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)

Stefano Salizzoni, A. D'Onofrio, M. Agrifoglio, A. Colombo, A. Chieffo, M. Cioni, Laura Besola, Tommaso Regesta, Filippo Rapetto, G. Tarantini, Massimo Napodano, Davide Gabbieri, Francesco Saia, Corrado Tamburino, Flavio Ribichini, Diego Cugola, M. Aiello, Francesca Sanna, A. Iadanza, E. PompeiP. Di Stefano, Antonello Cappai, Alessandro Minati, Mauro Cassese, G. L. Martinelli, Alessandro Agostinelli, Rosario Fiorilli, F. Casilli, M. Reale, F. Bedogni, A. Sonia Petronio, Rosa Alba Mozzillo, Roberto Bonmassari, C. Briguori, Armando Liso, Savino G. Sardella, G. Bruschi, Claudia Fiorina, C. Filippini, C. Moretti, M. D'Amico, M. Torre, Federico Conrotto, Rosa Bartolomeo, G. Gerosa, M. 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
Publication statusPublished - 2016

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Italy
Registries
Bioprosthesis
Equipment and Supplies
Mortality
Acute Kidney Injury
Multicenter Studies
Blood Vessels
Stroke
Myocardial Infarction
Hemorrhage
Transcatheter Aortic Valve Replacement
Research

Keywords

  • Aortic stenosis
  • Registry
  • TAVI

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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). / Salizzoni, Stefano; D'Onofrio, A.; Agrifoglio, M.; Colombo, A.; Chieffo, A.; Cioni, M.; Besola, Laura; Regesta, Tommaso; Rapetto, Filippo; Tarantini, G.; Napodano, Massimo; Gabbieri, Davide; Saia, Francesco; Tamburino, Corrado; Ribichini, Flavio; Cugola, Diego; Aiello, M.; Sanna, Francesca; Iadanza, A.; Pompei, E.; Di Stefano, P.; Cappai, Antonello; Minati, Alessandro; Cassese, Mauro; Martinelli, G. L.; Agostinelli, Alessandro; Fiorilli, Rosario; Casilli, F.; Reale, M.; Bedogni, F.; Petronio, A. Sonia; Mozzillo, Rosa Alba; Bonmassari, Roberto; Briguori, C.; Liso, Armando; Sardella, Savino G.; Bruschi, G.; Fiorina, Claudia; Filippini, C.; Moretti, C.; D'Amico, M.; Torre, M.; Conrotto, Federico; Bartolomeo, Rosa; Gerosa, G.; Rinaldi, M. M.; Team, TAVI.

In: European Journal of Cardio-thoracic Surgery, Vol. 50, No. 6, 2016, p. 1139-1148.

