Ruel Marc, Chu Michael W A, Graeve Allen, Gerdisch Marc W, Damiano Ralph J, Smith Robert L, Keeling William Brent, Wait Michael A, Hagberg Robert C, Quinn Reed D, Sethi Gulshan K, Floridia Rosario, Barreiro Christopher J, Pruitt Andrew L, Accola Kevin D, Dagenais Francois, Markowitz Alan H, Ye Jian, Sekela Michael E, Tsuda Ryan Y, Duncan David A, Swistel Daniel G, Harville Lacy E, DeRose Joseph J, Lehr Eric J, Alexander John H, Puskas John D
Division of Cardiac Surgery, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.
Division of Cardiac Surgery, London Health Sciences Centre, Western University, London, Ontario, Canada.
J Thorac Cardiovasc Surg. 2024 Nov 29. doi: 10.1016/j.jtcvs.2024.11.029.
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).
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.
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.
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.
基于前瞻性随机On-X抗凝临床试验（PROACT）的5年结果，评估On-X机械二尖瓣的中期生存率、临床及血流动力学结果。
PROACT二尖瓣研究是一项多中心研究，评估了401例行二尖瓣置换术（MVR）并植入标准型或Conform-X型On-X二尖瓣的患者，比较了低剂量和标准剂量华法林的效果。在此，我们报告汇总人群在1年、3年和5年时通过核心实验室判定的超声心动图评估的预设次要结局，包括生存率、纽约心脏协会（NYHA）功能分级和瓣膜血流动力学。
1年时精算生存率为99.7%，3年时为95.1%，5年时为92.4%，标准型和Conform-X型瓣膜袖口之间无显著差异。血流动力学分析显示，1年时平均跨瓣压差（MG）为4.6±2.0 mmHg，瓣膜尺寸与患者体表面积之间无相互作用。MG值随时间保持一致。在3年或5年的最新可用随访中，96.6%的患者NYHA分级为I或II级，生活质量得到改善。不同瓣膜尺寸在生存率、临床或血流动力学结果方面无显著差异。
On-X机械二尖瓣在植入后5年内显示出良好的生存率、稳定的血流动力学和提高的生活质量。这些结果源自高质量、严格的随机试验数据，可为需要MVR的年轻患者的决策提供指导。
