FDA/CDC
FDA approves Sapien 3 transcatheter valve for bioprosthetic valve failure
Patients at high risk can now avoid open surgery when prosthetic valves fail.
Survival climbing with operator experience
“In the early days of the TMVR MAC registry, the 30-day mortality rate was 37%. It came down to 22% in the middle third of the registry, then about 18% in the final third. Now we’ve got it down in MITRAL to 16.7%, but when you separate the rate in the transseptal versus the transatrial patients, it’s 13% versus 20%. The difference is not statistically significant, but it’s promising, and I think we are making great progress,” Dr. Guerrero said.
Safety and efficacy endpoints in MITRAL will be reported again at 1 year of follow-up.
The MITRAL trial was partially supported by Edwards Lifesciences. Dr. Guerrero reported receiving a research grant from that company and serving as a consultant to Tendyne Holdings/Abbott and on a speakers bureau for Abiomed.
SOURCE: Guerrero M. No abstract.