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| Content Provider | Springer Nature : BioMed Central |
|---|---|
| Author | Jamieson, W. R. Eric Ely, John L. Brink, Johan Pennel, Timothy Bannon, Paul Patel, Jashvant Kumar Gupta, Rajiv Mohan Rao, Prasanna Simha Agrawal, Damyanti Wiklund, Lars Kappetein, A. Pieter Haaverstad, Rune Geisner, Thomas Doenst, Torsten Schlensak, Christian Nair, Salgunan Brown, Craig Siepe, Matthias Damiano, Ralph J. Langlois, Yves Cherian, K. M. Azar, Hormoz Chen, John C. Bavaria, Joseph E. Fedoruk, Lynn M. Munfakh, Nabil A. Sridhar, V. Scholz, Peter M. Pfeffer, Thomas A. Ye, Jian |
| 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. |
| Related Links | https://cardiothoracicsurgery.biomedcentral.com/counter/pdf/10.1186/s13019-021-01632-6.pdf |
| Ending Page | 10 |
| Page Count | 10 |
| Starting Page | 1 |
| File Format | HTM / HTML |
| ISSN | 17498090 |
| DOI | 10.1186/s13019-021-01632-6 |
| Journal | Journal of Cardiothoracic Surgery |
| Issue Number | 1 |
| Volume Number | 16 |
| Language | English |
| Publisher | BioMed Central |
| Publisher Date | 2021-11-03 |
| Access Restriction | Open |
| Subject Keyword | Cardiac Surgery Thoracic Surgery Mechanical prostheses (demographics and risk factors) Experience Western world and Developing world |
| Content Type | Text |
| Resource Type | Article |
| Subject | Surgery Cardiology and Cardiovascular Medicine Pulmonary and Respiratory Medicine |
| Journal Impact Factor | 1.5/2023 |
| 5-Year Journal Impact Factor | 1.6/2023 |
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