• Marc Ruel, ChuMichael W AMWADivision of Cardiac Surgery, London Health Sciences Centre, Western University, London, ON, Canada., Allen Graeve, Marc W Gerdisch, Ralph J Damiano, Robert L Smith, William Brent Keeling, Michael A Wait, Robert C Hagberg, Reed D Quinn, Gulshan K Sethi, Rosario Floridia, Christopher J Barreiro, Andrew L Pruitt, Kevin D Accola, Francois Dagenais, Alan H Markowitz, Jian Ye, Michael E Sekela, Ryan Y Tsuda, David A Duncan, Daniel G Swistel, Lacy E Harville, Joseph J DeRose, Eric J Lehr, John H Alexander, John D Puskas, and PROACT Mitral Investigators.
• Division of Cardiac Surgery, University of Ottawa Heart Institute, Ottawa, ON, Canada. Electronic address: mruel@ottawaheart.ca.
• J. Thorac. Cardiovasc. Surg. 2024 Nov 29.

ObjectivesTo evaluate the midterm survival, clinical, and hemodynamic outcomes of the On-X mechanical mitral valve, based on the 5-year results of the Prospective Randomized On-X Anticoagulation Clinical Trial (PROACT).MethodsPROACT Mitral was a multicenter study evaluating 401 patients who underwent mitral valve replacement (MVR) with either Standard or Conform-X On-X mitral valves, comparing low-dose and standard-dose warfarin. Here, we report pre-specified, secondary outcomes of survival, New York Heart Association (NYHA) Functional Classification, and valve hemodynamics as assessed by core-lab-adjudicated echocardiography at 1, 3, and 5 years within the pooled population.ResultsActuarial survival was 99.7%, 95.1%, and 92.4% at 1, 3, and 5 years, with no significant difference between Standard and Conform-X cuffs. Hemodynamic analysis revealed mean transvalvular gradients of 4.6 ± 2.0 mmHg at 1 year with no interaction between valve size and patient body surface area (BSA). MGs were consistent over time. Quality of life improved with 96.6% of patients in NYHA class I or II at the latest available follow-up of 3 or 5 years. There were no significant differences in survival, clinical, or hemodynamic outcomes between valve sizes.ConclusionsThe On-X mechanical mitral valve demonstrated favorable survival, stable hemodynamics, and enhanced quality of life up to five years post-implantation. Derived from high-quality, rigorous randomized trial data, these findings can guide decision-making in young patients requiring MVR.Copyright © 2024. Published by Elsevier Inc.

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