Comparison of transcatheter versus surgical aortic valve implantation in high-risk patients: A nationwide study in France
Résumé
Objective: 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. © 2018 The American Association for Thoracic Surgery
Mots clés
human
intermethod comparison
longitudinal study
major clinical study
male
morbidity
multicenter study
outcome assessment
pacemaker implantation
priority journal
propensity score
proportional hazards model
risk assessment
statistical analysis
transcatheter aortic valve implantation
adult
aged
aortic valve disease
aortic valve replacement
Article
cause of death
cerebrovascular accident
clinical outcome
cohort analysis
confidence interval
controlled study
female
FIne and Gray competing risk model
follow up
France
hazard ratio
health care cost
heart failure
heart infarction
high risk patient
hospital mortality
hospitalization cost