Author + information
- Received July 20, 2020
- Revision received August 20, 2020
- Accepted August 21, 2020
- Published online October 12, 2020.
- Philippe Pibarot, DVM, PhDa,∗ (, )@ppibarot,
- Julien Ternacle, MD, PhDa,
- Wael A. Jaber, MDb,
- Erwan Salaun, MD, PhDa,
- Abdellaziz Dahou, MD, PhDc,d,
- Federico M. Asch, MDe,
- Neil J. Weissman, MDe,
- Leonardo Rodriguez, MDb,
- Ke Xu, PhDf,
- Mohamed-Salah Annabi, MD, MSa,
- Ezequiel Guzzetti, MDa,
- Jonathan Beaudoin, MDa,
- Mathieu Bernier, MDa,
- Jonathon Leipsic, MDg,
- Philipp Blanke, MDg,
- Marie-Annick Clavel, DVM, PhDa,
- Erin Rogers, MEngf,
- Maria C. Alu, MSc,d,
- Pamela S. Douglas, MDh,
- Raj Makkar, MDi,
- D. Craig Miller, MDj,
- Samir R. Kapadia, MDb,
- Michael J. Mack, MDk,
- John G. Webb, MDg,
- Susheel K. Kodali, MDc,d,
- Craig R. Smith, MDc,d,
- Howard C. Herrmann, MDl,
- Vinod H. Thourani, MDm,
- Martin B. Leon, MDc,d,
- Rebecca T. Hahn, MDc,d,
- for the PARTNER 2 Investigators
- aInstitut Universitaire de Cardiologie et de Pneumologie de Québec/Québec Heart & Lung Institute, Laval University, Québec, Québec, Canada
- bHeart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio
- cColumbia University Medical Center/New York-Presbyterian Hospital, New York, New York
- dCardiovascular Research Foundation, New York, New York
- eMedStar Health Research Institute at Washington Hospital Center, Washington, DC
- fEdwards Lifesciences, Irvine, California
- gSt. Paul's Hospital, Vancouver, British Columbia, Canada
- hDuke University Medical Center and Duke Clinical Research Institute, Durham, North Carolina
- iCedars–Sinai Heart Institute, Los Angeles, California
- jDivision of Cardiovascular Medicine, Department of Medicine, Stanford University School of Medicine, Stanford, California
- kBaylor Scott & White Healthcare, Plano, Texas
- lPerelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania
- mDepartment of Cardiovascular Surgery, Piedmont Heart Institute, Atlanta, Georgia
- ↵∗Address for correspondence:
Dr. Philippe Pibarot, Institut Universitaire de Cardiologie et de Pneumologie de Québec, 2725 Chemin Sainte-Foy #A2075, Québec, Québec G1V 4G5, Canada.
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)
- aortic stenosis
- bioprosthetic valve
- structural valve deterioration
- transcatheter aortic valve replacement
Edwards Lifesciences sponsored the PARTNER 2A trial and SAPIEN 3 study and, alongside the executive committee, collaboratively designed both studies. Edwards Lifesciences funded both studies, participated in the selection and management of sites, and monitored the data. Edwards Lifesciences was not directly involved in the drafting of this manuscript. Dr. Pibarot has received research grants from Edwards Lifesciences and Medtronic for echocardiography core laboratory services, for which he receives no direct industry compensation; and has been supported by a Canada Research Chair and Foundation grant (FDN-143225) from the Canadian Institutes of Health Research. Dr. Jaber has echocardiographic core laboratory contracts from Edwards Lifesciences, for which he receives no direct compensation. Drs. Asch and Weissman have core laboratory contracts with Abbott, Neovasc, Ancora, Medtronic, Boston Scientific, Edwards, Biotronik, and Livanova, for which they receive no direct compensation. Dr. Leipsic has received research grants from Edwards Lifesciences and Medtronic for CT core laboratory analyses in transcatheter aortic valve replacement; and has served as a consultant for Circle CVI. Dr. Blanke has served as a consultant to Edwards Lifesciences, Tendyne, Neovasc, and Circle Cardiovascular Imaging. Drs. Leipsic and Blanke have provided cardiac CT core laboratory services for Edwards Lifesciences, Tendyne, Medtronic, and Abbott for which they do not receive any direct compensation. Dr. Makkar has received grants from Edwards Lifesciences and Abbott; and has served as a consultant for Cordis and Medtronic. Dr. Kapadia has received a research grant to his institution from Edwards Lifesciences (no direct physician compensation). Dr. Clavel has received a core laboratory contract with Edwards Lifesciences without direct compensation; and has received a research grant from Medtronic. Drs. Xu and Rogers are employees of Edwards Lifesciences. Dr. Alu has received institutional research support (no direct compensation) from Abbott and Edwards Lifesciences. Dr. Mack has received institutional research support (no direct physician compensation) from Edwards Lifesciences. Dr. Webb has served as a proctor and consultant for Edwards Lifesciences. Dr. Kodali has received institutional research grants from Edwards Lifesciences, Medtronic, and Abbott; has received consulting fees from Abbott, Admedus, and Meril Lifesciences; and has equity options from Biotrace Medical and Thubrikar Aortic Valve Inc. Drs. Kodali and Thourani are the National Co-PIs of the PARTNER 2 SAPIEN registry (no compensation). Drs. Smith and Leon are the National Co-PIs of the PARTNER 2A Trial (no compensation). Dr. Herrmann has received institutional grant support from Abbott Vascular and Edwards Lifesciences. Dr. Thourani has performed research and served as a consultant for Abbott Vascular, Allergen, Boston Scientific, Cryolife, Edwards Lifesciences, Gore Vascular, and Jenavalve. Dr. Leon has received institutional research support from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott; and has served as a consultant and/or on the Advisory Board for Medtronic, Boston Scientific, Gore, Meril Lifescience, and Abbott. Dr. Hahn has served as a speaker for Abbott Vascular, Boston Scientific, Bayliss, Edwards Lifesciences, Philips Healthcare, and Siemens Healthineers; has served as a consultant and/or on the Advisory Board for 3Mensio, Abbott Structural, Edwards Lifescience, Gore & Associates, Medtronic, Navigate, Philips Healthcare, and Siemens Healthineers; and has served as Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored trials, for which she receives no direct industry compensation. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Charles D. Resor, MD, MSc, served as Guest Associate Editor for this paper. Deepak L. Bhatt, MD, MPH, served as Guest Editor-in-Chief for this paper.
The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC author instructions page.
- Received July 20, 2020.
- Revision received August 20, 2020.
- Accepted August 21, 2020.
- 2020 American College of Cardiology Foundation
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