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Randomized Controlled Trial
. 2019 Dec 10;74(23):2833-2842.
doi: 10.1016/j.jacc.2019.09.007. Epub 2019 Sep 29.

Health Status After Transcatheter Versus Surgical Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis

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Free article
Randomized Controlled Trial

Health Status After Transcatheter Versus Surgical Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis

Suzanne J Baron et al. J Am Coll Cardiol. .
Free article

Abstract

Background: In patients with severe aortic stenosis (AS) at low surgical risk, treatment with transcatheter aortic valve replacement (TAVR) results in lower rates of death, stroke, and rehospitalization at 1 year compared with surgical aortic valve replacement; however, the effect of treatment strategy on health status is unknown.

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.

Keywords: low surgical risk; quality of life; transcatheter aortic valve replacement.

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