Key result
Off-label TAVR using the SAPIEN-3 balloon-expandable valve for native aortic regurgitation achieved procedural success in all 6 patients, though it resulted in a 40% rate of new permanent pacemakers.
Why the study?
Does off-label use of the SAPIEN-3 balloon-expandable valve improve procedural success in patients with native aortic regurgitation?
Does off-label use of the SAPIEN-3 balloon-expandable valve improve procedural success in patients with native aortic regurgitation?
While experienced operators can achieve technical success using balloon-expandable valves off-label for native aortic regurgitation, accumulated data suggests dedicated AR devices offer superior safety and efficacy.
Transcatheter aortic valve replacement (TAVR) has changed the paradigm for the treatment of valvular heart disease over the past 2 decades, in large part due to continuous iteration and improvement. While initially developed for aortic stenosis (AS), patients with pure native aortic valve regurgitation (AR) have been treated using these same devices in an “off-label” application. Over time, dedicated devices using unique anchoring mechanisms for patients with AR have been developed with accumulating clinical data in recent years.
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Krishnaswamy et al. (2024) conducted an editorial in Native aortic regurgitation (n=6). SAPIEN-3 balloon-expandable valve was evaluated on Procedural success and complications. Off-label TAVR using the SAPIEN-3 balloon-expandable valve for native aortic regurgitation achieved procedural success in all 6 patients, though it resulted in a 40% rate of new permanent pacemakers.
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