Mid-Term Outcomes of Transcatheter Aortic Valve Replacement in Extremely Large Annuli With Edwards SAPIEN 3 Valve.
Sengupta, A., S. Zaid, N. Kamioka, J. Terre, M. Miyasaka, S. A. Hirji, M. Hensey, N. Geloo, G. Petrossian, N. Robinson, E. Sarin, L. Ryan, S. H. Yoon, C. W. Tan, O. K. Khalique, S. K. Kodali, T. Kaneko, P. B. Shah, S. C. Wong, A. Salemi, K. Sharma, J. A. Kozina, M. A. Szerlip, C. W. Don, S. Gafoor, M. Zhang, Z. Newhart, S. R. Kapadia, S. L. Mick, A. Krishnaswamy, A. Kini, H. Ahmad, S. L. Lansman, M. J. Mack, J. G. Webb, V. Babaliaros, V. H. Thourani, R. R. Makkar, M. B. Leon, I. George and G. H. L. Tang (2020). “Mid-Term Outcomes of Transcatheter Aortic Valve Replacement in Extremely Large Annuli With Edwards SAPIEN 3 Valve.” JACC Cardiovasc Interv 13(2): 210-216.
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 mm(2) 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 mm(2) (range 683.5 to 852.0 mm(2)) 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 mm(2) is feasible, with favorable mid-term outcomes.