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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 A; Wolf, Alexander; Van Mieghem, Nicolas M; Sedaghat, Alexander; Wöhrle, Jochen; Khogali, Saib; Heyden, Jan A S Van Der; Webb, John G; Loureiro, Rodrigo Estévez; Mylotte, Darren; MacCarthy, Philip; Brugaletta, Salvatore; Hamm, Christian W; Bhadra, Oliver D; Schäfer, Ulrich; Costa, Giuliano; Tamburino, Corrado; Cannata, Francesco; Reimers, Benhard5; Veulemans, Verena; Asami, Masahiko; Windecker, Stephan; Eitan, Amnon; Schmidt, Albrecht; Bianchi, Giovanni; Bedogni, Francesco; Saccocci, Matteo; Maisano, Francesco; Alsanjari, Osama; Siqueira, Dimytri; Latib, Azeem; Colombo, Antonio; Jensen, Christop; Naber, Christoph K; Ziviello, Francesca; Sinning, Jan Malte; Seeger, Julia; Rottbauer, Wolfgang; Brouwer, Jorn; Alenezi, Abdullah; Wood, David A; Tzalamouras, Vasileios; Regueiro, Ander.
Affiliation
  • Pagnesi, Matteo; San Raffaele Scientific Institute. Milão. IT
  • Kim, Won Keun; Kerckhoff Heart and Lung Center Bad Nauheim. Bad Nauheim. DE
  • Conradi, Lenard; University Heart Center Hamburg. Hamburgo. DE
  • Barbanti, Marco; University of Catania. Department of Cardiology C.A.S.T. Policlinic G. Rodolico Hospital. Catânia. IT
  • Stefanini, Giulio G; Cardio Center Humanitas Research Hospital. Rozzano. IT
  • Zeus, Tobias; University Hospital Düsseldorf. Düsseldorf. DE
  • Pilgrim, Thomas; Department of Cardiology Inselspital. Bern University Hospital. University of Bern. CH
  • Schofer, Joachim; Department for Percutaneous Treatment of Structural Heart Disease Albertinen Heart Center. Hamburgo. DE
  • Zweiker, David; Medical University of Graz. Graz. AT
  • Testa, Luca; IRCCS Policlinico San Donato. Milão. IT
  • Taramasso, Maurizio; Heart Valve Clinic University Hospital of Zürich. Zurique. CH
  • Hildick, Smith David; Royal Sussex County Hospital Brighton. Brighton. NL
  • Abizaid, Alexandre A; Instituto Dante Pazzanese de Cardiologia. São Paulo. BR
  • Wolf, Alexander; Contilia Heart and Vascular Centre Elisabeth Krankenhaus Essen. Essen. DE
  • Van Mieghem, Nicolas M; Department of Cardiology Thoraxcenter Erasmus Medical Center. Roterdã. NL
  • Sedaghat, Alexander; Department of Medicine II Heart Center bonn University Hospital bonn. Bonn. DE
  • Wöhrle, Jochen; Department of Internal Medicine II University of Ulm. Ulm. DE
  • Khogali, Saib; Heart and Lung Centre New Cross Hospital Wolverhampton. Wolverhampton. GB
  • Heyden, Jan A S Van Der; Department of Cardiology St. Antonius Hospital Nieuwegein. Nieuwegein. NL
  • Webb, John G; Centre for Heart Valve Innovation St. Paul's and Vancouver General Hospital. vancouver. CA
  • Loureiro, Rodrigo Estévez; Department of Cardiology Hospital of León. León. ES
  • Mylotte, Darren; Department of Cardiology Galway University Hospitals. Galway. IE
  • MacCarthy, Philip; Department of Cardiology King's College Hospital London. Londres. GB
  • Brugaletta, Salvatore; Cardiovascular Institute University Hospital Clinic IDIBAPS. Barcelona. ES
  • Hamm, Christian W; Department of Cardiology and Cardiac Surgery Kerckhoff, Heart and Lung Center Bad Nauheim. Bad Nauheim. DE
  • Bhadra, Oliver D; Surgery University Heart Center Hamburg. Hamburgo. DE
  • Schäfer, Ulrich; University Heart Center, Hamburg. Hamburgo. DE
