Abstract WP28: Eligibility for Mechanical Thrombectomy in Acute Ischemic Stroke: a Phase IV Multi-center Screening Log Registry

Stroke ◽  
2016 ◽  
Vol 47 (suppl_1) ◽  
Author(s):  
Georgios Tsivgoulis ◽  
Nitin Goyal ◽  
Robert Mikulik ◽  
Ramin Zand ◽  
Andromachi Roussopoulou ◽  
...  

Background & Purpose: No eligibility screening logs were kept to support recent mechanical thrombectomy (MT) RCTs establishing safety and efficacy for acute ischemic stroke (AIS). We sought to evaluate the potential eligibility for MT among consecutive AIS patients in a prospective multicenter study. Methods: We prospectively evaluated consecutive patients admitted with the diagnosis of AIS in three tertiary care stroke centers during a twelve-month period. Admission stroke severity was documented using NIHSS-score, while all patients underwent baseline neurovascular imaging using MRA/CTA. Potential eligibility for MT was evaluated using inclusion criteria from MR CLEAN & REVASCAT as these protocols utilized imaging and selection methods that most closely mirrored everyday clinical practice. Results: Our study population consisted of 1161 AIS patients (mean age 66±14 years, 55% men, median admission NIHSS-score: 5 points, IQR 2-8). A total of 86 (7%, 95%CI: 6%-9%) and 66 (6%, 95%CI: 4%-7%) patients fulfilled the inclusion criteria for MR CLEAN & REVASCAT respectively, while 57 cases were eligible for inclusion in both trials (5%, 95%CI: 4%-6%). There was no evidence of heterogeneity (p>0.150) regarding the eligibility of AIS for MT across the three participating centers. Absence of proximal intracranial occlusion (70%), followed by hospital arrival outside the eligible time window (31% for MR CLEAN 6-hour window & 29% for REVASCAT 8-hour window), low baseline NIHSS-score (16% below the 2 point cut-off of MR Clean & 46% below the 6 point cut-off of REVASCAT) and posterior circulation cerebral ischemia (16%) were the four most common reasons for ineligibility for MT. Conclusion: Our everyday clinical practice experience suggests that approximately one out of fourteen to seventeen consecutive AIS may be eligible for MT if inclusion criteria for MR CLEAN and REVASCAT are strictly adhered to. Delayed presentation from symptom onset represents the only modifiable MT exclusion factor.

2020 ◽  
Vol 132 (4) ◽  
pp. 1182-1187 ◽  
Author(s):  
Carrie E. Andrews ◽  
Nikolaos Mouchtouris ◽  
Evan M. Fitchett ◽  
Fadi Al Saiegh ◽  
Michael J. Lang ◽  
...  

OBJECTIVEMechanical thrombectomy (MT) is now the standard of care for acute ischemic stroke (AIS) secondary to large-vessel occlusion, but there remains a question of whether elderly patients benefit from this procedure to the same degree as the younger populations enrolled in the seminal trials on MT. The authors compared outcomes after MT of patients 80–89 and ≥ 90 years old with AIS to those of younger patients.METHODSThe authors retrospectively analyzed records of patients undergoing MT at their institution to examine stroke severity, comorbid conditions, medical management, recanalization results, and clinical outcomes. Univariate and multivariate logistic regression analysis were used to compare patients < 80 years, 80–89 years, and ≥ 90 years old.RESULTSAll groups had similar rates of comorbid disease and tissue plasminogen activator (tPA) administration, and stroke severity did not differ significantly between groups. Elderly patients had equivalent recanalization outcomes, with similar rates of readmission, 30-day mortality, and hospital-associated complications. These patients were more likely to have poor clinical outcome on discharge, as defined by a modified Rankin Scale (mRS) score of 3–6, but this difference was not significant when controlled for stroke severity, tPA administration, and recanalization results.CONCLUSIONSOctogenarians, nonagenarians, and centenarians with AIS have similar rates of mortality, hospital readmission, and hospital-associated complications as younger patients after MT. Elderly patients also have the capacity to achieve good functional outcome after MT, but this potential is moderated by stroke severity and success of treatment.


