Mid-Term Outcomes of Transcatheter Aortic Valve Replacement in Extremely Large Annuli With Edwards SAPIEN 3 Valve.
(Journal Article;Multicenter Study)
OBJECTIVES: The aim of this study was to report the 1-year results of transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN 3 (S3) valve in extremely large annuli. BACKGROUND: Favorable 30-day outcomes of S3 TAVR in annuli >683 mm2 have previously been reported. Pacemaker implantation rates were acceptable, and a larger left ventricular outflow tract and more eccentric annular anatomy were associated with increasing paravalvular leak. METHODS: From December 2013 to December 2018, 105 patients across 15 centers with mean area 721.3 ± 36.1 mm2 (range 683.5 to 852.0 mm2) underwent TAVR using an S3 device. Clinical, anatomic, and procedural characteristics were analyzed. One-year survival and echocardiographic follow-up were reached in 94.3% and 82.1% of patients, respectively. Valve Academic Research Consortium-2 30-day and 1-year outcomes were reported. RESULTS: The mean age was 76.9 ± 10.4 years, and Society of Thoracic Surgeons predicted risk score averaged 5.2 ± 3.4%. One-year overall mortality and stroke rates were 18.2% and 2.4%, respectively. Quality-of-life index improved from baseline to 30 days and at 1 year (p < 0.001 for both). Mild paravalvular aortic regurgitation occurred in 21.7% of patients, while moderate or greater paravalvular aortic regurgitation occurred in 4.3%. Mild and moderate or severe transvalvular aortic regurgitation occurred in 11.6% and 0%, respectively. Valve gradients remained stable at 1 year. CONCLUSIONS: S3 TAVR in annular areas >683 mm2 is feasible, with favorable mid-term outcomes.
Sengupta, A; Zaid, S; Kamioka, N; Terre, J; Miyasaka, M; Hirji, SA; Hensey, M; Geloo, N; Petrossian, G; Robinson, N; Sarin, E; Ryan, L; Yoon, S-H; Tan, CW; Khalique, OK; Kodali, SK; Kaneko, T; Shah, PB; Wong, SC; Salemi, A; Sharma, K; Kozina, JA; Szerlip, MA; Don, CW; Gafoor, S; Zhang, M; Newhart, Z; Kapadia, SR; Mick, SL; Krishnaswamy, A; Kini, A; Ahmad, H; Lansman, SL; Mack, MJ; Webb, JG; Babaliaros, V; Thourani, VH; Makkar, RR; Leon, MB; George, I; Tang, GHL
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