Cerebral embolic protection in transcatheter aortic valve replacement with bicuspid aortic stenosis

Abstract

Abstract Background In the PROTECTED-TAVR randomized controlled trial, use of cerebral embolic protection device (CEPD) during transcatheter aortic valve replacement (TAVR) did not reduce procedural stroke. It is, however, not clear whether certain high-risk subgroups like young patients with bicuspid aortic stenosis may derive benefit from CEPD. Purpose This study aimed to determine the effectiveness of CEPD in preventing cerebrovascular events during TAVR in patients with severe bicuspid aortic stenosis. Methods We retrospectively analyzed 3505 patients who underwent transfemoral TAVR at a single center between 2016-2020 and identified 257 patients with bicuspid aortic valve stenosis. Baseline demographic, clinical, and procedural characteristics were stratified by CEPD use. We performed Cox Proportional Hazards regression analysis to examine whether the use of CEPD in patients was associated with a lower rate of cerebrovascular events (stroke or transient ischemic attack) after adjusting for baseline characteristics. Results Among 257 patients receiving TAVR for bicuspid aortic stenosis, median age was 74.7 years (IQR 66.9 – 83.2 years) and 62.6% were men. There were no significant differences in the baseline demographic and clinical characteristics between patients with (n=94) and without CEPD (n=163) (Figure 1a). In univariate analysis, there was no significant difference in rates of stroke or transient ischemic attack in-hospital or at 30-days (Figure 1b). In adjusted analysis, CEPD use (HR 1.55 [95% CI, 0.1-3.8)] was not associated with a decreased rate of stroke or transient ischemic attack. Conclusion These findings indicate that CEPD use is not associated with lower rates of cerebrovascular events in patients with bicuspid aortic stenosis and add to the growing body of evidence that questions the utility of CEPD during TAVR.Baseline Characteristics