BackgroundThe PerfusiOn imaging Selection of Ischemic sTroke patIents for endoVascular thErapy (POSITIVE) trial was designed to evaluate functional outcome in patients with emergent large vessel occlusion (ELVO) presenting within 0–12 hours with pre-specified bifurcated arms of early and late window presentation, who were selected for endovascular thrombectomy with non-vendor specific commercially available perfusion imaging software. Recent trials demonstrating the benefit of thrombectomy up to 16–24 hours following ELVO removed equipoise to randomize late window ELVO patients and therefore the trial was halted.MethodsUp to 200 patients were to be enrolled in this FDA-cleared, prospective, randomized, multicenter international trial to compare thrombectomy and best medical management in patients with ELVO ineligible for or refractory to treatment with IV tissue plasminogen activator (IV-tPA) selected with perfusion imaging and presenting within 0–12 hours of last seen normal. The primary outcome was 90-day clinical outcome as measured by the raw modified Rankin Scale (mRS) with scores 5 and 6 collapsed (mRS shift analysis).ResultsThe POSITIVE trial suspended enrollment with the release of results from the DAWN trial and was stopped after the release of the DEFUSE 3 trial results. Thirty-three patients were enrolled (21 for medical management and 12 for thrombectomy). Twelve of the 33 patients were enrolled in the 6–12 hour window. Despite the early cessation, the primary outcome demonstrated statistically significant superior clinical outcomes for patients treated with thrombectomy (P=0.0060). The overall proportion of patients achieving an mRS score of 0–2 was 75% in the thrombectomy cohort and 43% in the medical management cohort (OR 4.00, 95% CI 0.84 to 19.2).ConclusionPOSITIVE supports the already established practice of delayed thrombectomy for appropriately selected patients presenting within 0–12 hours selected by perfusion imaging from any vendor. The results of the POSITIVE trial are consistent with other thrombectomy trials. The statistically significant effect on functional improvement, despite the small number of patients, reinforces the robust benefits of thrombectomy.Clinical trial registrationNCT01852201
Background and Purpose: Triage of patients with emergent large vessel occlusion stroke to primary stroke centers followed by transfer to comprehensive stroke centers leads to increased time to endovascular therapy. A Mobile Interventional Stroke Team (MIST) provides an alternative model by transferring a MIST to a Thrombectomy Capable Stroke Center (TSC) to perform endovascular therapy. Our aim is to determine whether the MIST model is more time-efficient and leads to improved clinical outcomes compared with standard drip-and-ship (DS) and mothership models. Methods: This is a prospective observational cohort study with 3-month follow-up between June 2016 and December 2018 at a multicenter health system, consisting of one comprehensive stroke center, 4 TSCs, and several primary stroke centers. A total of 228 of 373 patients received endovascular therapy via 1 of 4 models: mothership with patient presentation to a comprehensive stroke center, DS with patient transfer from primary stroke center or TSC to comprehensive stroke center, MIST with patient presentation to TSC and MIST transfer, or a combination of DS with patient transfer from primary stroke center to TSC and MIST. The prespecified primary end point was initial door-to-recanalization time and secondary end points measured additional time intervals and clinical outcomes at discharge and 3 months. Results: MIST had a faster mean initial door-to-recanalization time than DS by 83 minutes ( P <0.01). MIST and mothership had similar median door-to-recanalization times of 192 minutes and 179 minutes, respectively ( P =0.83). A greater proportion had a complete recovery (National Institutes of Health Stroke Scale of 0 or 1) at discharge in MIST compared with DS (37.9% versus 16.7%; P <0.01). MIST had 52.8% of patients with modified Rankin Scale of ≤2 at 3 months compared with 38.9% in DS ( P =0.10). Conclusions: MIST led to significantly faster initial door-to-recanalization times compared with DS, which was comparable to mothership. This decrease in time has translated into improved short-term outcomes and a trend towards improved long-term outcomes. REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT03048292.
