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Temporal Trends and Contemporary Outcomes After Transcatheter Aortic Valve Replacement With Evolut PRO/PRO+ Self-Expanding Valves: Insights From the NEOPRO/NEOPRO-2 Registries.
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.
Affiliation
  • Scotti A; Montefiore-Einstein Center for Heart and Vascular Care, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY (A.S., A.L.).
  • Baggio S; Department of Biomedical Sciences, Humanitas University, Pieve Emanuele-Milan, Italy (S.B., B.R., A.C., A.M.).
  • Pagnesi M; IRCCS Humanitas Research Hospital, Rozzano-Milan, Italy (S.B., B.R., A.C., A.M.).
  • Barbanti M; Cardiothoracic Department, ASST Spedali Civili di Brescia University of Brescia, Italy (M.P., M.A., M. Massussi).
  • Adamo M; Department of Medical Surgical Specialties, Radiological Sciences, and Public Health, University of Brescia, Italy (M.P., M.A., M. Massussi).
  • Eitan A; Department of Cardiology, C.A.S.T. Policlinico G. Rodolico, Catania, Italy (M.B., G.C.).
  • Estévez-Loureiro R; Cardiothoracic Department, ASST Spedali Civili di Brescia University of Brescia, Italy (M.P., M.A., M. Massussi).
  • Veulemans V; Department of Medical Surgical Specialties, Radiological Sciences, and Public Health, University of Brescia, Italy (M.P., M.A., M. Massussi).
  • Toggweiler S; Department of Cardiology, Carmel Medical Center, Haifa, Israel (A.E.).
  • Mylotte D; Cardiology Department, University Hospital Alvaro Cunqueiro, Galicia Sur Health Research Institute, Vigo, Spain (R.E.-L., R.A.).
  • De Marco F; Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital Düsseldorf, Germany (V.V., T.Z.).
  • Giannini F; Heart Center Lucerne, Department of Cardiology, Luzerner Kantonsspital, Lucerne, Switzerland (S.T.).
  • Ferlini M; Department of Cardiology, Galway University Hospitals, Ireland (D.M., M.L.).
  • Naber CK; Centro Cardiologico Monzino IRCCS, Milan, Italy (F.D.M.).
  • Buono A; Interventional Cardiology Unit, GVM Care and Research, Maria Cecilia Hospital, Cotignola, Italy (F.G., L.D.I.).
  • Schofer J; Division of Cardiology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (M.F., G.L.).
  • Rottbauer W; Contilia Heart and Vascular Centre, Elisabeth-Krankenhaus Essen, Germany (C.K.N., A.W.).
  • Van Mieghem NM; Interventional Cardiology Unit, Fondazione Poliambulanza, Brescia, Italy (A.B., D.M.).
  • Khogali S; Department for Percutaneous Treatment of Structural Heart Disease, Albertinen Heart Center, Hamburg, Germany (J.S.).
  • Taramasso M; MVZ Department Structural Heart Disease, Asklepios St Georg Clinic, Hamburg, Germany (J.S.).
  • Pilgrim T; Department of Internal Medicine II, University Hospital Ulm, Germany (W.R., S.W.).
  • Sinning JM; Department of Cardiology, Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands (N.M.V.M., F.Z.).
  • Zweiker D; Heart and Lung Center, New Cross Hospital, Wolverhampton, UK (S.K.).
  • Montorfano M; Division of Cardiothoracic Surgery, HerzZentrum Hirslanden Zürich, Switzerland (M.T., M.S.).
  • Van der Heyden JAS; Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Switzerland (T.P.).
  • Brugaletta S; Department of Cardiology, Heart Center Bonn, University Hospital Bonn, Germany (J.-M.S., A. Sedaghat).
  • Ielasi A; Division of Cardiology, Medical University of Graz, Austria (D.Z., A. Schmidt).
  • Hamm CW; Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy (M. Montorfano).
