Philippe Pibarot1, Julien Ternacle2, Wael A Jaber3, Erwan Salaun2, Abdellaziz Dahou4, Federico M Asch5, Neil J Weissman5, Leonardo Rodriguez3, Ke Xu6, Mohamed-Salah Annabi2, Ezequiel Guzzetti2, Jonathan Beaudoin2, Mathieu Bernier2, Jonathon Leipsic7, Philipp Blanke7, Marie-Annick Clavel2, Erin Rogers6, Maria C Alu4, Pamela S Douglas8, Raj Makkar9, D Craig Miller10, Samir R Kapadia3, Michael J Mack11, John G Webb7, Susheel K Kodali4, Craig R Smith4, Howard C Herrmann12, Vinod H Thourani13, Martin B Leon4, Rebecca T Hahn4. 1. Institut Universitaire de Cardiologie et de Pneumologie de Québec/Québec Heart & Lung Institute, Laval University, Québec, Québec, Canada. Electronic address: Philippe.Pibarot@med.ulaval.ca. 2. Institut Universitaire de Cardiologie et de Pneumologie de Québec/Québec Heart & Lung Institute, Laval University, Québec, Québec, Canada. 3. Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio. 4. Columbia University Medical Center/New York-Presbyterian Hospital, New York, New York; Cardiovascular Research Foundation, New York, New York. 5. MedStar Health Research Institute at Washington Hospital Center, Washington, DC. 6. Edwards Lifesciences, Irvine, California. 7. St. Paul's Hospital, Vancouver, British Columbia, Canada. 8. Duke University Medical Center and Duke Clinical Research Institute, Durham, North Carolina. 9. Cedars-Sinai Heart Institute, Los Angeles, California. 10. Division of Cardiovascular Medicine, Department of Medicine, Stanford University School of Medicine, Stanford, California. 11. Baylor Scott & White Healthcare, Plano, Texas. 12. Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania. 13. Department of Cardiovascular Surgery, Piedmont Heart Institute, Atlanta, Georgia.
Abstract
BACKGROUND: It is unknown whether transcatheter valves will have similar durability as surgical bioprosthetic valves. Definitions of structural valve deterioration (SVD), based on valve related reintervention or death, underestimate the incidence of SVD. OBJECTIVES: This study sought to determine and compare the 5-year incidence of SVD, using new standardized definitions based on echocardiographic follow-up of valve function, in intermediate-risk patients with severe aortic stenosis giventranscatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) in the PARTNER (Placement of Aortic Transcatheter Valves) 2A trial and registry. METHODS: In the PARTNER 2A trial, patients were randomly assigned to receive either TAVR with the SAPIEN XT or SAVR, whereas in the SAPIEN 3 registry, patients were assigned to TAVR with the SAPIEN 3. The primary endpoint was the incidence of SVD, that is, the composite of SVD-related hemodynamic valve deterioration during echocardiographic follow-up and/or SVD-related bioprosthetic valve failure (BVF) at 5 years. RESULTS: Compared with SAVR, the SAPIEN-XT TAVR cohort had a significantly higher 5-year exposure adjusted incidence rates (per 100 patient-years) of SVD (1.61 ± 0.24% vs. 0.63 ± 0.16%), SVD-related BVF (0.58 ± 0.14% vs. 0.12 ± 0.07%), and all-cause (structural or nonstructural) BVF (0.81 ± 0.16% vs. 0.27 ± 0.10%) (p ≤ 0.01 for all). The 5-year rates of SVD (0.68 ± 0.18% vs. 0.60 ± 0.17%; p = 0.71), SVD-related BVF (0.29 ± 0.12% vs. 0.14 ± 0.08%; p = 0.25), and all-cause BVF (0.60 ± 0.15% vs. 0.32 ± 0.11%; p = 0.32) in SAPIEN 3 TAVR were not significantly different to a propensity score matched SAVR cohort. The 5-year rates of SVD and SVD-related BVF were significantly lower in SAPIEN 3 versus SAPIEN XT TAVR matched cohorts. CONCLUSIONS: Compared with SAVR, the second-generation SAPIEN XT balloon-expandable valve has a higher 5-year rate of SVD, whereas the third-generation SAPIEN 3 has a rate of SVD that was not different from SAVR. (The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves - PII A [PARTNERII A]; NCT01314313; The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - PARTNER II - PARTNERII - S3 Intermediate [PARTNERII S3i]; NCT03222128).
