Midterm survival, clinical, and hemodynamic outcomes of a novel mechanical mitral valve prosthesis

Marc Ruel, Division of Cardiac Surgery, University of Ottawa Heart Institute, Ottawa, Ontario, Canada. Electronic address: mruel@ottawaheart.ca.
Michael W. Chu, Division of Cardiac Surgery, London Health Sciences Centre, Western University, London, Ontario, Canada.
Allen Graeve, Cardiothoracic Division, MultiCare Health System, Tacoma, Wash.
Marc W. Gerdisch, Department of Cardiovascular and Thoracic Surgery, Franciscan St Francis Health, Indianapolis, Ind.
Ralph J. Damiano, Department of Surgery, Washington University SL, St. Louis, Mo.
Robert L. Smith, Robotic Cardiac Surgery, The Heart Hospital Baylor Plano, Plano, Tex.
William Brent Keeling, Division of Cardiothoracic Surgery, Emory University Hospital Midtown, Atlanta, Ga.
Michael A. Wait, Department of Cardiovascular and Thoracic Surgery, UT Southwestern Medical Center, Dallas, Tex.
Robert C. Hagberg, Department of Cardiac Surgery, Hartford Hospital, Hartford, Conn.
Reed D. Quinn, Department of Cardiac Services, Maine Medical Center, Portland, Maine.
Gulshan K. Sethi, Division of Cardiothoracic Surgery, University of Arizona, Tucson Heart Center, Tucson, Ariz.
Rosario Floridia, Department of Cardiovascular and Thoracic Surgery, Loma Linda University Medical Center, Loma Linda, Calif.
Christopher J. Barreiro, Sentara Health Research Center, Sentara Norfolk General Hospital, Norfolk, Va.
Andrew L. Pruitt, Cardiovascular and Thoracic Surgery, St Joseph Mercy Hospital, Ann Arbor, Mich.
Kevin D. Accola, Cardiovascular Surgery, Florida Hospital, Orlando, Fla.
Francois Dagenais, Department of Cardiac Surgery, Institut universitaire de cardiologie et de pneumologie de Québec, Quebec City, Quebec, Canada.
Alan H. Markowitz, Heart & Vascular Institute, University Hospitals-Cleveland, Cleveland, Ohio.
Jian Ye, Division of Cardiovascular Surgery, St Paul's and Vancouver General Hospital, Vancouver, British Columbia, Canada.
Michael E. Sekela, Division of Cardiothoracic Surgery, University of Kentucky, Lexington, Ky.
Ryan Y. Tsuda, Department of Cardiology, Southern Arizona VA Medical Center, Tucson, Ariz.
David A. Duncan, Cardiovascular and Thoracic Surgery, Novant Clinical Research Institute, Winston-Salem, NC.
Daniel G. Swistel, Department of Cardiac Surgery, NYU Langone Hospitals, New York, NY.
Lacy E. Harville, Department of Surgery, University of Oklahoma Health Sciences Center, Oklahoma City, Okla.
Joseph J. DeRose, Division of Cardiothoracic Surgery, Montefiore Medical Center, Bronx, NY.
Eric J. Lehr, Cardiac Surgery, Swedish Medical Center, Seattle, Wash.
John H. Alexander, Division of Cardiology, Duke Clinical Research Institute, Duke University, Durham, NC.
John D. Puskas, Division of Cardiothoracic Surgery, Mount Sinai Saint Luke's, New York, NY.

Document Type

Article

Publication Date

10-1-2025

Journal Title

The Journal of thoracic and cardiovascular surgery

MeSH Headings

Humans; Heart Valve Prosthesis; Mitral Valve (surgery, physiopathology, diagnostic imaging); Female; Male; Hemodynamics; Prosthesis Design; Heart Valve Prosthesis Implantation (instrumentation, adverse effects, mortality); Middle Aged; Aged; Treatment Outcome; Prospective Studies; Time Factors; Anticoagulants (administration & dosage); Warfarin (administration & dosage); Quality of Life

Abstract

OBJECTIVE: To 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). METHOD: PROACT 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 prespecified 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 in the pooled population. RESULTS: Actuarial survival was 99.7% at 1 year, 95.1% at 3 years, and 92.4% at 5 years, with no significant difference between the Standard and Conform-X cuffs. Hemodynamic analysis revealed a mean transvalvular pressure gradient (MG) of 4.6 ± 2.0 mm Hg at 1 year, with no interaction between valve size and patient body surface area. MG values 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. CONCLUSIONS: The On-X mechanical mitral valve demonstrated favorable survival, stable hemodynamics, and enhanced quality of life up to 5 years postimplantation. Derived from high-quality, rigorous randomized trial data, these findings can guide decision making in young patients requiring MVR.

First Page

1060

Last Page

1068.e3

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