Preliminary experience using the transcatheter mitral valve leaflet repair procedure.

Background: Mitral regurgitation (MR) causes increased morbidity and mortality in heart failure patients and is often associated with augmented surgical risk.

Objectives: To assess the preliminary results oftranscatheter mitral valve leaflet repair (TMLR) in a single academic center.

Methods: Data were collected prospectively in the cardiology department of Rabin Medical Center in 2012. Ten consecutive patients (age 69.3 +/- 15.9 years, ejection fraction 36.5 +/- 9.4) who were poor surgical candidates with severe functional MR underwent general anesthesia, followed by trans-septal puncture and a TMLR procedure using the MitraClip device.

Results: All 10 patients were considered to have severe functional MR prior to TMLR treatment and were all symptomatic; the mean New York Heart Association (NYHA) class was 3.4 +/- 0.5. The MR severity was 4 +/- 0. There were no immediate complications or failures of the procedure. One patient died on day 5 due to massive gastrointestinal bleeding. Immediately following TMLR all 10 patients showed a profound MR reduction to a mean severity grade of 1.6 +/- 0.6. At one month after the procedure, NYHA had decreased to an average of 1.7 +/- 1.0 and was at least grade 2 in all but one patient. After 6 months the MR remained < or = 2 in six of eight patients, with a NYHA average of 1.4 +/- 0.5.

Conclusions: The MitraClip procedure was shown to be relatively safe, providing significant clinical benefit to a relatively sick population with severe MR. It is therefore an important alternative to surgery in these high risk patients.