scholarly journals Embotrap Extraction & Clot Evaluation & Lesion Evaluation for NeuroThrombectomy (EXCELLENT) Registry design and methods

2021 ◽  
pp. neurintsurg-2021-017671
Author(s):  
Adnan H Siddiqui ◽  
Muhammad Waqas ◽  
Waleed Brinjikji ◽  
Simon De Meyer ◽  
Karen Doyle ◽  
...  

BackgroundRelationships between occlusive clot histopathology, baseline characteristics, imaging findings, revascularization rates, and clinical outcomes of stroke patients with large vessel occlusion (LVO) are not well understood. This study will assess the real-world experience on the efficacy and safety of using the EmboTrap device as the first approach in LVO patients and explore the associations between clot histological characteristics, imaging and clinical findings, revascularization rates, and clinical outcomes.MethodsProspective, global, multicenter, single-arm, imaging core laboratory, and clot analysis central laboratory observational registry. Adult patients (>18 years) with LVO, treated with EmboTrap as the first attempted device, will be eligible for study participation.ResultsUp to 1000 subjects at 50 international sites may be enrolled. Occlusive clots will be collected from at least 500 subjects. Independent central and imaging core laboratories will perform clot analysis and image adjudication. Statistical analysis will assess the association between imaging and clinical findings, clot characteristics, subject comorbidities, revascularization, and clinical outcomes. Study endpoints are functional independence (modified Rankin Scale score ≤2 at 90 days), expanded Thrombolysis In Cerebral Infarction (eTICI) score ≥2b50 rate, first-pass effect, number of passes, embolization into new territory, symptomatic intracranial hemorrhage, and 90-day mortality.ConclusionsThe EXCELLENT registry will provide reproducible effectiveness and safety data of EmboTrap for its use for mechanical thrombectomy. Additionally, the study will characterize the blood clots retrieved during mechanical thrombectomy with respect to their composition and histopathological analysis and potential correlations with clinical and imaging findings.Trial registration numberNCT03685578.

Stroke ◽  
2021 ◽  
Vol 52 (Suppl_1) ◽  
Author(s):  
Ameer E Hassan ◽  
Mahmoud Dibas ◽  
Amr Ehab El-Qushayri ◽  
Sherief Ghozy ◽  
Adam A Dmytriw ◽  
...  

Background: Mechanical thrombectomy (MT) has significantly improved outcomes of acute ischemic stroke (AIS) patients due to large vessel occlusion (LVO). The first-pass effect (FPE), defined as achieving complete reperfusion (mTICI3/2c) with a single pass, was reported to be associated with higher functional independence rates following EVT and has been emphasized as an important procedural target. We compared MT outcomes in patients who achieved FPE to those who did not in a real world large database. Method: A retrospective analysis of LVO pts who underwent MT from a single center prospectively collected database. Patients were stratified into those who achieved FPE and non-FPE. The primary outcome (discharge and 90 day mRS 0-2) and safety (sICH, mortality and neuro-worsening) were compared between the two groups. Results: Of 580 pts, 261 (45%) achieved FPE and 319 (55%) were non-FPE. Mean age was (70 vs 71, p=0.051) and mean initial NIHSS (16 vs 17, p=0.23) and IV tPA rates (37% bs 36%, p=0.9) were similar between the two groups. Other baseline characteristics were similar. Non-FPE pts required more stenting (15% vs 25%, p=0.003), and angioplasty (19% vs 29%, p=0.01). The FPE group had significantly more instances of discharge (33% vs 17%, p<0.001), and 90-day mRS score 0-2 (29% vs 20%, p<0.001), respectively. Additionally, the FPE group had a significant lower mean discharge NIHSS score (12 vs 17, p<0.001). FPE group had better safety outcomes with lower mortality (14.2% vs 21.6%, p=0.03), sICH (5.7% vs 13.5, p=0.004), and neurological worsening (71.3% vs 78.4%, p=0.02), compared to the non-FPE group. Conclusion: Patients with first pass complete or near complete reperfusion with MT had higher functional independence rates, reduced mortality, symptomatic hemorrhage and neurological worsening. Improvement in MT devices and techniques is vital to increase first pass effect and improve clinical outcomes.


