Mitral Valve Replacement with a Third Generation Porcine Valve: an Italian Multicentered Study

Roberto Lorusso; Antonio Miceli; Sandro Gelsomino; Antonio Lio; Orlando Parise; Andrea Montisci; Enrico Vizzardi; Davide Pacini; Roberto Di Bartolomeo; Attilio Renzulli; Filiberto G Serraino; Chiara Comoglio; Roberta Liberi; GianLuca Martinelli; Alfonso Sciangula; Alessandro Mazzola; Francesca Faragalli; Michele De Bonis; Maurizio Taramasso; Ottavio Alfieri; Philippe Caimmi; Ezio Micalizzi; Domenico Mercogliano; Gloria Demicheli; Michele Celiento; Uberto Bortolotti; Marco Solinas; Mattia Glauber

doi:10.1016/j.athoracsur.2019.08.111

Mitral Valve Replacement with a Third Generation Porcine Valve: an Italian Multicentered Study

Roberto Lorusso^*, Antonio Miceli, Sandro Gelsomino, Antonio Lio, Orlando Parise, Andrea Montisci, Enrico Vizzardi, Davide Pacini, Roberto Di Bartolomeo, Attilio Renzulli, Filiberto G Serraino, Chiara Comoglio, Roberta Liberi, GianLuca Martinelli, Alfonso Sciangula, Alessandro Mazzola, Francesca Faragalli, Michele De Bonis, Maurizio Taramasso, Ottavio AlfieriPhilippe Caimmi, Ezio Micalizzi, Domenico Mercogliano, Gloria Demicheli, Michele Celiento, Uberto Bortolotti, Marco Solinas, Mattia Glauber

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

Background. Postoperative outcomes of a third-generation porcine bioprosthesis for mitral valve replacement (MVR) have been poorly addressed. The objective of this study was to perform an independent, retrospective, multicenter study on outcomes of patients undergoing MVR with a Mosaic (Medtronic Inc, Minneapolis, MN) porcine bioprosthesis.

Methods. From 1998 to 2011, 805 patients underwent MVR with a Mosaic porcine valve in 11 cardiac centers. There were 465 female patients (58%), and the overall mean age was 73.5 +/- 7 years. Associated procedures included coronary artery bypass grafting (201 patients; 24.9%), aortic valve replacement (152 patients; 18.9%), tricuspid annuloplasty (187 patients; 22.3%), and other cardiac procedures (116 patients; 14.4%).

Results. Median follow-up was 44 months (interquartile range, 16 to 63), with a cumulative duration of 2.769 patientyears. Early mortality for isolated elective MVR was 3.8% (12 of 313), and overall early mortality was 7.8% (n = 63). The rate of late mortality was 3.4%/patient-year (95 late deaths). At 10 years, overall survival was 57.4% (95% confidence interval [CI], 48.8% to 67.5%), and cumulative rates of cardiac- and valve-related death were 7.4% (95% CI, 4.8% to 10.1%) and 1.1% (95% CI, 0.2% to 1.9%), respectively. The 10-year cumulative rates of thromboembolic and hemorrhagic events were 6.6% (95% CI, 1.4% to 11.8%) and 3.9% (95% CI, 0.1% to 8%), respectively, and the 10-year cumulative incidence of prosthetic valve endocarditis was 3%(95% CI, 1.2% to 4.9%). Finally, the 10-year cumulative incidences of structuralvalve degeneration andreoperationswere5.8%(95% CI, 0.2% to 11.5%) and 4.8% (95% CI, 0.7% to 10.3%), respectively.

Conclusions. This independent, multicenter, retrospective study indicated that the Mosaic porcine bioprosthesis forMVR provides satisfactory results in terms of both early andlong-termoutcomes upto 14 years fromits implantation. (C) 2020 by The Society of Thoracic Surgeons

Original language	English
Pages (from-to)	1865-1872
Number of pages	8
Journal	Annals of Thoracic Surgery
Volume	109
Issue number	6
Early online date	11 Oct 2019
DOIs	https://doi.org/10.1016/j.athoracsur.2019.08.111
Publication status	Published - Jun 2020

Keywords

MOSAIC BIOPROSTHESIS
OUTCOMES

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10.1016/j.athoracsur.2019.08.111

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Lorusso, R., Miceli, A., Gelsomino, S., Lio, A., Parise, O., Montisci, A., Vizzardi, E., Pacini, D., Di Bartolomeo, R., Renzulli, A., Serraino, F. G., Comoglio, C., Liberi, R., Martinelli, G., Sciangula, A., Mazzola, A., Faragalli, F., De Bonis, M., Taramasso, M., ... Glauber, M. (2020). Mitral Valve Replacement with a Third Generation Porcine Valve: an Italian Multicentered Study. Annals of Thoracic Surgery, 109(6), 1865-1872. https://doi.org/10.1016/j.athoracsur.2019.08.111

