AUTHOR=Scotti Andrea , Fovino Luca Nai , Coisne Augustin , Fabris Tommaso , Cardaioli Francesco , Massussi Mauro , Rodinò Giulio , Barolo Alberto , Boiago Mauro , Continisio Saverio , Montonati Carolina , Sciarretta Tommaso , Zuccarelli Vittorio , Bernardini Valentina , Masiero Giulia , Napodano Massimo , Fraccaro Chiara , Marchese Alfredo , Esposito Giovanni , Granada Juan F. , Latib Azeem , Iliceto Sabino , Tarantini Giuseppe 

TITLE=10-Year Impact of Transcatheter Aortic Valve Replacement Leaflet Design (Intra- Versus Supra-Annular) in Mortality and Hemodynamic Performance

JOURNAL=Frontiers in Cardiovascular Medicine

VOLUME=Volume 9 - 2022

YEAR=2022

URL=https://www.frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2022.924958

DOI=10.3389/fcvm.2022.924958

ISSN=2297-055X

ABSTRACT=BACKGROUND: The impact of transcatheter aortic valve replacement (TAVR) leaflet design on long-term device performance is still unknown. This study sought to compare the clinical and hemodynamic outcomes of intra- (IA) versus supra-annular (SA) TAVR designs up-to 10-years following implantation.

METHODS: Consecutive patients with at least 5-years follow-up following TAVR for severe symptomatic aortic stenosis from June 2007 to December 2016 were included. Bioprosthetic valve failure (BVF) and hemodynamic valve deterioration (HVD) were defined according to VARC-3 updated definitions and estimated using cumulative incidence function to account for the competing risk of death. 

RESULTS: A total of 604 patients (82 years; 53% female) were analyzed and divided into IA (482) and SA (122) groups. Overall survival rates at 10-years were similar (IA 15%, 95%CI: 10-22; SA 11%, 95%CI: 6-20; p=0.21). Compared to the SA TAVR, mean transaortic gradients were significantly higher and increased over time in the IA group. IA TAVRs showed higher 10-year cumulative incidences of BVF (IA 8% vs. SA 1%, p=0.02) and severe HVD (IA 5% vs. SA 1%, p=0.05). The occurrence of BVF and HVD in the IA group occurred primarily in the smallest TAVR devices (20-23-mm). After excluding these sizes, the cumulative incidences of BVF (IA 5% vs. SA 1%, p=0.40) and severe HVD (IA 2% vs. SA 1%, p=0.11) were similar. 

CONCLUSIONS: In this study, TAVR leaflet design had no impact on survival at 10-years. IA devices showed higher transaortic gradients and cumulative incidences of HVD and BVF predominantly occurring in the smallest valve sizes.