PROSE: Prospective Randomized Trial of the On-X Mechanical Prosthesis and the St Jude Medical Mechanical Prosthesis Evaluation

Abstract Objectives The PROSE trial purpose is to investigate whether the incidence of thromboembolic—related complications is reduced with a current generation mechanical prosthesis (On-X Life Technologies/CryoLife Inc.—On-X) compared with a previous generation mechanical prosthesis (St Jude Medica...

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Autores principales:	W. R. Eric Jamieson, John L. Ely, Johan Brink, Timothy Pennel, Paul Bannon, Jashvant Patel, Rajiv Kumar Gupta, Prasanna Simha Mohan Rao, Damyanti Agrawal, Lars Wiklund, A. Pieter Kappetein, Rune Haaverstad, Thomas Geisner, Torsten Doenst, Christian Schlensak, Salgunan Nair, Craig Brown, Matthias Siepe, Ralph J. Damiano, Yves Langlois, K. M. Cherian, Hormoz Azar, John C. Chen, Joseph E. Bavaria, Lynn M. Fedoruk, Nabil A. Munfakh, V. Sridhar, Peter M. Scholz, Thomas A. Pfeffer, Jian Ye
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Mechanical prostheses (demographics and risk factors) Experience Western world and Developing world Surgery RD1-811 Anesthesiology RD78.3-87.3
Acceso en línea:	https://doaj.org/article/bead5d7648a34951bb9d5bac186e8a8b
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spelling	oai:doaj.org-article:bead5d7648a34951bb9d5bac186e8a8b2021-11-08T11:05:21ZPROSE: Prospective Randomized Trial of the On-X Mechanical Prosthesis and the St Jude Medical Mechanical Prosthesis Evaluation10.1186/s13019-021-01632-61749-8090https://doaj.org/article/bead5d7648a34951bb9d5bac186e8a8b2021-11-01T00:00:00Zhttps://doi.org/10.1186/s13019-021-01632-6https://doaj.org/toc/1749-8090Abstract Objectives The PROSE trial purpose is to investigate whether the incidence of thromboembolic—related complications is reduced with a current generation mechanical prosthesis (On-X Life Technologies/CryoLife Inc.—On-X) compared with a previous generation mechanical prosthesis (St Jude Medical—SJM). The primary purpose of the initial report is to document the preoperative demographics, and the preoperative and operative risk factors by individual prosthesis and by Western and Developing populations. Methods The PROSE study was conducted in 28 worldwide centres and incorporated 855 subjects randomized between 2003 and 2016. The study enrollment was discontinued on August 31, 2016. The preoperative demographics incorporated age, gender, functional class, etiology, prosthetic degeneration, primary rhythm, primary valve lesion, weight, height, BSA and BMI. The preoperative and operative evaluation incorporated 24 risk factors. Results The total patient population (855) incorporated On-X population (462) and the St Jude Medical population (393). There was no significant difference of any of the preoperative demographics between the On-X and SJM groups. The preoperative and operative risk factors evaluation showed there was no significant difference between the On-X and St Jude Medical populations. The preoperative and operative risk factors by valve position (aortic and mitral) also documented no differentiation. The dominant preoperative demographics of the Western world population were older age, male gender, sinus rhythm, aortic stenosis, congenital aortic lesion, and mitral regurgitation. The dominant demographics of the Developing world population were rheumatic etiology, atrial fibrillation, aortic regurgitation, mixed aortic lesions, mitral stenosis and mixed mitral lesions. The Developing world group had only one significant risk factor, congestive heart failure. The majority of the preoperative and operative risk factors were significant in the Western world population. Conclusions The preoperative demographics do not differentiate the prostheses but do differentiate the Western and Developing world populations. The preoperative and operative risk factors do not differentiate the prostheses BUT do differentiate the Western and Developing world populations.W. R. Eric JamiesonJohn L. ElyJohan BrinkTimothy PennelPaul BannonJashvant PatelRajiv Kumar GuptaPrasanna Simha Mohan RaoDamyanti AgrawalLars WiklundA. Pieter KappeteinRune HaaverstadThomas GeisnerTorsten DoenstChristian SchlensakSalgunan NairCraig BrownMatthias SiepeRalph J. DamianoYves LangloisK. M. CherianHormoz AzarJohn C. ChenJoseph E. BavariaLynn M. FedorukNabil A. MunfakhV. SridharPeter M. ScholzThomas A. PfefferJian YeBMCarticleMechanical prostheses (demographics and risk factors)Experience Western world and Developing worldSurgeryRD1-811AnesthesiologyRD78.3-87.3ENJournal of Cardiothoracic Surgery, Vol 16, Iss 1, Pp 1-10 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Mechanical prostheses (demographics and risk factors) Experience Western world and Developing world Surgery RD1-811 Anesthesiology RD78.3-87.3
