Comparison of transcatheter to surgical aortic valve implantation in high risk patients : a nationwide study in France

Objective: To compare the clinical outcomes and direct costs at 5 years between TAVI or SAVR using real-world evidence. Methods: We performed a nationwide longitudinal study using data from the French Hospital Information System over 2009-2015. We matched inside hospitals two cohorts of adults who underwent TAVI or SAVR in 2010 on propensity score based on patients characteristics. Outcomes analysis included mortality, morbidity, and total costs and with a maximum 60-month follow-up. Clinical outcomes were compared between cohorts using Hazard Ratios (HR) estimated from Cox proportional hazards model for all-cause death, and from Fine and Gray’s competing risk model for morbidity. Results: Based on a cohort of 1598 patients (799 in each group) from 27 centers, a higher risk of death was observed after 1 year with TAVI compared to SAVR (16.8% vs. 12.8% respectively; HR 1.33, 95%CI 1.02-1.72) and was sustained up to 5 years (52.4% vs. 37.2%; HR 1.56, 95%CI 1.33-1.84). At 5 years, the risk of stroke was increased (HR 1.64, 95%CI 1.07-2.54) as was myocardial infarction (HR 2.30, 95%CI 1.12-4.69) and pacemaker implantation (HR 2.40, 95%CI 1.81-3.17) after TAVI. The hospitalization costs per patient at 5 years were €69,083 after TAVI and €55,687 after SAVR (p