2019 ◽  
Vol 12 (6) ◽  
pp. 548-551 ◽  
Author(s):  
Daniel A Tonetti ◽  
Shashvat M Desai ◽  
Stephanie Casillo ◽  
Jeremy Stone ◽  
Merritt Brown ◽  
...  

IntroductionFor patients undergoing mechanical thrombectomy, numerous (>3) thrombectomy passes may be harmful. However, non-recanalization leads to poor outcomes. For patients requiring multiple thrombectomy passes to achieve reperfusion, it remains unclear if the risk/benefit ratio favors recanalization.ObjectiveTo test the hypothesis that the benefits afforded by successful reperfusion outweigh the risk conveyed by the numerous passes required.MethodsWe retrospectively reviewed prospectively collected data for patients presenting to a comprehensive stroke center with anterior circulation large vessel occlusion (ACLVO) and undergoing thrombectomy requiring more than one pass over 24 months. We stratified patients into three groups: group 1 (successful reperfusion in 2–3 passes), group 2 (successful reperfusion in ≥4 passes), and group 3 (unsuccessful reperfusion).Results250 patients with ACLVO constituted the study cohort. Despite similar demographics, group 2 patients had better clinical outcomes than those in group 3 at 24 hours (National Institutes of Health Stroke Scale (NIHSS) score 13.5 vs 19.1, p<0.001) and at 90 days (modified Rankin Scale score 0–2 rates of 31.1% vs 0.0%, p=0.006) On multivariate logistic regression analysis, age (p=0.034), Alberta Stroke Program Early CT Score (p<0.01), NIHSS score (p=0.02), and parenchymal hematoma type 2 (p=0.015) were significant predictors of functional independence among those who achieved successful reperfusion, but the number of passes required did not predict outcome for these patients (p=0.74).ConclusionPatients who achieve successful reperfusion after many passes have better clinical outcomes than those who do not, despite the number of passes and procedural time required. The number of passes required to achieve successful reperfusion beyond the first pass is not a predictor of functional independence.


Stroke ◽  
2021 ◽  
Vol 52 (Suppl_1) ◽  
Author(s):  
Zachary Hubbard ◽  
Guilherme B Porto ◽  
Sami Al Kasab ◽  
Eyad Almallouhi ◽  
Alejandro M Spiotta ◽  
...  

Introduction: Patients with poor baseline images were excluded from most clinical trials so the data about whether these patients could benefit from MT remains unknown. In this study, we aim to investigate the safety and efficacy of MT in patients with large vessel occlusion (LVO) and large core infarct (LCI). Methods: The Stroke Thrombectomy and Aneurysm Registry (STAR) was interrogated. We included thrombectomy patients presenting with LVO within 24 hours and with a LCI as defined by Alberta Stroke Program Early CT Score (ASPECTS) < 6. Patients presenting within 6 hours of last known normal (LKN) were considered in the early window and patients presenting after 6 hours were considered in the late window. 90-day outcomes were assessed. We used a logistic regression model to assess the factors associated with good 90-day outcome in patients in the early and late windows. Results: 144 patients were included in this study (table). Median age was 69 and 92 (64%) patients were treated in the early MT window. ICA was the most common site of occlusion (48.6%) and ADAPT was used in 34.7%. Admission NIHSS was 17.5. Successful recanalization (TICI>2b) was achieved in 84.7% and median procedure time was 54 minutes. sICH hemorrhage was observed in 22 (15.3%). Median mRS was 4 at 90 days. Favorable outcome was observed in 41 patients (28.5%) and mortality occurred in in 59 (41%). There was no difference in 90-day functional outcome between patients in early and late windows. In patients presenting in the early window, age (aOR=0.905, p=0.0002) and baseline NIHSS (aOR=0.909, p=0.0423) were independently associated with 90-day outcome. In patients presenting in the late window, only age (aOR=0.934, p=0.0069) was independently associated with good outcome. Conclusion: More than one in four patients presenting with ASPECTS<6 may achieve functional independence at 90-day following MT. Patient age remains the main predictor of 90-day outcome in patients with low ASPECTS in both late and early windows.


