5-Year Outcomes Comparing Surgical Versus Transcatheter Aortic Valve Replacement in Patients With Chronic Kidney Disease.


Journal

JACC. Cardiovascular interventions
ISSN: 1876-7605
Titre abrégé: JACC Cardiovasc Interv
Pays: United States
ID NLM: 101467004

Informations de publication

Date de publication:
27 09 2021
Historique:
received: 06 04 2021
revised: 14 06 2021
accepted: 06 07 2021
entrez: 24 9 2021
pubmed: 25 9 2021
medline: 3 11 2021
Statut: ppublish

Résumé

The aim of this study was to compare 5-year cardiovascular, renal, and bioprosthetic valve durability outcomes in patients with severe aortic stenosis (AS) and chronic kidney disease (CKD) undergoing transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR). Patients with severe AS and CKD undergoing TAVR or SAVR are a challenging, understudied clinical subset. Intermediate-risk patients with moderate to severe CKD (estimated glomerular filtration rate <60 mL/min/m The study population included 1,045 TAVR patients (512 SAPIEN XT, 533 SAPIEN 3) and 479 SAVR patients. At 5 years, SAVR was better than SAPIEN XT TAVR (52.8% vs 68.0%; P = 0.04) but similar to SAPIEN 3 TAVR (52.8% vs 58.7%; P = 0.89). Perioperative AKI was more common after SAVR than TAVR (26.3% vs 10.3%; P < 0.001) and was independently associated with long-term outcomes. Compared with SAVR, bioprosthetic valve failure and stage 2 or 3 structural valve deterioration were significantly greater for SAPIEN XT TAVR (P < 0.05) but not for SAPIEN 3 TAVR. In intermediate-risk patients with AS and CKD, SAPIEN 3 TAVR and SAVR were associated with a similar risk for the primary endpoint at 5 years. AKI was more common after SAVR than TAVR, and SAPIEN 3 valve durability was comparable with that of surgical bioprostheses.

Sections du résumé

OBJECTIVES
The aim of this study was to compare 5-year cardiovascular, renal, and bioprosthetic valve durability outcomes in patients with severe aortic stenosis (AS) and chronic kidney disease (CKD) undergoing transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR).
BACKGROUND
Patients with severe AS and CKD undergoing TAVR or SAVR are a challenging, understudied clinical subset.
METHODS
Intermediate-risk patients with moderate to severe CKD (estimated glomerular filtration rate <60 mL/min/m
RESULTS
The study population included 1,045 TAVR patients (512 SAPIEN XT, 533 SAPIEN 3) and 479 SAVR patients. At 5 years, SAVR was better than SAPIEN XT TAVR (52.8% vs 68.0%; P = 0.04) but similar to SAPIEN 3 TAVR (52.8% vs 58.7%; P = 0.89). Perioperative AKI was more common after SAVR than TAVR (26.3% vs 10.3%; P < 0.001) and was independently associated with long-term outcomes. Compared with SAVR, bioprosthetic valve failure and stage 2 or 3 structural valve deterioration were significantly greater for SAPIEN XT TAVR (P < 0.05) but not for SAPIEN 3 TAVR.
CONCLUSIONS
In intermediate-risk patients with AS and CKD, SAPIEN 3 TAVR and SAVR were associated with a similar risk for the primary endpoint at 5 years. AKI was more common after SAVR than TAVR, and SAPIEN 3 valve durability was comparable with that of surgical bioprostheses.

Identifiants

pubmed: 34556273
pii: S1936-8798(21)01313-3
doi: 10.1016/j.jcin.2021.07.004
pii:
doi:

Types de publication

Journal Article Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

1995-2005

Commentaires et corrections

Type : CommentIn

Informations de copyright

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Déclaration de conflit d'intérêts