RCT Entities:
BACKGROUND: It is unknown whether transcatheter valves will have similar durability as surgical bioprosthetic valves. Definitions of structural valve deterioration (SVD), based on valve related reintervention or death, underestimate the incidence of SVD. OBJECTIVES: This study sought to determine and compare the 5-year incidence of SVD, using new standardized definitions based on echocardiographic follow-up of valve function, in intermediate-risk patients with severe aortic stenosis given transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) in the PARTNER (Placement of Aortic Transcatheter Valves) 2A trial and registry. METHODS: In the PARTNER 2A trial, patients were randomly assigned to receive either TAVR with the SAPIEN XT or SAVR, whereas in the SAPIEN 3 registry, patients were assigned to TAVR with the SAPIEN 3. The primary endpoint was the incidence of SVD, that is, the composite of SVD-related hemodynamic valve deterioration during echocardiographic follow-up and/or SVD-related bioprosthetic valve failure (BVF) at 5 years. RESULTS: Compared with SAVR, the SAPIEN-XT TAVR cohort had a significantly higher 5-year exposure adjusted incidence rates (per 100 patient-years) of SVD (1.61 ± 0.24% vs. 0.63 ± 0.16%), SVD-related BVF (0.58 ± 0.14% vs. 0.12 ± 0.07%), and all-cause (structural or nonstructural) BVF (0.81 ± 0.16% vs. 0.27 ± 0.10%) (p ≤ 0.01 for all). The 5-year rates of SVD (0.68 ± 0.18% vs. 0.60 ± 0.17%; p = 0.71), SVD-related BVF (0.29 ± 0.12% vs. 0.14 ± 0.08%; p = 0.25), and all-cause BVF (0.60 ± 0.15% vs. 0.32 ± 0.11%; p = 0.32) in SAPIEN 3 TAVR were not significantly different to a propensity score matched SAVR cohort. The 5-year rates of SVD and SVD-related BVF were significantly lower in SAPIEN 3 versus SAPIEN XT TAVR matched cohorts. CONCLUSIONS: Compared with SAVR, the second-generation SAPIEN XT balloon-expandable valve has a higher 5-year rate of SVD, whereas the third-generation SAPIEN 3 has a rate of SVD that was not different from SAVR. (The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves - PII A [PARTNERII A]; NCT01314313; The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - PARTNER II - PARTNERII - S3 Intermediate [PARTNERII S3i]; NCT03222128).
Authors: Hashrul N Rashid; Michael Michail; Abdul R Ihdayhid; Cameron Dowling; Nancy Khav; Sean Tan; Jaineel Ramnarain; James D Cameron; Arthur Nasis; Stephen J Nicholls; Robert P Gooley Journal: Heart Vessels Date: 2021-03-04 Impact factor: 2.037
Authors: Dritan Useini; Markus Schlömicher; Assem Aweimer; Peter Haldenwang; Justus Strauch; Polykarpos C Patsalis Journal: Gerontol Geriatr Med Date: 2022-01-19
Authors: Nicolas M Van Mieghem; Stephan Windecker; Ganesh Manoharan; Johan Bosmans; Sabine Bleiziffer; Thomas Modine; Axel Linke; Werner Scholtz; Didier Tchétché; Ariel Finkelstein; Saki Ito; Ruth Eisenberg; Eberhard Grube Journal: Catheter Cardiovasc Interv Date: 2021-07-31 Impact factor: 2.585