2019 ◽  
Vol 23 (3) ◽  
pp. 363-368 ◽  
Author(s):  
Bing Zhou ◽  
Xiao-Chuan Wang ◽  
Jun-Yi Xiang ◽  
Ming-Zhao Zhang ◽  
Bo Li ◽  
...  

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.


PeerJ ◽  
2016 ◽  
Vol 4 ◽  
pp. e1866 ◽  
Author(s):  
Yu-Chin Su ◽  
Kuo-Feng Huang ◽  
Fu-Yi Yang ◽  
Shinn-Kuang Lin

Background. Cardiac morbidities account for 20% of deaths after ischemic stroke and is the second commonest cause of death in acute stroke population. Elevation of cardiac troponin has been regarded as a prognostic biomarker of poor outcome in patients with acute stroke.Methods. This retrospective study enrolled 871 patients with acute ischemic stroke from August 2010 to March 2015. Data included vital signs, laboratory parameters collected in the emergency department, and clinical features during hospitalization. National Institutes of Health Stroke Scale (NIHSS), Barthel index, and modified Rankin Scale (mRS) were used to assess stroke severity and outcome.Results.Elevated troponin I (TnI) > 0.01 µg/L was observed in 146 (16.8%) patients. Comparing to patients with normal TnI, patients with elevated TnI were older (median age 77.6 years vs. 73.8 years), had higher median heart rates (80 bpm vs. 78 bpm), higher median white blood cells (8.40 vs. 7.50 1,000/m3) and creatinine levels (1.40 mg/dL vs. 1.10 mg/dL), lower median hemoglobin (13.0 g/dL vs. 13.7 g/dL) and hematocrit (39% vs. 40%) levels, higher median NIHSS scores on admission (11 vs. 4) and at discharge (8 vs. 3), higher median mRS scores (4 vs3) but lower Barthel index scores (20 vs. 75) at discharge (p< 0.001). Multivariate analysis revealed that age ≥ 76 years (OR 2.25, CI [1.59–3.18]), heart rate ≥ 82 bpm (OR 1.47, CI [1.05–2.05]), evidence of clinical deterioration (OR 9.45, CI [4.27–20.94]), NIHSS score ≥ 12 on admission (OR 19.52, CI [9.59–39.73]), and abnormal TnI (OR 1.98, CI [1.18–3.33]) were associated with poor outcome. Significant factors for in-hospital mortality included male gender (OR 3.69, CI [1.45–9.44]), evidence of clinical deterioration (OR 10.78, CI [4.59–25.33]), NIHSS score ≥ 12 on admission (OR 8.08, CI [3.04–21.48]), and elevated TnI level (OR 5.59, CI [2.36–13.27]).C-statistics revealed that abnormal TnI improved the predictive power of both poor outcome and in-hospital mortality. Addition of TnI > 0.01 ug/L or TnI > 0.1 ug/L to the model-fitting significantly improvedc-statistics for in-hospital mortality from 0.887 to 0.926 (p= 0.019) and 0.927 (p= 0.028), respectively.Discussion.Elevation of TnI during acute stroke is a strong independent predictor for both poor outcome and in-hospital mortality. Careful investigation of possible concomitant cardiac disorders is warranted for patients with abnormal troponin levels.


Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
Nitin Goyal ◽  
Georgios Tsivgoulis ◽  
Donald Frei ◽  
Aquilla Turk ◽  
Blaise Baxter ◽  
...  

Background: Recent recommendations for mechanical thrombectomy (MT) of acute ischemic stroke (AIS) patients with emergent large-vessel occlusions (ELVO) appropriately award top tier evidence (TTE) to the same selective criteria that were employed in recent clinical trials. We sought to evaluate the safety and efficacy of MT in AIS patients with ELVO who fail TTE criteria in a prospective multi-center study. Methods: Data on consecutive AIS patients with ELVO who underwent mechanical thrombectomy were collected from 6 high-volume endovascular centers. Standard safety and efficacy outcomes were compared between patients meeting and failing TTE criteria. Results: TTE criteria for MT were fulfilled in 349 (60%) cases (mean age 63±18 years; 47% men; median admission NIHSS-score 17 points, interquartile range 14-21), whereas 234 (40%) patients did not meet TTE criteria (mean age 62±19 years; 53% men; median admission NIHSS-score 16 points, interquartile range 9-21). (Table 1) The two most common reasons for failing TTE criteria were location of intracranial occlusion (n=144) and treatment window (n=108). In multivariate logistic regression models adjusting for potential confounders cases failing TTE criteria had similar safety (three-month mortality and symptomatic intracranial hemorrhage) and efficacy (three-month functional independence) outcomes with patients meeting TTE. Location of occlusion and proposed time-window according to TTE was also not related to any safety or efficacy outcome. (Table 2) Conclusions: Approximately 40% of AIS patients with ELVO offered MT do not fulfill TTE criteria for MT. Our multi-center experience indicates that MT may be offered to these patients with similar safety and efficacy to ELVO cases meeting TTE. Evidence-based medicine requires that health care providers understand published data and how those data might apply to a given patient’s treatment options. In a changing treatment environment this is a dynamic process.


