Author + information
- Karl-Heinz Kuck,
- Antonio Colombo,
- Ottavio Alfieri,
- Alec Vahanian,
- Stephan Baldus,
- Georg Nickenig,
- Francesco Maisano,
- Ralph Stephan Von Bardeleben,
- Jan van der Heyden,
- Joerg Hausleiter,
- Arthur Kerner and
- Corrado Tamburino
Background: The Cardioband system enables percutaneous implantation of an adjustable “surgical-like” mitral annuloplasty ring using a transseptal approach. The aim of this multicenter study was to evaluate feasibility, safety and outcomes up to 24 months of Cardioband implantation in patients with secondary mitral regurgitation (MR).
Methods: Between February 2013 and June 2016, 59 high-risk patients with significant secondary MR were enrolled at 11 European sites. All patients were screened by a heart team using echocardiography and cardiac CT.
Results: Mean patient age was 72 ± 8 years; 43 (73%) were men. Mean EuroSCORE II was 7.2%. At baseline, 51 patients (86%) were in NYHA functional class III-IV, with a mean left ventricular ejection fraction of 33 ± 11%. Device implantation was achieved in all patients. At discharge, 50 patients (85%) had MR ≤2+. After device cinching, an average 30% reduction in septolateral diameter was observed (from 37 ± 4 mm to 26 ± 4 mm; p<0.01). Thirty-day mortality was 3.4% (2 patients; death adjudicated as unrelated to the device). At the 24-month follow-up, 11 (92%) of 12 patients had MR ≤2+ and 9 (77%) presented in NYHA functional class I/II. A significant improvement was observed in the mean quality of life score (Minnesota Living with Heart Failure Questionnaire) from 38 to 22 (p<0.01); mean six-minute walk distance changed from 325 to 333 m (p=0.86).
Conclusions: Transseptal mitral valve repair with the Cardioband device resulted in MR reduction by reconstruction of the mitral annulus. Thirty-day mortality is comparable to other transcatheter mitral valve procedures. MR severity reduction and clinical benefit remain stable up to 24 months.
Moderated Poster Contributions
Interventional Cardiology Moderated Poster Theater, Poster Hall, Hall C
Sunday, March 19, 2017, 1:00 p.m.-1:10 p.m.
Session Title: Frontiers in Mitral Valve Disease and Treatment
Abstract Category: 24. Interventional Cardiology: Mitral and Structural Heart Disease
Presentation Number: 1316M-07
- 2017 American College of Cardiology Foundation