ACC.24: The SMART Trial

ACC.24 — Investigator, Dr Howard C Hermann (Penn Medicine, Philadelphia, PA, US) joins us to discuss the findings from the SMART Trial (NCT04722250).

This prospective, multi-center, randomized controlled study aims to investigate the valve safety and performance of self expanding as compared to balloon-expandable transcatheter aortic valve replacement (TAVR) in patients with small aortic annuli and severe symptomatic aortic stenosis. At select sites, a stress echocardiography sub-study also evaluated the performance of self expandable and balloon-expandable TAVR in this patient group, after exercise stress testing.

716 patients were enrolled in the trial, and were randomized on a 1:1 basis to receive TAVR with either a Medtronic self-expanding transcatheter aortic valve, or an Edwards balloon-expandable transcatheter heart valve. Co-primary endpoints included a composite of clinical outcomes, including mortality, disabling stroke and heart failure rehospitalisation, as well as bioprosthetic valve function through 12 months.

Findings showed that the trial met both primary endpoints, with no significant difference between groups in terms of a composite of death, disabling stroke or rehospitalization for heart failure, which occurred in 9.5% of patients with the self-expandable valve, and 10.6 of those with the balloon-expandable valve. In terms of valve function, the self-expandable valve was found to be superior in a composite of structural and non-structural valve deterioration, blood clotting around the valve, infection of the valve and aortic valve reintervention.

1. What is the importance of this study?
2. Could you tell us a bit more about the devices used in this study, and why SE and BE devices are compared in this patient group?
3. What are the key findings?
4. What is the impact of these findings on clinical practice?
5. What is your take-home message?
6. What further research is required?

Recorded onsite at the ACC Conference in Atlanta, 2024.

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