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22. Randomized Trial of Convential Mechanical Prostheses to Evaluate the Incidence of Thromboembolic-Related Complications: Results of PROSE Trial NCT000639782

May 14, 2022

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OBJECTIVE: The PROSE (Prospective Randomized Trial of On-X and SJM Evaluation) trial was to investigate if the incidence of thromboembolic related complications was reduced with the current generation mechanical prosthesis (On-X Prosthetic Heart Valve – On-X) compared with a previous generation prosthesis (St. Jude Mechanical – SJM).
METHODS: The study was conducted in 28 worldwide centers with 855 subjects randomized from 2003 to 2016. The protocol, preoperative demographics, and patient risk factors were published in the Journal of Cardiothoracic Surgery in 2021. The preoperative demographics included age, gender, etiology, New York Heart Association (NYHA) class, primary rhythm, primary valve lesion, BSA and BMI. The evaluation incorporated 24 patient risk factors.
RESULTS: The overall freedom evaluation showed no difference at 5 years between the prostheses for thromboembolism (TE) – On-X 96.8±0.9 % and SJM 95.8±1.1 % (p=0.606) or for valve thrombosis (VT) – On-X 98.8±0.5 % and SJM 98.9±0.5 % (p=0.919). There were also no differences in mortalities. VT was different by valve position at 5 years: aortic – 96.6±0.3 % and mitral – 97.8±0.8 % (p=0.0217). There were several differences between Developing(D) and Western(W) world populations. The freedom relations at 5-years were: all-cause mortality - 88.4±1.6 % for D and 92.9±1.3 % for W (p=0.0055); valve related mortality & sudden death - 93.3±1.3 % for D and 96.8±0.9 % for W (p=0.0106); TE - 98.1±0.7 % for D and 94.7±1.1 % for W
(p=0.0201); VT - 97.9±0.7 % for D and 99.8±0.2% for W (p=0.0137); TE for mitral valve was 97.7±0.9 % for D and 92.4±3.6 % for W (p=0.0072); all-cause mortality for mitral valve patients was 88.4±1.9 % for D and 100.00 % for W (p=0.0306). The linearized event rates were not different for the prostheses: TE – On-X 0.5%/ptyr and SJM 0.5%/ptyr (p=0.992) and VT On-X 0.2%/ptyr and SJM 0.3%/ptyr (p=0.778). VT was differentiated by position: aortic – 2 (0.1%/ptyr) and mitral – 8 (0.5%/ptyr) -p=0.007. VT for the W world was 1(0.04%/ptyr) and for the D world was 9 (0.5%/ptyr)-p=0.005. In the mitral position there were no VT cases in the W world while there were 8 (0.6%/ptyr) in the D world (p=0.217). The risk assessment was conducted with the following parameters – age, BMI, CHF, COPD, CVA, NYHA and rhythm. Risk factor assessment showed VT to occur in younger patients in the mitral position. NYHA status showed improvement in higher than 70 percent in all groups. Cardiac rhythm improved significantly with reduction of atrial fibrillation in all groups.
CONCLUSION: The On-X and SJM performed equally well in the study with no differences found. The only differentiation occurred with valve thrombosis in the mitral position occurring in the Developing world more than the Western world and occurring in a younger population possibly due to anticoagulation compliance issues.

W. R. Eric Jamieson (1), Timothy Pennel (2), Paul Bannon (3), Jashvant Patel (4), Rajiv Kumar Gupta (5), A. Pieter Kappetein (6), Rune Haaverstad (7), Torsten Doenst (8), Craig Brown (9), John Ely (10), (1) Vancouver General Hospital, University of British Columbia, Vancouver, BC, (2) Groote Schuur Hospital, Cape Town, Western Cape, (3) Royal Prince Alfred, Sydney, Nsw South Wales, (4) Mehta Mahavir Heart Institute, Surat, Gujarat, (5) Dayanand Medical College, Ludhiana, Punjab, (6) Erasmus, Rotterdam, Netherlands, (7) Haukeland University Hospital, Bergen, Norway, (8) Jena University Hospital, Jena, Germany, Jena, Thuringia, (9) Saint John Regional Hospital, Saint John, NB, (10) N/A, Austin, TX

Kendra Grubb

Invited Discussant

Dr. Kendra J. Grubb, MD, MHA, FACC, Surgical Director Emory University Structural Heart and Valve Center, is dedicated to improving the lives of patients through innovation and building collaborative teams to promote patient-centered treatment of cardiovascular disease. Previously, she was Director of Minimally Invasive Cardiac Surgery and the Heart Valve Program at University of Louisville.
Dr. Grubb has led and participated in numerous clinical trials of innovative technologies, including studies of transcatheter aortic valve replacement, mitral valve percutaneous therapies, endovascular treatment of descending thoracic aortic aneurysms, and transcatheter heart failure devices.
Dr. Grubb attended University of Southern California, where she received her MD degree from Keck School of Medicine and her Master of Health Administration. She completed general surgery residency at University of Illinois at Chicago (2010), fellowship in cardiothoracic surgery at University of Virginia (2012), and fellowship in interventional cardiology and transcatheter therapies at New York Presbyterian-Columbia University (2013).


W. R. Eric Jamieson

Abstract Presenter

Dr. W R Eric Jamieson is a career member of AATS. He is Professor of Surgery (Retired) of the University of British Columbia.  He has served the B C Heart Centre (Vancouver General Hospital & St Paul’s Hospital) as an internationally recognized Surgeon-Scientist and Director of Clinical Cardiac Surgery Research. He is the lead investigator of the PROSE TRIAL (presentation) of 28 international centers. He is the co-director with Dr Paul Cartier (deceased) of the Canadian Cardiovascular Society Consensus: Surgical Management of Valvular Heart Disease. He has been recognized as a Giant in Cardiac Surgery. He has also been a long-standing Academic Director of the Vancouver Coastal Research Institute.

Specialties: Adult Cardiac, Adult (General), Aortic Valve, Mitral Valve, Anatomy and Conditions, Valve, Aortic Valve, Mitral Valve, Treatment/Procedure/Operation/Surgery, Valve, Aortic valve, Mitral Valve