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.


Stroke ◽  
2020 ◽  
Vol 51 (11) ◽  
pp. 3241-3249 ◽  
Author(s):  
Hamidreza Saber ◽  
Kasra Khatibi ◽  
Viktor Szeder ◽  
Satoshi Tateshima ◽  
Geoffrey P. Colby ◽  
...  

Background and Purpose: More than half of patients with acute ischemic stroke have minor neurological deficits; however, the frequency and outcomes of reperfusion therapy in regular practice has not been well-delineated. Methods: Analysis of US National Inpatient Sample of hospitalizations with acute ischemic stroke and mild deficits (National Institutes of Health Stroke Scale [NIHSS] score 0–5) from October 1, 2016, to December 31, 2017. Patient- and hospital-level characteristics associated with use and outcome of reperfusion therapies were analyzed. Primary outcomes included excellent discharge disposition (discharge to home without assistance); poor discharge disposition (discharge to facility or death); in-hospital mortality; and radiological intracranial hemorrhage. Results: Among 179 710 acute ischemic stroke admissions with recorded NIHSS during the 15-month study period, 103 765 (57.7%) had mild strokes (47.3% women; median age, 69 [interquartile range, 59–79] years; median NIHSS score of 2 [interquartile range, 1–4]). Considering reperfusion therapies among strokes with documented NIHSS, mild deficit hospitalizations accounted for 40.0% of IVT and 10.7% of mechanical thrombectomy procedures. Characteristics associated with IVT and with mechanical thrombectomy utilization were younger age, absence of diabetes, higher NIHSS score, larger/teaching hospital status, and Western US region. Excellent discharge outcome occurred in 48.2% of all mild strokes, and in multivariable analysis, was associated with younger age, male sex, White race, lower NIHSS score, absence of diabetes, heart failure, and kidney disease, and IVT use. IVT was associated with increased likelihood of excellent outcome (odds ratio, 1.90 [95% CI, 1.71–2.13], P <0.001) despite an increased risk of intracranial hemorrhage (odds ratio, 1.41 [95% CI, 1.09–1.83], P <0.001). Conclusions: In national US practice, more than one-half of acute ischemic stroke hospitalizations had mild deficits, accounting for 4 of every 10 IVT and 1 of every 10 mechanical thrombectomy treatments, and IVT use was associated with increased discharge to home despite increased intracranial hemorrhage.


2015 ◽  
Vol 8 (9) ◽  
pp. 889-893 ◽  
Author(s):  
Seungnam Son ◽  
Yong-Won Kim ◽  
Min Kyun Oh ◽  
Soo-Kyoung Kim ◽  
Ki-Jong Park ◽  
...  