  • Vanhaverbeke M; Department of Cardiology, St Antonius Hospital, Nieuwegein, the Netherlands (J.A.S.V.d.H., J.B.).
  • Costa G; Interventional Cardiology Unit, AZ Sint-Jan Hospital, Bruges, Belgium (J.A.S.V.d.H.).
  • Massussi M; Clinic Cardiovascular Institute, Hospital Clinic, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), University of Barcelona, Spain (S.B., A.R.).
  • Alarcón R; Clinical and Interventional Cardiology Unit, Istituto Clinico Sant'Ambrogio, Milan, Italy (A.I.).
  • Zeus T; Department of Cardiology and Cardiac Surgery, Kerckhoff Heart Center, Bad Nauheim, Germany (C.W.H., W.-K.K.).
  • Lunardi M; The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Denmark (M.V., L.S.).
  • Testa L; Department of Cardiology, C.A.S.T. Policlinico G. Rodolico, Catania, Italy (M.B., G.C.).
  • Di Ienno L; Cardiothoracic Department, ASST Spedali Civili di Brescia University of Brescia, Italy (M.P., M.A., M. Massussi).
  • Lanzillo G; Department of Medical Surgical Specialties, Radiological Sciences, and Public Health, University of Brescia, Italy (M.P., M.A., M. Massussi).
  • Wolf A; Cardiology Department, University Hospital Alvaro Cunqueiro, Galicia Sur Health Research Institute, Vigo, Spain (R.E.-L., R.A.).
  • Maffeo D; Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital Düsseldorf, Germany (V.V., T.Z.).
  • Ziviello F; Department of Cardiology, Galway University Hospitals, Ireland (D.M., M.L.).
  • Saccocci M; Department of Clinical and Interventional Cardiology, IRCCS Policlinico San Donato, Milan, Italy (L.T.).
  • Windecker S; Interventional Cardiology Unit, GVM Care and Research, Maria Cecilia Hospital, Cotignola, Italy (F.G., L.D.I.).
  • Sedaghat A; Division of Cardiology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (M.F., G.L.).
  • Schmidt A; Contilia Heart and Vascular Centre, Elisabeth-Krankenhaus Essen, Germany (C.K.N., A.W.).
  • Brouwer J; Interventional Cardiology Unit, Fondazione Poliambulanza, Brescia, Italy (A.B., D.M.).
  • Regueiro A; Department of Cardiology, Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands (N.M.V.M., F.Z.).
  • Reimers B; Division of Cardiothoracic Surgery, HerzZentrum Hirslanden Zürich, Switzerland (M.T., M.S.).
  • Kim WK; Department of Internal Medicine II, University Hospital Ulm, Germany (W.R., S.W.).
  • Sondergaard L; Department of Cardiology, Heart Center Bonn, University Hospital Bonn, Germany (J.-M.S., A. Sedaghat).
  • Colombo A; Division of Cardiology, Medical University of Graz, Austria (D.Z., A. Schmidt).
Circ Cardiovasc Interv ; 16(1): e012538, 2023 01.
Article in En | MEDLINE | ID: mdl-36649387
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.
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Aortic Valve Stenosis / Heart Valve Prosthesis / Transcatheter Aortic Valve Replacement Type of study: Clinical_trials / Etiology_studies / Prognostic_studies / Risk_factors_studies Limits: Humans Language: En Journal: Circ Cardiovasc Interv Journal subject: ANGIOLOGIA / CARDIOLOGIA Year: 2023 Document type: Article
Fulltext
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Aortic Valve Stenosis / Heart Valve Prosthesis / Transcatheter Aortic Valve Replacement Type of study: Clinical_trials / Etiology_studies / Prognostic_studies / Risk_factors_studies Limits: Humans Language: En Journal: Circ Cardiovasc Interv Journal subject: ANGIOLOGIA / CARDIOLOGIA Year: 2023 Document type: Article