Temporal Trends and Contemporary Outcomes After Transcatheter Aortic Valve Replacement With Evolut PRO/PRO+ Self-Expanding Valves: Insights From the NEOPRO/NEOPRO-2 Registries-Reference-Cited by-同舟云学术

Temporal Trends and Contemporary Outcomes After Transcatheter Aortic Valve Replacement With Evolut PRO/PRO+ Self-Expanding Valves: Insights From the NEOPRO/NEOPRO-2 Registries

Published:2023-01 Issue:1 Volume:16 Page:
ISSN:1941-7640
Container-title:Circulation: Cardiovascular Interventions
language:en
Short-container-title:Circ: Cardiovascular Interventions

Author:

Scotti Andrea¹^ORCID,Baggio Sara²³^ORCID,Pagnesi Matteo⁴⁵,Barbanti Marco⁶^ORCID,Adamo Marianna⁴⁵,Eitan Amnon⁷^ORCID,Estévez-Loureiro Rodrigo⁸^ORCID,Veulemans Verena⁹^ORCID,Toggweiler Stefan¹⁰^ORCID,Mylotte Darren¹¹,De Marco Federico¹²^ORCID,Giannini Francesco¹³^ORCID,Ferlini Marco¹⁴^ORCID,Naber Christoph K.¹⁵,Buono Andrea¹⁶,Schofer Joachim¹⁷¹⁸,Rottbauer Wolfgang¹⁹,Van Mieghem Nicolas M.²⁰^ORCID,Khogali Saib²¹,Taramasso Maurizio²²,Pilgrim Thomas²³^ORCID,Sinning Jan-Malte²⁴,Zweiker David²⁵^ORCID,Montorfano Matteo²⁶^ORCID,Van der Heyden Jan A.S.²⁷²⁸,Brugaletta Salvatore²⁹^ORCID,Ielasi Alfonso³⁰,Hamm Christian W.³¹,Vanhaverbeke Maarten³²,Costa Giuliano⁶^ORCID,Massussi Mauro⁴⁵^ORCID,Alarcón Robert⁸^ORCID,Zeus Tobias⁹^ORCID,Lunardi Mattia¹¹^ORCID,Testa Luca³³^ORCID,Di Ienno Luca¹³,Lanzillo Giuseppe¹⁴,Wolf Alexander¹⁵,Maffeo Diego¹⁶,Ziviello Francesca²⁰,Saccocci Matteo²²^ORCID,Windecker Stephan¹⁹^ORCID,Sedaghat Alexander²⁴^ORCID,Schmidt Albrecht²⁵,Brouwer Jorn²⁷^ORCID,Regueiro Ander²⁹,Reimers Bernhard²³^ORCID,Kim Won-Keun³¹^ORCID,Sondergaard Lars³²,Colombo Antonio²³^ORCID,Mangieri Antonio²³^ORCID,Latib Azeem¹^ORCID,

Affiliation:

1. Montefiore-Einstein Center for Heart and Vascular Care, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY (A.S., A.L.).

2. Department of Biomedical Sciences, Humanitas University, Pieve Emanuele-Milan, Italy (S.B., B.R., A.C., A.M.).

3. IRCCS Humanitas Research Hospital, Rozzano-Milan, Italy (S.B., B.R., A.C., A.M.).

4. Cardiothoracic Department, ASST Spedali Civili di Brescia University of Brescia, Italy (M.P., M.A., M. Massussi).

5. Department of Medical Surgical Specialties, Radiological Sciences, and Public Health, University of Brescia, Italy (M.P., M.A., M. Massussi).

6. Department of Cardiology, C.A.S.T. Policlinico G. Rodolico, Catania, Italy (M.B., G.C.).

7. Department of Cardiology, Carmel Medical Center, Haifa, Israel (A.E.).

8. Cardiology Department, University Hospital Alvaro Cunqueiro, Galicia Sur Health Research Institute, Vigo, Spain (R.E.-L., R.A.).

9. Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital Düsseldorf, Germany (V.V., T.Z.).

10. Heart Center Lucerne, Department of Cardiology, Luzerner Kantonsspital, Lucerne, Switzerland (S.T.).

11. Department of Cardiology, Galway University Hospitals, Ireland (D.M., M.L.).

12. Centro Cardiologico Monzino IRCCS, Milan, Italy (F.D.M.).

13. Interventional Cardiology Unit, GVM Care and Research, Maria Cecilia Hospital, Cotignola, Italy (F.G., L.D.I.).

14. Division of Cardiology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (M.F., G.L.).

15. Contilia Heart and Vascular Centre, Elisabeth-Krankenhaus Essen, Germany (C.K.N., A.W.).

16. Interventional Cardiology Unit, Fondazione Poliambulanza, Brescia, Italy (A.B., D.M.).

17. Department for Percutaneous Treatment of Structural Heart Disease, Albertinen Heart Center, Hamburg, Germany (J.S.).

18. MVZ Department Structural Heart Disease, Asklepios St Georg Clinic, Hamburg, Germany (J.S.).

19. Department of Internal Medicine II, University Hospital Ulm, Germany (W.R., S.W.).

20. Department of Cardiology, Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands (N.M.V.M., F.Z.).

21. Heart and Lung Center, New Cross Hospital, Wolverhampton, UK (S.K.).

22. Division of Cardiothoracic Surgery, HerzZentrum Hirslanden Zürich, Switzerland (M.T., M.S.).

23. Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Switzerland (T.P.).

24. Department of Cardiology, Heart Center Bonn, University Hospital Bonn, Germany (J.-M.S., A. Sedaghat).

25. Division of Cardiology, Medical University of Graz, Austria (D.Z., A. Schmidt).

26. Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy (M. Montorfano).

27. Department of Cardiology, St Antonius Hospital, Nieuwegein, the Netherlands (J.A.S.V.d.H., J.B.).

28. Interventional Cardiology Unit, AZ Sint-Jan Hospital, Bruges, Belgium (J.A.S.V.d.H.).

29. Clinic Cardiovascular Institute, Hospital Clinic, Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), University of Barcelona, Spain (S.B., A.R.).

30. Clinical and Interventional Cardiology Unit, Istituto Clinico Sant’Ambrogio, Milan, Italy (A.I.).

31. Department of Cardiology and Cardiac Surgery, Kerckhoff Heart Center, Bad Nauheim, Germany (C.W.H., W.-K.K.).

32. The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Denmark (M.V., L.S.).

33. Department of Clinical and Interventional Cardiology, IRCCS Policlinico San Donato, Milan, Italy (L.T.).

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.

Publisher

Ovid Technologies (Wolters Kluwer Health)

Subject

Cardiology and Cardiovascular Medicine

Reference36 articles.

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