D'Onofrio, Augusto, Tessari, Chiara, Filippini, Claudia, Bagozzi, Lorenzo, Diena, Marco, Alamanni, Francesco, Massetti, Massimo, Livi, Ugolino, Di Eusanio, Marco, Mignosa, Carmelo, Russo, Claudio, Rinaldi, Mauro, Di Bartolomeo, Roberto, Salvador, Loris, Antona, Carlo, Maselli, Daniele, De Paulis, Ruggero, Luzi, Giampaolo, Alfieri, Ottavio, De Filippo, Carlo Maria, Portoghese, Michele, Musumeci, Francesco, Bortolotti, Uberto, Gerosa, Gino and Rahmanian, Parwis B. ORCID: 0000-0002-3978-9251 (2018). Early and Mid-Term Results of Rapid Deployment Valves: The Intuity Italian Registry (INTU-ITA). Ann. Thorac. Surg., 106 (6). S. 1742 - 1752. NEW YORK: ELSEVIER SCIENCE INC. ISSN 1552-6259

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Abstract

Background. Rapid deployment bioprostheses (RDBs) have been recently introduced into clinical practice for the treatment of severe aortic valve stenosis. The aim of this retrospective multicenter study was to assess early and mid-term clinical and hemodynamic outcomes of patients undergoing RDB implantation. Methods. Data from a national registry that included patients who underwent isolated or combined aortic valve replacement with RDB in Italy were analyzed. Definitions of the European System for Cardiac Operative Risk Evaluation were used for preoperative variables and updated definitions from the Valve Academic Research Consortium were used for postoperative outcomes assessment. Univariable and multivariable analyses were performed to identify independent predictors of mortality. Follow-up was performed with clinical and echocardiographic examinations at each study site and, if this was not possible, through telephonic interviews. The Kaplan-Meier method was used for survival analysis. Results. A total of 902 patients (December 2012 through November 2017) from 20 national centers were included in the registry. Device success was 95.9%, and 30-day all-cause mortality was 2.8%. Postoperative pacemaker implantation was needed in 63 patients (6.9%). At discharge, peak and mean transaortic gradients were 19 +/- 7 mm Hg and 11 +/- 4 mm Hg, respectively. Mild and moderate aortic regurgitation were found in 71 patients (8.2%) and in 10 patients (1.2%), respectively. Median follow-up time was 357 days (interquartile range: 103 to 638 days). Survival at 4 years was 86% +/- 1%. Preoperative conduction disturbances and history of previous myocardial infarction were independently associated with mortality. Conclusions. Aortic RDBs provide good early and midterm clinical and hemodynamic outcomes. These devices may be considered as a reasonable alternative to conventional bioprostheses, especially in minimally invasive and combined operations. (C) 2018 by The Society of Thoracic Surgeons

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
D'Onofrio, AugustoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Tessari, ChiaraUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Filippini, ClaudiaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bagozzi, LorenzoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Diena, MarcoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Alamanni, FrancescoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Massetti, MassimoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Livi, UgolinoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Di Eusanio, MarcoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mignosa, CarmeloUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Russo, ClaudioUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rinaldi, MauroUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Di Bartolomeo, RobertoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Salvador, LorisUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Antona, CarloUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Maselli, DanieleUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
De Paulis, RuggeroUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Luzi, GiampaoloUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Alfieri, OttavioUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
De Filippo, Carlo MariaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Portoghese, MicheleUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Musumeci, FrancescoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bortolotti, UbertoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gerosa, GinoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rahmanian, Parwis B.UNSPECIFIEDorcid.org/0000-0002-3978-9251UNSPECIFIED
URN: urn:nbn:de:hbz:38-164722
DOI: 10.1016/j.athoracsur.2018.07.002
Journal or Publication Title: Ann. Thorac. Surg.
Volume: 106
Number: 6
Page Range: S. 1742 - 1752
Date: 2018
Publisher: ELSEVIER SCIENCE INC
Place of Publication: NEW YORK
ISSN: 1552-6259
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
PERMANENT PACEMAKER IMPLANTATION; INTERMEDIATE-RISK; AORTIC-STENOSIS; REPLACEMENT; OUTCOMES; TRANSCATHETER; MULTICENTER; TRIAL; PREDICTORSMultiple languages
Cardiac & Cardiovascular Systems; Respiratory System; SurgeryMultiple languages
Refereed: Yes
URI: http://kups.ub.uni-koeln.de/id/eprint/16472

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