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

Authors :
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
Source :
Journal of Cardiothoracic Surgery, Vol 16, Iss 1, Pp 1-10 (2021)
Publication Year :
2021
Publisher :
BMC, 2021.

Abstract

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.

Details

Language :
English
ISSN :
17498090
Volume :
16
Issue :
1
Database :
Directory of Open Access Journals
Journal :
Journal of Cardiothoracic Surgery
Publication Type :
Academic Journal
Accession number :
edsdoj.bead5d7648a34951bb9d5bac186e8a8b
Document Type :
article
Full Text :
https://doi.org/10.1186/s13019-021-01632-6