Author(s):  
Adnan Mujanovic ◽  
Christoph Kammer ◽  
Christoph C Kurmann ◽  
Lorenz Grunder ◽  
Morin Beyeler ◽  
...  

Introduction : The value of intravenous thrombolysis (IVT) in patients eligible for mechanical thrombectomy (MT) remains unclear. We hypothesized that pre‐treatment with and/or ongoing IVT may facilitate reperfusion of distal vessel occlusion after incomplete MT. We evaluated this potential association using follow‐up perfusion imaging. Methods : Retrospective observational analysis of our institution`s stroke registry included patients with incomplete reperfusion after MT, admitted between February 1, 2015 and December 8, 2020. Delayed reperfusion (DR) was defined as the absence of a persistent perfusion deficit on contrast‐enhanced perfusion imaging ⁓24h±12h after the intervention. The association between baseline parameters and the occurrence of DR was evaluated using a logistic regression analyses. To account for possible time‐dependent associations of IVT with DR, additional stratification sets were made based on different time windows between IVT start time and final angiography runs. Results : Among the 378 included patients (median age 73.5, 50.8% female), DR occurred in 226 (59.8%). Atrial fibrillation (aOR 2.53 [95% CI 1.34 ‐ 4.90]), eTICI score (aOR 3.79 [95% CI 2.71 ‐ 5.48] per TICI grade increase), and intervention‐to‐follow‐up time (aOR 1.08 [95% CI 1.04 ‐ 1.13] per hour delay) were associated with DR. Dichotomized IVT strata showed no association with DR (aOR 0.75 [95% CI 0.42 ‐ 1.33]), whereas shorter intervals between IVT start and end of the procedure showed a borderline significant association with DR (OR 2.24 [95% CI 0.98 ‐ 5.43, and OR 2.07 [95% 1.06 – 4.31], for 80 and 100 minutes respectively). Patients with DR had higher rates of functional independence (modified Rankin scale 0–2 at 90 days, DR: 63.3% vs PPD: 38.8%; p<0.01) and longer survival time (at 3 years, DR: 69.2% vs PPD: 45.8%; p = 0.001). Conclusions : There is weak evidence that IVT may favor DR after incomplete MT if the time interval between IVT administration and end of the procedure is short. In general, perfusion follow‐up imaging may constitute a suitable surrogate parameter for evaluating medical rescue strategies after incomplete MT, because a considerable proportion of patients do not experience DR, and there seems to be a close correlation with clinical outcomes.


2017 ◽  
Vol 10 (9) ◽  
pp. 828-833 ◽  
Author(s):  
Abhi Pandhi ◽  
Georgios Tsivgoulis ◽  
Rashi Krishnan ◽  
Muhammad F Ishfaq ◽  
Savdeep Singh ◽  
...  

BackgroundFew data are available regarding the safety and efficacy of antiplatelet (APT) pretreatment in acute ischemic stroke (AIS) patients with emergent large vessel occlusions (ELVO) treated with mechanical thrombectomy (MT). We sought to evaluate the association of APT pretreatment with safety and efficacy outcomes following MT for ELVO.MethodsConsecutive ELVO patients treated with MT during a 4-year period in a tertiary stroke center were evaluated. The following outcomes were documented using standard definitions: symptomatic intracranial hemorrhage (sICH), successful recanalization (SR; modified TICI score 2b/3), mortality, and functional independence (modified Rankin Scale scores of 0–2).ResultsThe study population included 217 patients with ELVO (mean age 62±14 years, 50% men, median NIH Stroke Scale score 16). APT pretreatment was documented in 71 cases (33%). Patients with APT pretreatment had higher SR rates (77% vs 61%; P=0.013). The two groups did not differ in terms of sICH (6% vs 7%), 3-month mortality (25% vs 26%), and 3-month functional independence (50% vs 48%). Pretreatment with APT was independently associated with increased likelihood of SR (OR 2.18, 95% CI1.01 to 4.73; P=0.048) on multivariable logistic regression models adjusting for potential confounders. A significant interaction (P=0.014) of intravenous thrombolysis (IVT) pretreatment on the association of pre-hospital antiplatelet use with SR was detected. APT pretreatment was associated with SR (OR 2.74, 95% CI 1.15 to 6.54; P=0.024) in patients treated with combination therapy (IVT and MT) but not in those treated with direct MT (OR 1.78, 95% CI 0.63 to 5.03; P=0.276).ConclusionAPT pretreatment does not increase the risk of sICH and may independently improve the odds of SR in patients with ELVO treated with MT. The former association appears to be modified by IVT.


