Aims: The aim of this multicenter study was to evaluate the feasibility, safety and outcomes up to 12 months of the Edwards Cardioband transcatheter mitral valve repair system in the treatment of patients with secondary mitral regurgitation (MR). Methods and Results: Between February 2013 and June 2016, 61 patients at high risk for surgery with significant secondary MR were enrolled at 11 European sites. All patients were screened by a heart team using echocardiography and cardiac CT. Mean patient age was 72 ± 7 years, 44 were males (72%). Mean EuroSCORE II was 7.1%. At baseline, 53 patients (87%) were in NYHA functional class III-IV, with a mean left ventricular ejection fraction of 33 ± 11%. The implant success rate was 98% and the device success rate 80%. After implant size adjustment, an average 28% reduction in septolateral mitral annular diameter was observed (from 37 ± 4 mm to 26 ± 4 mm; P < .01). At one month follow-up, two patients died from non-device related causes. 87% of patients had MR ≤ 2 + as assessed by independent core lab. One year follow-up is available for 38 patients and shows that 79% of patients are in NYHA class I/II, with an average 21 points improvement in Minnesota Living with Heart Failure Questionnaire scores and an average increase of 63 meters in 6-minute walk distance. MR ≤ 2 + was demonstrated in 94% of patients at one year. Conclusions: These results show that transcatheter mitral valve repair using the Edwards Cardioband system is feasible and safe and provides a clinically significant reduction in MR grade. The favorable acute clinical and hemodynamic results are maintained up to one year. In addition this new treatment leaves options open for future interventions for patients with functional mitral regurgitation.
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