Abstract 17839: Transcatheter Annuloplasty Ring Multicentre Trial Report
Aim: Cardioband system enables percutaneous implantation of an adjustable “surgical-like” mitral annuloplasty ring using a transseptal approach. The aim of this study was to evaluate the feasibility, safety and up to 12 month outcome of Cardioband in patients with functional mitral regurgitation (FMR) in a multicentre study.
Methods and Results: Between February 2013 and March 2015, 40 high-risk patients with significant FMR were enrolled at 6 sites in Europe. After a Heart Team evaluation all patients were screened by echocardiography and cardiac CT to assess feasibility. Echocardiographic data were analysed by an independent core-lab.
Mean age was 72±7 years, thirty patients were males (75%). Mean EuroScore II 9.0%±7.02% and median STS score 7.2 % (1.0%-34.0%). At baseline 93% of patients were in NYHA class III-IV with mean EF of 33.3±10% (15%-57%). Device implantation was feasible in all patients (100%). Acute procedural success (device successfully implanted with acute reduction of MR <2+) was achieved in 92% of the patients (37/40. After cinching of the device, an average of 20% reduction of the septo-lateral diameter was observed (from 37±5 mm to 29±5 mm; p<0.01). Thirty-day mortality was 5.0% (adjudicated unrelated to the device). At 6 months follow up (n=20) 80% of patients were in NYHA class I-II with significant improvement in quality of life (MLWHFQ from 38 to 18; p<0.05) and 85% of patients had MR≤2+. At 12 months follow up (n=14), 93% of patients had MR<2+).
Conclusions: Transseptal direct annuloplasty with an adjustable “surgical-like” ring is feasible, with a comparable safety profile similar to other transcatheter mitral procedures. Effective reduction in MR severity is observed in most patients related to a significant septo-lateral dimension reduction. MR reduction is stable and consistent up to 12 months, with clinical benefit.
Author Disclosures: K. Kuck: Honoraria; Modest; Valtech. A. Vahanian: Honoraria; Significant; Valtech. G. Nickenig: Honoraria; Modest; Valtech. O. Alfieri: Honoraria; Significant; Valtech. A. Colombo: Honoraria; Modest; Valtech. S. Baldus: Honoraria; Modest; Valtech. F. Maisano: Honoraria; Significant; Valtech.
- © 2015 by American Heart Association, Inc.