Temporal Trends and Contemporary Outcomes After Transcatheter Aortic Valve Replacement With Evolut PRO/PRO+ Self-Expanding Valves: Insights From the NEOPRO/NEOPRO-2 Registries
Authors: Scotti Andrea , Baggio Sara , Pagnesi Matteo , Barbanti Marco , Adamo Marianna , Eitan Amnon , Estévez-Loureiro Rodrigo , Veulemans Verena , Toggweiler Stefan , Mylotte Darren , De Marco Federico , Giannini Francesco , Ferlini Marco , Naber Christoph K. , Buono Andrea , Schofer Joachim , Rottbauer Wolfgang , Van Mieghem Nicolas M. , Khogali Saib , Taramasso Maurizio , Pilgrim Thomas , Sinning Jan-Malte , Zweiker David , Montorfano Matteo , Van der Heyden Jan A.S. , Brugaletta Salvatore , Ielasi Alfonso , Hamm Christian W. , Vanhaverbeke Maarten , Costa Giuliano , Massussi Mauro , Alarcón Robert , Zeus Tobias , Lunardi Mattia , Testa Luca , Di Ienno Luca , Lanzillo Giuseppe , Wolf Alexander , Maffeo Diego , Ziviello Francesca , Saccocci Matteo , Windecker Stephan , Sedaghat Alexander , Schmidt Albrecht , Brouwer Jorn , Regueiro Ander , Reimers Bernhard , Kim Won-Keun , Sondergaard Lars , Colombo Antonio , Mangieri Antonio , Latib Azeem ,   on behalf of the NEOPRO and NEOPRO-2 Investigators‡
Published: January 2023

Background:

In recent years, transcatheter aortic valve replacement (TAVR) techniques and technology have continuously improved. Data regarding the impact of these advancements on outcomes in large real-world settings are still limited. The aim of this study was to investigate temporal trends and assess contemporary outcomes after TAVR with Evolut PRO/PRO+ supra-annular self-expanding valves.

Methods:

This study included patients enrolled in the multicenter NEOPRO (A Multicenter Comparison of Acurate NEO Versus Evolut PRO Transcatheter Heart Valves) and NEOPRO-2 (A Multicenter Comparison of ACURATE NEO2 Versus Evolut PRO/PRO+ Transcatheter Heart Valves 2) registries who underwent transfemoral TAVR with Evolut PRO/PRO+. Procedural dates (August 2017 through November 2021) were stratified in quartiles (Q) and used to investigate temporal trends in TAVR outcomes. Predischarge, 30-day Valve Academic Research Consortium-3 defined, and 1-year outcomes were evaluated.

Results:

In total, 1616 patients from 28 centers were included. Over time, patients had lower Society of Thoracic Surgeon-Predicted Risk of Mortality score (Q1–4, 4.1% [2.8–6.3%], 3.7% [2.6–5.3%], 3.3% [2.4–4.9%], 2.9% [2.2–4.3%];
P
<0.001) and more moderate or heavy valve calcification (Q1–4, 80%, 80%, 82%, 88%;
P
=0.038). Overall Valve Academic Research Consortium-3 technical success was 94.1%, with 30-day and 1-year all-cause mortality of 2.4% and 10%, respectively. Throughout the study period, procedures were associated with higher rates of 30-day device success (Q1–4, 81.2%, 82.2%, 82.0%, 88.0%; Cochran-Armitage
P
=0.023) and early safety (Q1–4, 66.8%, 67.5%, 74.0%, 77.6%; Cochran-Armitage
P
<0.001), with fewer permanent pacemaker implantations (Q1–4: 15.3%, 20.0%, 12.1%, 11.6%; Cochran-Armitage
P
=0.023) and residual mild or greater paravalvular leaks (Q1–4, 50.4%, 42.1%, 36.5%, 35.8%; Cochran-Armitage
P
<0.001).

Conclusions:

TAVR with Evolut PRO/PRO+ self-expanding valve is safe and effective. Despite the treatment of heavier calcified anatomies, procedural outcomes are improving over time with less need for pacemaker implantation and less significant paravalvular leaks.