scholarly journals Study Criteria Applied to Real Life—A Multicenter Analysis of Stroke Patients Undergoing Endovascular Treatment in Clinical Practice

Author(s):  
Hannes Leischner ◽  
Caspar Brekenfeld ◽  
Lukas Meyer ◽  
Gabriel Broocks ◽  
Tobias Faizy ◽  
...  

Background Randomized controlled clinical trials (RCT) have demonstrated the efficacy of endovascular treatment in anterior circulation large vessel occlusions. However, outcome of patients treated in daily practice differs from the results of the clinical trials. We hypothesize that this is attributable to the study criteria and that application of the criteria on patients undergoing endovascular therapy in daily routine would improve their outcome. Methods and Results Data from a multicenter prospective registry of GSR‐ET (German Stroke Registry – Endovascular Treatment) was used. Inclusion criteria and selectivity of SWIFT‐PRIME (Solitaire with the Intention for Thrombectomy as Primary Endovascular Treatment trial), MR CLEAN (Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands trial), ESCAPE (Endovascular Treatment for Small Core and Anterior Circulation Proximal Occlusion with Emphasis on Minimizing CT to Recanalization Times trial), DAWN (DWI or CTP Assessment with Clinical Mismatch in the Triage of Wake‐Up and Late Presenting Strokes Undergoing Neurointervention with Trevo trial) and DEFUSE‐3 (Endovascular Therapy Following Imaging Evaluation for Ischemic Stroke trial) trials were analyzed. Baseline characteristics, procedural and outcome data of patients from GSR‐ET before and after selection were compared with the results of the RCTs. Furthermore, outcome of patients who underwent endovascular treatment despite not fulfilling the RCT criteria was analyzed. A total of 2611 patients were included (median age, 75 years; 49.6% women; median National Institute of Health Stroke Scale, 16). A minority of patients met all inclusion criteria, ranging from 3% (DEFUSE‐3 criteria) to 35% (MR CLEAN criteria). Of the patients fulfilling the MR CLEAN criteria, 41% of patients had a good clinical outcome, compared with 34% of patients that did not fulfill MR CLEAN criteria. Conclusions The RCTs represent a selected population with higher rates of good clinical outcome compared with daily practice. The good outcomes of RCTs can be reproduced in clinical routine in patients who fulfill the RCT inclusion criteria. Furthermore, patients who did not meet the criteria of the RCT still had substantial rates of good clinical outcome.

Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Kars C Compagne ◽  
Manon Kappelhof ◽  
Robert-Jan B Goldhoorn ◽  
Charles B Majoie ◽  
Yvo B Roos ◽  
...  

Introduction: Outcomes after endovascular treatment (EVT) for acute ischemic stroke are highly time dependent, but whether active reduction of time to treatment leads to better outcome has not been demonstrated. We compared data of the two subsequent MR CLEAN Registry cohorts, comprising all patients in the Netherlands who had EVT for acute ischemic stroke from 2014-2017, for a trend in time to treatment and its association with outcome. Methods: We compared workflow, successful reperfusion (eTICI 2B-3), NIHSS at 24h, functional outcome (mRS) at 90 days, occurrence of symptomatic intracranial hemorrhage (sICH) and mortality in patients with ischemic stroke and a proximal intracranial occlusion in the anterior circulation included in the second cohort of the Registry (June 2016-November 2017; n = 1779) to those in patients included in the first cohort (March 2014-June 2016; n = 1526) using logistic regression. Results: Baseline NIHSS was 16 in both cohorts. Times from onset-to-groin and onset-to-reperfusion were shorter in the second cohort than in the first (185 versus 210 minutes; p<0.01 and 238 versus 270 minutes; p<0.01, respectively) (Figure 1). Successful reperfusion was achieved more often in the second than in the first cohort (72% versus 58%; p<0.01). Rates of sICH and mortality did not differ (5.9% versus 5.7%; p=0.94 and 29% versus 29%; p=0.60). However, follow-up NIHSS was lower (median 10 versus 11; p<0.001) and more patients achieved functional independence at 90 days (42.6% versus 38.9%; p = 0.012) in the second cohort (Figure 1). In a logistic regression model, the difference in good outcome between the two cohorts (aOR 1.27; 95%CI 1.08-1.50) was reduced after additional adjustment for time to reperfusion (aOR 1.15; 95%CI 0.96-1.36) as well as successful reperfusion (aOR 1.16; 95%CI 0.95-1.41). Discussion: Our data show that outcomes after EVT in routine clinical practice are improving, likely attributable to improved workflow and experience.


