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

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dc.contributor.authorJamieson, W R E
dc.contributor.authorEly, John L
dc.contributor.authorBrink, Johan
dc.contributor.authorPennel, Timothy
dc.contributor.authorBannon, Paul
dc.contributor.authorPatel, Jashvant
dc.contributor.authorKumar Gupta, Rajiv
dc.contributor.authorMohan Rao, Prasanna S
dc.contributor.authorAgrawal, Damyanti
dc.contributor.authorWiklund, Lars
dc.contributor.authorKappetein, A P
dc.contributor.authorHaaverstad, Rune
dc.contributor.authorGeisner, Thomas
dc.contributor.authorDoenst, Torsten
dc.contributor.authorSchlensak, Christian
dc.contributor.authorNair, Salgunan
dc.contributor.authorBrown, Craig
dc.contributor.authorSiepe, Matthias
dc.contributor.authorDamiano, Ralph J
dc.contributor.authorLanglois, Yves
dc.contributor.authorCherian, K M
dc.contributor.authorAzar, Hormoz
dc.contributor.authorChen, John C
dc.contributor.authorBavaria, Joseph E
dc.contributor.authorFedoruk, Lynn M
dc.contributor.authorMunfakh, Nabil A
dc.contributor.authorSridhar, V
dc.contributor.authorScholz, Peter M
dc.contributor.authorPfeffer, Thomas A
dc.contributor.authorYe, Jian
dc.date.accessioned2021-11-22T08:33:41Z
dc.date.available2021-11-22T08:33:41Z
dc.date.issued2021-11-03
dc.date.updated2021-11-07T04:14:06Z
dc.description.abstractObjectives 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.en_US
dc.identifier.apacitationJamieson, W. R. E., Ely, J. L., Brink, J., Pennel, T., Bannon, P., Patel, J., ... Ye, J. (2021). PROSE: Prospective Randomized Trial of the On-X Mechanical Prosthesis and the St Jude Medical Mechanical Prosthesis Evaluation. <i>Journal of Cardiothoracic Surgery</i>, 16(1), 323. http://hdl.handle.net/11427/35328en_ZA
dc.identifier.chicagocitationJamieson, W R E, John L Ely, Johan Brink, Timothy Pennel, Paul Bannon, Jashvant Patel, Rajiv Kumar Gupta, et al "PROSE: Prospective Randomized Trial of the On-X Mechanical Prosthesis and the St Jude Medical Mechanical Prosthesis Evaluation." <i>Journal of Cardiothoracic Surgery</i> 16, 1. (2021): 323. http://hdl.handle.net/11427/35328en_ZA
dc.identifier.citationJamieson, W.R.E., Ely, J.L., Brink, J., Pennel, T., Bannon, P., Patel, J., Kumar Gupta, R. & Mohan Rao, P.S. et al. 2021. PROSE: Prospective Randomized Trial of the On-X Mechanical Prosthesis and the St Jude Medical Mechanical Prosthesis Evaluation. <i>Journal of Cardiothoracic Surgery.</i> 16(1):323. http://hdl.handle.net/11427/35328en_ZA
dc.identifier.ris TY - Journal Article AU - Jamieson, W R E AU - Ely, John L AU - Brink, Johan AU - Pennel, Timothy AU - Bannon, Paul AU - Patel, Jashvant AU - Kumar Gupta, Rajiv AU - Mohan Rao, Prasanna S AU - Agrawal, Damyanti AU - Wiklund, Lars AU - Kappetein, A P AU - Haaverstad, Rune AU - Geisner, Thomas AU - Doenst, Torsten AU - Schlensak, Christian AU - Nair, Salgunan AU - Brown, Craig AU - Siepe, Matthias AU - Damiano, Ralph J AU - Langlois, Yves AU - Cherian, K M AU - Azar, Hormoz AU - Chen, John C AU - Bavaria, Joseph E AU - Fedoruk, Lynn M AU - Munfakh, Nabil A AU - Sridhar, V AU - Scholz, Peter M AU - Pfeffer, Thomas A AU - Ye, Jian AB - 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. DA - 2021-11-03 DB - OpenUCT DP - University of Cape Town IS - 1 J1 - Journal of Cardiothoracic Surgery KW - Mechanical prostheses (demographics and risk factors) KW - Experience Western world and Developing world LK - https://open.uct.ac.za PY - 2021 T1 - PROSE: Prospective Randomized Trial of the On-X Mechanical Prosthesis and the St Jude Medical Mechanical Prosthesis Evaluation TI - PROSE: Prospective Randomized Trial of the On-X Mechanical Prosthesis and the St Jude Medical Mechanical Prosthesis Evaluation UR - http://hdl.handle.net/11427/35328 ER - en_ZA
dc.identifier.urihttps://doi.org/10.1186/s13019-021-01632-6
dc.identifier.urihttp://hdl.handle.net/11427/35328
dc.identifier.vancouvercitationJamieson WRE, Ely JL, Brink J, Pennel T, Bannon P, Patel J, et al. PROSE: Prospective Randomized Trial of the On-X Mechanical Prosthesis and the St Jude Medical Mechanical Prosthesis Evaluation. Journal of Cardiothoracic Surgery. 2021;16(1):323. http://hdl.handle.net/11427/35328.en_ZA
dc.language.isoenen_US
dc.language.rfc3066en
dc.publisher.departmentDivision of Cardiothoracic Surgeryen_US
dc.publisher.facultyFaculty of Health Sciencesen_US
dc.rights.holderThe Author(s)
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/en_US
dc.sourceJournal of Cardiothoracic Surgeryen_US
dc.source.journalissue1en_US
dc.source.journalvolume16en_US
dc.source.pagination323en_US
dc.source.urihttps://cardiothoracicsurgery.biomedcentral.com/
dc.subjectMechanical prostheses (demographics and risk factors)en_US
dc.subjectExperience Western world and Developing worlden_US
dc.titlePROSE: Prospective Randomized Trial of the On-X Mechanical Prosthesis and the St Jude Medical Mechanical Prosthesis Evaluationen_US
dc.typeJournal Articleen_US
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