Author(s):  
Brandon Nguyen ◽  
Ichiro Yuki ◽  
Dana Stradling ◽  
Jordan C Xu ◽  
Kiarash Golshani ◽  
...  

Introduction : Performing mechanical thrombectomy (MT) in patients with basilar artery occlusion (BAO) is currently not evidence‐based. In the real‐world practice, it is also often encountered that the delayed initiation of the MT happens for this particular patient groups due to lack of cortical signs and other medical confounding factors. Methods : We retrospectively analyzed the angiographical and clinical outcomes of consecutive BAO patient who underwent MT in single institution. Onset to treatment (OTT), Door to Puncture (DTP) time were compared with those in anterior circulation large vessel occlusion (ACLVO) group who underwent MT in the same time period. For those showed significantly longer DTP time, the factors associated with the delayed initiation of the MT were analyzed. Results : A total of 271 patients underwent mechanical thrombectomy at UCI Medical Center between Jan 2016 and June 2021. Of these, 32 patients diagnosed as BAO by CTA and underwent MT were included in the study. Successful recanalization was achieved in 28 cases (87.5%), and symptomatic ICH occurred in 3 cases (9.4%). Nine patients (28.1%) showed good clinical outcomes (mRS 0–3) at 3 months. The median Onset to Puncture Time (OTT) was 340 min. The median DTP time (145 min) was significantly longer as compared to the ACLVO patients (99 min) (p value = 0.04). Of the 6 patients who showed significant delay in the initiation of intervention (DTP>300 min), 5 patients (83.3%) did not have the initial “stroke‐code activation” at the time of ED arrival. The cause of the delay was due to lack of cortical sign (3), bilateral spontaneous sustained clonus, which misinterpreted as seizure (1), AMS with non‐focal neurological signs interpreted as encephalopathy (2). Conclusions : DTP of the patients who underwent MT for BAO was significantly longer than that in ACLAO. Lack of cortical sings which are markers of ACLVO were associated with delayed activation of stroke code. Establishment of BAO screening in the ED assessment and prompt activation of Stroke code may contribute to the improvement of MT treatment for the BAO patients.


Stroke ◽  
2021 ◽  
Vol 52 (Suppl_1) ◽  
Author(s):  
Taha Nisar ◽  
Jimmy Patel ◽  
Muhammad Z Memon ◽  
Amit Singla ◽  
Priyank Khandelwal

Introduction: Solumbra technique involves the simultaneous use of stent-retriever and large-bore aspiration for clot retrieval in mechanical thrombectomy (MT). We aim to compare various time parameters in patients who undergo MT via solumbra technique via transradial artery (TRA) approach vs. transfemoral artery (TRF) approach. Methods: We performed a retrospective chart review of patients who underwent MT via solumbra technique for anterior circulation large vessel occlusion at a comprehensive stroke center from 7/2014 to 5/2020. We compared time to recanalization parameters, score of TICI≥2b, and functional independence (3-month mRS≤2) in patients who underwent MT via TRA vs.TRF approach via the solumbra technique. A binary logistic regression analysis was performed, controlling for age, sex, pre-treatment-NIHSS, type of anesthesia (general vs.moderate), laterality, and clot location [proximal (internal carotid or M1 segment of the middle cerebral artery) vs.distal (M2 or M3 segment of the middle cerebral artery)]. Results: A total of 98 patients met our inclusion criteria. The mean age was 63.59±14.40 years. 18 (18.37%) patients underwent MT through transradial approach. In our cohort, there was a significant association of TRA with shorter angio suite arrival-time to puncture-time (22.12±9.92mins vs.28.83±12.26mins; OR, 0.94; 95% CI, 0.88-1; P 0.026), but not with puncture-time to recanalization-time (84.34±61.34mins vs.63.73±35.29mins; OR, 1.01; 95% CI, 1-1.03; P 0.085), angio suite arrival-time to recanalization-time (103.12±51.29mins vs.93.42±39.08mins; OR, 1.01; 95% CI, 1-1.02; P 0.524), number of passes to recanalization (1.78±1.36 vs.1.68±1.05; OR, 1.03; 95% CI, 0.66-1.63 ; P 0.899), number of patients with TICI≥2b (83.34% vs.91.25%; OR, 0.68; 95% CI, 0.14-3.4; P 0.633), and functional independence (66.67% vs.78.75%; OR, 0.49; 95% CI, 0.13-1.86; P 0.292), when compared to TRF approach for MT using solumbra technique. Conclusion: Our study demonstrates a significant association between TRA approach with shorter angio suite arrival-time to puncture-time but not with overall time to recanalization, number of patients with TICI≥2b, and functional independence, when compared to TRF approach for MT using solumbra technique.


