Temporal trends and contemporary outcomes after transcatheter aortic valve replacement with Evolut PRO/PRO+ self-expanding valves: insights from the NEOPRO/NEOPRO-2 registries.
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Authors
Khogali, Saib
Issue Date
2023-01-17
Journal
Type
Article
Peer-Reviewed Publication
Peer-Reviewed Publication
Keywords
Multicentre study
Heart valve prosthesis
Aortic stenosis
Comparative Study
Aortic stenosis
Bioprosthesis
Time factors
Heart valve prosthesis implantation
Aortic valve
Treatment outcome
Prosthesis design
Registries
Risk factors
Transcatheter aortic valve replacement
Pacemaker
Peer-reviewed article
Heart valve prosthesis
Aortic stenosis
Comparative Study
Aortic stenosis
Bioprosthesis
Time factors
Heart valve prosthesis implantation
Aortic valve
Treatment outcome
Prosthesis design
Registries
Risk factors
Transcatheter aortic valve replacement
Pacemaker
Peer-reviewed article
Journal Title
Circulation: Cardiovascular Interventions
Volume
16
Issue
1
Begin page
e012538
End page
Abstract
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.
Citation
Scotti A, Baggio S, Pagnesi M, Barbanti M, Adamo M, Eitan A, Estévez-Loureiro R, Veulemans V, Toggweiler S, Mylotte D, De Marco F, Giannini F, Ferlini M, Naber CK, Buono A, Schofer J, Rottbauer W, Van Mieghem NM, Khogali S, Taramasso M, Pilgrim T, Sinning JM, Zweiker D, Montorfano M, Van der Heyden JAS, Brugaletta S, Ielasi A, Hamm CW, Vanhaverbeke M, Costa G, Massussi M, Alarcón R, Zeus T, Lunardi M, Testa L, Di Ienno L, Lanzillo G, Wolf A, Maffeo D, Ziviello F, Saccocci M, Windecker S, Sedaghat A, Schmidt A, Brouwer J, Regueiro A, Reimers B, Kim WK, Sondergaard L, Colombo A, Mangieri A, Latib A; NEOPRO and NEOPRO-2 Investigators‡. Temporal Trends and Contemporary Outcomes After Transcatheter Aortic Valve Replacement With Evolut PRO/PRO+ Self-Expanding Valves: Insights From the NEOPRO/NEOPRO-2 Registries. Circ Cardiovasc Interv. 2023 Jan;16(1):e012538. doi: 10.1161/CIRCINTERVENTIONS.122.012538. Epub 2023 Jan 17. PMID: 36649387.