Self-Expanding or Balloon-Expandable TAVR in Patients with a Small Aortic Annulus.
Publication/Presentation Date
6-6-2024
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: We randomly assigned patients with symptomatic severe aortic stenosis and an aortic-valve annulus area of 430 mm
RESULTS: A total of 716 patients were treated at 83 sites in 13 countries (mean age, 80 years; 87% women; mean Society of Thoracic Surgeons Predicted Risk of Mortality, 3.3%). The Kaplan-Meier estimate of the percentage of patients who died, had a disabling stroke, or were rehospitalized for heart failure through 12 months was 9.4% with the self-expanding valve and 10.6% with the balloon-expandable valve (difference, -1.2 percentage points; 90% confidence interval [CI], -4.9 to 2.5; P< 0.001 for noninferiority). The Kaplan-Meier estimate of the percentage of patients with bioprosthetic-valve dysfunction through 12 months was 9.4% with the self-expanding valve and 41.6% with the balloon-expandable valve (difference, -32.2 percentage points; 95% CI, -38.7 to -25.6; P< 0.001 for superiority). The aortic-valve mean gradient at 12 months was 7.7 mm Hg with the self-expanding valve and 15.7 mm Hg with the balloon-expandable valve, and the corresponding values for additional secondary end points through 12 months were as follows: mean effective orifice area, 1.99 cm
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.).
Volume
390
Issue
21
First Page
1959
Last Page
1971
ISSN
1533-4406
Published In/Presented At
Herrmann, H. C., Mehran, R., Blackman, D. J., Bailey, S., Möllmann, H., Abdel-Wahab, M., Ben Ali, W., Mahoney, P. D., Ruge, H., Wood, D. A., Bleiziffer, S., Ramlawi, B., Gada, H., Petronio, A. S., Resor, C. D., Merhi, W., Garcia Del Blanco, B., Attizzani, G. F., Batchelor, W. B., Gillam, L. D., … SMART Trial Investigators (2024). Self-Expanding or Balloon-Expandable TAVR in Patients with a Small Aortic Annulus. The New England journal of medicine, 390(21), 1959–1971. https://doi.org/10.1056/NEJMoa2312573
Disciplines
Medicine and Health Sciences
PubMedID
38587261
Department(s)
Department of Surgery
Document Type
Article