Abstract | BACKGROUND: OBJECTIVES: This study sought to compare health status outcomes of TAVR versus surgery in low-risk patients with severe AS. METHODS: Between March 2016 and October 2017, 1,000 low-risk patients with AS were randomized to transfemoral TAVR using a balloon-expandable valve or surgery in the PARTNER 3 (Placement of Aortic Transcatheter Valves) trial. Health status was assessed at baseline and 1, 6, and 12 months using the KCCQ (Kansas City Cardiomyopathy Questionnaire), SF-36 (Short Form-36 Health Survey), and EQ-5D (EuroQoL). The primary endpoint was change in KCCQ-OS (KCCQ Overall Summary) score over time. Longitudinal growth curve modeling was used to compare changes in health status between treatment groups over time. RESULTS: At 1 month, TAVR was associated with better health status than surgery (mean difference in KCCQ-OS 16.0 points; p < 0.001). At 6 and 12 months, health status remained better with TAVR, although the effect was reduced (mean difference in KCCQ-OS 2.6 and 1.8 points respectively; p < 0.04 for both). The proportion of patients with an excellent outcome (alive with KCCQ-OS ≥75 and no significant decline from baseline) was greater with TAVR than surgery at 6 months (90.3% vs. 85.3%; p = 0.03) and 12 months (87.3% vs. 82.8%; p = 0.07). CONCLUSIONS: Among low-risk patients with severe AS, TAVR was associated with meaningful early and late health status benefits compared with surgery.
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Authors | Suzanne J Baron, Elizabeth A Magnuson, Michael Lu, Kaijun Wang, Khaja Chinnakondepalli, Michael Mack, Vinod H Thourani, Susheel Kodali, Raj Makkar, Howard C Herrmann, Samir Kapadia, Vasilis Babaliaros, Mathew R Williams, Dean Kereiakes, Alan Zajarias, Maria C Alu, John G Webb, Craig R Smith, Martin B Leon, David J Cohen, PARTNER 3 Investigators |
Journal | Journal of the American College of Cardiology
(J Am Coll Cardiol)
Vol. 74
Issue 23
Pg. 2833-2842
(12 10 2019)
ISSN: 1558-3597 [Electronic] United States |
PMID | 31577923
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved. |
Topics |
- Aged
- Aortic Valve
(surgery)
- Aortic Valve Stenosis
(diagnosis, surgery)
- Echocardiography
- Female
- Follow-Up Studies
- Health Status
- Heart Valve Prosthesis
- Humans
- Male
- Prospective Studies
- Quality of Life
- Severity of Illness Index
- Transcatheter Aortic Valve Replacement
(methods)
- Treatment Outcome
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