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


Journal

Circulation. Cardiovascular interventions
ISSN: 1941-7632
Titre abrégé: Circ Cardiovasc Interv
Pays: United States
ID NLM: 101499602

Informations de publication

Date de publication:
01 2023
Historique:
entrez: 17 1 2023
pubmed: 18 1 2023
medline: 20 1 2023
Statut: ppublish

Résumé

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. 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. 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%]; 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.

Sections du résumé

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%];
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.

Identifiants

pubmed: 36649387
doi: 10.1161/CIRCINTERVENTIONS.122.012538
doi:

Types de publication

Multicenter Study Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

e012538

Auteurs

Andrea Scotti (A)

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

Sara Baggio (S)

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

Matteo Pagnesi (M)

Cardiothoracic Department, ASST Spedali Civili di Brescia University of Brescia, Italy (M.P., M.A., M. Massussi).
Department of Medical Surgical Specialties, Radiological Sciences, and Public Health, University of Brescia, Italy (M.P., M.A., M. Massussi).

Marco Barbanti (M)

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

Marianna Adamo (M)

Cardiothoracic Department, ASST Spedali Civili di Brescia University of Brescia, Italy (M.P., M.A., M. Massussi).
Department of Medical Surgical Specialties, Radiological Sciences, and Public Health, University of Brescia, Italy (M.P., M.A., M. Massussi).

Amnon Eitan (A)

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

Rodrigo Estévez-Loureiro (R)

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

Verena Veulemans (V)

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

Stefan Toggweiler (S)

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

Darren Mylotte (D)

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

Federico De Marco (F)

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

Francesco Giannini (F)

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

Marco Ferlini (M)

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

Christoph K Naber (CK)

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

Andrea Buono (A)

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

Joachim Schofer (J)

Department for Percutaneous Treatment of Structural Heart Disease, Albertinen Heart Center, Hamburg, Germany (J.S.).
MVZ Department Structural Heart Disease, Asklepios St Georg Clinic, Hamburg, Germany (J.S.).

Wolfgang Rottbauer (W)

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

Nicolas M Van Mieghem (NM)

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

Saib Khogali (S)

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

Maurizio Taramasso (M)

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

Thomas Pilgrim (T)

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

Jan-Malte Sinning (JM)

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

David Zweiker (D)

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

Matteo Montorfano (M)

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

Jan A S Van der Heyden (JAS)

Department of Cardiology, St Antonius Hospital, Nieuwegein, the Netherlands (J.A.S.V.d.H., J.B.).
Interventional Cardiology Unit, AZ Sint-Jan Hospital, Bruges, Belgium (J.A.S.V.d.H.).

Salvatore Brugaletta (S)

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

Alfonso Ielasi (A)

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

Christian W Hamm (CW)

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

Maarten Vanhaverbeke (M)

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

Giuliano Costa (G)

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

Mauro Massussi (M)

Cardiothoracic Department, ASST Spedali Civili di Brescia University of Brescia, Italy (M.P., M.A., M. Massussi).
Department of Medical Surgical Specialties, Radiological Sciences, and Public Health, University of Brescia, Italy (M.P., M.A., M. Massussi).

Robert Alarcón (R)

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

Tobias Zeus (T)

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

Mattia Lunardi (M)

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

Luca Testa (L)

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

Luca Di Ienno (L)

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

Giuseppe Lanzillo (G)

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

Alexander Wolf (A)

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

Diego Maffeo (D)

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

Francesca Ziviello (F)

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

Matteo Saccocci (M)

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

Stephan Windecker (S)

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

Alexander Sedaghat (A)

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

Albrecht Schmidt (A)

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

Jorn Brouwer (J)

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

Ander Regueiro (A)

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

Bernhard Reimers (B)

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

Won-Keun Kim (WK)

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

Lars Sondergaard (L)

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

Antonio Colombo (A)

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

Antonio Mangieri (A)

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

Azeem Latib (A)

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

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