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BackgroundThe pilot use of a smartphone platform for electronic informed consent (e-Consent) in large vessel occlusion acute stroke (LVOS) trials has recently been reported. The degree of satisfaction from Legal Authorized Representatives (LARs) with regard to this process remains to be established.MethodsA single-center study evaluating the experience of LARs with the use of e-Consent in a LVOS randomized trial of an investigational drug administered within 12 hours of last known normal was carried out. A structured survey was used to evaluate the experience of the LARs with the e-consenting process.ResultsFrom February to November 2018, 60 consecutive patients were e-Consented. Of these, 53 LARs completed the survey. The median (IQR) age of the patients was 63 (53–70) years, baseline/discharge National Institutes of Health Stroke Scale score was 17 (12–20)/3(1–12), and 45% were independent at discharge. The survey was applied in person in 43% of cases and via telephone in 57%. Median LAR age was 48 (39–59) years, 64% were female, and a multi-ethnic composition was observed. Forty percent of LARs had less than tertiary level of education (high-school or less). Regarding the e-Consent, 98% of LARs reported to be ‘clear’ and 83% felt ‘very comfortable’ in signing. The overall experience was ‘excellent/good’ in 91%. Despite the positive general impression regarding the use of e-Consent, 12 LARs (22%) would have preferred paper consent. Multivariable regression indicated that lower educational status (tertiary education or less: OR 5.09, 95% CI 1.02 to 25.48; p=0.04) and lower baseline ASPECTS score (OR 0.63, 95% CI 0.41 to 0.96; p=0.03) were independently associated with preference for paper consent.Conclusionse-Consent was overall very well perceived by LARs in a randomized clinical trial of LVOS. A minority of proxies, who were more commonly less formally educated, would have preferred paper consenting.

Background and Purpose— The informed consent process is a major limitation for enrollment in acute stroke clinical investigations. We aim to describe the novel application of smartphone electronic informed consenting (e-Consent) in trials of cerebral thrombectomy. Methods— The e-Consent tool consists of a secure/Health Insurance Portability and Accountability Act compliant smartphone platform based on REDCap (Research Electronic Data Capture; Vanderbilt University, TN) that uses a survey project located on a static webpage. A link to the webpage is sent via text message or email to the legally authorized representative. The e-Consent form is filled and a freehand electronic signature added in the smartphone browser; a record ID and an e-Consent Process Attestation form are automatically generated. The e-Consent application was piloted in a randomized trial comparing endovascular versus medical therapy in late presenting patients (DAWN [Clinical Mismatch in the Triage of Wake Up and Late Presenting Strokes Undergoing Neurointervention With Trevo]). Trial enrollment began in January 2015; e-Consent was approved by the local institutional review board in December 2016, and the study was stopped in February 2017. Results— During the trial period, Grady Memorial Hospital performed 273 thrombectomies with 47 patients being consented and 38 patients enrolled in the DAWN trial. Of the randomized patients, 29 (76%) were transferred from outside hospitals. A total of 6 surrogates were e-Consented, with 2 patients being screen failures. Enrolled e-Consented patients (n=4) had similar age (73±14 versus 69±12 years; P =0.65) and National Institutes of Health Stroke Scale (16±5 versus 16±5; P =0.88) as compared with conventionally consented (n=25). Time from door-to-randomization was decreased with e-Consenting (28±9 versus 57±24 minutes; P =0.002). Conclusions— e-Consenting streamlined the consenting process in a randomized trial of patients with emergent large vessel occlusion strokes.

Introduction: We have recently reported the pilot use of a smartphone platform for electronic informed consenting (e-Consent) in acute stroke trials. We here report the feedback provided by legal authorized representatives (LAR) after consenting for a large vessel occlusion acute ischemic stroke (LVOS) randomized clinical trial. Methods: This is a single-center prospective study investigating the criticism of LAR after the use of e-Consent for a clinical trial of neuroprotectant in LVOS within 12 hours of last normal. REDCap (Research Electronic Data Capture) is a secure, Health Insurance Portability and Accountability Act compliant, web-based platform designed for research data capture that was used to create a survey project located on a static URL that can be remotely accessed (via smartphone browser). Regardless of the geographical position of the LAR, a standard link to the URL was sent via text message to the LAR and signed. A structured survey was applied to each LAR at least 12 hours after enrollment. Results: From February-August 2018, 33 patients were enrolled in the trial. Four LARs were unavailable, 3 expired before the questionnaire could be applied, and 1 refused to participate, leaving 25 patients for the primary analysis. Mean LAR age was 49±13 years, 68% were female, 44% black/48% white, 44% had high-school education or less. All LARs reported e-Consent to be “clear”. Eighty percent felt “ very confortable” in signing an e-Consent, 16% “somewhat” and 4% “not comfortable at all”. Four (16%) LARs would prefer paper consent. The overall experience was “excellent” in 64%, “good” in 28%, and “poor” in 8%. Seventy-two percent of surveys were done via phone and 28% in person. The patient’s median baseline and discharge NIHSS was 17[IQR 12-22] and 2[1-7], and 60% had discharge modified Rankin Scale 0-2. Male gender (75% vs 6%;p=0.04) and education level less than college (100% vs 0%);p=0.03 were associated with preference of paper over e-consent, while baseline and discharge NIHSS were not. Conclusion: e-Consent was overall very well perceived by LAR in a randomized clinical trial of LVOS. A small percentage of LAR, who were more commonly male and formally less educated, preferred paper consent.