Research output: Contribution to journalArticle

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, Pompei, E, Di Stefano, P, Cappai, A, Minati, A, Cassese, M, Martinelli, GL, Agostinelli, A, Fiorilli, R, Casilli, F, Reale, M, Bedogni, F, Petronio, AS, Mozzillo, RA, Bonmassari, R, Briguori, C, Liso, A, Sardella, SG, Bruschi, G, Fiorina, C, Filippini, C, Moretti, C, D'Amico, M, Torre, M, Conrotto, F, Bartolomeo, R, Gerosa, G, Rinaldi, MM & 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, vol. 50, no. 6, pp. 1139-1148.
Salizzoni, Stefano ; D'Onofrio, A. ; Agrifoglio, M. ; Colombo, A. ; Chieffo, A. ; Cioni, M. ; Besola, Laura ; Regesta, Tommaso ; Rapetto, Filippo ; Tarantini, G. ; Napodano, Massimo ; Gabbieri, Davide ; Saia, Francesco ; Tamburino, Corrado ; Ribichini, Flavio ; Cugola, Diego ; Aiello, M. ; Sanna, Francesca ; Iadanza, A. ; Pompei, E. ; Di Stefano, P. ; Cappai, Antonello ; Minati, Alessandro ; Cassese, Mauro ; Martinelli, G. L. ; Agostinelli, Alessandro ; Fiorilli, Rosario ; Casilli, F. ; Reale, M. ; Bedogni, F. ; Petronio, A. Sonia ; Mozzillo, Rosa Alba ; Bonmassari, Roberto ; Briguori, C. ; Liso, Armando ; Sardella, Savino G. ; Bruschi, G. ; Fiorina, Claudia ; Filippini, C. ; Moretti, C. ; D'Amico, M. ; Torre, M. ; Conrotto, Federico ; Bartolomeo, Rosa ; Gerosa, G. ; Rinaldi, M. M. ; Team, TAVI. / 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). In: European Journal of Cardio-thoracic Surgery. 2016 ; Vol. 50, No. 6. pp. 1139-1148.
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title = "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)",
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",
keywords = "Aortic stenosis, Registry, TAVI",
author = "Stefano Salizzoni and A. D'Onofrio and M. Agrifoglio and A. Colombo and A. Chieffo and M. Cioni and Laura Besola and Tommaso Regesta and Filippo Rapetto and G. Tarantini and Massimo Napodano and Davide Gabbieri and Francesco Saia and Corrado Tamburino and Flavio Ribichini and Diego Cugola and M. Aiello and Francesca Sanna and A. Iadanza and E. Pompei and {Di Stefano}, P. and Antonello Cappai and Alessandro Minati and Mauro Cassese and Martinelli, {G. L.} and Alessandro Agostinelli and Rosario Fiorilli and F. Casilli and M. Reale and F. Bedogni and Petronio, {A. Sonia} and Mozzillo, {Rosa Alba} and Roberto Bonmassari and C. Briguori and Armando Liso and Sardella, {Savino G.} and G. Bruschi and Claudia Fiorina and C. Filippini and C. Moretti and M. D'Amico and M. Torre and Federico Conrotto and Rosa Bartolomeo and G. Gerosa and Rinaldi, {M. M.} and TAVI Team",
note = "LR: 20170208; CI: (c) The Author 2016; JID: 8804069; OTO: NOTNLM; 2015/06/29 [received]; 2016/04/08 [revised]; 2016/04/13 [accepted]; ppublish M1 - Journal Article",
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T1 - 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)

AU - Salizzoni, Stefano

AU - D'Onofrio, A.

AU - Agrifoglio, M.

AU - Colombo, A.

AU - Chieffo, A.

AU - Cioni, M.

AU - Besola, Laura

AU - Regesta, Tommaso

AU - Rapetto, Filippo

AU - Tarantini, G.

AU - Napodano, Massimo

AU - Gabbieri, Davide

AU - Saia, Francesco

AU - Tamburino, Corrado

AU - Ribichini, Flavio

AU - Cugola, Diego

AU - Aiello, M.

AU - Sanna, Francesca

AU - Iadanza, A.

AU - Pompei, E.

AU - Di Stefano, P.

AU - Cappai, Antonello

AU - Minati, Alessandro

AU - Cassese, Mauro

AU - Martinelli, G. L.

AU - Agostinelli, Alessandro

AU - Fiorilli, Rosario

AU - Casilli, F.

AU - Reale, M.

AU - Bedogni, F.

AU - Petronio, A. Sonia

AU - Mozzillo, Rosa Alba

AU - Bonmassari, Roberto

AU - Briguori, C.

AU - Liso, Armando

AU - Sardella, Savino G.

AU - Bruschi, G.

AU - Fiorina, Claudia

AU - Filippini, C.

AU - Moretti, C.

AU - D'Amico, M.

AU - Torre, M.

AU - Conrotto, Federico

AU - Bartolomeo, Rosa

AU - Gerosa, G.

AU - Rinaldi, M. M.

AU - Team, TAVI

N1 - LR: 20170208; CI: (c) The Author 2016; JID: 8804069; OTO: NOTNLM; 2015/06/29 [received]; 2016/04/08 [revised]; 2016/04/13 [accepted]; ppublish M1 - Journal Article

PY - 2016

Y1 - 2016

N2 - 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

AB - 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

KW - Aortic stenosis

KW - Registry

KW - TAVI

M3 - Article

VL - 50

SP - 1139

EP - 1148

JO - European Journal of Cardio-thoracic Surgery

JF - European Journal of Cardio-thoracic Surgery

SN - 1010-7940

IS - 6

ER -