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

Abstract

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. 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. 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. 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). 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).