Background and Purpose: Smoking is a well-established risk factor for stroke. However, several studies have shown that smokers with stroke have better outcomes after thrombolysis, a phenomenon commonly known as the smoking-thrombolysis paradox. We investigated whether clinical and procedural outcomes differ between smokers and non-smokers with large vessel occlusion stroke after endovascular therapy. Methods: We reviewed our prospectively collected endovascular database at a tertiary care academic institution between Sep 2010-Dec 2016. All patients that underwent endovascular therapy for anterior circulation large vessel occlusion acute ischemic stroke were included and categorized into two groups: (1) current smokers and (2) non-smokers. The 2 groups were then matched for age, baseline NIHSS and glucose levels using a weighted Euclidian distance method. Baseline, procedural, and radiological characteristics, as well as outcome parameters were compared. Results: A total of 326 (163 matched pairs) qualified for the study. Smokers had higher rates of dyslipidemia (48.5% vs 28.8%, p Conclusion: Our data shows that smoking is not associated with outcomes in patients with large vessel occlusion stroke treated with mechanical thrombectomy.

Background: Patients who are admitted during off-hours (nights and weekends) are thought to have worse outcomes. This might be explained by delayed times to treatment. We sought to determine the effect of off-hour presentation on processes of care and outcomes at a comprehensive stroke center. Methods: We reviewed our prospectively collected endovascular database at a tertiary care academic institution between Sep 2010-Dec 2016. All patients that underwent endovascular therapy for large vessel occlusion acute ischemic stroke were included and categorized into two groups: those arriving during regular hours (weekday 7AM-7PM) or off-hours. The 2 groups were then matched for age, baseline NIHSS and glucose levels using a weighted Euclidian distance method. Baseline, procedural, and radiological characteristics, as well as outcome parameters were compared. Results: 926 (463 pairs) patients were included. Patients presenting off-hours had higher rates of hypertension (78.2% vs 66.7%, p Conclusions: Our study shows that patients presenting off-hours have similar picture to puncture times and clinical outcomes as those presenting during regular hours.

Background: The ethnic disparities in stroke outcomes have been well described. Stroke is twice more common and leads to higher mortality rates among blacks as compared to whites. We compared the outcomes of patients undergoing endovascular stroke therapy (ET) in a high-volume center according to their racial profile after age adjustment. Methods: Retrospective analysis of a prospectively collected ET database between September/2010-September/2015. The baseline characteristics of African-American vs. Caucasian patients were compared. Given the impact of age on stroke outcomes additional analyses were performed dichotomizing patients using the median age of the overall cohort. Primary and secondary efficacy outcomes included the rates of good outcome (90-day mRS 0-2) and successful reperfusion (mTICI 2b-3), respectively. Safety outcome was accessed by rates of any parenchymal hematoma (PH-1 and PH-2) and 90-day mortality. Results: 781 patients fit the inclusion criteria and were included in the analysis; 440 were included in the Caucasian group (56% overall cohort) and 341 in the African-American group (44%). Caucasian patients were significantly older (69±13 vs. 60±14 years-old, p Conclusion: Aggressive treatment of acute ischemic stroke with endovascular therapy leads to similar outcomes across African-American and Caucasian patients. Greater availability of ET may diminish the ethnic/racial disparities in stroke outcomes.

