Cardioband, a transcatheter surgical-like direct mitral valve annuloplasty system: early results of the feasibility trial

The study was a single-arm, multicentre, prospective study enrolling 31 high-risk adult individuals with symptomatic mitral regurgitation despite optimal medical therapy from five institutions in Europe.  The primary efficacy endpoints included: (a) Technical success rate of the device implantation; (b) Technical feasibility of Cardioband adjustment; and (c) Cardioband ability to reduce the annular septolateral dimension and MR.  The technical success rate of implantation was 93.6%. Cardioband adjustment was successful in 29 of 31 subjects.  At 30 days, 22 of 25 patients had MR ≤2+. Procedural mortality was zero and in-hospital mortality was 6.5%.  The authors conclude that the initial experience with the Cardioband system shows that transfemoral implantation of a surgical-like direct annuloplasty device is feasible, safe, and effective.