2019 ◽  
Vol 11 (1) ◽  
pp. 41-46 ◽  
Author(s):  
Eva Szuchy Kristiansen ◽  
Hannah Holm Vestergaard ◽  
Boris Modrau ◽  
Lorenz Martin Oppel

Pregnancy has usually been an exclusion criterion in clinical trials with thrombolysis and endovascular therapy in acute ischemic stroke. For that reason, these therapies are not recommended causing lack of evidence and vice versa. In this case report, we describe a pregnant woman in week 33 + 3 presenting with acute ischemic stroke, which was successfully treated with systemic thrombolysis and endovascular therapy, resulting in a good clinical outcome for both mother and child. The altered fibrinolytic system and the risk factors related to pregnancy constitute a challenge for clinicians when choosing the most suitable treatment modality for treating acute ischemic stroke in pregnancy. It is still uncertain whether thrombolysis in combination with endovascular therapy or endovascular therapy alone is the most appropriate treatment option. However, there is slowly growing evidence that thrombolysis and thrombectomy in pregnancy are feasible and safe with a good clinical outcome for both the mother and the child.


Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
Amie W Hsia ◽  
Marie Luby ◽  
Rocco Armonda ◽  
Ai-hsi Liu ◽  
Richard T Benson ◽  
...  

Background and Purpose: Early and complete recanalization achieved in this new era of endovascular therapy (ET) can result in nearly imperceptible lesions on post-treatment MRI. In this context we have observed a pattern of lesion evolution on MRI that is atypical from that seen following IV tPA alone, including striking reversal of the ischemic core. We sought to determine the frequency of acute lesion reversal following ET, and its association with sustained reversal and clinical outcome. Methods: Patients were included in this study if: 1) ET for anterior territory ischemic stroke from Jan 2015 to July 2016, 2) baseline pre-ET and 24h MRI, and 3) consent for research. Two raters evaluated ADC maps for early “reversal” (defined visually as >50%) by comparing 24h to baseline. FLAIR MRI at 30d were later assessed for reversal from baseline, blinded to 24h scan. Early neurological improvement (ENI) was defined as decrease in NIHSS≥8 at 24h. Good clinical outcome defined as mRS≤2. Results: Twenty-two patients were included: median age 68.5 years, 73% women, median baseline NIHSS 19. Median time from last known well to recanalization 254 min. TICI 2b/3 in 91%. ADC reversal in 12 of 22 (55%) at 24h. Reversal at 30d was associated with 24hr (p=0.002) with two having no visually appreciable infarct at 30d. Baseline NIHSS did not differ for early reversal versus without (18.5 vs. 19.5), however NIHSS differed at discharge (1.5 vs. 8.5, p=0.003); early reversal is significantly associated with ENI (83% vs. 30%, p=0.027), but not with good clinical outcome at 30-90d (50% vs. 30%, p=0.415). Conclusions: In this new era of consistently effective ET, salvageable tissue includes not just penumbra but ischemic core, previously considered irreversibly injured. Despite lesion reversal and ENI, for some patients, independent outcome is not achieved, a finding that reinforces the need for adjunctive treatments to build upon the success of ET. Figure: Example of a patient with early ADC reversal.


2015 ◽  
Vol 8 (3) ◽  
pp. 240-243 ◽  
Author(s):  
Maxim Mokin ◽  
Peter Kan ◽  
Sananthan Sivakanthan ◽  
Erol Veznedaroglu ◽  
Mandy J Binning ◽  
...  

BackgroundEndovascular treatment of wake-up strokes (WUS) has been previously described, mostly with the use of pharmacological thrombolysis or first generation thrombectomy devices.ObjectiveTo describe outcomes of WUS treated with modern endovascular therapy since the Food and Drug Administration approval of stent retrievers, and to identify predictors of good clinical outcome in this population of stroke patients.MethodsWe performed a multicenter retrospective analysis of consecutive patients with WUS who underwent thrombectomy with stent retrievers Trevo (Stryker, Kalamazoo, Michigan, USA) and Solitaire FR (Covidien, Irvine, California, USA), or primary aspiration thrombectomy. We correlated favorable clinical outcomes with demographic, clinical, and technical characteristics.Results52 patients were included in this study; 46 (88%) cases were treated with stent retrievers and 6 (12%) were treated with primary aspiration thrombectomy alone. Successful recanalization (Thrombolysis in Cerebral Infarction (TICI) 2b/3) was achieved in 36 (69%) patients. Favorable clinical outcome at 3 months, defined as a modified Rankin Scale score of 0–2, was achieved in 25 (48%) patients. Duration of intervention <30 min and its success, defined as TICI 2b/3 recanalization, were strong predictors of favorable clinical outcome at 90 days (p<0.001 and p<0.0001, respectively).ConclusionsOur study indicates that endovascular treatment of WUS with stent retrievers and aspiration thrombectomy is safe and effective.


