Safety and feasibility of a novel adjustable mitral annuloplasty ring: a multicentre European experience(†)

OBJECTIVES: Recurrent mitral regurgitation is a significant problem after mitral valve repair in patients with functional valve disease. We report the safety and feasibility of a novel adjustable mitral annuloplasty device that permits downsizing of the anterior–posterior diameter late after initial surgery. METHODS: In this multicentre, non-randomized, observational register, patients with moderate or severe mitral regurgitation undergoing surgical mitral valve repair with the MiCardia EnCor(SQ)™ Mitral Valve Repair system were evaluated. Patient characteristics, operative specifications and results as well as postoperative follow-up were collected for all five centres. RESULTS: Ninety-four patients with a median age of 71 (64–75) years (EuroSCORE II 6.7 ± 6.3; 66% male, 48% ischaemic MR, 37% dilated cardiomyopathy and 15% degenerative disease) were included. Operative mortality was 1% and the 1-year survival was 93%. Ring adjustment was attempted in 12 patients at a mean interval of 9 ± 6 months after surgery. In three of these attempts, a technical failure occurred. In 1 patient, mitral regurgitation was reduced two grades, in 2 patients mitral regurgitation was reduced one grade and in 6 patients, mitral regurgitation did not change significantly. The mean grade of mitral regurgitation changed from 2.9 ± 0.9 to 2.1 ± 0.7 (P = 0.02). Five patients were reoperated after 11 ± 9 months (Ring dehiscence: 2; failed adjustment: 3). CONCLUSION: We conclude that this device may provide an additional treatment option in patients with functional mitral regurgitation, who are at risk for reoperation due to recurrent mitral regurgitation. Clinical results in this complex disease were ambiguous and patient selection seems to be a crucial step for this device. Further trials are required to estimate the clinical value of this therapeutic concept.