Relationship between baseline patient-reported health status and patient-centered outcomes after transcatheter aortic valve replacement

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 to 49-222 (32.1%), 50 to 74-271 (39.2%), and ≥ 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% confidence interval [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/study/NCT03011346.