Transfemoral System for Mitral Valve Reconstruction – Up to 2 Years Multicentre Trial Results

Vahanian Alec ¹ Marina Urena Alcazar ¹ Karl-Heinz Kuck ⁴ Felix Kreidel ⁴ Christian Frerker ⁴ Stephan Baldus ⁵ Michael Huntgeburth ⁵ Volker Roudolph ⁵ Georg Nickenig ⁶ Cristoph Hammerstingl ⁶ Kaja Twelker ⁶ Paul Grayburn ² Giovanni La Canna ³ Antonio Colombo ³ Ottavio Alfieri ³ Eustachio Agricola ³ Azeem Latib ³ David Messika-Zeitoun ¹ Francesco Maisano ⁷ Felix Tanner ⁷ Yan Topilsky ⁸

¹Cardiology, Bichat Hospital, France
²Heart & Vascular, Baylor University Medical Center, USA
³Cardiovascular Surgery, San Raffaele Hospital, Italy
⁴Cardiology, St. George Hospital Hamburg, Germany
⁵Cardiology, University Hospital Köln, Germany
⁶Cardiology, University Hospital Bonn, Germany
⁷Cardiovascular Surgery, University Hospital Zurich
⁸Cardiology, The Tel Aviv Sourasky Medical center, Israel

Aims: Cardioband system enables percutaneous implantation of an adjustable “surgical-like” mitral annuloplasty ring using a transseptal approach. The aim of this multi-center study was to evaluate the feasibility, safety and up to 24 months outcomes of Cardioband in patients with secondary mitral regurgitation (MR).

Methods and Results:

Between February 2013 and November 2015, 50 high-risk patients with significant secondary MR were enrolled at 7 European sites. All patients were screened by a heart team and using echocardiography and cardiac CT.

Mean age was 71±8 years, 39 were males (78%). Mean EuroScore II was 7.5%. At baseline 84% of patients were NYHA class III-IV with mean left ventricular ejection fraction 33±11%. Device implantation was feasible in 100% patients. At discharge 88% of patients had MR ≤2+. After device cinching, an average ~30% reduction of the septo-lateral diameter was observed (from 37±4mm to 26±4mm; p<0.01). Thirty-day mortality was 4% (adjudicated as unrelated to the device).

At 24 months follow up (N=10) 90% of patients had MR≤2+ and 73% presented NYHA class I-II. A significant improvement was reported in quality of life (MLWHFQ) from 38 to 21 (p<0.05) and exercise tolerance 6MWT improved from 323 to 348 meters (p=0.61).

Conclusions: Transseptal mitral repair with the Cardioband device resulted in MR reduction by reconstruction of the mitral annulus. Safety profile is comparable to other transcatheter mitral procedures. MR severity reduction and clinical benefit are stable up to 24 months.