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Transcatheter Aortic Valve Replacement With Next-Generation Self-Expanding Devices: A Multicenter, Retrospective, Propensity-Matched Comparison of Evolut PRO Versus Acurate neo Transcatheter Heart Valves.
Pagnesi, Matteo; Kim, Won-Keun; Conradi, Lenard; Barbanti, Marco; Stefanini, Giulio G; Zeus, Tobias; Pilgrim, Thomas; Schofer, Joachim; Zweiker, David; Testa, Luca; Taramasso, Maurizio; Hildick-Smith, David; Abizaid, Alexandre; Wolf, Alexander; Van Mieghem, Nicolas M; Sedaghat, Alexander; Wöhrle, Jochen; Khogali, Saib; Van der Heyden, Jan A S; Webb, John G; Estévez-Loureiro, Rodrigo; Mylotte, Darren; MacCarthy, Philip; Brugaletta, Salvatore; Hamm, Christian W; Bhadra, Oliver D; Schäfer, Ulrich; Costa, Giuliano; Tamburino, Corrado; Cannata, Francesco; Reimers, Bernhard; Veulemans, Verena; Asami, Masahiko; Windecker, Stephan; Eitan, Amnon; Schmidt, Albrecht; Bianchi, Giovanni; Bedogni, Francesco; Saccocci, Matteo; Maisano, Francesco; Alsanjari, Osama; Siqueira, Dimytri; Jensen, Christoph J; Naber, Christoph K; Ziviello, Francesca; Sinning, Jan-Malte; Seeger, Julia; Rottbauer, Wolfgang; Brouwer, Jorn; Alenezi, Abdullah.
Afiliação
  • Pagnesi M; Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy.
  • Kim WK; Department of Cardiology and Cardiac Surgery, Kerckhoff Heart and Lung Center, Bad Nauheim, Germany.
  • Conradi L; Department of Cardiovascular Surgery, University Heart Center, Hamburg, Germany.
  • Barbanti M; Department of Cardiology, C.A.S.T. Policlinic G. Rodolico Hospital, University of Catania, Catania, Italy.
  • Stefanini GG; Cardio Center, Humanitas Research Hospital, Rozzano-Milan, Italy.
  • Zeus T; Division of Cardiology, Pulmonology, and Vascular Medicine, University Hospital Düsseldorf, Düsseldorf, Germany.
  • Pilgrim T; Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
  • Schofer J; Department for Percutaneous Treatment of Structural Heart Disease, Albertinen Heart Center, Hamburg, Germany.
  • Zweiker D; Division of Cardiology, Medical University of Graz, Graz, Austria.
  • Testa L; Department of Cardiology, IRCCS Policlinico San Donato, Milan, Italy.
  • Taramasso M; Heart Valve Clinic, University Hospital of Zürich, Zürich, Switzerland.
  • Hildick-Smith D; Department of Cardiology, Royal Sussex County Hospital, Brighton, United Kingdom.
  • Abizaid A; Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil.
  • Wolf A; Contilia Heart and Vascular Centre, Elisabeth-Krankenhaus Essen, Essen, Germany.
  • Van Mieghem NM; Department of Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands.
  • Sedaghat A; Department of Medicine II, Heart Center Bonn, University Hospital Bonn, Bonn, Germany.
  • Wöhrle J; Department of Internal Medicine II, University of Ulm, Ulm, Germany.
  • Khogali S; Heart and Lung Centre, New Cross Hospital, Wolverhampton, United Kingdom.
  • Van der Heyden JAS; Department of Cardiology, St. Antonius Hospital, Nieuwegein, the Netherlands.
  • Webb JG; Centre for Heart Valve Innovation, St. Paul's and Vancouver General Hospital, Vancouver, British Columbia, Canada.
  • Estévez-Loureiro R; Department of Cardiology, Hospital of León, León, Spain.
  • Mylotte D; Department of Cardiology, Galway University Hospitals, Galway, Ireland.
  • MacCarthy P; Department of Cardiology, King's College Hospital, London, United Kingdom.
  • Brugaletta S; Clinic Cardiovascular Institute, University Hospital Clinic, IDIBAPS, Barcelona, Spain.
  • Hamm CW; Department of Cardiology and Cardiac Surgery, Kerckhoff Heart and Lung Center, Bad Nauheim, Germany.
  • Bhadra OD; Department of Cardiovascular Surgery, University Heart Center, Hamburg, Germany.
  • Schäfer U; Department of Cardiology, University Heart Center, Hamburg, Germany.
  • Costa G; Department of Cardiology, C.A.S.T. Policlinic G. Rodolico Hospital, University of Catania, Catania, Italy.
  • Tamburino C; Department of Cardiology, C.A.S.T. Policlinic G. Rodolico Hospital, University of Catania, Catania, Italy.
  • Cannata F; Cardio Center, Humanitas Research Hospital, Rozzano-Milan, Italy.
