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

Thursday, December 10, 2015

Submitted by

J. Rafael Sadaba

Source

Source Name: European Heart Journal

Source URL: http://www.ncbi.nlm.nih.gov/pubmed/26586779

Author(s)

Maisano F, Taramasso M, Nickenig G, Hammerstingl C, Vahanian A, Messika-Zeitoun D, Baldus S, Huntgeburth M, Alfieri O, Colombo A, La Canna G, Agricola E, Zuber M, Tanner FC, Topilsky Y, Kreidel F, Kuck KH.

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.