TY - JOUR
T1 - 10-Year Impact of Transcatheter Aortic Valve Replacement Leaflet Design (Intra- Versus Supra-Annular) in Mortality and Hemodynamic Performance
AU - Scotti, Andrea
AU - Fovino, Luca Nai
AU - Coisne, Augustin
AU - Fabris, Tommaso
AU - Cardaioli, Francesco
AU - Massussi, Mauro
AU - Rodinò, Giulio
AU - Barolo, Alberto
AU - Boiago, Mauro
AU - Continisio, Saverio
AU - Montonati, Carolina
AU - Sciarretta, Tommaso
AU - Zuccarelli, Vittorio
AU - Bernardini, Valentina
AU - Masiero, Giulia
AU - Napodano, Massimo
AU - Fraccaro, Chiara
AU - Marchese, Alfredo
AU - Esposito, Giovanni
AU - Granada, Juan F.
AU - Latib, Azeem
AU - Iliceto, Sabino
AU - Tarantini, Giuseppe
N1 - Publisher Copyright:
Copyright © 2022 Scotti, Fovino, Coisne, Fabris, Cardaioli, Massussi, Rodinò, Barolo, Boiago, Continisio, Montonati, Sciarretta, Zuccarelli, Bernardini, Masiero, Napodano, Fraccaro, Marchese, Esposito, Granada, Latib, Iliceto and Tarantini.
PY - 2022/6/8
Y1 - 2022/6/8
N2 - 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. Conclusion: 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.
AB - 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. Conclusion: 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.
KW - bioprosthetic valve failure
KW - hemodynamic valve deterioration
KW - intra-annular
KW - supra-annular
KW - transcatheter aortic valve replacement
UR - http://www.scopus.com/inward/record.url?scp=85139098149&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85139098149&partnerID=8YFLogxK
U2 - 10.3389/fcvm.2022.924958
DO - 10.3389/fcvm.2022.924958
M3 - Article
AN - SCOPUS:85139098149
SN - 2297-055X
VL - 9
JO - Frontiers in Cardiovascular Medicine
JF - Frontiers in Cardiovascular Medicine
M1 - 924958
ER -