Abstract

Introduction: Health-related quality of life (HRQoL) is a prioritized outcome for older adults undergoing transcatheter aortic valve replacement (TAVR). Previous studies have used the Kansas City Cardiomyopathy Questionnaire (KCCQ) to evaluate HRQoL, which is heavily weighted on heart failure symptoms with only one question on mental wellbeing. We sought to determine the incidence and determinants of poor HRQoL using a novel holistic scale. Methods: The FRAILTY-AVR prospective multi-centre cohort study of older adults undergoing TAVR was used to develop a holistic HRQoL scale. Construct validity was evaluated using the Spearman’s rank correlation with the 12-item KCCQ, and clinically meaningful change was evaluated using the anchor-based method. The primary endpoint was “poor outcome” defined as all-cause mortality or clinically meaningful decrease in HRQoL at 1 year. Results: The cohort consisted of 693 patients with a mean age of 82.9 years and 47% females. A 23-item HRQoL scale was developed, with the total score ranging from 0 (worst) to 40 (best) across 5 domains: disease burden (3 items), general health (1 item), physical (6 items), mental (5 items), and social (8 items) functioning. This scale was correlated with the KCCQ (Spearman’s rho 0.56, P<0.0001) and a 3-unit change was found to be clinically meaningful in longitudinal follow-up. A total of 269 (39%) patients experienced a poor outcome at 1 year post-TAVR, including 144 (21%) deaths. The predictors of poor outcome were Essential Frailty Toolset score >=3 [OR 1.88; 95% CI 1.28, 2.76], mean aortic gradient <40 mmHg [OR 1.83; 95% CI 1.27, 2.63] and Charlson comorbidity index [OR 1.09; 95% CI 1.01, 1.18]. Conclusions: Two of five patients had a poor outcome 1 year post-TAVR, despite a procedure success rate of 95%. The incidence and determinants of poor outcome using our holistic HRQoL scale, notably the impact of frailty, are highly consistent with previous studies using the KCCQ. These determinants should be integrated in patient-centered decision making and optimized to improve HRQoL post-procedure.

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