Self-Expanding vs Balloon Expandable TAVI: The SMART Trial

Published: 08 Apr 2024

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Dr Didier Tchétché (Clinique Pasteur, Toulouse, FR) joins us to discuss findings from the SMART Trial.

This prospective, multi-centre, randomised controlled study aims to investigate the valve safety and performance of self expanding as compared to balloon-expandable transcatheter aortic valve implantation (TAVI) 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 TAVI in this patient group, after exercise stress testing.

716 patients were enrolled in the trial, and were randomised on a 1:1 basis to receive TAVI with either a Medtronic self-expanding transcatheter aortic valve, or an Edwards balloon-expandable transcatheter heart valve.

Findings showed that the trial met both primary endpoints, with no significant difference between groups for the composite outcome of death, disabling stroke or rehospitalisation 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. For the co-primary endpoint of valve dysfunction through 12 months, 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.

Recorded onsite at the ACC Conference in Atlanta, 2024.

Interview Questions

  1. What is the background to this study?
  2. Can you briefly tell us about the devices compared in this study?
  3. What was the study design, eligibility criteria and outcome measures?
  4. What were the baseline characteristics of the randomised patients?
  5. Which percentage of the patient population does small annuli represent?
  6. What are the key findings?
  7. What are the take-home messages for practicing clinicians?
  8. What are the next steps?

This video is supported by Medtronic.


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