Abstract / Summary
Background Aortic stenosis (AS) impairs health-related quality of life but the prognostic impact of patient-reported health status prior to transcatheter aortic valve replacement (TAVR) is not fully established.Objectives To investigate the association of patient-reported health status at baseline with clinical outcomes and health status after transfemoral TAVR in patients with symptomatic severe AS.Methods In the investigator-initiated, multicenter SCOPE I randomized trial, patients underwent TAVR who provided baseline Kansas City Cardiomyopathy Questionnaire (KCCQ) assessment were included in this post-hoc analysis. An integrated patient-centered outcome was defined as being alive with good health status (KCCQ overall summary score [KCCQ-OS] ≥75 without a decline of >10 points from baseline).Results Of 739 patients enrolled in SCOPE I, 692 were included in the present analysis. Median baseline KCCQ-OS was 54.9 [39.6-71.9] distributed as follows: KCCQ-OS <25 - 74 (10.7%), 25-49 - 222 (32.1%), 50-74 - 271 (39.2%), ≥75 - 125 (18.1%). At 3 years after TAVR, higher baseline KCCQ-OS was associated with a greater likelihood of being alive with good health status (KCCQ-OS 50-75 vs. 0-25: adjusted odds ratio 2.25, 95% CI 1.12-4.54; 75-100 vs. 0-25: adjusted odds ratio 5.15, 95% CI 2.33-11.3). Restricted cubic spline modelling demonstrated an approximately linear relationship between baseline KCCQ-OS and all-cause mortality, and alive with good health status.Conclusions In this post-hoc analysis of SCOPE I, better baseline patient-reported health status was associated with a higher probability of being alive with good health status up to 3 years after TAVR.Clinical Trial Registration https://www.Clinicaltrials gov. NCT03011346.