Background and purposeTo determine the initial factors, including patient characteristics, stroke etiology and severity, time factors, and imaging findings, that could affect the clinical outcome of patients with acute ischemic stroke (AIS) caused by basilar artery occlusion (BAO) where successful recanalization was achieved via mechanical thrombectomy.MethodsBetween March 2011 and December 2014, 35 patients with AIS caused by BAO received MRI/MR angiography-based mechanical thrombectomies, and recanalization was achieved with a Thrombolysis In Cerebral Infarction score of >2b. The patients were divided into a good outcome group (n=19), defined as those with a modified Rankin Scale (mRS) score of 0–2 at 3 months after stroke onset, and a poor outcome group (n=16), defined as a mRS score of 3–6. The differences between the groups were analyzed.ResultsInitial National Institutes of Health Stroke Scale (NIHSS) score (good vs poor: 17.9±8.9 vs 27.6±8.5, p=0.003), posterior circulation Acute Stroke Prognosis Early CT Score (pc-ASPECTS) based on initial diffusion-weighted images (DWI) (good vs poor: 7.8±1.6 vs 5.4±1.8, p=0.001), pc-ASPECTS based on contrast staining on the post-thrombectomy control CT (good vs poor: 9.2±1.5 vs 6.3±2.2, p<0.001), and presence of contrast staining in the brainstem on that CT (good vs poor: 15.8% vs 81.6%, p<0.001) were significantly different between the groups.ConclusionsPatients with AIS caused by BAO with a lower initial NIHSS score, fewer lesions on initial DWI, and less contrast staining on the post-thrombectomy control CT have higher probabilities of a good clinical outcome after successful recanalization via a mechanical thrombectomy.


Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 713-713 ◽  
Author(s):  
David G. Sherman ◽  
Gregory W. Albers ◽  
Christopher Bladin ◽  
Min Chen ◽  
Cesare Fieschi ◽  
...  

Abstract Background: Venous thromboembolism (VTE) prophylaxis with low-molecular-weight heparin (LMWH) or unfractionated heparin (UFH) is recommended in acute ischemic stroke patients, but most studies comparing LMWH and UFH are limited in methodology or sample size. The PREVAIL study was designed to assess the superiority of enoxaparin over UFH for VTE prophylaxis in acute ischemic stroke patients and to evaluate efficacy and safety according to stroke severity. Methods: Patients with acute ischemic stroke, confirmed by CT scan, and unable to walk unassisted due to motor impairment of the leg were enrolled in this prospective, open-label, parallel group, multicenter study. Patients from 15 countries were randomized within 48 h of stroke symptoms to receive enoxaparin 40 mg SC qd or UFH 5000 IU SC q12h for 10±4 days. Patients were stratified by NIH Stroke Scale score (NIHSS; severe ≥14, less severe &lt;14). The primary efficacy endpoint was the composite of symptomatic or asymptomatic deep-vein thrombosis (DVT), symptomatic pulmonary embolism (PE), or fatal PE during treatment. DVT was confirmed primarily by venography, or ultrasonography when venography was not practical. PE was confirmed by VQ or CT scan, or angiography. Primary safety endpoints included clinically significant intracranial and major extracranial bleeding. Results: 1762 acute ischemic stroke patients were randomized. Characteristics were similar between groups; mean age was 66.0±12.9 yrs, mean NIHSS score was 11.3. In the efficacy population, enoxaparin (n=666) and UFH (n=669) were given for a mean of 10.5±3.2 days. Enoxaparin resulted in a 43% relative reduction in the risk of the primary efficacy endpoint compared with UFH (10.2% vs 18.1%; RR 0.57; 95% CI 0.44–0.76; p=0.0001, adjusted for NIHSS score). Incidences of VTE events are shown in Table 1. Reductions in the primary endpoint remained significant in patients with a NIHSS score ≥14 (16.3% vs 29.7%, p=0.0036) and &lt;14 (8.3% vs 14.0%, p=0.0043). The composite of clinically significant intracranial and major extracranial bleeding was low and not significantly different between groups (Table 1). Conclusion: Enoxaparin 40 mg qd is superior to UFH q12h for reducing the risk of VTE in acute ischemic stroke patients, with no significant difference in clinically relevant bleeding. The reduction in VTE risk was consistent in patients with a NIHSS score ≥14 or &lt;14. Table 1: Incidence of VTE and bleeding Endpoint Enoxaparin n/N (%, 95% CI) UFH n/N (%, 95% CI) *P&lt;0.001 Symptomatic VTE 2/666 (0.3, 0.0–0.7) 6/669 (0.9, 0.2–1.6) Proximal DVT 30/666 (4.5, 2.9–6.1) 64/669 (9.6, 7.3–11.8)* Distal DVT 44/666 (6.6, 4.7–8.5) 85/669 (12.7, 10.2–15.2)* PE 1/666 (0.2, 0.0–0.4) 6/669 (0.9, 0.2–1.6) Composite of major extracranial and clinically significant intracranial bleeding 11/877 (1.3, 0.5–1.9) 6/872 (0.7, 0.1–1.2)


2019 ◽  
pp. neurintsurg-2018-014569 ◽  
Author(s):  
Guillaume Turc ◽  
Pervinder Bhogal ◽  
Urs Fischer ◽  
Pooja Khatri ◽  
Kyriakos Lobotesis ◽  
...  