Stroke ◽  
2021 ◽  
Vol 52 (Suppl_1) ◽  
Author(s):  
Muhammad Z Memon ◽  
Taha Nisar ◽  
Amit Singla ◽  
Anil Nanda ◽  
Gaurav Gupta ◽  
...  

Background: COVID-19 has been shown to induce a hypercoagulable state thereby increasing the risk of arterial thrombosis resulting in Large Vessel Occlusion Stroke (LVOs) Objective: We performed a systematic review of published reports to study the clinical characteristics, and outcomes of COVID-19 acute ischemic stroke (AIS) patients with LVO treated with mechanical thrombectomy (MT) and compared them with historical controls. Methods: We conducted a systematic literature search from December 2019 to July 2020 using multiple combinations of keywords from PubMed and Ovid databases according to the PRISMA meta-analyses and systemic reviews guidelines and then pooled data from individual case series. We included studies where COVID -19 associated LVO cases were treated with MT and their clinical outcomes were reported. We then compared these findings with the historic patient data from the five landmark randomized MT trials, the Hermes collaborators (HC). Results: An initial search generated 12 studies but after excluding case reports and multiple reports comprising of the same series of patients, a total of five reports consisting of 51 patients were analyzed. The mean age of patients was 59 years (IQR 36-75), and 40 (78 %) were men. Median NIHSS on presentation was 20 (IQR 10-29). AIS with LVO was the presenting manifestation of COVID-19 in 16 (20%) of patients. Intracranial ICA was the most common site of occlusion found in 27 (53%) of patients with multi-territory occlusion in 10 (20 %). Final recanalization TICI ≥ 2b was achieved in 33 (64%) of patients but reocclusion was noted in 7 (14 %). Modified Rankin score (mRS) 0-2 was reported in 12 (23 %) of patients with 40 % in-hospital mortality. When compared to historic data from HC, COVID -19 patients were younger (59 vs 69 years), presented with a higher median NIHSS score (20 vs 17), and had a higher prevalence of ICA terminus occlusion (53% vs 21% ). Similarly, patient outcomes were poor in the COVID -19 group with mRs 0-2 in (23 % versus 46 %) and mortality (40 % vs 15 %) compared to Hermes group. Conclusion: COVID -19 AIS patients with LVO who underwent MT were younger, had multiple territory occlusions with a propensity for ICA terminus location, and had poor angiographic and clinical outcomes as compared to historic data.


Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Stephanie Chen ◽  
David McCarthy ◽  
Vasu Saini ◽  
Marie Brunet ◽  
Eric Peterson ◽  
...  