Stroke ◽  
2021 ◽  
Vol 52 (2) ◽  
pp. 482-490
Author(s):  
Fabian Flottmann ◽  
Caspar Brekenfeld ◽  
Gabriel Broocks ◽  
Hannes Leischner ◽  
Rosalie McDonough ◽  
...  

Background and Purpose: Endovascular therapy is the standard of care in the treatment of acute ischemic stroke due to large-vessel occlusion. Often, more than one retrieval attempt is needed to achieve reperfusion. We aimed to quantify the influence of endovascular therapy on clinical outcome depending on the number of retrievals needed for successful reperfusion in a large multi-center cohort. Methods: For this observational cohort study, 2611 patients from the prospective German Stroke Registry included between June 2015 and April 2018 were analyzed. Patients who received endovascular therapy for acute anterior circulation stroke with known admission National Institutes of Health Stroke Scale score and Alberta Stroke Program Early CT Score, final Thrombolysis in Cerebral Infarction score, and number of retrievals were included. Successful reperfusion was defined as a Thrombolysis in Cerebral Infarction score of 2b or 3. The primary outcome was defined as functional independence (modified Rankin Scale score of 0–2) at day 90. Multivariate mixed-effects models were used to adjust for cluster effects of the participating centers and confounders. Results: The inclusion criteria were met by 1225 patients. The odds of good clinical outcome decreased with every retrieval attempt required for successful reperfusion: the first retrieval had the highest odds of good clinical outcome (adjusted odds ratio, 6.45 [95% CI, 4.0–10.4]), followed by the second attempt (adjusted odds ratio, 4.56 [95% CI, 2.7–7.7]), and finally the third (adjusted odds ratio, 3.16 [95% CI, 1.8–5.6]). Conclusions: Successful reperfusion within the first 3 retrieval attempts is associated with improved clinical outcome compared with patients without reperfusion. We conclude that at least 3 retrieval attempts should be performed in endovascular therapy of anterior circulation strokes. Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT03356392.


Stroke ◽  
2016 ◽  
Vol 47 (suppl_1) ◽  
Author(s):  
Dezhi Liu ◽  
Fabien Scalzo ◽  
Sidney Starkman ◽  
Neal M Rao ◽  
Jason D Hinman ◽  
...  

Introduction: In acute arterial occlusion, the FLAIR vascular hyperintensity (FVH) sign have been linked to slow flow in leptomeningeal collaterals and cerebral hypoperfusion, but the impact on clinical outcome is still controversial. In this study, we aimed to investigate the association between FVH-ASPECTS pattern and outcome in acute M1-MCA occlusion patients with endovascular treatment. Methods: We included acute M1-MCA occlusion patients treated with endovascular therapy. All patients had DWI and FLAIR before endovascular therapy. Distal FVH ASPECT score was evaluated according to distal MCA-ASPECT area (M1-M6) and acute DWI lesion was also reviewed. Presence of FVH inside DWI positive lesion and outside DWI positive lesion was separately analyzed. We analyzed clinical outcome after endovascular therapy based on these different FVH-ASPECTS patterns. Results: Among 101 patients that met inclusion criteria for the study, mean age was 66.2±17.8 and median NIHSS was 17.0 (IQR 12.0-21.0). FVH-ASPECTS measured outside of the DWI lesion was significantly higher in patients with good outcome (mRS 0-2), (8.0 vs 4.0, p<0.001). Logistic regression demonstrated that FVH-ASPECTS outside of the DWI lesion was independently associated with clinical outcome of these patients (OR 1.3, p=0.013). FVH-ASPECTS inside the DWI lesion was associated with hemorrhage transformation (OR 1.3, p=0.019). Conclusion: Higher FVH-ASPECTS measured outside the DWI lesion is associated with good clinical outcomes in patients undergoing endovascular therapy. FVH-ASPECTS measured inside the DWI lesion was predictive of hemorrhage transformation. FVH pattern, not number, can predict outcome of acute M1-MCA occlusion patients after endovascular therapy.


2015 ◽  
Vol 8 (6) ◽  
pp. 559-562 ◽  
Author(s):  
Lucas Elijovich ◽  
Nitin Goyal ◽  
Shraddha Mainali ◽  
Dan Hoit ◽  
Adam S Arthur ◽  
...  

