Transcatheter Aortic Valve Replacement for Degenerative Bioprosthetic Surgical Valves

Results From the Global Valve-in-Valve Registry

Danny Dvir, MD; John Webb, MD; Stephen Brecker, MD; Sabine Bleiziffer, MD; David Hildick-Smith, MD; Antonio Colombo, MD; Fleur Descoutures, MD; Christian Hengstenberg, MD; Neil E. Moat, FRCS; Raffi Bekeredjian, MD; Massimo Napodano, MD; Luca Testa, MD, PhD;
Thierry Lefevre, MD; Victor Guetta, MD; Henrik Nissen, MD, PhD; José-María Hernández, MD; David Roy, MD; Rui C. Teles, MD; Amit Segev, MD; Nicolas Dumonteil, MD; Claudia Fiorina, MD; Michael Gotzmann, MD; Didier Tchetche, MD; Mohamed Abdel-Wahab, MD; Federico De Marco, MD; Andreas Baumbach, MD; Jean-Claude Laborde, MD; Ran Kornowski, MD

Circulation. 2012; 126: 2335-2344

Abstract
Background—Transcatheter aortic valve-in-valve implantation is an emerging therapeutic alternative for patients with a failed surgical bioprosthesis and may obviate the need for reoperation. We evaluated the clinical results of this technique using a large, worldwide registry.

Methods and Results—The Global Valve-in-Valve Registry included 202 patients with degenerated bioprosthetic valves (aged 77.7±10.4 years; 52.5% men) from 38 cardiac centers. Bioprosthesis mode of failure was stenosis (n=85; 42%), regurgitation (n=68; 34%), or combined stenosis and regurgitation (n=49; 24%). Implanted devices included CoreValve (n=124) and Edwards SAPIEN (n=78). Procedural success was achieved in 93.1% of cases. Adverse procedural outcomes included initial device malposition in 15.3% of cases and ostial coronary obstruction in 3.5%. After the procedure, valve maximum/mean gradients were 28.4±14.1/15.9±8.6 mm Hg, and 95% of patients had ≤+1 degree of aortic regurgitation. At 30-day follow-up, all-cause mortality was 8.4%, and 84.1% of patients were at New York Heart Association functional class I/II. One-year follow-up was obtained in 87 patients, with 85.8% survival of treated patients.

Conclusions—The valve-in-valve procedure is clinically effective in the vast majority of patients with degenerated bioprosthetic valves. Safety and efficacy concerns include device malposition, ostial coronary obstruction, and high gradients after the procedure.