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title = "Mitral Valve Replacement with a Third Generation Porcine Valve: an Italian Multicentered Study",

abstract = "Background. Postoperative outcomes of a third-generation porcine bioprosthesis for mitral valve replacement (MVR) have been poorly addressed. The objective of this study was to perform an independent, retrospective, multicenter study on outcomes of patients undergoing MVR with a Mosaic (Medtronic Inc, Minneapolis, MN) porcine bioprosthesis.Methods. From 1998 to 2011, 805 patients underwent MVR with a Mosaic porcine valve in 11 cardiac centers. There were 465 female patients (58%), and the overall mean age was 73.5 +/- 7 years. Associated procedures included coronary artery bypass grafting (201 patients; 24.9%), aortic valve replacement (152 patients; 18.9%), tricuspid annuloplasty (187 patients; 22.3%), and other cardiac procedures (116 patients; 14.4%).Results. Median follow-up was 44 months (interquartile range, 16 to 63), with a cumulative duration of 2.769 patientyears. Early mortality for isolated elective MVR was 3.8% (12 of 313), and overall early mortality was 7.8% (n = 63). The rate of late mortality was 3.4%/patient-year (95 late deaths). At 10 years, overall survival was 57.4% (95% confidence interval [CI], 48.8% to 67.5%), and cumulative rates of cardiac- and valve-related death were 7.4% (95% CI, 4.8% to 10.1%) and 1.1% (95% CI, 0.2% to 1.9%), respectively. The 10-year cumulative rates of thromboembolic and hemorrhagic events were 6.6% (95% CI, 1.4% to 11.8%) and 3.9% (95% CI, 0.1% to 8%), respectively, and the 10-year cumulative incidence of prosthetic valve endocarditis was 3%(95% CI, 1.2% to 4.9%). Finally, the 10-year cumulative incidences of structuralvalve degeneration andreoperationswere5.8%(95% CI, 0.2% to 11.5%) and 4.8% (95% CI, 0.7% to 10.3%), respectively.Conclusions. This independent, multicenter, retrospective study indicated that the Mosaic porcine bioprosthesis forMVR provides satisfactory results in terms of both early andlong-termoutcomes upto 14 years fromits implantation. (C) 2020 by The Society of Thoracic Surgeons",

keywords = "MOSAIC BIOPROSTHESIS, OUTCOMES",

author = "Roberto Lorusso and Antonio Miceli and Sandro Gelsomino and Antonio Lio and Orlando Parise and Andrea Montisci and Enrico Vizzardi and Davide Pacini and {Di Bartolomeo}, Roberto and Attilio Renzulli and Serraino, {Filiberto G} and Chiara Comoglio and Roberta Liberi and GianLuca Martinelli and Alfonso Sciangula and Alessandro Mazzola and Francesca Faragalli and {De Bonis}, Michele and Maurizio Taramasso and Ottavio Alfieri and Philippe Caimmi and Ezio Micalizzi and Domenico Mercogliano and Gloria Demicheli and Michele Celiento and Uberto Bortolotti and Marco Solinas and Mattia Glauber",

note = "Copyright {\textcopyright} 2019. Published by Elsevier Inc.",

year = "2020",

month = jun,

doi = "10.1016/j.athoracsur.2019.08.111",

language = "English",

volume = "109",

pages = "1865--1872",

journal = "Annals of Thoracic Surgery",

issn = "0003-4975",

publisher = "Elsevier Science",

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Lorusso, R, Miceli, A, Gelsomino, S, Lio, A, Parise, O, Montisci, A, Vizzardi, E, Pacini, D, Di Bartolomeo, R, Renzulli, A, Serraino, FG, Comoglio, C, Liberi, R, Martinelli, G, Sciangula, A, Mazzola, A, Faragalli, F, De Bonis, M, Taramasso, M, Alfieri, O, Caimmi, P, Micalizzi, E, Mercogliano, D, Demicheli, G, Celiento, M, Bortolotti, U, Solinas, M & Glauber, M 2020, 'Mitral Valve Replacement with a Third Generation Porcine Valve: an Italian Multicentered Study', Annals of Thoracic Surgery, vol. 109, no. 6, pp. 1865-1872. https://doi.org/10.1016/j.athoracsur.2019.08.111

