To compare the clinical outcomes and direct costs at 5 years between transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR) using real-world evidence.Methods
We performed a nationwide longitudinal study using data from the French Hospital Information System from 2009 to 2015. We matched, inside hospitals, 2 cohorts of adults who underwent TAVI or SAVR during 2010 on propensity score based on patient 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 (HRs) estimated from a 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 with SAVR (16.8% vs 12.8%, respectively; HR, 1.33; 95% confidence interval [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 < .001).Conclusions
In our study, high-risk patients harbored a greater risk of mortality and morbidity at 5 years after TAVI compared with those who underwent SAVR and higher hospitalizations costs. Those results should encourage caution before expanding the indications of TAVI.