Rebecca T Hahn1, John Webb2, Philippe Pibarot3, Julien Ternacle4, Howard C Herrmann5, Rakesh M Suri6, Danny Dvir7, Jonathon Leipsic2, Philipp Blanke2, Wael A Jaber6, Susheel Kodali8, Samir Kapadia6, Raj Makkar9, Vinod Thourani10, Mathew Williams11, Erwan Salaun3, Flavien Vincent12, Ke Xu13, Martin B Leon14, Michael Mack15. 1. Columbia University Medical Center/New York-Presbyterian Hospital, New York, New York, USA. Electronic address: rth2@columbia.edu. 2. University of British Columbia and St. Paul's Hospital, Vancouver, Canada. 3. Institut Universitaire de Cardiologie et de Pneumologie de Québec/Québec Heart and Lung Institute, Department of Medicine, Laval University, Québec, Canada. 4. Institut Universitaire de Cardiologie et de Pneumologie de Québec/Québec Heart and Lung Institute, Department of Medicine, Laval University, Québec, Canada; Heart Valve Unit, Haut-Leveque Cardiologic Hospital, Bordeaux University, Pessac, France. 5. Cardiovascular Division, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, USA. 6. Cleveland Clinic, Cleveland, Ohio, USA. 7. Jesselson Integrated Heart Center, Shaare Zedek Medical Centre, Hebrew University, Jerusalem, Israel. 8. Columbia University Medical Center/New York-Presbyterian Hospital, New York, New York, USA. 9. Smidt Heart Institute, Cedars Sinai Medical Center, Los Angeles, California, USA. 10. Department of Cardiothoracic Surgery, Piedmont Heart Institute, Atlanta, Georgia, USA. 11. Department of Cardiothoracic Surgery, Piedmont Heart Institute, Atlanta, Georgia, USA; NYU Langone Medical Center, New York, New York, USA. 12. Clinical Trials Center, Cardiovascular Research Foundation, New York, New York, USA; Department of Cardiology, Institut Pasteur de Lille, CHU Lille, Lille, France. 13. Edwards Lifesciences, Irvine, California, USA. 14. Columbia University Medical Center/New York-Presbyterian Hospital, New York, New York, USA; Clinical Trials Center, Cardiovascular Research Foundation, New York, New York, USA. 15. Baylor Scott & White Health, Dallas, Texas, USA.
Abstract
OBJECTIVES: The aim of this study was to report the outcomes of valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) at 5 years. BACKGROUND: TAVR for degenerated surgical bioprostheses in patients at high risk for reoperative surgery is an important treatment option that may delay or obviate the need for surgical intervention; however, long-term outcomes of this procedure are unknown. METHODS: The PARTNER (Placement of Aortic Transcatheter Valves) 2 ViV and continued access registries prospectively enrolled patients with failed surgical bioprostheses at high risk for reoperation. Five-year clinical and echocardiographic follow-up data were obtained in 95.9% of patients. RESULTS: In 365 (96 registry and 269 continued access) patients, the mean age was 78.9 ± 10.2 years, the mean Society of Thoracic Surgeons predicted risk of surgical mortality score was 9.1 ± 4.7%, and New York Heart Association functional class was III or IV in 90.4%. At 5 years, the Kaplan-Meier rates of all-cause mortality and any stroke were 50.6% and 10.5%, respectively. Using Valve Academic Research Consortium 3 definitions, the incidence of structural valve deterioration, related hemodynamic valve deterioration, or bioprosthetic valve failure at 5 years was 6.6%. Aortic valve re-replacement was performed in 6.3% (n = 14), the majority of which was due to stenosis (n = 6) and combined aortic insufficiency/paravalvular regurgitation (n = 3). The mean gradient, Doppler velocity index, paravalvular regurgitation, and quality of life measured by Kansas City Cardiomyopathy Questionnaire scores in survivors remained stable from 30 days postprocedure through 5 years. CONCLUSIONS: At the 5-year follow-up, TAVR for bioprosthetic aortic valve failure in high surgical risk patients was associated with sustained improvement in clinical and echocardiographic outcomes.
OBJECTIVES: The aim of this study was to report the outcomes of valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) at 5 years. BACKGROUND: TAVR for degenerated surgical bioprostheses in patients at high risk for reoperative surgery is an important treatment option that may delay or obviate the need for surgical intervention; however, long-term outcomes of this procedure are unknown. METHODS: The PARTNER (Placement of Aortic Transcatheter Valves) 2 ViV and continued access registries prospectively enrolled patients with failed surgical bioprostheses at high risk for reoperation. Five-year clinical and echocardiographic follow-up data were obtained in 95.9% of patients. RESULTS: In 365 (96 registry and 269 continued access) patients, the mean age was 78.9 ± 10.2 years, the mean Society of Thoracic Surgeons predicted risk of surgical mortality score was 9.1 ± 4.7%, and New York Heart Association functional class was III or IV in 90.4%. At 5 years, the Kaplan-Meier rates of all-cause mortality and any stroke were 50.6% and 10.5%, respectively. Using Valve Academic Research Consortium 3 definitions, the incidence of structural valve deterioration, related hemodynamic valve deterioration, or bioprosthetic valve failure at 5 years was 6.6%. Aortic valve re-replacement was performed in 6.3% (n = 14), the majority of which was due to stenosis (n = 6) and combined aortic insufficiency/paravalvular regurgitation (n = 3). The mean gradient, Doppler velocity index, paravalvular regurgitation, and quality of life measured by Kansas City Cardiomyopathy Questionnaire scores in survivors remained stable from 30 days postprocedure through 5 years. CONCLUSIONS: At the 5-year follow-up, TAVR for bioprosthetic aortic valve failure in high surgical risk patients was associated with sustained improvement in clinical and echocardiographic outcomes.