PROSE: Prospective Randomized Trial of the On-X Mechanical Prosthesis and the St Jude Medical Mechanical Prosthesis Evaluation: Part 1(Patient Dynamics): Preoperative demographics and preoperative and operative risk factors

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 LangloisK. 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

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

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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.

Original languageEnglish
Article number323
JournalJournal of Cardiothoracic Surgery
Volume16
Issue number1
DOIs
Publication statusPublished - 3 Nov 2021

Bibliographical note

Funding: The funding at each of the 28 centres was the responsibility of the study sponsor (On-X Technologies/CryoLife Inc.) that had no role other than fnancial support.

Publisher Copyright: © 2021, The Author(s).

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