Transcatheter mitral valve replacement (TMVR) using the MitraClip System in commercial use in the U.S. is safe and effective for the treatment of prohibitive risk patients with symptomatic mitral regurgitation (MR) and results compare favorably to pre-approval studies and other national registries, according to research presented Oct. 11 during TCT 2015.

The study, presented by Gorav Ailawadi, MD, of the University of Virginia, on behalf of the ACC/STS TVT Registry, analyzed all commercial TMVR cases with MitraClip performed in the U.S. from Nov. 2013 to March 2015 (n=1601) using data from the registry. Outcomes included major adverse cardiac events, device-related events, and in-hospital and 30-day mortality.

At baseline the majority of patients had MR ratings of 4+ or less, with 20 percent at 3+ or less, and had a median STS risk of mortality of 9.5 percent (for MV replacement). Post-procedure, 92.9 percent of patients had moderate MR (2+ or less) and 62 percent had mild MR (1+ or less). Nearly 85 percent of patients were discharged home.  After 30 days, 87 percent of patients had moderate or less MR and no surgery, while 55 percent had mild or less MR and no surgery. In-hospital mortality was 2.6 percent and 30-day mortality was 5.5 percent.

Compared to other countries, U.S. patients had an average age of 82 and were roughly 10 years older than European and Asian registries. In the U.S., MitraClip is only approved for patients with degenerative MR, while in Europe the device is largely used for functional MR. Despite these differences, the percentage of patients with moderate or less MR post-procedure (92 percent) was on par with other countries, as was the percentage of in-hospital death (2.6 percent).

The study is an update to research presented at ACC.15 in San Diego, CA, this past March by Paul Sorajja, MD, FACC.

Keywords: Transcatheter Cardiovascular Therapeutics, Hospital Mortality, Mitral Valve, Mitral Valve Insufficiency, Patient Discharge, Registries, STS/ACC TVT Registry, CathPCI Registry

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