Self-Expanding vs. Balloon-Expandable TAVR with Small Aortic Annulus | NEJM

Summary

A recent international randomized trial compared two types of TAVR prostheses—self-expanding supraannular valves and balloon-expandable valves—in patients with severe aortic stenosis and a small aortic annulus. The study found that the self-expanding valve was non-inferior to the balloon-expandable valve for major clinical outcomes, and superior for preventing bioprosthetic valve dysfunction. Safety outcomes, including the need for pacemaker implantation and major adverse events, were similar between the two groups. These findings suggest that the self-expanding valve is a promising option for this patient population.

Takeaways

• 😀 The study focuses on patients with severe aortic stenosis and a small aortic annulus undergoing TAVR (Transcatheter Aortic Valve Replacement).
• 😀 A total of 716 patients were randomly assigned to receive either a self-expanding supraannular valve or a balloon-expandable valve.
• 😀 The first co-primary endpoint was the composite of death, disabling stroke, or rehospitalization for heart failure through 12 months.
• 😀 The self-expanding valve demonstrated non-inferiority to the balloon-expandable valve for the first co-primary endpoint.
• 😀 The second co-primary endpoint evaluated the superiority of the valves regarding bioprosthetic valve dysfunction.
• 😀 The self-expanding valve was superior to the balloon-expandable valve in reducing bioprosthetic valve dysfunction, with 99.4% vs. 41.6%, respectively.
• 😀 Major safety outcomes, including permanent pacemaker implantation at 30 days and the composite of death or disabling stroke, were similar between the two groups.
• 😀 The study concluded that for patients with a small aortic annulus undergoing TAVR for severe aortic stenosis, the self-expanding valve was non-inferior to the balloon-expandable valve in major clinical outcomes.
• 😀 The self-expanding valve was superior in terms of bioprosthetic valve dysfunction when compared to the balloon-expandable valve.
• 😀 Both valve types showed similar safety profiles, including pacemaker implantation rates and death/disabling stroke rates.
• 😀 The full trial results are available at nj.org, providing more detailed data on the study.

Q & A

What was the primary purpose of the trial described in the transcript?

The primary purpose of the trial was to compare two types of TAVR (transcatheter aortic valve replacement) prostheses—self-expanding supraannular valves and balloon-expandable valves—in patients with severe aortic stenosis and a small aortic annulus.

How many patients were enrolled in the trial and what were their characteristics?

The trial enrolled 716 patients who had severe symptomatic aortic stenosis and a small aortic annulus. These patients were randomly assigned to undergo TAVR with either a self-expanding supraannular valve or a balloon-expandable valve.

What was the first co-primary endpoint in this trial?

The first co-primary endpoint evaluated non-inferiority and was a composite of death, disabling stroke, or rehospitalization for heart failure through 12 months.

What were the results of the first co-primary endpoint?

The self-expanding valve was found to be non-inferior to the balloon-expandable valve for the first co-primary endpoint, with 99.4% of patients in the self-expanding valve group and 10.6% of patients in the balloon-expandable valve group experiencing this endpoint.

What was the second co-primary endpoint of the trial?

The second co-primary endpoint evaluated superiority and was focused on bioprosthetic valve dysfunction.

What were the results regarding the second co-primary endpoint?

The self-expanding valve was found to be superior to the balloon-expandable valve for bioprosthetic valve dysfunction, with 99.4% of the self-expanding valve group experiencing dysfunction compared to 41.6% in the balloon-expandable valve group.

How did the two valve groups compare in terms of major safety outcomes?

The two valve groups appeared similar in terms of major safety outcomes, including the implantation of a new permanent pacemaker at 30 days and a composite of death or disabling stroke.

What conclusion did the authors draw from the trial?

The authors concluded that among patients with a small aortic annulus undergoing TAVR for severe aortic stenosis, the self-expanding valve was non-inferior to the balloon-expandable valve for major clinical outcomes and superior for bioprosthetic valve dysfunction.

Where can full trial results be accessed?

Full trial results can be accessed at nj.org.

What specific patient condition was the trial population dealing with?

The trial population consisted of patients with severe symptomatic aortic stenosis and a small aortic annulus, which is a challenging condition for TAVR procedures.