30-Day and 1-Year Outcomes of Navitor Transcatheter Aortic Valve in Low- or Intermediate-Risk Patients

Le résumé fourni par la source

BACKGROUND: The Navitor transcatheter aortic valve is a self-expanding, intra-annular valve indicated for patients with severe aortic stenosis (AS) at high or extreme surgical risk. OBJECTIVES: The aim of this study was to assess the safety and effectiveness of the Navitor valve in severe AS patients at low or intermediate surgical risk. METHODS: VANTAGE (Evaluation of TAVR Using the Navitor Valve in a Global Investigation) is a prospective, single-arm, multicenter study. The primary effectiveness endpoint was moderate or greater paravalvular leak (PVL) at 30 days; the primary safety endpoint was all-cause mortality or fatal stroke or stroke with disability at 12 months. Both endpoints were assessed against a performance goal (PG) when the sample size requirements were met. Clinical events and imaging assessments were evaluated by an independent committee and a core laboratory, respectively. RESULTS: ) was seen through 12 months. CONCLUSIONS: The Navitor valve demonstrated favorable safety and performance outcomes at 12 months, supporting its expansion to low- and intermediate-risk populations.

Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.