The risk and extent of neurologic events are equivalent for high-risk patients treated with transcatheter or surgical aortic valve replacement

Abstract Objectives This study was designed to characterize the incidence of new clinically detectable neurologic events, or any comparative change in indices of higher cognitive function following transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) within the framework of a prospective, randomized clinical trial for high-risk patients. Methods High-risk patients (predicted SAVR mortality 15%) with severe aortic stenosis (n = 750) were randomized 1:1 to TAVR or SAVR and underwent evaluation using the National Institutes of Health Stroke Scale (NIHSS) and modified Rankin Scale assessment at each follow-up and any suspected event. Neurologic outcomes were ascertained by a neurologist and further evaluated by Mini-Mental State Examination (MMSE), visual fields testing, gait assessment, hand function, writing evaluation, and drawing assessment. Results The 30-day, 1-year, and 2-year stroke rates were 4.9%, 8.7%, and 10.9%, respectively, for TAVR and 6.2%, 12.5%, and 16.6%, respectively, for SAVR ( P = .46, .11, and .05, respectively). All-cause mortality in patients with a major stroke was 83.3% for TAVR and 54.5% for SAVR at 2 years ( P = .29). Late major stroke was disproportionately higher (23.8% at 2 years) among patients with poor iliofemoral access randomized to SAVR. Peripheral vascular disease and falls within 6 months predicted early stroke, and severe aortic calcification and high Charlson score (≥5) predicted 1-year stroke post-TAVR. NIHSS and MMSE scores trended higher after SAVR than after TAVR. Lack of dual antiplatelet therapy use during and after TAVR was associated with early stroke. Conclusions This study defines an equivalent postprocedural stroke risk, stroke extent, and degree of cognitive change after TAVR or SAVR in a high-risk population, and also defines several predictors of stroke after TAVR.