Background: Obesity is an established risk factor for acute ischemic stroke (AIS), but its impact on clinical outcomes and mortality after AIS remains controversial. In this study, we evaluate the association of body mass index (BMI) on outcomes after mechanical thrombectomy (MT) for large vessel occlusion acute ischemic stroke (LVOS). Methods: We reviewed our prospective MT database for LVOS between 2015 and 2018. BMI was analyzed as a continuous and categorical variable with underweight BMI <18.5, normal BMI 18.5-24.9, overweight BMI 25-29.9, and obese BMI>30. Multivariate analysis was used to determine predictors of outcome. Results: 335 patients underwent MT with 7 (2.1%) patients classified as underweight, 107 (31.9%) normal, 141 (42.1%) overweight, and 80 (23.9%) obese. Compared to normal weight (reference), obese patients had higher rates of hypertension and hyperlipidemia, while underweight patients had higher rates of previous stroke and presentation NIHSS. The time from symptom onset to puncture, procedural techniques, and reperfusion success (>TICI 2b) was not significantly different between BMI categories. There was a significant inverse linear correlation between BMI and symptomatic hemorrhagic. In patients with successful reperfusion (>TICI 2b), there was also a significant bell-shaped relationship between BMI and functional independence (mRS < 3) with both low and high BMIs associated with worse outcomes. In patients without post-procedural symptomatic hemorrhage, there was a significant linear correlation between BMI and inpatient mortality. Conclusion: In LVOS patients treated with MT, BMI is inversely related with post-procedural symptomatic hemorrhage. Yet in those whom reperfusion is achieved, both lower and higher than normal BMI were associated with worse functional outcomes. Thus, the obesity paradox does not appear to pertain to mechanical thrombectomy, although larger prospective studies are necessary.


Stroke ◽  
2019 ◽  
Vol 50 (4) ◽  
pp. 880-888 ◽  
Author(s):  
Johannes Kaesmacher ◽  
Panagiotis Chaloulos-Iakovidis ◽  
Leonidas Panos ◽  
Pasquale Mordasini ◽  
Patrik Michel ◽  
...  

Background and Purpose— If anterior circulation large vessel occlusion acute ischemic stroke patients presenting with ASPECTS 0–5 (Alberta Stroke Program Early CT Score) should be treated with mechanical thrombectomy remains unclear. Purpose of this study was to report on the outcome of patients with ASPECTS 0–5 treated with mechanical thrombectomy and to provide data regarding the effect of successful reperfusion on clinical outcomes and safety measures in these patients. Methods— Multicenter, pooled analysis of 7 institutional prospective registries: Bernese-European Registry for Ischemic Stroke Patients Treated Outside Current Guidelines With Neurothrombectomy Devices Using the SOLITAIRE FR With the Intention for Thrombectomy (Clinical Trial Registration—URL: https://www.clinicaltrials.gov . Unique identifier: NCT03496064). Primary outcome was defined as modified Rankin Scale 0–3 at day 90 (favorable outcome). Secondary outcomes included rates of day 90 modified Rankin Scale 0–2 (functional independence), day 90 mortality and occurrence of symptomatic intracerebral hemorrhage. Multivariable logistic regression analyses were performed to assess the association of successful reperfusion with clinical outcomes. Outputs are displayed as adjusted Odds Ratios (aOR) and 95% CI. Results— Two hundred thirty-seven of 2046 patients included in this registry presented with anterior circulation large vessel occlusion and ASPECTS 0–5. In this subgroup, the overall rates of favorable outcome and mortality at day 90 were 40.1% and 40.9%. Achieving successful reperfusion was independently associated with favorable outcome (aOR, 5.534; 95% CI, 2.363–12.961), functional independence (aOR, 5.583; 95% CI, 1.964–15.873), reduced mortality (aOR, 0.180; 95% CI, 0.083–0.390), and lower rates of symptomatic intracerebral hemorrhage (aOR, 0.235; 95% CI, 0.062–0.887). The mortality-reducing effect remained in patients with ASPECTS 0–4 (aOR, 0.167; 95% CI, 0.056–0.499). Sensitivity analyses did not change the primary results. Conclusions— In patients presenting with ASPECTS 0–5, who were treated with mechanical thrombectomy, successful reperfusion was beneficial without increasing the risk of symptomatic intracerebral hemorrhage. Although the results do not allow for general treatment recommendations, formal testing of mechanical thrombectomy versus best medical treatment in these patients in a randomized controlled trial is warranted.


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