TY - JOUR

T1 - Mitral Valve Replacement with a Third Generation Porcine Valve

T2 - an Italian Multicentered Study

AU - Lorusso, Roberto

AU - Miceli, Antonio

AU - Gelsomino, Sandro

AU - Lio, Antonio

AU - Parise, Orlando

AU - Montisci, Andrea

AU - Vizzardi, Enrico

AU - Pacini, Davide

AU - Di Bartolomeo, Roberto

AU - Renzulli, Attilio

AU - Serraino, Filiberto G

AU - Comoglio, Chiara

AU - Liberi, Roberta

AU - Martinelli, GianLuca

AU - Sciangula, Alfonso

AU - Mazzola, Alessandro

AU - Faragalli, Francesca

AU - De Bonis, Michele

AU - Taramasso, Maurizio

AU - Alfieri, Ottavio

AU - Caimmi, Philippe

AU - Micalizzi, Ezio

AU - Mercogliano, Domenico

AU - Demicheli, Gloria

AU - Celiento, Michele

AU - Bortolotti, Uberto

AU - Solinas, Marco

AU - Glauber, Mattia

PY - 2020/6

Y1 - 2020/6

N2 - Background. Postoperative outcomes of a third-generation porcine bioprosthesis for mitral valve replacement (MVR) have been poorly addressed. The objective of this study was to perform an independent, retrospective, multicenter study on outcomes of patients undergoing MVR with a Mosaic (Medtronic Inc, Minneapolis, MN) porcine bioprosthesis.Methods. From 1998 to 2011, 805 patients underwent MVR with a Mosaic porcine valve in 11 cardiac centers. There were 465 female patients (58%), and the overall mean age was 73.5 +/- 7 years. Associated procedures included coronary artery bypass grafting (201 patients; 24.9%), aortic valve replacement (152 patients; 18.9%), tricuspid annuloplasty (187 patients; 22.3%), and other cardiac procedures (116 patients; 14.4%).Results. Median follow-up was 44 months (interquartile range, 16 to 63), with a cumulative duration of 2.769 patientyears. Early mortality for isolated elective MVR was 3.8% (12 of 313), and overall early mortality was 7.8% (n = 63). The rate of late mortality was 3.4%/patient-year (95 late deaths). At 10 years, overall survival was 57.4% (95% confidence interval [CI], 48.8% to 67.5%), and cumulative rates of cardiac- and valve-related death were 7.4% (95% CI, 4.8% to 10.1%) and 1.1% (95% CI, 0.2% to 1.9%), respectively. The 10-year cumulative rates of thromboembolic and hemorrhagic events were 6.6% (95% CI, 1.4% to 11.8%) and 3.9% (95% CI, 0.1% to 8%), respectively, and the 10-year cumulative incidence of prosthetic valve endocarditis was 3%(95% CI, 1.2% to 4.9%). Finally, the 10-year cumulative incidences of structuralvalve degeneration andreoperationswere5.8%(95% CI, 0.2% to 11.5%) and 4.8% (95% CI, 0.7% to 10.3%), respectively.Conclusions. This independent, multicenter, retrospective study indicated that the Mosaic porcine bioprosthesis forMVR provides satisfactory results in terms of both early andlong-termoutcomes upto 14 years fromits implantation. (C) 2020 by The Society of Thoracic Surgeons

AB - Background. Postoperative outcomes of a third-generation porcine bioprosthesis for mitral valve replacement (MVR) have been poorly addressed. The objective of this study was to perform an independent, retrospective, multicenter study on outcomes of patients undergoing MVR with a Mosaic (Medtronic Inc, Minneapolis, MN) porcine bioprosthesis.Methods. From 1998 to 2011, 805 patients underwent MVR with a Mosaic porcine valve in 11 cardiac centers. There were 465 female patients (58%), and the overall mean age was 73.5 +/- 7 years. Associated procedures included coronary artery bypass grafting (201 patients; 24.9%), aortic valve replacement (152 patients; 18.9%), tricuspid annuloplasty (187 patients; 22.3%), and other cardiac procedures (116 patients; 14.4%).Results. Median follow-up was 44 months (interquartile range, 16 to 63), with a cumulative duration of 2.769 patientyears. Early mortality for isolated elective MVR was 3.8% (12 of 313), and overall early mortality was 7.8% (n = 63). The rate of late mortality was 3.4%/patient-year (95 late deaths). At 10 years, overall survival was 57.4% (95% confidence interval [CI], 48.8% to 67.5%), and cumulative rates of cardiac- and valve-related death were 7.4% (95% CI, 4.8% to 10.1%) and 1.1% (95% CI, 0.2% to 1.9%), respectively. The 10-year cumulative rates of thromboembolic and hemorrhagic events were 6.6% (95% CI, 1.4% to 11.8%) and 3.9% (95% CI, 0.1% to 8%), respectively, and the 10-year cumulative incidence of prosthetic valve endocarditis was 3%(95% CI, 1.2% to 4.9%). Finally, the 10-year cumulative incidences of structuralvalve degeneration andreoperationswere5.8%(95% CI, 0.2% to 11.5%) and 4.8% (95% CI, 0.7% to 10.3%), respectively.Conclusions. This independent, multicenter, retrospective study indicated that the Mosaic porcine bioprosthesis forMVR provides satisfactory results in terms of both early andlong-termoutcomes upto 14 years fromits implantation. (C) 2020 by The Society of Thoracic Surgeons

KW - MOSAIC BIOPROSTHESIS

KW - OUTCOMES

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DO - 10.1016/j.athoracsur.2019.08.111

M3 - Article

C2 - 31610166

SN - 0003-4975

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SP - 1865

EP - 1872

JO - Annals of Thoracic Surgery

JF - Annals of Thoracic Surgery

IS - 6

ER -