Transcatheter Aortic Valve Implantation in Failed Bioprosthetic Surgical Valves

Dvir, Danny ; Webb, John G. ; Bleiziffer, Sabine ; Pasic, Miralem ; Waksman, Ron ; Kodali, Susheel ; Barbanti, Marco

; Latib, Azeem

; Schaefer, Ulrich ; Rodés-Cabau, Josep ; Treede, Hendrik ; Piazza, Nicolo ; Hildick-Smith, David ; Himbert, Dominique ; Walther, Thomas ; Hengstenberg, Christian ; Nissen, Henrik ; Bekeredjian, Raffi ; Presbitero, Patrizia ; Ferrari, Enrico ; Segev, Amit ; de Weger, Arend ; Windecker, Stephan ; Moat, Neil E. ; Napodano, Massimo ; Wilbring, Manuel ; Cerillo, Alfredo G.

; Brecker, Stephen ; Tchetche, Didier ; Lefèvre, Thierry ; De Marco, Federico ; Fiorina, Claudia ; Petronio, Anna Sonia ; Teles, Rui C. ; Testa, Luca ; Laborde, Jean-Claude ; Leon, Martin B. ; Kornowski, Ran

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IMPORTANCE Owing to a considerable shift toward bioprosthesis implantation rather than mechanical valves, it is expected that patients will increasingly present with degenerated bioprostheses in the next few years. Transcatheter aortic valve-in-valve implantation is a less invasive approach for patients with structural valve deterioration; however, a comprehensive evaluation of survival after the procedure has not yet been performed. OBJECTIVE To determine the survival of patients after transcatheter valve-in-valve implantation inside failed surgical bioprosthetic valves. DESIGN, SETTING, AND PARTICIPANTS Correlates for survivalwere evaluated using a multinational valve-in-valve registry that included 459 patients with degenerated bioprosthetic valves undergoing valve-in-valve implantation between 2007 and May 2013 in 55 centers (mean age, 77.6 [SD, 9.8] years; 56% men; median Society of Thoracic Surgeons mortality prediction score, 9.8%[interquartile range, 7.7%-16%]). Surgical valves were classified as small (<= 21 mm; 29.7%), intermediate (> 21 and < 25 mm; 39.3%), and large (<= 25 mm; 31%). Implanted devices included both balloon-and self-expandable valves. MAIN OUTCOMES AND MEASURES Survival, stroke, and New York Heart Association functional class. RESULTS Modes of bioprosthesis failure were stenosis (n = 181 [39.4%]), regurgitation (n = 139 [30.3%]), and combined (n = 139 [30.3%]). The stenosis group had a higher percentage of small valves (37% vs 20.9% and 26.6% in the regurgitation and combined groups, respectively; P =.005). Within 1 month following valve-in-valve implantation, 35 (7.6%) patients died, 8 (1.7%) had major stroke, and 313 (92.6%) of surviving patients had good functional status (New York Heart Association class I/II). The overall 1-year Kaplan-Meier survival rate was 83.2%(95% CI, 80.8%-84.7%; 62 death events; 228 survivors). Patients in the stenosis group had worse 1-year survival (76.6%; 95% CI, 68.9%-83.1%; 34 deaths; 86 survivors) in comparison with the regurgitation group (91.2%; 95% CI, 85.7%-96.7%; 10 deaths; 76 survivors) and the combined group (83.9%; 95% CI, 76.8%-91%; 18 deaths; 66 survivors) (P =.01). Similarly, patients with small valves had worse 1-year survival (74.8%[95% CI, 66.2%-83.4%]; 27 deaths; 57 survivors) vs with intermediate-sized valves (81.8%; 95% CI, 75.3%-88.3%; 26 deaths; 92 survivors) and with large valves (93.3%; 95% CI, 85.7%-96.7%; 7 deaths; 73 survivors) (P =.001). Factors associated with mortality within 1 year included having small surgical bioprosthesis (<= 21 mm; hazard ratio, 2.04; 95% CI, 1.14-3.67; P =.02) and baseline stenosis (vs regurgitation; hazard ratio, 3.07; 95% CI, 1.33-7.08; P =.008). CONCLUSIONS AND RELEVANCE In this registry of patients who underwent transcatheter valve-in-valve implantation for degenerated bioprosthetic aortic valves, overall 1-year survival was 83.2%. Survival was lower among patients with small bioprostheses and those with predominant surgical valve stenosis.

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