Self-Expanding or Balloon-Expandable TAVR in Patients with a Small Aortic Annulus
Howard C. Herrmann, Roxana Mehran, Daniel J. Blackman, Stephen Bailey, Helge Möllmann, Mohamed Abdel‐Wahab, Walid Ben Ali, Paul Mahoney, Hendrik Ruge, David Wood, Sabine Bleiziffer, Basel Ramlawi, Hemal Gada, Anna Sonia Petronio, Charles D. Resor, William Merhi, Bruno García del Blanco, Guilherme F. Attizzani, Wayne Batchelor, Linda D. Gillam, Mayra Guerrero, Toby Rogers, Joshua D. Rovin, Molly Szerlip, Brian Whisenant, G. Michael Deeb, Kendra J. Grubb, Ratnasari Padang, Myra T Fan, Andrew D. Althouse, Didier Tchétché
Abstract
BACKGROUND: Patients with severe aortic stenosis and a small aortic annulus are at risk for impaired valvular hemodynamic performance and associated adverse cardiovascular clinical outcomes after transcatheter aortic-valve replacement (TAVR). METHODS: or less in a 1:1 ratio to undergo TAVR with either a self-expanding supraannular valve or a balloon-expandable valve. The coprimary end points, each assessed through 12 months, were a composite of death, disabling stroke, or rehospitalization for heart failure (tested for noninferiority) and a composite end point measuring bioprosthetic-valve dysfunction (tested for superiority). RESULTS: ; percentage of patients with hemodynamic structural valve dysfunction, 3.5% and 32.8%; and percentage of women with bioprosthetic-valve dysfunction, 10.2% and 43.3% (all P<0.001). Moderate or severe prosthesis-patient mismatch at 30 days was found in 11.2% of the patients in the self-expanding valve group and 35.3% of those in the balloon-expandable valve group (P<0.001). Major safety end points appeared to be similar in the two groups. CONCLUSIONS: Among patients with severe aortic stenosis and a small aortic annulus who underwent TAVR, a self-expanding supraannular valve was noninferior to a balloon-expandable valve with respect to clinical outcomes and was superior with respect to bioprosthetic-valve dysfunction through 12 months. (Funded by Medtronic; SMART ClinicalTrials.gov number, NCT04722250.).