Introduction: Endovascular therapy is the standard of care for the treatment of proximal large vessel occlusion strokes (LVOS). Its safety and efficacy in the treatment of distal intracranial occlusions has not been well studied. Methods: We retrospectively reviewed a prospectively collected endovascular database (September 2010-December 2015, n=898) for all patients with distal intracranial occlusions treated with endovascular therapy. Distal occlusions were defined as any occlusion of the anterior cerebral artery (ACA), any occlusion of the posterior cerebral artery (PCA), or any occlusion at or distal to the middle cerebral artery (MCA)-M3 opercular segment. Results: Distal occlusions were treated in 70 patients. The mean age was 66+/-14 and 57% of the patients were male. Thirty-one (44%) of the patients received IV-tPA. The median pre-procedure NIHSS was 19 (IQR, 13-23). The distal occlusion was the primary treatment location in 54 patients and in 16 patients the distal occlusion was treated as a rescue strategy after successful treatment of a proximal LVOS. The locations of the primary cases were MCA-M3 (n=21), ACA with a concomitant MCA-M1 or MCA-M2 (n=16), ACA alone (n=9), PCA (n=6), and ACA with a concomitant MCA-M3 (n=2). The locations of the rescue cases were MCA-M3 (n=8), ACA (n=7), and both MCA-M3 and ACA (n=1). The most common treatment modalities employed were intra-arterial tPA (n=37, 52%), small (3mm) stent-retrievers (n=24, 33%), and thromboaspiration (n=30, 42%). Near or complete reperfusion (mTICI 2b-3) was achieved in 56 cases (80%). Overall, there were 5 (7%) cases of any parenchymal hematoma (PH). However, two of the PHs were in patients with both a MCA-M1 and an ACA occlusion, and both of these hemorrhages were in the MCA territory. Thus only 3 PHs (4.3%) occurred in the territory of the treated distal occlusion with two of these patients also receiving IV tPA. At 90 days, 24 patients (40%) had a mRS of 0-2 and 13 (21%) had died. Conclusions: Distal intracranial occlusions can be treated safely and successfully with endovascular therapy. Although promising our results need to be corroborated by larger prospective controlled studies.

Background and Purpose: The smoking-thrombolysis paradox has been well described in myocardial infarction. However, its existence in the stroke population remains elusive. In the past decade, several studies have investigated the phenomenon with mixed results. We sought to determine whether clinical outcomes differ between smokers and non-smokers with acute ischemic stroke undergoing endovascular therapy. Methods: We reviewed our prospectively collected endovascular database at a tertiary care academic institution. All patients who underwent endovascular therapy for acute large vessel occlusion acute ischemic stroke were categorized into current smokers and non-smokers. Baseline characteristics, procedural radiological as well as outcome parameters where compared. Results: A total of 968 patients qualified for the study of which 189 (19.5%) were current smokers. Smokers were younger (60.78±11.95 vs. 66.41±15.05 years, p Conclusion: In stroke patients treated with mechanical thrombectomy, smoking does not seem to be associated with outcomes regardless of stroke subtype or location.

Background and Purpose: Timely reperfusion in large vessel occlusion strokes (LVOS) is crucial to achieving optimal functional outcomes. Acute neurointerventional therapy requires a team of individuals be assembled and ready as soon as the workup is completed and the patient is deemed an eligible and appropriate thrombectomy candidate. On occasion, the endovascular on call team is activated but the patient is subsequently determined ineligible for interventional therapy. We aimed to explore the frequency and financial impact of on-call neuroendovascular team activation when the procedure is a “Non-Go” situation and to determine its impact on the operating budget of an acute endovascular stroke program. Methods: From February-July 2014, information was collected on all instances of the neuroendovascular team being activated during the “After Hours”/On-Call period (defined as: weekdays 7PM-7AM and weekends e.g. Fri 7PM-Mon7AM) but a procedure not done due to patient ineligibility. The information collected included patient demographics, date and time of the activation, and reason why the procedure was not performed. Results: During the five month data collection period, there were 12 occasions of “Non-Go Activation” of the Neuroendovascular Team during “After Hours”. Three patients (25%) were randomized to IV tPA only in a clinical trial, four patients (33%) had marked improved symptoms and/or no-occlusion on CT angiography, and five patients (42%) had large core on initial imaging. During this same period, a total of 70 thrombectomies were performed for a ratio 5.8 overall thrombectomies for every “Non-Go After Hours” activation which seems to be a financially viable model. Conclusions: The “stand-by strategy” for the neuroendovascular team for selected stroke transfers and emergency room cases is justifiable based on the need for rapid reperfusion in LVOS. The extra burden on the “on-call” personnel is acceptable and the extra costs represent a relatively small fraction of the treatment expenses.