  • Reimers B; Cardio Center, Humanitas Research Hospital, Rozzano-Milan, Italy.
  • Veulemans V; Division of Cardiology, Pulmonology, and Vascular Medicine, University Hospital Düsseldorf, Düsseldorf, Germany.
  • Asami M; Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
  • Windecker S; Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
  • Eitan A; Department for Percutaneous Treatment of Structural Heart Disease, Albertinen Heart Center, Hamburg, Germany.
  • Schmidt A; Division of Cardiology, Medical University of Graz, Graz, Austria.
  • Bianchi G; Department of Cardiology, IRCCS Policlinico San Donato, Milan, Italy.
  • Bedogni F; Department of Cardiology, IRCCS Policlinico San Donato, Milan, Italy.
  • Saccocci M; Heart Valve Clinic, University Hospital of Zürich, Zürich, Switzerland.
  • Maisano F; Heart Valve Clinic, University Hospital of Zürich, Zürich, Switzerland.
  • Alsanjari O; Department of Cardiology, Royal Sussex County Hospital, Brighton, United Kingdom.
  • Siqueira D; Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil.
  • Jensen CJ; Contilia Heart and Vascular Centre, Elisabeth-Krankenhaus Essen, Essen, Germany.
  • Naber CK; Contilia Heart and Vascular Centre, Elisabeth-Krankenhaus Essen, Essen, Germany.
  • Ziviello F; Department of Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands.
  • Sinning JM; Department of Medicine II, Heart Center Bonn, University Hospital Bonn, Bonn, Germany.
  • Seeger J; Department of Internal Medicine II, University of Ulm, Ulm, Germany.
  • Rottbauer W; Department of Internal Medicine II, University of Ulm, Ulm, Germany.
  • Brouwer J; Department of Cardiology, St. Antonius Hospital, Nieuwegein, the Netherlands.
  • Alenezi A; Centre for Heart Valve Innovation, St. Paul's and Vancouver General Hospital, Vancouver, British Columbia, Canada.
JACC Cardiovasc Interv ; 12(5): 433-443, 2019 03 11.
Article em En | MEDLINE | ID: mdl-30846081
OBJECTIVES: The aim of this study was to compare transcatheter aortic valve replacement (TAVR) with the Acurate neo (NEO) and Evolut PRO (PRO) devices. BACKGROUND: The NEO and PRO bioprostheses are 2 next-generation self-expanding devices developed for TAVR. METHODS: The NEOPRO (A Multicenter Comparison of Acurate NEO Versus Evolut PRO Transcatheter Heart Valves) registry retrospectively included patients who underwent transfemoral TAVR with either NEO or PRO valves at 24 centers between January 2012 and March 2018. One-to-one propensity score matching resulted in 251 pairs. Pre-discharge and 30-day Valve Academic Research Consortium (VARC)-2 defined outcomes were evaluated. Binary logistic regression was performed to adjust the treatment effect for propensity score quintiles. RESULTS: A total of 1,551 patients (n = 1,263 NEO; n = 288 PRO) were included. The mean age was 82 years, and the mean Society of Thoracic Surgeons score was 5.1%. After propensity score matching (n = 502), VARC-2 device success (90.6% vs. 91.6%; p = 0.751) and pre-discharge moderate to severe (II+) paravalvular aortic regurgitation (7.3% vs. 5.7%; p = 0.584) were comparable between the NEO and PRO groups. Furthermore, there were no significant differences in any 30-day clinical outcome between matched NEO and PRO pairs, including all-cause mortality (3.2% vs. 1.2%; p = 0.221), stroke (2.4% vs. 2.8%; p = 1.000), new permanent pacemaker implantation (11.0% vs. 12.8%; p = 0.565), and VARC-2 early safety endpoint (10.6% vs. 10.4%; p = 1.000). Logistic regression on the unmatched cohort confirmed a similar risk of VARC-2 device success, paravalvular aortic regurgitation II+, and 30-day clinical outcomes after NEO and PRO implantation. CONCLUSIONS: In this multicenter registry, transfemoral TAVR with the NEO and PRO bioprostheses was associated with high device success, acceptable rates of paravalvular aortic regurgitation II+, and good 30-day clinical outcomes. After adjusting for potential confounders, short-term outcomes were similar between the devices.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Valva Aórtica / Estenose da Valva Aórtica / Bioprótese / Próteses Valvulares Cardíacas / Substituição da Valva Aórtica Transcateter Tipo de estudo: Etiology_studies / Observational_studies / Risk_factors_studies Limite: Aged / Aged80 / Female / Humans / Male Idioma: En Ano de publicação: 2019 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Valva Aórtica / Estenose da Valva Aórtica / Bioprótese / Próteses Valvulares Cardíacas / Substituição da Valva Aórtica Transcateter Tipo de estudo: Etiology_studies / Observational_studies / Risk_factors_studies Limite: Aged / Aged80 / Female / Humans / Male Idioma: En Ano de publicação: 2019 Tipo de documento: Article