Abstract 3052: Initial Human Experiences with a Non-Stented Coronary Sinus Device for the Treatment of Functional Mitral Regurgitation in Heart Failure Patients

Abstract

Recently, several approaches have been developed for percutaneous mitral valve repair. The percutaneous transvenous mitral annuloplasty system (PTMA TM , Viacor Inc., Wilmington, USA) is an indirect annuloplasty device deployed within the coronary sinus (CS). Its mechanism is based on reduction of the anterior-posterior diameter of the mitral annulus to decrease mitral regurgitation (MR) by reestablishing leaflet coaptation in functional MR. We report the ongoing first-in-human experience with this non-stented device. 27 heart failure patients (NYHA II–IV) with functional MR II–III were enrolled at 5 centers. Via subclavian access, a multi-lumen diagnostic catheter was positioned within the anterior interventricular vein of the CS. Nitinol rods of various length and stiffness patterns were subsequently introduced into the lumina in order to exert pressure to the posterior mitral leaflet and to reduce AP diameter. Under fluoroscopic and echo guidance, different rod combinations were evaluated for maximal effectiveness before exchanging the diagnostic system to the permanent device. After assuring significant MR reduction by the permanent implant, the whole device was implanted in a subcutaneous pocket. 8 patients were excluded prior procedure due to unfavorable CS anatomy. The remaining 19 patients proceeded through a complete diagnostic exam. While the device was ineffective in 6 cases, echocardiography revealed a significant reduction of MR in 13 patients. 9 of these patients underwent successful implantation of the permanent device. 4 devices were subsequently removed, one at 7 days due to device fracture and the other 3 when the patients were referred for annuloplasty surgery due to device migration or diminished efficacy. Sustained reduction in MR and AP dimensions was noted in the remaining 4 long-term implants. No procedure related adverse events with permanent sequelae were observed in all patients. Initial human experiences with the PTMA TM device demonstrate safety and feasibility of this method as well as sustained favorable geometric modifications of the mitral annulus with reduction of MR in responding patients.