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Clinical and Hemodynamic Outcomes of Rapid-Deployment Aortic Bioprostheses.
D'Onofrio, Augusto; Tessari, Chiara; Cibin, Giorgia; Lorenzoni, Giulia; Martinelli, Gian Luca; Solinas, Marco; Gerosa, Gino; Gregori, Dario; Alamanni, Francesco; Polvani, Gianluca; Massetti, Massimo; Eusanio, Marco Di; Merlo, Maurizio; Vendramin, Igor; Mangino, Domenico; Mignosa, Carmelo; Russo, Claudio; Rinaldi, Mauro; De Paulis, Ruggero; Pacini, Davide; Luzi, Giampaolo; Antona, Carlo; Salvador, Loris; Musumeci, Francesco; Maselli, Daniele; Colli, Andrea; Portoghese, Michele; Alfieri, Ottavio; De Filippo, Carlo Maria.
Afiliación
  • D'Onofrio A; Division of Cardiac Surgery, University of Padova, Padova, Italy. Electronic address: adonofrio@hotmail.it.
  • Tessari C; Division of Cardiac Surgery, University of Padova, Padova, Italy.
  • Cibin G; Division of Cardiac Surgery, University of Padova, Padova, Italy.
  • Lorenzoni G; Division of Biostatistics, University of Padova, Padova, Italy.
  • Martinelli GL; Division of Cardiac Surgery, San Gaudenzio Hospital, Novara, Italy.
  • Solinas M; Division of Cardiac Surgery, Ospedale del Cuore "G. Pasquinucci", Massa.
  • Gerosa G; Division of Cardiac Surgery, University of Padova, Padova, Italy.
  • Gregori D; Division of Biostatistics, University of Padova, Padova, Italy.
  • Alamanni F; Departments of Cardiac Surgery, Centro Cardiologico Monzino, Milan, Italy.
  • Polvani G; Departments of Cardiac Surgery, Centro Cardiologico Monzino, Milan, Italy.
  • Massetti M; Departments of Cardiac Surgery, Policlinico Universitario Agostino Gemelli, Catholic University, Rome, Italy.
  • Eusanio MD; Departments of Cardiac Surgery, Ospedali Riuniti, Ancona, Italy.
  • Merlo M; Departments of Cardiac Surgery, Papa Giovanni XXIII Hospital, Bergamo, Italy.
  • Vendramin I; Departments of Cardiac Surgery, S. Maria della Misericordia Hospital - University of Udine, Udine, Italy.
  • Mangino D; Departments of Cardiac Surgery, L'Angelo Hospital, Mestre-Venezia, Italy.
  • Mignosa C; Departments of Cardiac Surgery, G.B. Morgagni Hospital, Catania, Italy.
  • Russo C; Departments of Cardiac Surgery, Niguarda Hospital, Milan, Italy.
  • Rinaldi M; Departments of Cardiac Surgery, University Hospital of Turin, Turin, Italy.
  • De Paulis R; Departments of Cardiac Surgery, European Hospital, Roma, Italy.
  • Pacini D; Departments of Cardiac Surgery, University Hospital of Bologna, Bologna, Italy.
  • Luzi G; Departments of Cardiac Surgery, San Carlo Hospital, Potenza, Italy.
  • Antona C; Departments of Cardiac Surgery, Sacco Hospital, Milan, Italy.
  • Salvador L; Departments of Cardiac Surgery, San Bortolo Hospital, Vicenza, Italy.
  • Musumeci F; Departments of Cardiac Surgery, San Camillo Hospital, Roma, Italy.
  • Maselli D; Departments of Cardiac Surgery, S. Anna Hospital, Catanzaro, Italy.
  • Colli A; Departments of Cardiac Surgery, University Hospital of Pisa, Pisa, Italy.
  • Portoghese M; Departments of Cardiac Surgery, Santissima Annunziata Hospital, Sassari, Italy.
  • Alfieri O; Departments of Cardiac Surgery, San Raffaele University Hospital, Milano, Italy.
  • De Filippo CM; Departments of Cardiac Surgery, Giovanni Paolo II Hospital, Campobasso, Italy.
Semin Thorac Cardiovasc Surg ; 34(2): 453-461, 2022.
Article en En | MEDLINE | ID: mdl-33979664
Aim of this retrospective, multicenter study was to evaluate early and mid-term clinical and hemodynamic results of patients who underwent surgical aortic valve replacement (SAVR) with Intuity rapid-deployment bioprostheses (RDB) (Edwards Lifesciences, Irvine, CA). We analyzed data from the Italian Registry of Intuity Valve (INTU-ITA registry) that is a national, real-world and independent from the industry registry. Preoperative variables were defined according to EuroSCORE and postoperative outcomes according to Valve Academic Research Consortium (VARC). Survival distribution was evaluated using the Kaplan-Meier approach. A Cox-Proportional Hazard Model was employed to assess the effect of the covariates on patients' survival. The registry included 1687 patients from 23 centers (June 2012-September 2019). Aortic cross clamp time for isolated SAVR was 55 minutes (IQR: 45-70 minute). Postoperative pace-maker rate was 6.3%. At discharge transaortic peak and mean gradients were: 18 mm Hg (IQR: 14-23 mm Hg) and 10 mmHg (IQR: 8-13 mm Hg), respectively. Indexed effective orifice area was 1.10 cm2/m2 (IQR: 0.91-1.31 cm2/m2) and the incidence of severe patient-prosthesis mismatch was 0.6%. Hemodynamic data for all valve sizes remained stable during follow-up. Thirty-day overall mortality was 1.8% (30 patients), and at follow-up it was 5.3% (89 patients). Kaplan-Meier overall survival was 95.5% (94.3-96.7%); 90.7% (88.3-93.1%); 86.4% (82.6-90.4%) at 1, 3, and 5 years, respectively. Serum creatinine (HR: 1.36; 95%CI: 1.04-1.81; p = 0.0397) and cross-clamp time (HR: 1.01; 95%CI: 1.002-1.017; p = 0.0077) were identified as independent predictors of mortality. According to our data from the INTU-ITA registry, SAVR with RDB provides good early clinical and hemodynamic results that are confirmed at follow-up.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Estenosis de la Válvula Aórtica / Bioprótesis / Prótesis Valvulares Cardíacas / Implantación de Prótesis de Válvulas Cardíacas Tipo de estudio: Observational_studies / Prognostic_studies / Risk_factors_studies Límite: Humans Idioma: En Revista: Semin Thorac Cardiovasc Surg Asunto de la revista: ANGIOLOGIA / CARDIOLOGIA Año: 2022 Tipo del documento: Article Pais de publicación: Estados Unidos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Estenosis de la Válvula Aórtica / Bioprótesis / Prótesis Valvulares Cardíacas / Implantación de Prótesis de Válvulas Cardíacas Tipo de estudio: Observational_studies / Prognostic_studies / Risk_factors_studies Límite: Humans Idioma: En Revista: Semin Thorac Cardiovasc Surg Asunto de la revista: ANGIOLOGIA / CARDIOLOGIA Año: 2022 Tipo del documento: Article Pais de publicación: Estados Unidos