Mitral Annuloplasty Device Implantation for Non-Surgical Treatment of Mitral Regurgitation: Clinical Experience After the Approval Studies.

BACKGROUND AND AIMS: One option for interventional treatment of secondary mitral regurgitation is the placement of an indirect mitral annuloplasty device (Carillon Mitral Contour System) cinching the mitral annulus to facilitate coaptation of the mitral leaflets. The aim of this study is to evaluate the implantation success and hemodynamic results. METHODS AND RESULTS: Seventeen consecutive patients (11 females, 6 males) suffering from moderate to severe secondary mitral regurgitation (40% ischemic, 59% non-ischemic) received a Carillon Mitral Contour System device, which was evaluated prospectively in a single-center setting. The mean procedure time was 95.5 ± 2.1 minutes, fluoroscopy time was 13.1 ± 6.1 minutes, and the amount of contrast dye was 120.6 ± 39.3 mL. The mitral regurgitation grade was reduced from 2.8 ± 2.4 to 1.9 ± 0.8 acutely (P<.01), with an additional improvement seen after 3 months to 1.5 ± 0.75 (P<.01 to baseline). In 41.2% of patients, acute reduction of coronary artery flow was seen and managed with a stepwise approach: (1) intracoronary nitroglycerin was administered; (2) release of device tension; (3) a new device was changed and placed at a different location; and (4) the device was left in place and a stent was implanted in the coronary artery. Only 1 patient (5.8%) could not receive the device due to coronary compression. No periprocedural myocardial infarction occurred. CONCLUSION: Indirect mitral annuloplasty is feasible outside of controlled trials, and is associated with successful improvement of mitral regurgitation. Although coronary compromise needs to be addressed as part of the implantation procedure, this issue limits implantation of the device in only a small percentage of cases.