  • Costa, Giuliano; Department of Cardiology C.A.S.T. Policlinic G. Rodolico Hospital. University of Catania. Catânia. IT
  • Tamburino, Corrado; Department of Cardiology C.A.S.T. Policlinic G. Rodolico Hospital. University of Catania. Catânia. IT
  • Cannata, Francesco; Humanitas Research Hospital. Rozzano. IT
  • Reimers, Benhard5; Humanitas Research Hospital. Rozzano. IT
  • Veulemans, Verena; Division of Cardiology Pulmonology, and Vascular Medicine, University Hospital Düsseldorf. Düsseldorf. DE
  • Asami, Masahiko; Department of Cardiology Inselspital, Bern University Hospital. University of Bern. Berna. CH
  • Windecker, Stephan; Department of Cardiology Inselspital, Bern University Hospital. University of Bern. Berna. CH
  • Eitan, Amnon; Department for Percutaneous Treatment of Structural Heart Disease Albertinen Heart Center. Hamburgo. DE
  • Schmidt, Albrecht; Division of Cardiology, Medical University of Graz. Graz. AT
  • Bianchi, Giovanni; IRCCS Policlinico San Donato. San Donato Milanese. IT
  • Bedogni, Francesco; IRCCS Policlinico San Donato. San Donato Milanese. IT
  • Saccocci, Matteo; Heart Valve Clinic, University Hospital of Zürich. Zurique. CH
  • Maisano, Francesco; Heart Valve Clinic, University Hospital of Zürich. Zurique. CH
  • Alsanjari, Osama; Department of Cardiology Royal Sussex County Hospital Brighton. Brighton. GB
  • Siqueira, Dimytri; Instituto Dante Pazzanese de Cardiologia. São Paulo. BR
  • Latib, Azeem; San Raffaele Scientific Institute. Milão. IT
  • Colombo, Antonio; San Raffaele Scientific Institute. Milão. IT
  • Jensen, Christop; Vascular Centre Elisabeth-Krankenhaus. Essen. DE
  • Naber, Christoph K; Vascular Centre Elisabeth-Krankenhaus. Essen. DE
  • Ziviello, Francesca; Center Erasmus Medical Center, Rotterdam. Roterdão. NL
  • Sinning, Jan Malte; Department of Heart Center Bonn University Hospital Bonn. Bonn. DE
  • Seeger, Julia; Department of Internal Medicine II University of Ulm. Ulm. DE
  • Rottbauer, Wolfgang; Department of Internal Medicine II University of Ulm. Ulm. DE
  • Brouwer, Jorn; Department of Cardiology St. Antonius Hospital. Nieuwegein. NL
  • Alenezi, Abdullah; Vancouver General Hospital. Vancouver. CA
  • Wood, David A; Vancouver General Hospital. Vancouver. CA
  • Tzalamouras, Vasileios; Department of Cardiology King's College Hospital of London. Londres. GB
  • Regueiro, Ander; Cardiovascular Institute University Hospital Clinic IDIBAPS. Barcelona. ES
JACC cardiovasc. interv ; 12(5): 433-443, Mar. 2019. tabela, gráfico
Article in En | SES-SP, SESSP-IDPCPROD, SES-SP | ID: biblio-1024526
Responsible library: BR79.1
Localization: BR79.1
ABSTRACT
Abstract

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:

(AU)
Subject(s)
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Collection: 06-national / BR Database: SES-SP / SESSP-IDPCPROD Main subject: Transcatheter Aortic Valve Replacement Type of study: Clinical_trials / Risk_factors_studies Limits: Humans Language: En Journal: JACC cardiovasc. interv Year: 2019 Document type: Article
Search on Google
Collection: 06-national / BR Database: SES-SP / SESSP-IDPCPROD Main subject: Transcatheter Aortic Valve Replacement Type of study: Clinical_trials / Risk_factors_studies Limits: Humans Language: En Journal: JACC cardiovasc. interv Year: 2019 Document type: Article