BackgroundAcute ischemic stroke (AIS) due to emergent large-vessel occlusion (ELVO) has a poor prognosis.ObjectiveTo examine the hypothesis that a better collateral score on pretreatment CT angiography (CTA) would correlate with a smaller final infarct volume and a more favorable clinical outcome after endovascular therapy (EVT).MethodsA retrospective chart review of the University of Tennessee AIS database from February 2011 to February 2013 was conducted. All patients with CTA-proven LVO treated with EVT were included. Recanalization after EVT was defined by Thrombolysis in Cerebral Infarction (TICI) score ≥2. Favorable outcome was assessed as a modified Rankin Score ≤3.ResultsFifty patients with ELVO were studied. The mean National Institutes of Health Stroke Scale score was 17 (2–27) and 38 of the patients (76%) received intravenous tissue plasminogen activator. The recanalization rate for EVT was 86.6%. Good clinical outcome was achieved in 32% of patients. Univariate predictors of good outcome included good collateral scores (CS) on presenting CTA (p=0.043) and successful recanalization (p=0.02). Multivariate analysis confirmed both good CS (p=0.024) and successful recanalization (p=0.009) as predictors of favorable outcome. Applying results of the multivariate analysis to our cohort we were able to determine the likelihood of good clinical outcome as well as predictors of smaller final infarct volume after successful recanalization.ConclusionsGood CS predict smaller infarct volumes and better clinical outcome in patients recanalized with EVT. These data support the use of this technique in selecting patients for EVT. Poor CS should be considered as an exclusion criterion for EVT as patients with poor CS have poor clinical outcomes despite recanalization.


2018 ◽  
Vol 11 (4) ◽  
pp. 342-346 ◽  
Author(s):  
Jung-Soo Park ◽  
Jong Myong Lee ◽  
Hyo-Sung Kwak ◽  
Gyoung Ho Chung

Background and purposeThe objective of this study was to investigate the predictive value of computed tomographic angiography (CTA) source image Alberta Stroke Program Early CT Score (ASPECTS) on clinical outcome and final infarction extent after endovascular treatment (EVT) in patients with acute ischemic stroke (AIS).MethodsAll eligible patients from January 2014 to March 2018 undergoing EVT due to anterior circulation AIS were retrospectively reviewed. The baseline ASPECTS on initial noncontrast CT (NCCT) and the CTA source image were compared with the follow-up MR diffusion-weighted imaging (DWI) ASPECTS. Receiver operating characteristic (ROC) curve analysis was used to assess the predictive value of CTA ASPECTS for prediction of final infarct extent and good clinical outcome.ResultsOur sample included a total of 122 eligible patients (64 males, mean age 70 years) with a median baseline National Institute of Health Stroke Scale (NIHSS) score of 12. Baseline ASPECTS on the CTA source image correlated with follow-up MR DWI ASPECTS better than NCCT ASPECTS (P<0.001). ROC curve analysis revealed baseline CTA ASPECTS (area under the curve [AUC] =0.74, 95% CI: 0.65 to 0.83, P<0.001) can better predict favorable functional outcome than NCCT ASPECTS (AUC=0.64, 95% CI: 0.54 to 0.74, P=0.008). Baseline NIHSS score <15, CTA ASPECTS≥8, and successful recanalization were independent predictors of good clinical outcomes.ConclusionThe ASPECTS on the CTA source image provides more information in the prediction of good clinical outcome and final infarction size than NCCT in patients with AIS treated with EVT.


Neurology ◽  
2020 ◽  
Vol 95 (2) ◽  
pp. e131-e139 ◽  
Author(s):  
Adrien E. Groot ◽  
Kilian M. Treurniet ◽  
Ivo G.H. Jansen ◽  
Hester F. Lingsma ◽  
Wouter Hinsenveld ◽  
...  

ObjectiveTo explore clinical outcomes in older adults with acute ischemic stroke treated with endovascular thrombectomy (EVT).MethodsWe included consecutive patients (2014–2016) with an anterior circulation occlusion undergoing EVT from the Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands (MR CLEAN) Registry. We assessed the effect of age (dichotomized at ≥80 years and as continuous variable) on the modified Rankin Scale (mRS) score at 90 days, symptomatic intracranial hemorrhage (sICH), and reperfusion rate. The association between age and mRS was assessed with multivariable ordinal logistic regression, and a multiplicative interaction term was added to the model to assess modification of reperfusion by age on outcome.ResultsOf the 1,526 patients, 380 (25%) were ≥80 years of age (referred to here as older adults). Older adults had a worse functional outcome than younger patients (adjusted common odds ratio [acOR] for an mRS score shift toward better outcome 0.31, 95% confidence interval [CI] 0.24–0.39). Mortality was also higher in older adults (51% vs 22%, adjusted odds ratio 3.12, 95% CI 2.33–4.19). There were no differences in proportion of patients with mRS scores of 4 to 5, sICH, or reperfusion rates. Successful reperfusion was more strongly associated with a shift toward good functional outcome in older adults than in younger patients (acOR 3.22, 95% CI 2.04–5.10 vs 2.00, 95% CI 1.56–2.57, pinteraction = 0.026).ConclusionOlder age is associated with an increased absolute risk of poor clinical outcome, while the relative benefit of successful reperfusion seems to be higher in these patients. These results should be taken into consideration in the selection of older adults for EVT.


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