Neuroendovascular clinical trials disruptions due to COVID-19. Potential future challenges and opportunities

Objective: To assess the impact of COVID-19 on neurovascular research and deal with the challenges imposed by the pandemic. Methods: A survey-based study focused on randomized controlled trials (RCTs) and single-arm studies for acute ischemic stroke and cerebral aneurysms was developed by a group of senior neurointerventionalists and sent to sites identified through the clinical trials website (https:// clinicaltrials. gov/), study sponsors, and physician investigators. Results: The survey was sent to 101 institutions, with 65 responding (64%). Stroke RCTs were being conducted at 40 (62%) sites, aneurysm RCTs at 22 (34%) sites, stroke single-arm studies at 37 (57%) sites, and aneurysm single-arm studies at 43 (66%) sites. Following COVID-19, enrollment was suspended at 51 (78%) sites—completely at 21 (32%) and partially at 30 (46%) sites. Missed trial-related clinics and imaging follow-ups and protocol deviations were reported by 27 (42%), 24 (37%), and 27 (42%) sites, respectively. Negative reimbursements were reported at 17 (26%) sites. The majority of sites, 49 (75%), had put new trials on hold. Of the coordinators, 41 (63%) worked from home and 20 (31%) reported a personal financial impact. Remote consent was possible for some studies at 34 (52%) sites and for all studies at 5 (8%) sites. At sites with suspended trials (n=51), endovascular treatment without enrollment occurred at 31 (61%) sites for stroke and 23 (45%) sites for aneurysms. A total of 277 patients with acute ischemic stroke and 184 with cerebral aneurysms were treated without consideration for trial enrollment. Conclusion: Widespread disruption of neuroendovascular trials occurred because of COVID-19. As sites resume clinical research, steps to mitigate similar challenges in the future should be considered

3 Building effective stroke systems of care through a regional emergency medical services (EMS) coalition and data transparency initiative: the south florida experience

IntroductionAdvances in acute stroke treatment of emergency large vessel occlusions (ELVO) have led to a transformation in the delivery of stroke care. Because of the importance of time to treatment with endovascular thrombectomy (EVT), there has been renewed emphasis on improving stroke systems of care. In south Florida, there has been a proliferation of stroke centers over the past decade claiming to offer EVT due to the practice of self-attestation by the Agency for Healthcare Administration (AHCA). Concurrently, there are over a dozen EMS agencies in the region, leading to variability in pre-hospital protocols.MethodsTo address the fragmented stroke landscape, in 2015 local EMS Medical Directors along with NeuroInterventionalists (NI) developed the South Florida Stroke Coalition (SFSC), and collaborated with the University of Miami Florida Stroke Registry (UM FSR) team. The core tenets were to: 1) Develop pre-hospital EMS stroke protocols; 2) Optimize in-hospital stroke processes to reduce times to treatment for ELVO; 3) Encourage all tri-county stroke centers to submit data to AHA/ASA Get with the Guidelines-Stroke (GWTG-S) program and participate in the UM FSR; 4) Develop a sustainable data transparency model for CSCs to allow EMS Medical Directors to understand quality of stroke care in their region; 5) Eliminate the practice of AHCA self-attestation of CSCs and require stroke centers to apply for Joint Commission certification.ResultsThe SFSC and the UM FSR analyzed AHCA criteria for Comprehensive Stroke Center (CSC) designation and compared them to those of the Joint Commission to better understand limitations of self-attestation. A sustainable mechanism for local hospitals to share stroke data with the EMS Medical Directors in their catchment areas was created through a regional dashboard initiative (figure 1). The following key variables were selected by the SFSC to provide a better understanding of the quality of care: 1) treatment rates for tPA and EVT, 2) door-to-needle time for tPA, 3) door-to-puncture time for EVT, 4) outcomes at 90 days using modified Rankin scale.Abstract 3 Figure 1ConclusionTo our knowledge, the Florida Stroke Registry Regional Dashboards developed as a grassroots effort between the SFSC and the UM FSR represents the first-of-its-kind, EMS-driven effort to improve stroke systems of care in a region that is comprised of a multitude of EMS agencies and numerous ELVO triage destinations within short distance of each other. Taken together, this data transparency initiative will be instrumental for EMS Medical Directors in future triage decision-making.DisclosuresB. Mehta: None. P. Antevy: None. R. Katz: None. J. Sessa: None. K. Scheppke: None. P. Pepe: None. R. Hanel: None. M. Mokin: None. C. Gutierrez: None. J. Romano: None. R. Nogueira: None. A. Jadhav: None. T. Leslie-Mazwi: None. R. Sacco: None

Mechanical thrombectomy decision making and prognostication: Stroke treatment Assessments prior to Thrombectomy In Neurointervention (SATIN) study

Background Mechanical thrombectomy (MT) is the standard-of-care treatment for stroke patients with emergent large vessel occlusions. Despite this, little is known about physician decision making regarding MT and prognostic accuracy. Methods A prospective multicenter cohort study of patients undergoing MT was performed at 11 comprehensive stroke centers. The attending neurointerventionalist completed a preprocedure survey prior to arterial access and identified key decision factors and the most likely radiographic and clinical outcome at 90 days. Post hoc review was subsequently performed to document hospital course and outcome. Results 299 patients were enrolled. Good clinical outcome (modified Rankin Scale (mRS) score of 0–2) was obtained in 38% of patients. The most frequently identified factors influencing the decision to proceed with thrombectomy were site of occlusion (81%), National Institutes of Health Stroke Scale score (74%), and perfusion imaging mismatch (43%). Premorbid mRS score determination in the hyperacute setting accurately matched retrospectively collected data from the hospital admission in only 140 patients (46.8%). Physicians correctly predicted the patient’s 90 day mRS tertile (0–2, 3–4, or 5–6) and final modified Thrombolysis in Ischemic Cerebral Infarction score preprocedure in only 44.2% and 44.3% of patients, respectively. Clinicians tended to overestimate the influence of occlusion site and perfusion imaging on outcomes, while underestimating the importance of pre-morbid mRS. Conclusions This is the first prospective study to evaluate neurointerventionalists’ ability to accurately predict clinical outcome after MT. Overall, neurointerventionalists performed poorly in prognosticating patient 90 day outcomes, raising ethical questions regarding whether MT should be withheld in patients with emergent large vessel occlusions thought to have a poor prognosis