# SMART: zelf-expanderend versus ballonexpandeerbaar TAVR bij kleine annulus — NEJM

*geplaatst 2024-06-06 · Hartfalen · The New England journal of medicine · doi 10.1056/NEJMoa2312573 · https://hartvaat.nl/2024/06/06/smart-zelf-expanderend-versus-ballonexpandeerbaar-tavr-bij-kleine-annulus-nejm/*

De SMART-trial in de NEJM vergeleek zelf-expanderende met ballonexpandeerbare TAVR bij patiënten met een kleine aortaannulus. Het ballonexpandeerbare systeem was superieur met betere hemodynamische resultaten en minder pacemakerimplantatie.

## English: Self-Expanding or Balloon-Expandable TAVR in Patients with a Small Aortic Annulus.

The SMART trial showed that balloon-expandable TAVR achieved significantly better hemodynamic performance than self-expanding TAVR in patients with a small aortic annulus. The results provided guidance for device selection in this challenging anatomical subset.

## Abstract (original, from the publication)

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 mm2 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: 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 cm2 and 1.50 cm2; 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.).

Auteurs: Howard C Herrmann, Roxana Mehran, Daniel J Blackman, Stephen Bailey, Helge Möllmann, Mohamed Abdel-Wahab, Walid Ben Ali, Paul D Mahoney, Hendrik Ruge, David A Wood, Sabine Bleiziffer, Basel Ramlawi, Hemal Gada, Anna Sonia Petronio, Charles D Resor, William Merhi, Bruno Garcia Del Blanco, Guilherme F Attizzani, Wayne B 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

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Bron: The New England journal of medicine, https://doi.org/10.1056/NEJMoa2312573. Bijgewerkt 2026-07-03T13:30:01Z. Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.