Author + information
- Karl-Heinz Kuck,
- Francesco Maisano,
- Ottavio Alfieri,
- Antonio Colombo,
- Stephan Baldus,
- Alec Vahanian and
- Georg Nickenig
The Cardioband mitral valve reconstruction system enables percutaneous implantation of an adjustable “surgical-like” device for mitral remodelling and MR reduction using a transseptal approach. The aim of this multicenter study was to evaluate the feasibility, safety and up to 12 months outcome of Cardioband implantation in patients with secondary mitral regurgitation (MR).
Between February 2013 and August 2015, 45 high-risk patients with significant secondary MR were enrolled at 6 European sites. All patients were screened by echocardiography and cardiac CT to assess feasibility.
Mean patient age was 71 (range 49-81) years; 34 patients were males (76%). Mean EuroSCORE II was 7.7% ± 6.7%, median STS score 7.2 % (1.0%-34.0%). At baseline, 87% of patients were in NYHA functional class III-IV with a mean left ventricular ejection fraction of 32 ± 11% (range 15%-59%). Device implantation was feasible in all patients. Procedural success (device successfully implanted with MR ≤2+ at discharge) was achieved in 95.6% of patients (43/45). After device cinching, an average ~20% reduction in septolateral diameter was observed (from 39 ± 6 mm to 34 ± 7 mm; p<0.01). Thirty-day mortality was 4.4% (adjudicated as unrelated to the device). At 12-month follow-up (n=20), 71% of patients presented in NYHA class I-II, with improvement in quality of life (Minnesota Living with Heart Failure questionnaire score from 38 to 19; p<0.05) and significant improvement in 6-minute walk distance (from 256 to 386 meters; p<0.05); 95% of patients (n=19) had MR ≤2+.
Transseptal mitral repair with the Cardioband device resulted in MR reduction by reconstruction of the mitral valve. Safety profile is similar and comparable to other transcatheter mitral valve procedures. MR severity reduction is stable and consistent up to 12 months, with clinical benefit.
Sunday, April 03, 2016, 8:15 a.m.-8:27 a.m.
Session Title: Highlighted Original Research: ACC.i2 Interventional Cardiology and the Year in Review
Abstract Category: 10. ACC.i2 Interventional Cardiology: Mitral and Structural Heart Disease
Presentation Number: 901-04
- 2016 American College of Cardiology Foundation