A New Valve Type for Transcatheter Aortic-Valve Replacement?

In patients with severe aortic stenosis, a new mechanically expanded valve is noninferior to an established self-expanding valve, but problems remain.

The use of transcatheter aortic-valve replacement (TAVR) has increased rapidly in recent years and is especially helpful for patients at high surgical risk. This manufacturer-funded study tested a new valve type, a mechanically expanded, non–FDA-approved valve (MEV [Lotus]), in 912 patients with severe symptomatic aortic stenosis and high or even extreme risk for surgery (NCT02202434).

Participants were randomized in a 2:1 ratio to the MEV or to an FDA-approved, self-expanding valve (SEV [CoreValve]). On the primary 30-day safety composite outcome (all-cause mortality, stroke, major bleeding, acute kidney injury, and major vascular complications), the MEV was noninferior to the SEV (20% and 17%, respectively). On the primary 1-year effective…

Reviewing Author

Pascal Meier, MD

Disclosures

Editorial BoardsOpen Heart

Leadership Positions in Professional SocietiesEuropean Society of Cardiology (Communication Committee); European Association of Percutaneous Cardiovascular Interventions (Chair, Web & Communication Committee)

Pascal Meier, MD

Disclosures

Editorial BoardsOpen Heart

A New Valve Type for Transcatheter Aortic-Valve Replacement?

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Reviewing Author