Early and mid-term outcomes of 1904 patients undergoing transcatheter balloon-expandable valve implantation in Italy: results from the Italian Transcatheter Balloon-Expandable Valve Implantation Registry (ITER)

S. Salizzoni, A. D'Onofrio, M. Agrifoglio, A. Colombo, A. Chieffo, M. Cioni, L. Besola, T. Regesta, F. Rapetto, G. Tarantini, M. Napodano, D. Gabbieri, F. Saia, C. Tamburino, F. Ribichini, D. Cugola, M. Aiello, F. Sanna, A. Iadanza, E. PompeiP. Stefano, A. Cappai, A. Minati, M. Cassese, G. L. Martinelli, A. Agostinelli, R. Fiorilli, F. Casilli, M. Reale, F. Bedogni, A. S. Petronio, R. A. Mozzillo, R. Bonmassari, C. Briguori, A. Liso, G. Sardella, G. Bruschi, C. Fiorina, C. Filippini, C. Moretti, M. D'Amico, M. La Torre, F. Conrotto, R. Di Bartolomeo, G. Gerosa, M. Rinaldi, TAVI Team

Research output: Contribution to journalArticle

Abstract

OBJECTIVES: The aim of this multicentre study is to report the clinical experiences of all patients undergoing transcatheter aortic valve implantation (TAVI) with a balloon-expandable device in Italy. METHODS: The Italian Transcatheter balloon-Expandable valve Registry (ITER) is a real-world registry that includes patients who have undergone TAVI with the Sapien (Edwards Lifesciences, Irvine, CA, USA) bioprosthesis in Italy since it became available in clinical practice. From 2007 to 2012, 1904 patients were enrolled to undergo TAVI in 33 Italian centres. Outcomes were classified according to the updated Valve Academic Research Consortium (VARC-2) definitions. A multivariable analysis was performed to identify independent predictors of all-cause mortality. RESULTS: Mean age was 81.7 (SD:6.2) years, and 1147 (60.2%) patients were female. Mean Logistic EuroSCORE was 21.1% (SD:13.7). Transfemoral, transapical, transaortic and transaxillary TAVI was performed in 1252 (65.8%), 630 (33.1%), 18 (0.9%) and 4 (0.2%) patients, respectively. Operative mortality was 7.2% (137 patients). The VARC-2 outcomes were as follows: device success, 88.1%; disabling stroke, 1.0%; life-threatening and major bleeding 9.8 and 10.5%, respectively; major vascular complication, 9.7%; acute kidney injury, 8.2%; acute myocardial infarction
Original languageEnglish
Pages (from-to)1139-1148
Number of pages10
JournalEuropean Journal of Cardio-thoracic Surgery
Volume50
Issue number6
DOIs
Publication statusPublished - Dec 1 2016

Keywords

  • Aged
  • Aged, 80 and over
  • Aortic Valve Stenosis/diagnostic imaging/surgery
  • Bioprosthesis
  • Echocardiography
  • Female
  • Heart Valve Prosthesis
  • Humans
  • Italy
  • Male
  • Registries
  • Transcatheter Aortic Valve Replacement/adverse effects/instrumentation/methods/mortality
  • Treatment Outcome
  • Aortic stenosis
  • Registry
  • TAVI

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    Salizzoni, S., D'Onofrio, A., Agrifoglio, M., Colombo, A., Chieffo, A., Cioni, M., Besola, L., Regesta, T., Rapetto, F., Tarantini, G., Napodano, M., Gabbieri, D., Saia, F., Tamburino, C., Ribichini, F., Cugola, D., Aiello, M., Sanna, F., Iadanza, A., ... Team, TAVI. (2016). Early and mid-term outcomes of 1904 patients undergoing transcatheter balloon-expandable valve implantation in Italy: results from the Italian Transcatheter Balloon-Expandable Valve Implantation Registry (ITER). European Journal of Cardio-thoracic Surgery, 50(6), 1139-1148. https://doi.org/10.1093/ejcts/ezw218 [doi]