Two Studies of a Self-Expanding Bioprosthesis for Severe Aortic Stenosis

The new kid on the TAVR block beats surgery.

By offering an alternative to surgery, transcatheter aortic valve replacement (TAVR) has changed the treatment landscape for patients with severe, symptomatic aortic stenosis (AS). In the U.S., a balloon-expandable system (Sapien) is approved for AS patients who are at extreme risk (inoperable) or high risk (Society of Thoracic Surgeons [STS] 30-day mortality risk >≈8%). The FDA recently approved a self-expanding TAVR platform (CoreValve) for extreme-risk patients on the basis of data from a prospective nonrandomized study. Results of that study and from a separate randomized comparison of TAVR with surgery in high-risk patients have now been published. CoreValve's manufacturer funded both studies.

The nonrandomized study, conducted at 41 ce…

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)