Abstract
RESPOND is a prospective, single-arm study enrolling 1014 transcatheter aortic valve replacement (TAVR) patients. The objective of this analysis is to assess the impact of cerebral embolic protection (CEP) devices and prosthetic valve repositioning on the risk of neurologic complications in patients treated with the fully repositionable Lotus Valve in the RESPOND postmarket study. Valve repositioning and CEP use were at the operators' discretion. Stroke events were adjudicated by an independent medical reviewer. This analysis assessed the baseline differences among patients according to CEP use and valve repositioning and evaluated the neurological complications at 72 hours after TAVR, hospital discharge, and 30-day follow-up. A multivariate analysis was performed to identify the potential predictors of stroke. Of the 996 patients implanted with the Lotus Valve (mean age: 80.8 years, 50.8% female, STS score 6.0 ± 6.9), 92 cases (9.2%) used CEP. The overall rate of acute stroke/transient ischemic attack (TIA) was 3.0% at 72 hours after TAVR. The 72-hour stroke/TIA rate was 1.1% in patients who had CEP and 3.2% in those who did not. Use of CEP was associated with a 2.1% absolute reduction in the risk of acute neurological events (relative risk reduction: 65.6%), although the difference was not statistically significant (p=0.51). Repositioning of the Lotus Valve occurred in 313/996 procedures (31.4%). The 72-hour rate of stroke/TIA was similar in patients who had valve repositioning (2.9%) compared with those who did not (3.1%; p=0.86). The selective use of a CEP device in the RESPOND study was associated with a nonsignificantly lower risk for stroke within 72 hours. The use of the repositioning feature of the Lotus Valve did not increase the stroke risk.
Highlights
Transcatheter aortic valve replacement (TAVR) is the preferred treatment for many patients with aortic stenosis at increased surgical risk
In the randomized SENTINEL trial, use of a double-filter cerebral embolic protection (CEP) device was associated with a trend towards a lower periprocedural stroke rate within 72 hours compared with patients undergoing unprotected TAVR [3]
Results e RESPOND study enrolled 1014 patients between May 2014 and February 2016; 996 patients were implanted with a Lotus Valve
Summary
Transcatheter aortic valve replacement (TAVR) is the preferred treatment for many patients with aortic stenosis at increased surgical risk. Neurologic complications remain a concern, with regard to repositioning of the prosthetic valve during the procedure, which has been associated with early stroke [1, 2]. To mitigate this risk, transcatheter filters have been used to capture debris embolized during the TAVR procedure [3,4,5]. In the randomized SENTINEL trial, use of a double-filter cerebral embolic protection (CEP) device was associated with a trend towards a lower periprocedural stroke rate within 72 hours compared with patients undergoing unprotected TAVR [3]. A large patient-level meta-analysis of CEP use in TAVR patients showed a significant reduction of periprocedural stroke and the composite of periprocedural mortality and stroke in patients in whom a double-filter CEP device was used [6].
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
