Comparison of transcatheter versus surgical aortic valve implantation in high-risk patients: A nationwide study in France

• Published in: The Journal of thoracic and cardiovascular surgery Vol. 156; no. 3; pp. 1017 - 1025.e4
• Main Authors: Armoiry, Xavier, Obadia, Jean-François, Pascal, Léa, Polazzi, Stéphanie, Duclos, Antoine
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01-09-2018; Elsevier
• Subjects: aortic stenosis; cost; Engineering Sciences; epidemiology; French medico-administrative databases; Materials; surgical aortic valve replacement; transcatheter aortic valve; epidemiology; transcatheter aortic valve; French medico-administrative databases; RCT; cost; aortic stenosis; PMSI; TAVI; PSM; surgical aortic valve replacement; SAVR; euroSCORE; risk assessment; aortic valve replacement; FIne and Gray competing risk model; cohort analysis; major clinical study; Article; heart infarction; longitudinal study; cause of death; hospitalization cost; aortic valve disease; follow up; pacemaker implantation; proportional hazards model; outcome assessment; priority journal; morbidity; female; France; human; hospital mortality; transcatheter aortic valve implantation; heart failure; high risk patient; aged; health care cost; cerebrovascular accident; controlled study; clinical outcome; hazard ratio; multicenter study; confidence interval; statistical analysis; adult; male; intermethod comparison; propensity score
• ISSN: 0022-5223; 1097-685X
• DOI: 10.1016/j.jtcvs.2018.02.092

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.
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.
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).
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.