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

Cessation and Resumption of Elective Neurointerventional Procedures during the Coronavirus Disease 2019 Pandemic and Future Pandemics

At the time of this writing, the coronavirus disease 2019 pandemic continues to be a global threat, disrupting usual processes, and protocols for delivering health care around the globe. There have been significant regional and national differences in the scope and timing of these disruptions. Many hospitals were forced to temporarily halt elective neurointerventional procedures with the first wave of the pandemic in the spring of 2020, in order to prioritize allocation of resources for acutely ill patients and also to minimize coronavirus disease 2019 transmission risks to non-acute patients, their families, and health care workers. This temporary moratorium on elective neurointerventional procedures is generally credited with helping to flatten the curve and direct scarce resources to more acutely ill patients; however, there have been reports of some delaying seeking medical care when it was in fact urgent, and other reports of patients having elective treatment delayed with the result of morbidity and mortality. Many regions have resumed elective neurointerventional procedures, only to now watch coronavirus disease 2019 positivity rates again climbing as winter of 2020 approaches. A new wave is now forecast which may have larger volumes of hospitalized coronavirus disease 2019 patients than the earlier wave(s) and may also coincide with a wave of patients hospitalized with seasonal influenza. This paper discusses relevant and practical elements of cessation and safe resumption of nonemergent neurointerventional services in the setting of a pandemic

Endovascular and Surgical Treatment of Unruptured MCA Aneurysms: Meta-Analysis and Review of the Literature

Introduction. The best treatment for unruptured middle cerebral artery (MCA) aneurysms is unclear. We perform a meta-analysis of recent publications to evaluate the results of unruptured MCA aneurysms treated with surgical clipping and endovascular coiling. Methods. A PubMed search for articles published between January 2004 and November 2013 was performed. The R statistical software package was used to create a random effects model for each desired incidence rate. Cochran's Q test was used to evaluate possible heterogeneity among the rates observed in each study. Results. A total of 1891 unruptured MCA aneurysms, 1052 clipped and 839 coiled, were included for analysis. The complete occlusion rate at 6-9 months mean follow-up was 95.5% in the clipped group and 67.8% in the coiled group ( < 0.05). The periprocedural thromboembolism rate in the clipping group was 1.8% compared with 10.7% in the aneurysms treated by coiling ( < 0.05). The recanalization rate was 0% for clipping and 14.3% for coiling ( = 0.05). Modified Rankin scores of 0-2 were obtained in 98.9% of clipped patients compared to 95.5% of coiled (NS). Conclusions. This review weakly supports clipping as the preferred treatment of unruptured MCA aneurysms. Clinical outcomes did not differ significantly between the two groups

Predictors of Citations in Neurosurgical Research: A 5-year Follow-Up

Introduction Citation rates are an important measure for the impact of publications. This study is the most comprehensive analysis of predictors for scientific neurosurgical research articles. Methods Scientific articles published in 13 neurosurgical journals in 2015 were selected. Data collected included: article subject, level of evidence (LOE), journal impact factor (IF), authorship, contributing centers, and study design. Citation counts were collected for each article in the Web of Science (WoS), Google Scholar (GS), and Scopus 2.5 and 5 years after publication. A generalized linear mixed effects model using the predictors of search engine, LOE, number of centers, number of authors, and IF was constructed to predict total citation count at 5 years. Results 2867 articles generated 39190 citations in WoS, 61682 in GS, and 43481 in Scopus. The median [interquartile range] number of citations per article was 10 [14] in WoS, 15 [20] in GS, and 11 [15] in Scopus. On average, for every 1 citation in WoS, Scopus and GS identified 1.11 and 1.58 citations, respectively. Significant predictors of citation count in all databases 5 years after publication included search engine, LOE, number of centers, number of authors, number of countries, journal IF, and the month of publication (p<0.05). The article subject (tumor, spine, etc.) did not significantly predict citation counts. Conclusions In the most thorough analysis of citation predictors in the neurosurgical literature, search engine, LOE, number of centers, number of authors, number of countries, journal impact factor, and month of publication influenced citations 5 years after publication

The professional and personal impact of the coronavirus pandemic on US neurointerventional practices: a nationwide survey

Background Little is currently known about the effects of the coronavirus (COVID-19) pandemic on neurointerventional (NI) procedural volumes or its toll on physician wellness. Methods A 37-question online survey was designed and distributed to physician members of three NI physician organizations. Results A total of 151 individual survey responses were obtained. Reduced mechanical thrombectomy procedures compared with pre-pandemic were observed with 32% reporting a greater than 50% reduction in thrombectomy volumes. In concert with most (76%) reporting at least a 25% reduction in non-mechanical thrombectomy urgent NI procedures and a nearly unanimous (96%) cessation of non-urgent elective cases, 68% of physicians reported dramatic reductions (\u3e50%) in overall NI procedural volume compared with pre-pandemic. Increased door-to- puncture times were reported by 79%. COVID-19-positive infections occurred in 1% of physician respondents: an additional 8% quarantined for suspected infection. Sixty-six percent of respondents reported increased career stress, 56% increased personal life/family stress, and 35% increased career burnout. Stress was significantly increased in physicians with COVID-positive family members (P\u3c0.05). Conclusions This is the first study designed to understand the effects of the COVID-19 pandemic on NI physician practices, case volumes, compensation, personal/family stresses, and work-related burnout. Future studies examining these factors following the resumption of elective cases and relaxing of social distancing measures will be necessary to better understand these phenomena

Bridging thrombolysis in atrial fibrillation stroke is associated with increased hemorrhagic complications without improved outcomes

BACKGROUND: Atrial fibrillation (AF) associated ischemic stroke is associated with worse functional outcomes, less effective recanalization, and increased rates of hemorrhagic complications after intravenous thrombolysis (IVT). Conversely, AF is not associated with hemorrhagic complications or functional outcomes in patients undergoing mechanical thrombectomy (MT). This differential effect of MT and IVT in AF associated stroke raises the question of whether bridging thrombolysis increases hemorrhagic complications in AF patients undergoing MT. METHODS: This international cohort study of 22 comprehensive stroke centers analyzed patients with large vessel occlusion (LVO) undergoing MT between June 1, 2015 and December 31, 2020. Patients were divided into four groups based on comorbid AF and IVT exposure. Baseline patient characteristics, complications, and outcomes were reported and compared. RESULTS: 6461 patients underwent MT for LVO. 2311 (35.8%) patients had comorbid AF. In non-AF patients, bridging therapy improved the odds of good 90 day functional outcomes (adjusted OR (aOR) 1.29, 95% CI 1.03 to 1.60, p=0.025) and did not increase hemorrhagic complications. In AF patients, bridging therapy led to significant increases in symptomatic intracranial hemorrhage and parenchymal hematoma type 2 (aOR 1.66, 1.07 to 2.57, p=0.024) without any benefit in 90 day functional outcomes. Similar findings were noted in a separate propensity score analysis. CONCLUSION: In this large thrombectomy registry, AF patients exposed to IVT before MT had increased hemorrhagic complications without improved functional outcomes, in contrast with non-AF patients. Prospective trials are warranted to assess whether AF patients represent a subgroup of LVO patients who may benefit from a direct to thrombectomy approach at thrombectomy capable centers