Danny Dvir1, John G Webb1, Sabine Bleiziffer2, Miralem Pasic3, Ron Waksman4, Susheel Kodali5, Marco Barbanti1, Azeem Latib6, Ulrich Schaefer7, Josep Rodés-Cabau8, Hendrik Treede9, Nicolo Piazza10, David Hildick-Smith11, Dominique Himbert12, Thomas Walther13, Christian Hengstenberg14, Henrik Nissen15, Raffi Bekeredjian16, Patrizia Presbitero17, Enrico Ferrari18, Amit Segev19, Arend de Weger20, Stephan Windecker21, Neil E Moat22, Massimo Napodano23, Manuel Wilbring24, Alfredo G Cerillo25, Stephen Brecker26, Didier Tchetche27, Thierry Lefèvre28, Federico De Marco29, Claudia Fiorina30, Anna Sonia Petronio31, Rui C Teles32, Luca Testa33, Jean-Claude Laborde26, Martin B Leon5, Ran Kornowski34. 1. St Paul's Hospital, Vancouver, British Columbia, Canada. 2. German Heart Center, Munich, Germany. 3. Deutsches Herzzentrum Berlin, Berlin, Germany. 4. Washington Hospital Center, Washington, DC. 5. Columbia University Medical Center/New York Presbyterian Hospital and the Cardiovascular Research Foundation, New York, New York. 6. San Raffaele Scientific Institute, Milan, Italy. 7. Asklepios Clinics St Georg, Hamburg, Germany. 8. Quebec Heart and Lung Institute, Quebec City, Quebec, Canada. 9. University Heart Center Hamburg, Hamburg, Germany. 10. Department of Interventional Cardiology at McGill University Health Centre, Montreal, Quebec, Canada. 11. Sussex Cardiac Centre, Brighton, England. 12. Hospital Bichat, Paris, France. 13. Kerckhoff Heart Center, Bad Nauheim, Germany. 14. Universitaetsklinikum Regensburg, Regensburg, Germany. 15. Odense University Hospital, Odense, Denmark. 16. University of Heidelberg, Heidelberg, Germany. 17. Hemodynamic and Invasive Cardiology Unit, IRCCS Istituto Clinico Humanitas, Milan, Italy. 18. University Hospital of Lausanne, Lausanne, Switzerland. 19. Sheba Medical Center, Ramat Gan, Israel. 20. Leids Universitair Medisch Centrum, Leiden, the Netherlands. 21. Bern University Hospital, Bern, Switzerland. 22. Royal Brompton Hospital, London, England. 23. Department of Cardiac, Thoracic, and Vascular Sciences, University of Padua, Padua, Italy. 24. University Heart Center Dresden, Dresden, Germany. 25. G. Pasquinucci Hospital, Massa, Italy. 26. St George's Hospital, London, England. 27. Clinique Pasteur, Toulouse, France. 28. Hopital Jacques Cartier, Massy, France. 29. Ospedale Niguarda Ca'Granda, Milan, Italy. 30. Azienda Ospedaliere Spedali Civili di Brescia, Brescia, Italy. 31. Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy. 32. Hospital de Santa Cruz, Lisbon, Portugal. 33. Clinical Institute S. Ambrogio, Milan, Italy. 34. Rabin Medical Center and Tel Aviv University, Tel Aviv, Israel.
Abstract
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 survival were 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.
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 survival were 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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