FDA Expands Sapien XT Indication to Include Aortic Valve-in-Valve TAVR

October 15, 2015

IRVINE and SAN FRANCISCO, CA — The FDA has approved an expanded indication for the Sapien XT (Edwards Lifesciences) to include "valve-in-valve" repair of failed surgical bioprosthetic heart valves[1]. The device is already available for standard transcatheter aortic-valve repair (TAVR) in the US and Europe and received the CE Mark for valve-in-valve procedures in 2014.

Transcatheter valve-in-valve procedures could prove to be a boon for patients considered too high risk for conventional surgical valve replacement. The first US approval of that indication for a transcatheter valve went to the CoreValve System (Medtronic) earlier this year, as reported by heartwire from Medscape.

Today at TCT 2015, 1-year data from the PARTNER II Valve-in-Valve study using the Sapien XT, a nonrandomized cohort analysis based on 197 PARTNER II patients, showed a 13.4% rate of death from any cause and 3.7% rate of stroke.

"This is very exciting and good news for the community," principal investigator Dr Danny Dvir (St. Paul's Hospital (Vancouver, Canada) told heartwire . "The study results are fantastic. But we should hope that everyone will know how to select the patients optimally for this procedure and that the results will be reproduced."

Other 1-year outcomes reported at the meeting by Dvir: 8.9% cardiac mortality and 11.8% rehospitalization.

Observers at the meeting applauded those numbers as impressively low.

"I'm excited that there's yet another valve available to treat patients with already-failed valves. Patients going for a reoperation is just not acceptable," Dr Roxana Mehran (Mount Sinai School of Medicine, New York) codirector of TCT, told heartwire.

"So I think this is going to become the default therapy," she said, referring to the procedure in general. "No patient with a failed surgical valve should have to go through another operation when you can have such good results in valve-in-valve."

heartwire will soon have complete coverage of the PARTNER II Valve-in-Valve study as presented at TCT 2015, along with expert commentary.

Dvir is a consultant for Edwards and Medtronic.


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