(BSPOT15) Transcatheter and Surgical Aortic Valve Implantation in the Management of Aortic Stenosis between 2010 and 2022: a French Nationwide Study

Background: Since 2010, with the publication of European guidelines and randomized controlled trials (RCT), the management of aortic stenosis (AS) has been revolutionised by the emergence of transcatheter aortic valve implantation (TAVI) not only in patients contraindicated to surgical aortic valve replacement (SAVR) but also to patients with lower surgical risk.

Objectives: To describe the trends for AS management type in French TAVI-eligible facilities between 2010 and 2022, and the possible impact of European guidelines and RCT on these trends.

Methods: A cohort study was conducted from the National Health Data System (SNDS). Patients aged 18 and over, hospitalized for AS and undergoing a first TAVI or SAVR between 2010 and 2022 were included. Patient characteristics (age, sex, Charlson comorbidities index [CCI]), and TAVI valve characteristics (self-expanding vs balloon-expandable, manufacturer name), and 30-days complications (critical care stays, myocardial infarction [MI], stroke, pacemaker implantation [PI], mortality) and valve-in-valve procedures rate were described. To assess the effect of guidelines and RCT on the evolution of AS management, 2010-2015, 2016-2018 and 2019-2022 periods were distinguished.

Results: We identified 255,453 adults, including 43.0% with TAVI. The number of SAVR was stable to 2015 then decreased from 11,579 in 2016 to 8,123 in 2022, while the number of TAVI increased sharply (1,389 in 2010 to 16,770 in 2022). The mean age ranged from 71.8 years between 2010-2015 to 67.8 years between 2019-2022 in SAVR group and remained stable in TAVI group at 82.4 years. The percentage of men increased from 49.0% between 2010-2015 to 53.5% between 2019-2022 in TAVI group and from 63.6% to 71.6% in SAVR group. The mean CCI decreased from 4.1 between 2010-2015 to 3.8 between 2019-2022 in TAVI group, and was stable in SAVR group at 3.2. Balloon-expandable TAVI valves were mainly used (2010-2015: 65.1%; 2019-2022: 62.8%), and the market share between Edwards, Medtronic, Boston and Abbott was respectively 62.5%, 34.4%, 2.0% and 1.1%. Within 30 days post-implantation, for TAVI and SAVR groups respectively, the percentage of critical care stays ranged from 15.0% between 2010-2015 to 6.1% between 2019-2022 and from 46.4% to 53.4%, the percentage of PI ranged from 16.6% between 2010-2015 to 18.3% between 2019-2022 and from 5.3% to 5.2% and the percentages of MI, stroke and death tended to decrease in two groups (≤1.1%, ≤2.9%, ≤3.1%, respectively). Few valve-in-valve procedures occurred (TAVI: ≤0.4%; SAVR: ≤2.2%).

Conclusions: This study provides comprehensive results over 13 years on the AS management type and patient profile. A EuroSCORE proxy is being developed to define patients' surgical risk and compare clinical outcomes according to the AS management type.