spellingShingle	Mechanical prostheses (demographics and risk factors) Experience Western world and Developing world Surgery RD1-811 Anesthesiology RD78.3-87.3 W. R. Eric Jamieson John L. Ely Johan Brink Timothy Pennel Paul Bannon Jashvant Patel Rajiv Kumar Gupta Prasanna Simha Mohan Rao Damyanti Agrawal Lars Wiklund A. Pieter Kappetein Rune Haaverstad Thomas Geisner Torsten Doenst Christian Schlensak Salgunan Nair Craig Brown Matthias Siepe Ralph J. Damiano Yves Langlois K. M. Cherian Hormoz Azar John C. Chen Joseph E. Bavaria Lynn M. Fedoruk Nabil A. Munfakh V. Sridhar Peter M. Scholz Thomas A. Pfeffer Jian Ye PROSE: Prospective Randomized Trial of the On-X Mechanical Prosthesis and the St Jude Medical Mechanical Prosthesis Evaluation
description	Abstract Objectives The PROSE trial purpose is to investigate whether the incidence of thromboembolic—related complications is reduced with a current generation mechanical prosthesis (On-X Life Technologies/CryoLife Inc.—On-X) compared with a previous generation mechanical prosthesis (St Jude Medical—SJM). The primary purpose of the initial report is to document the preoperative demographics, and the preoperative and operative risk factors by individual prosthesis and by Western and Developing populations. Methods The PROSE study was conducted in 28 worldwide centres and incorporated 855 subjects randomized between 2003 and 2016. The study enrollment was discontinued on August 31, 2016. The preoperative demographics incorporated age, gender, functional class, etiology, prosthetic degeneration, primary rhythm, primary valve lesion, weight, height, BSA and BMI. The preoperative and operative evaluation incorporated 24 risk factors. Results The total patient population (855) incorporated On-X population (462) and the St Jude Medical population (393). There was no significant difference of any of the preoperative demographics between the On-X and SJM groups. The preoperative and operative risk factors evaluation showed there was no significant difference between the On-X and St Jude Medical populations. The preoperative and operative risk factors by valve position (aortic and mitral) also documented no differentiation. The dominant preoperative demographics of the Western world population were older age, male gender, sinus rhythm, aortic stenosis, congenital aortic lesion, and mitral regurgitation. The dominant demographics of the Developing world population were rheumatic etiology, atrial fibrillation, aortic regurgitation, mixed aortic lesions, mitral stenosis and mixed mitral lesions. The Developing world group had only one significant risk factor, congestive heart failure. The majority of the preoperative and operative risk factors were significant in the Western world population. Conclusions The preoperative demographics do not differentiate the prostheses but do differentiate the Western and Developing world populations. The preoperative and operative risk factors do not differentiate the prostheses BUT do differentiate the Western and Developing world populations.
format	article
author	W. R. Eric Jamieson John L. Ely Johan Brink Timothy Pennel Paul Bannon Jashvant Patel Rajiv Kumar Gupta Prasanna Simha Mohan Rao Damyanti Agrawal Lars Wiklund A. Pieter Kappetein Rune Haaverstad Thomas Geisner Torsten Doenst Christian Schlensak Salgunan Nair Craig Brown Matthias Siepe Ralph J. Damiano Yves Langlois K. M. Cherian Hormoz Azar John C. Chen Joseph E. Bavaria Lynn M. Fedoruk Nabil A. Munfakh V. Sridhar Peter M. Scholz Thomas A. Pfeffer Jian Ye
author_facet	W. R. Eric Jamieson John L. Ely Johan Brink Timothy Pennel Paul Bannon Jashvant Patel Rajiv Kumar Gupta Prasanna Simha Mohan Rao Damyanti Agrawal Lars Wiklund A. Pieter Kappetein Rune Haaverstad Thomas Geisner Torsten Doenst Christian Schlensak Salgunan Nair Craig Brown Matthias Siepe Ralph J. Damiano Yves Langlois K. M. Cherian Hormoz Azar John C. Chen Joseph E. Bavaria Lynn M. Fedoruk Nabil A. Munfakh V. Sridhar Peter M. Scholz Thomas A. Pfeffer Jian Ye
author_sort	W. R. Eric Jamieson
title	PROSE: Prospective Randomized Trial of the On-X Mechanical Prosthesis and the St Jude Medical Mechanical Prosthesis Evaluation
title_short	PROSE: Prospective Randomized Trial of the On-X Mechanical Prosthesis and the St Jude Medical Mechanical Prosthesis Evaluation
title_full	PROSE: Prospective Randomized Trial of the On-X Mechanical Prosthesis and the St Jude Medical Mechanical Prosthesis Evaluation
title_fullStr	PROSE: Prospective Randomized Trial of the On-X Mechanical Prosthesis and the St Jude Medical Mechanical Prosthesis Evaluation
title_full_unstemmed	PROSE: Prospective Randomized Trial of the On-X Mechanical Prosthesis and the St Jude Medical Mechanical Prosthesis Evaluation
title_sort	prose: prospective randomized trial of the on-x mechanical prosthesis and the st jude medical mechanical prosthesis evaluation
publisher	BMC
publishDate	2021
url	https://doaj.org/article/bead5d7648a34951bb9d5bac186e8a8b
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PROSE: Prospective Randomized Trial of the On-X Mechanical Prosthesis and the St Jude Medical Mechanical Prosthesis Evaluation

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