Early and Mid-Term Results of Rapid Deployment Valves: The Intuity Italian Registry (INTU-ITA)

Augusto D'Onofrio, Chiara Tessari, Claudia Filippini, Lorenzo Bagozzi, Marco Diena, Francesco Alamanni, Massimo Massetti, Ugolino Livi, Marco Di Eusanio, Carmelo Mignosa, Claudio Russo, Mauro Rinaldi, Roberto Di Bartolomeo, Loris Salvador, Carlo Antona, Daniele Maselli, Ruggero De Paulis, Giampaolo Luzi, Ottavio Alfieri, Carlo Maria De FilippoMichele Portoghese, Francesco Musumeci, Uberto Bortolotti, Gino Gerosa

Research output: Contribution to journalArticle

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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 mid-term clinical and hemodynamic outcomes. These devices may be considered as a reasonable alternative to conventional bioprostheses, especially in minimally invasive and combined operations.

Original languageEnglish
Pages (from-to)1742-1749
Number of pages8
JournalAnnals of Thoracic Surgery
Volume106
Issue number6
DOIs
Publication statusPublished - Dec 1 2018

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Bioprosthesis
Registries
Mortality
Hemodynamics
Equipment and Supplies
Aortic Valve Insufficiency
Aortic Valve Stenosis
Survival Analysis
Aortic Valve
Italy
Multicenter Studies
Retrospective Studies
Myocardial Infarction
Outcome Assessment (Health Care)
Interviews
Survival
Research

ASJC Scopus subject areas

  • Surgery
  • Pulmonary and Respiratory Medicine
  • Cardiology and Cardiovascular Medicine

Cite this

Early and Mid-Term Results of Rapid Deployment Valves : The Intuity Italian Registry (INTU-ITA). / 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.

In: Annals of Thoracic Surgery, Vol. 106, No. 6, 01.12.2018, p. 1742-1749.

Research output: Contribution to journalArticle

D'Onofrio, A, Tessari, C, Filippini, C, Bagozzi, L, Diena, M, Alamanni, F, Massetti, M, Livi, U, Di Eusanio, M, Mignosa, C, Russo, C, Rinaldi, M, Di Bartolomeo, R, Salvador, L, Antona, C, Maselli, D, De Paulis, R, Luzi, G, Alfieri, O, De Filippo, CM, Portoghese, M, Musumeci, F, Bortolotti, U & Gerosa, G 2018, 'Early and Mid-Term Results of Rapid Deployment Valves: The Intuity Italian Registry (INTU-ITA)', Annals of Thoracic Surgery, vol. 106, no. 6, pp. 1742-1749. https://doi.org/10.1016/j.athoracsur.2018.07.002
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. / Early and Mid-Term Results of Rapid Deployment Valves : The Intuity Italian Registry (INTU-ITA). In: Annals of Thoracic Surgery. 2018 ; Vol. 106, No. 6. pp. 1742-1749.
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T1 - Early and Mid-Term Results of Rapid Deployment Valves

T2 - The Intuity Italian Registry (INTU-ITA)

AU - D'Onofrio, Augusto

AU - Tessari, Chiara

AU - Filippini, Claudia

AU - Bagozzi, Lorenzo

AU - Diena, Marco

AU - Alamanni, Francesco

AU - Massetti, Massimo

AU - Livi, Ugolino

AU - Di Eusanio, Marco

AU - Mignosa, Carmelo

AU - Russo, Claudio

AU - Rinaldi, Mauro

AU - Di Bartolomeo, Roberto

AU - Salvador, Loris

AU - Antona, Carlo

AU - Maselli, Daniele

AU - De Paulis, Ruggero

AU - Luzi, Giampaolo

AU - Alfieri, Ottavio

AU - De Filippo, Carlo Maria

AU - Portoghese, Michele

AU - Musumeci, Francesco

AU - Bortolotti, Uberto

AU - Gerosa, Gino

PY - 2018/12/1

Y1 - 2018/12/1

N2 - 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 mid-term clinical and hemodynamic outcomes. These devices may be considered as a reasonable alternative to conventional bioprostheses, especially in minimally invasive and combined operations.

AB - 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 mid-term clinical and hemodynamic outcomes. These devices may be considered as a reasonable alternative to conventional bioprostheses, especially in minimally invasive and combined operations.

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