BackgroundMechanical thrombectomy (MT) has become the cornerstone of acute ischemic stroke management in patients with large vessel occlusion (LVO).ObjectiveTo assist physicians in their clinical decisions with regard toMT.MethodsThese guidelines were developed based on the standard operating procedure of the European Stroke Organisation and followed the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach. An interdisciplinary working group identified 15 relevant questions, performed systematic reviews and meta-analyses of the literature, assessed the quality of the available evidence, and wrote evidence-based recommendations. Expert opinion was provided if not enough evidence was available to provide recommendations based on the GRADE approach.ResultsWe found high-quality evidence to recommend MT plus best medical management (BMM, including intravenous thrombolysis whenever indicated) to improve functional outcome in patients with LVO-related acute ischemic stroke within 6 hours after symptom onset. We found moderate quality of evidence to recommend MT plus BMM in the 6–24h time window in patients meeting the eligibility criteria of published randomized trials. These guidelinesdetails aspects of prehospital management, patient selection based on clinical and imaging characteristics, and treatment modalities.ConclusionsMT is the standard of care in patients with LVO-related acute stroke. Appropriate patient selection and timely reperfusion are crucial. Further randomized trials are needed to inform clinical decision-making with regard tothe mothership and drip-and-ship approaches, anesthaesia modalities during MT, and to determine whether MT is beneficial in patients with low stroke severity or large infarct volume.


Stroke ◽  
2012 ◽  
Vol 43 (suppl_1) ◽  
Author(s):  
David S Liebeskind ◽  
Ashfaq Shuaib ◽  
Martin Köhrmann ◽  
William P Dillon ◽  
Songling Liu ◽  
...  

Background: Collateral circulation may enhance recanalization in acute ischemic stroke. Augmentation of collaterals with partial aortic occlusion may promote recanalization and thereby influence outcomes in the SENTIS randomized controlled trial of the NeuroFlo device. We conducted a post hoc analysis of angiography acquired in SENTIS to evaluate potential differences in recanalization rates between NeuroFlo-treated and non-treated arms, accounting for site of arterial occlusion. Methods: Blinded imaging expert review of baseline and 6-hour follow-up angiography (CTA, MRA, or DSA) from the core lab was conducted for evaluation of recanalization. Recanalization was defined as TIMI 2-3 in the arterial segment distal to baseline occlusion. Baseline demographics, stroke presentation characteristics, and medical history variables were analyzed with respect to recanalization in univariate and subsequent multivariable logistic regression models after adjusting by treatment arm. Results: Serial angiography was available in 109/515 SENTIS subjects, including 56 in the treatment arm and 53 in the non-treated arm. Baseline demographics, stroke presentation characteristics, and medical history variables did not differ statistically between arms. Across all sites of arterial occlusion, recanalization occurred in 25.7% of cases, with similar rates between device (25.0%) and medical therapy (26.4%) arms. Age and baseline stroke severity (NIHSS score) were significant predictors of recanalization in univariate analyses. Multivariable logistic regression analyses confirmed that baseline NIHSS score was the sole predictor of recanalization (OR 0.90, p=0.0458) per one unit increase, with decreased recanalization in more severe strokes. Device treatment was not associated with significant increases in recanalization rates (p=NS). Recanalization of terminal internal carotid artery (12.5%), proximal MCA or M1 (17.9%) and M2 (46.7%) occlusions was not different between arms (all p=NS). Recanalization of proximal arterial occlusion in acute ischemic stroke cases enrolled in SENTIS was more frequent in M2 occlusions. Conclusions: More severe strokes at baseline were less likely to recanalize and device therapy did not increase recanalization rates. Treatment with the NeuroFlo device may invoke mechanisms of collateral perfusion distinct from direct arterial recanalization.


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