1. 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
- Author
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K. M. Cherian, Lars Wiklund, John L. Ely, Thomas Geisner, Prasanna Simha Mohan Rao, Christian Schlensak, Yves Langlois, Thomas A. Pfeffer, Hormoz Azar, Lynn M. Fedoruk, Vivek Kumar Rangarajan Sridhar, Joseph E. Bavaria, Jashvant Patel, John C. Chen, Peter M. Scholz, Nabil A. Munfakh, Johan Brink, Paul G. Bannon, Timothy Pennel, W.R. Eric Jamieson, Damyanti Agrawal, Jian Ye, Rune Haaverstad, A. Pieter Kappetein, Ralph J. Damiano, Salgunan Nair, Rajiv Kumar Gupta, Matthias Siepe, Craig Brown, Torsten Doenst, and Cardiothoracic Surgery
- Subjects
Male ,Pulmonary and Respiratory Medicine ,medicine.medical_specialty ,medicine.medical_treatment ,Population ,Prosthesis Design ,Prosthesis ,Risk Factors ,medicine ,Humans ,Sinus rhythm ,Prospective Studies ,education ,Aged ,Heart Valve Prosthesis Implantation ,education.field_of_study ,Mitral regurgitation ,business.industry ,Incidence ,Atrial fibrillation ,General Medicine ,medicine.disease ,Surgery ,Cardiac surgery ,Experience Western world and Developing world ,Stenosis ,Cardiothoracic surgery ,Heart Valve Prosthesis ,Mechanical prostheses (demographics and risk factors) ,Mitral Valve ,Cardiology and Cardiovascular Medicine ,business ,Research Article - 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.
- Published
- 2021