Transcatheter versus Surgical Aortic Valve Replacement: A Propensity-Matched Analysis from Two United States Registries

• Type of Material: Article
• Authors: J. Matthew Brennan, Duke University; Laine Thomas, Duke University; David Cohen, St Luke's Mid America Heart Institute; David Shahian, Harvard Medical School; Alice Wang, Duke Clinical Research Institute; Michael J. Mack, The Heart Hospital Baylor Plano Research Center; David R. Holmes, Mayo Clinic; Fred H. Edwards, University of Florida; Naftali Z. Frankel, Duke Clinical Research Institute; Suzanne J. Baron, St Luke's Mid America Heart Institute; John Carroll, University of Colorado Hospital; Vinod Thourani, Emory University; E. Murat Tuzcu, Cleveland Clinic Abu Dhabi; Suzanne V. Arnold, St Luke's Mid America Heart Institute; Roberta Cohn, Duke Clinical Research Institute; Todd Maser, Duke Clinical Research Institute; Brenda Schawe, Duke Clinical Research Institute; Susan Strong, Duke Clinical Research Institute; Allen Stickfort, Duke Clinical Research Institute; Elizabeth Patrick-Lake, Duke Clinical Research Institute; Felicia Graham, Duke Clinical Research Institute; Dadi (David) Dai, Duke Clinical Research Institute; Fan Li, Duke University; Roland A. Matsouaka, Duke University; Sean O'Brien, Duke University; Michael J. Pencina, Duke University; Eric D. Peterson, Duke University
• Language: English
• Date: 2017-07-25
• Publisher: Elsevier
• Publication Version: Author Accepted Manuscript (After Peer Review)
• Copyright Statement: © 2017 American College of Cardiology Foundation
• License: Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1016/j.jacc.2017.05.060
• Title of Journal or Parent Work: Journal of the American College of Cardiology
• ISSN: 0735-1097
• Volume: 70
• Issue: 4
• Start Page: 439
• End Page: 450
• Grant/Funding Information: Research reported in this article was funded through a Patient-Centered Outcomes Research Institute (PCORI) Award (CER-1306-04350).
• Keywords: CARDIAC-SURGERY DATABASE; Life Sciences & Biomedicine; surgical aortic valve replacement; INTERMEDIATE-RISK PATIENTS; transcatheter aortic valve replacement; OUTCOMES; Cardiac & Cardiovascular Systems; MEDICARE; REGISTRY; METAANALYSIS; INSIGHTS; SOCIETY; safety and effectiveness; Science & Technology; LINKING; outcomes; Cardiovascular System & Cardiology; UNITED-STATES
• Research Categories: Health Sciences, Medicine and Surgery

Abstract

Randomized trials support the use of transcatheter aortic valve replacement (TAVR) for the treatment of aortic stenosis in high- and intermediate-risk patients, but the generalizability of those results in clinical practice has been challenged. Objectives The aim of this study was to determine the safety and effectiveness of TAVR versus surgical aortic valve replacement (SAVR), particularly in intermediate- and high-risk patients, in a nationally representative real-world cohort. Methods Using data from the Transcatheter Valve Therapy Registry and Society of Thoracic Surgeons National Database linked to Medicare administrative claims for follow-up, 9,464 propensity-matched intermediate- and high-risk (Society of Thoracic Surgeons Predicted Risk of Mortality score ≥3%) U.S. patients who underwent commercial TAVR or SAVR were examined. Death, stroke, and days alive and out of the hospital to 1 year were compared, as well as discharge home, with subgroup analyses by surgical risk, demographics, and comorbidities. Results In a propensity-matched cohort (median age 82 years, 48% women, median Society of Thoracic Surgeons Predicted Risk of Mortality score 5.6%), TAVR and SAVR patients experienced no difference in 1-year rates of death (17.3% vs. 17.9%; hazard ratio: 0.93; 95% confidence interval [CI] : 0.83 to 1.04) and stroke (4.2% vs. 3.3%; hazard ratio: 1.18; 95% CI: 0.95 to 1.47), and no difference was observed in the proportion of days alive and out of the hospital to 1 year (rate ratio: 1.00; 95% CI: 0.98 to 1.02). However, TAVR patients were more likely to be discharged home after treatment (69.9% vs. 41.2%; odds ratio: 3.19; 95% CI: 2.84 to 3.58). Results were consistent across most subgroups, including among intermediate- and high-risk patients. Conclusions Among unselected intermediate- and high-risk patients, TAVR and SAVR resulted in similar rates of death, stroke, and DAOH to 1 year, but TAVR patients were more likely to be discharged home.