Background and Purpose— Although obesity is an established risk factor for cardiovascular disease and stroke, studies have shown evidence of an obesity paradox—a protective effect of obesity in patients who already have these disease states. Data on the obesity paradox in intracerebral hemorrhage is limited. Methods— Clinical data for adult intracerebral hemorrhage patients were extracted from the National Inpatient Sample between 2007 and 2014. Multivariable logistic regression analyzed the association of body habitus with in-hospital mortality, discharge disposition, length of stay, tracheostomy or gastrostomy placement, and ventriculoperitoneal shunt placement. Results— There were 99 212 patients who were eligible. Patients with both obesity (OR=0.69; 95% CI=0.62–0.76; P <0.001) and morbid obesity (OR=0.85; 95% CI=0.74–0.97; P =0.02) were associated with decreased odds of in-hospital mortality. Morbid obesity was significantly associated with increased odds of a tracheostomy or gastrostomy placement (OR=1.42; 1.20–1.69; P <0.001) and decreased odds of a routine discharge disposition (OR=0.84; 0.74–0.97; P =0.014). Conclusions— Obesity and morbid obesity appear to protect against mortality in intracerebral hemorrhage.
Introduction: Obesity is a well-established risk factor for cardiovascular disease and stroke. While a risk factor for the occurrence of these diseases, obesity has been shown to be unexpectedly protective in cardiac disease and ischemic stroke. Here we report the obesity paradox in patients with intracerebral hemorrhage (ICH) in the Nationwide Inpatient Sample (NIS). Methods: Clinical data for adult patients admitted for ICH were extracted from the Nationwide Inpatient Sample (NIS). Body habitus was classified as nonobese (body mass index [BMI] < 30 kg/m2), obese (BMI ≥ 30 kg/m2 and ≤ 40kg/m2), or morbidly obese (BMI>40kg/m2). Multivariable logistic regression analyzed the association of body habitus with in-hospital mortality rate, discharge disposition, extended length of stay, tracheostomy or placement of an endoscopic percutaneous gastrostomy, and ventriculoperitoneal shunt placement. Covariates included patient demographics, comorbidities, insurance status, occurrence of a craniotomy/craniectomy, and hospital characteristics. Cox proportional hazard regression also analyzed the effect of body habitus on in-hospital mortality. Results: In total, data from 61,324,882 patient discharges was screened from the NIS between 2007 to 2014. Of these, 99,212 patient discharges were 18 or older and admitted with atraumatic ICH as the primary diagnosis. In a multivariable logistic regression, both obese (0.67 [0.62, 0.76] p<.001) and morbidly-obese (0.85 [0.74, 0.97] p =0.02) patients were associated with decreased odds of in-hospital mortality as compared to those patients who were nonobese. This effect was not seen in other surrogate measures of outcome including non-routine discharge, extended hospitalization, tracheostomy/gastrostomy placement, and VP shunt placement. A Cox proportional hazards model also demonstrated that both obese (0.71 [-0.41, -0.26] p<.001) and morbidly obese (0.89 [-.021, -0.02] p<.001) patients had a significantly decreased risk of death during their hospital stay. Conclusion: Obesity appears to be associated with decreased inpatient mortality in spontaneous ICH in a large national dataset even when controlling for demographic and clinical course factors.
Introduction: With the continued expansion of acute stroke treatment options, urban tertiary referral centers such as ours are treating an increasingly diverse patient population. As we attempted to better understand barriers to improved door to treatment times in our acute stroke code protocol, we postulated that there might be differences in severity of presentation and swiftness of acute stroke care based on English fluency. Methods: Through a departmental quality improvement project to optimize local policy in the context of new acute stroke treatment guidelines, we compared National Institute of Health Stroke Scale (NIHSS) at presentation, time to presentation, and time to treatment of fluent English speakers to patients who were not fluent in English. We analyzed data from 667 acute stroke codes from January 2017 to March 2018 with Statistical Package for the Social Science (SPSS) using two-tailed t-tests. Results: In-Hospital stroke codes included 415 English speakers and 97 non-English speakers, while Outside Hospital (OSH) transfers comprised 92 English speakers and 35 non-English speakers. Non-English-speaking patients had higher average NIHSS scores at time of acute stroke presentation (11 vs 8 (p=0.013) in-hospital and 17 vs 13(p = 0.007) OSH transfer). Last known well (LKW) to stroke code time upon arrival to our center was significantly shorter in non-English speakers compared to English speakers coming from an OSH (315 minutes vs 515 minutes, p = 0.016), but there were no statistically significant differences between language groups for in-hospital codes’ LKW to stroke code times. There were no statistically significant differences in acute treatment times, but in the OSH transfer group, average LKW to groin puncture was 349 minutes for non-English speakers compared to 545 minutes for English speakers (p=0.085). Conclusions: This data suggests that at our center, non-English speakers present with more severe strokes and present more quickly. Increased stroke severity may partially explain an observed trend towards faster times from LKW to thrombectomy for non-English speakers transferred from an OSH.
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