A New TAVR Prosthesis for Aortic Regurgitation Shows Promise

A dedicated device for AR demonstrated safety and efficacy that was noninferior to performance goals.

Current transcatheter aortic valve replacement (TAVR) devices are indicated for calcific aortic stenosis and perform suboptimally in patients with aortic regurgitation (AR) and absent leaflet calcification. The non–FDA-approved Trilogy heart valve has clips to attach to the native leaflets and might perform better in these patients. In a manufacturer-funded, single-arm, multicenter study, investigators examined its safety and efficacy in patients with high surgical risk and at least moderate AR (NCT04415047).

A total of 180 symptomatic patients (mean age, 76 years; 47% women) were enrolled. Technical implantation success was 95%. Results were as follows:

A 30-day composite primary safety endpoint occurred in 27% of patients and included death…

Reviewing Author

Howard C. Herrmann, MD

Disclosures

Consultant/Advisory BoardAffluent Medical; Artedrone; Caranx; Johnson & Johnson; Medtronic; Prolifagen; Wells Fargo

EquityMicrointerventional Devices, Inc.

RoyaltiesUniversity of Pennsylvania

Grant/Research SupportAbbott Vascular; Edwards Lifesciences; Johnson & Johnson; Medtronic

Editorial BoardsCatheterization and Cardiovascular Interventions; Journal of the American College of Cardiology; Circulation: Cardiovascular Interventions; JACC Cardiovascular Interventions; JACC Case Reports; JSCAI

Leadership Positions in Professional SocietiesHeart Valve Collaboratory (Scientific Committee Member, Chair of the Publications Committee)