TY - JOUR
T1 - Early and Mid-Term Results of Rapid Deployment Valves: 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
Y1 - 2018
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.
KW - Cardiology and Cardiovascular Medicine
KW - Pulmonary and Respiratory Medicine
KW - Surgery
KW - Cardiology and Cardiovascular Medicine
KW - Pulmonary and Respiratory Medicine
KW - Surgery
UR - http://hdl.handle.net/10807/130563
UR - http://www.elsevier.com/locate/athoracsur
U2 - 10.1016/j.athoracsur.2018.07.002
DO - 10.1016/j.athoracsur.2018.07.002
M3 - Article
SN - 0003-4975
VL - 106
SP - 1742
EP - 1749
JO - Annals of Thoracic Surgery
JF - Annals of Thoracic Surgery
ER -