcome (aOR, 5.0; 95% CI, 1.2-20.0). Conclusions- Reocclusion within 24-hours of successful MT was independently associated with statin pretreatment, occlusion site, more complex procedures, atherosclerotic cause, and residual thrombus or stenosis after recanalization. Reocclusion impact on long-term outcome highlights the need to monitor and prevent this early complication.
Mechanical Thrombectomy for Acute Ischemic Stroke in the Cardiac Catheterization Laboratory.
Guidera Steven A,Aggarwal Sudhir,Walton J Doyle,Boland David,Jackel Roy,Gould Jeffrey D,Kearins Brooke,McGarvey Joseph,Qi Yan,Furlong Brian
JACC. Cardiovascular interventions
OBJECTIVES:The aim of this study was to determine the feasibility of establishing a mechanical thrombectomy (MT) program for acute ischemic stroke in a community hospital using interventional cardiologists working closely with neurologists. BACKGROUND:American Heart Association/American Stroke Association 2018 guidelines give a Class I (Level of Evidence: A) recommendation for MT in eligible patients with large vessel occlusion stroke. Improvement in neurological outcomes with MT is highly time sensitive. Most hospitals do not have trained neurointerventionalists to perform MT, leading to treatment delays that reduce the benefit of reperfusion therapy. METHODS:An MT program based in the cardiac catheterization laboratory was developed using interventional cardiologists with ST-segment elevation myocardial infarction teams. RESULTS:Forty patients underwent attempted MT for acute ischemic stroke. An additional 5 patients who underwent angiography did not undergo attempted thrombectomy, because of absence of target thrombus (n = 4) or unsuitable anatomy (n = 1). Median National Institutes of Health Stroke Scale score prior to MT was 19 and at discharge was 7. TICI (Thrombolysis In Cerebral Infarction) grade 2b or 3 flow was restored in 80% of patients (32 of 40). At 90 days, 55% of patients (22 of 40) were functionally independent (modified Rankin score ≤2). In-hospital mortality was 13% (5 of 40). Symptomatic intracranial hemorrhage occurred in 15% of patients (6 of 40). Major vascular complications occurred in 5% of patients (2 of 40). CONCLUSIONS:MT can be successfully performed by interventional cardiologists with carotid stenting experience working closely with neurologists in hospitals lacking formally trained neurointerventionists. This model has the potential to increase access to timely care for patients with acute ischemic stroke.
Local Anesthesia Without Sedation During Thrombectomy for Anterior Circulation Stroke Is Associated With Worse Outcome.
Benvegnù Francesco,Richard Sébastien,Marnat Gaultier,Bourcier Romain,Labreuche Julien,Anadani Mohammad,Sibon Igor,Dargazanli Cyril,Arquizan Caroline,Anxionnat René,Audibert Gérard,Zhu François,Mazighi Mikaël,Blanc Raphaël,Lapergue Bertrand,Consoli Arturo,Gory Benjamin,
BACKGROUND AND PURPOSE:The best anesthetic management for mechanical thrombectomy of large vessel occlusion strokes is still uncertain and could impact the quality of reperfusion and clinical outcome. We aimed to compare the efficacy and safety outcomes between local anesthesia (LA) and conscious sedation in a large cohort of acute ischemic stroke patients with anterior circulation large vessel occlusion strokes treated with mechanical thrombectomy in current, everyday clinical practice. METHODS:Patients undergoing mechanical thrombectomy for anterior large vessel occlusion strokes at 4 comprehensive stroke centers in France between January 1, 2018, and December 31, 2018, were pooled from the ongoing prospective multicenter observational Endovascular Treatment in Ischemic Stroke Registry in France. Intention-to-treat and per-protocol analyses were used. RESULTS:Among the included 1034 patients, 762 were included in the conscious sedation group and 272 were included in the LA group. In the propensity score matched cohort, the rate of favorable outcome (90-day modified Rankin Scale score 0-2) was significantly lower in the LA group than in the conscious sedation group (40.0% versus 52.0%, matched relative risk=0.76 [95% CI, 0.60-0.97]), as well as the rate of successful reperfusion (modified Thrombolysis in Cerebral Infarction grade 2b-3; 76.6% versus 87.1%; matched relative risk=0.88 [95% CI, 0.79-0.98]). There was no difference in procedure time between the 2 groups. In the inverse probability of treatment weighting-propensity score-adjusted cohort, similar significant differences were found for favorable outcomes and successful reperfusion. In inverse probability of treatment weighting-propensity score-adjusted cohort, a higher rate of 90-day mortality and a lower parenchymal hematoma were observed after LA. The sensitivity analysis restricted to our per-protocol sample provided similar results in the matched- and inverse probability of treatment weighting-propensity cohorts. CONCLUSIONS:In the Endovascular Treatment in Ischemic Stroke registry mainly included patients in early time window (<6 hours), LA was associated with lower odds of favorable outcome, successful reperfusion, and higher odds of mortality compared with conscious sedation for mechanical thrombectomy of large vessel occlusion.
Primary Multivessel Occlusions Treated With Mechanical Thrombectomy: A Multicenter Analysis and Systemic Literature Review.
Kaesmacher Johannes,Meyer Lukas,Styczen Hanna,Lobsien Donald,Seker Fatih,Piechowiak Eike,Tan Benjamin Y Q,Fischer Sebastian,Clajus Christin,Yeo Leonard,Papanagiotou Panagiotis,Kastrup Andreas,Maegerlein Christian,Wunderlich Silke,Möhlenbruch Markus A,Radbruch Alexander,Gralla Jan,Fiehler Jens,Maus Volker
BACKGROUND AND PURPOSE:Acute ischemic stroke caused by primary multivessel occlusions (pMVO) is a rare but devastating disease. Whether multi-target mechanical thrombectomy for pMVO is beneficial remains unknown. METHODS:Multicenter retrospective review of patients treated with multi-target mechanical thrombectomy. The following pMVO sites were included: basilar artery, internal carotid artery, and middle cerebral artery (M1 and M2). Baseline characteristics were reported together with interventional technique, technical efficacy, and safety parameters. Clinical outcomes were evaluated applying the National Institutes of Health Stroke Scale and modified Rankin Scale. A systematic literature review was performed to summarize previous reports on pMVO mechanical thrombectomy. RESULTS:Of 6081 patients screened, 21 patients met the inclusion criteria (0.35% [95% CI, 0.23%-0.53%]). In 70% (14/20) a cardioembolic cause was reported. A successful reperfusion of Thrombolysis in Cerebral Infarction scale score ≥2b was achieved in 95.2% (20/21) for the first and 76.1% (16/21) for the second target vessel. In those who survived the acute hospital stay (n=10/21), median admission National Institutes of Health Stroke Scale improved from 21 (interquartile range, 13-27) to 8 (interquartile range, 2-20) at discharge (=0.006). Mortality was 60% (12/20) at 90 days and only 20% (4/20) of patients reached modified Rankin Scale score ≤2. Acceptable outcomes were almost exclusively observed in pMVO patients presenting with at least one M2 occlusion. CONCLUSIONS:Multi-target mechanical thrombectomy for pMVOs is rarely performed; however, the procedure appears to be feasible and safe with high reperfusion rates for both occlusion sites. More than half of all treated patients deceased early and favorable outcomes may only be expected for pMVO patients including at least one M2 occlusion.