Health Status Outcomes 7 Years After Transcatheter or Surgical Aortic Valve Replacement in Low-Surgical Risk Patients With Aortic Stenosis

BACKGROUND: Transcatheter aortic valve replacement (TAVR) results in early improvements in health status outcomes relative to surgical aortic valve replacement (SAVR) in low-surgical risk patients with symptomatic severe aortic stenosis. However, long-term data comparing the detailed health status outcomes of these 2 treatments are lacking. OBJECTIVE: The purpose of this study was to compare long-term health status outcomes between TAVR and SAVR in low-risk patients and explore heterogeneity of treatment effect. METHODS: The PARTNER 3 (Placement of Aortic Transcatheter Valves) trial randomized patients with severe aortic stenosis and low surgical risk 1:1 to TAVR with a balloon-expandable valve vs SAVR. Health status was evaluated with the Kansas City Cardiomyopathy Questionnaire (KCCQ) and Short Form-36 Heath Survey at baseline and 1 month, 6 months, and annually from years 1 to 7. Between treatment group differences in health status scores over time were examined with mixed effects models for repeated measures adjusted for baseline. RESULTS: The analytic cohort included 943 patients enrolled in the PARTNER 3 trial who had baseline KCCQ assessments and underwent their assigned procedure (494 TAVR, 449 SAVR; mean age: 73.5 ± 5.9 years; 69.2% men; mean Society of Thoracic Surgeons-Predicted Risk of Mortality: 1.9% ± 0.6%; mean KCCQ-overall summary KCCQ-OS score: 70.9 ± 20.5). TAVR and SAVR both resulted in significant improvements in KCCQ and Short Form-36 Heath Survey summary scores relative to baseline through 7-year follow-up. KCCQ-OS scores were substantially higher at 1 month after TAVR vs SAVR (mean treatment difference: +16.2 points; 95% CI: 14.3-18.1) and remained modestly higher through 2 years of follow-up (mean difference at 2 years: +1.9 points; 95% CI: 0.2-3.7), but there were no significant between-group differences in years 3-7. At 7 years, ∼60% of patients in both treatment groups had an excellent outcome (alive, KCCQ-OS ≥75; no KCCQ-OS decline ≥10 from baseline). CONCLUSIONS: Patients with severe aortic stenosis at low surgical risk had substantial improvement in patient-reported health status with either TAVR or SAVR that was sustained through 7 years. Patients had earlier recovery with TAVR, but health status outcomes after 2 years were similar between treatment groups. (PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis; NCT02675114).