Funding Support and Author Disclosures Edwards Lifesciences funded the PARTNER 2A trial and the SAPIEN 3 Intermediate Risk Registry. Dr Garcia has received institutional research grants from Edwards Lifesciences, Abbott Vascular, BSCI, and Biotronik; is a consultant for NeoChord, Medtronic, BSCI, and Abbott Vascular; and is a proctor for Edwards Lifesciences. Dr Cubeddu is an educational speaker and has conducted proctor-related activities for Edwards Lifesciences and Abbott Vascular. Dr Hahn has received speaker fees from Edwards Lifesciences and Philips Healthcare; has received consulting fees from Abbott Structural, Boston Scientific, Edwards Lifesciences, Gore & Associates, and Medtronic; holds equity with Navigate; and is 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. Dr Kapadia has received institutional research grants from Edwards Lifesciences (no direct physician compensation). Dr Kodali is a consultant (honoraria) for Admedus and Dura Biotech; is a scientific advisory board member (equity) for Dura Biotech, MicroInterventional Devices, Thubrikar Aortic Valve, Supira, Admedus, TriFlo, and Adona; and has received institutional research funding from Edwards Lifesciences, Medtronic, Abbott Vascular, Boston Scientific, JenaValve, and Keystone Medical. Dr Thourani is a consultant for Abbott Vascular, Boston Scientific, Cryolife, Edwards Lifesciences, JenaValve, Shockwave, and W.L. Gore. Dr Jaber receives monetary institutional support for echocardiography core laboratory in TAVR, with no direct or indirect personal compensation. Dr Elmariah has received institutional research grants from Edwards Lifesciences, Medtronic, and Abbott Vascular; and is a consultant for Edwards Lifesciences. Dr Makkar has received grants from Edwards Lifesciences and Abbott; and has served as a consultant for Cordis and Medtronic. Dr Webb has served as a proctor and consultant for Edwards Lifesciences. Dr Herrmann has received institutional research grants from Abbott Vascular, Boston Scientific, Edwards Lifesciences, and Medtronic; and has received consulting and speaker honoraria from Edwards Lifesciences and Medtronic. Dr Lu is an employee of Edwards Lifesciences. Dr Devireddy has received consulting fees from Edwards Lifesciences, Medtronic, ReCor Medical, and Shockwave Medical. Dr Malaisrie has received consulting fees Edwards Lifesciences, Medtronic, and Cryolife. Dr Smith has been reimbursed for travel and other customary expenses related to trial management as a principal investigator of the PARTNER trials. Dr Mack has received consulting fees from Gore; has served as a trial coprimary investigator for Edwards Lifesciences and Abbott; and has served as a study chair for Medtronic. Dr Sorajja has received institutional research grants from Edwards Lifesciences, Abbott Vascular, Boston Scientific, and Medtronic; and is a consultant for Abbott Vascular, Boston Scientific, Medtronic, NeoVasc, TeleFlex, TriFlo, VDyne, and W.L. Gore. Dr Cavalcante has received research grants from and is a consultant for Abbott Vascular, Circle Cardiovascular Imaging, Boston Scientific, Medtronic, Siemens Healthineers, and Edwards Lifesciences; is a consultant for VDyne and Triflo; and is a member of the Speakers Bureau for Circle Cardiovascular Imaging, Medtronic, Siemens Healthineers. Dr Goessl is a consultant for Abbott Vascular. Dr Leon has received institutional research support from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott. Dr Pibarot has received research grants from Edwards Lifesciences and Medtronic for echocardiography core laboratory or in vitro analyses in TAVR, with no personal compensation. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Auteurs

Santiago Garcia (S)

Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis, Minnesota, USA; Valve Science Center, Minneapolis Heart Institute Foundation, Minneapolis, Minnesota, USA. Electronic address: santiagogarcia@me.com.

Robert J Cubeddu (RJ)

NCH Healthcare System, Naples, Florida, USA.

Rebecca T Hahn (RT)

Cardiovascular Research Foundation, New York, New York, USA; Division of Cardiology, Columbia University Medical Center/NewYork-Presbyterian Hospital, New York, New York, USA.

Julien Ternacle (J)

Institut Universitaire de Cardiologie et de Pneumologie de Québec/Québec Heart & Lung Institute, Laval University, Québec, Québec, Canada.

Samir R Kapadia (SR)

Department of Cardiovascular Medicine, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland, Ohio, USA.

Susheel K Kodali (SK)

Division of Cardiology, Columbia University Medical Center/NewYork-Presbyterian Hospital, New York, New York, USA.

Vinod H Thourani (VH)

Department of Cardiovascular Surgery, Marcus Heart and Vascular Center, Piedmont Heart and Vascular Institute, Atlanta, Georgia, USA.

Wael A Jaber (WA)

Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio, USA.

Craig R Asher (CR)

Department of Cardiovascular Medicine, Heart and Vascular Institute, Cleveland Clinic Weston, Weston, Florida, USA.

Sammy Elmariah (S)

Massachusetts General Hospital, Boston, Massachusetts, USA.

Raj Makkar (R)

Cedars-Sinai Heart Institute, Los Angeles, California, USA.

John G Webb (JG)

St. Paul's Hospital, Vancouver, British Columbia, Canada.

Howard C Herrmann (HC)

Department of Cardiology, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, USA.

Michael Lu (M)

Edwards Lifesciences, Irvine, California, USA.

Chandan M Devireddy (CM)

Department of Cardiology, Emory University School of Medicine, Atlanta, Georgia, USA.

S Chris Malaisrie (SC)

Department of Cardiac Surgery, Northwestern University Feinberg School of Medicine and Northwestern Memorial Hospital, Chicago, Illinois, USA.

Craig R Smith (CR)

Cardiovascular Research Foundation, New York, New York, USA; Division of Cardiology, Columbia University Medical Center/NewYork-Presbyterian Hospital, New York, New York, USA.

Michael J Mack (MJ)

Department of Cardiothoracic Surgery, Baylor Scott & White Health, Plano, Texas, USA.

Paul Sorajja (P)

Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis, Minnesota, USA; Valve Science Center, Minneapolis Heart Institute Foundation, Minneapolis, Minnesota, USA.

João L Cavalcante (JL)

Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis, Minnesota, USA; Valve Science Center, Minneapolis Heart Institute Foundation, Minneapolis, Minnesota, USA.

Mario Goessl (M)

Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis, Minnesota, USA; Valve Science Center, Minneapolis Heart Institute Foundation, Minneapolis, Minnesota, USA.

Gautam R Shroff (GR)

Hennepin Healthcare and University of Minnesota Medical School, Minneapolis, Minnesota, USA.

Martin B Leon (MB)

Cardiovascular Research Foundation, New York, New York, USA; Division of Cardiology, Columbia University Medical Center/NewYork-Presbyterian Hospital, New York, New York, USA.

Philippe Pibarot (P)

Institut Universitaire de Cardiologie et de Pneumologie de Québec/Québec Heart & Lung Institute, Laval University, Québec, Québec, Canada.

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