一种新型机械二尖瓣假体的中期生存期、临床和血流动力学结果。

IF 4.4 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

Journal of Thoracic and Cardiovascular Surgery Pub Date : 2025-10-01 DOI:10.1016/j.jtcvs.2024.11.029

Marc Ruel MD, MPH , Michael W.A. Chu MD, Med , Allen Graeve MD , Marc W. Gerdisch MD , Ralph J. Damiano Jr. MD , Robert L. Smith II MD , William Brent Keeling MD , Michael A. Wait MD , Robert C. Hagberg MD , Reed D. Quinn MD , Gulshan K. Sethi MD , Rosario Floridia MD , Christopher J. Barreiro MD , Andrew L. Pruitt MD , Kevin D. Accola MD , Francois Dagenais MD , Alan H. Markowitz MD , Jian Ye MD , Michael E. Sekela MD , Ryan Y. Tsuda MD , John D. Puskas MD

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引用次数: 0

摘要

目的：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期、临床和血流动力学结果。方法：PROACT二尖瓣是一项多中心研究，评估401例使用标准或con - x On-X二尖瓣置换术（MVR）的患者，比较低剂量和标准剂量华法林。在这里，我们报告了预先指定的次要结局，生存率，纽约心脏协会（NYHA）功能分类，以及通过核心实验室判定的超声心动图在合并人群中评估的1,3和5年的瓣膜血流动力学。结果：1年、3年和5年的精算生存率分别为99.7%、95.1%和92.4%，Standard和con - x袖口之间无显著差异。血流动力学分析显示，1年平均经瓣梯度为4.6±2.0 mmHg，瓣膜大小与患者体表面积（BSA）之间没有相互作用。mg随时间变化是一致的。在最近3年或5年的随访中，96.6%的NYHA I级或II级患者的生活质量得到改善。不同瓣膜大小患者的生存、临床或血流动力学结果无显著差异。结论：On-X机械二尖瓣植入后5年生存率高，血流动力学稳定，生活质量提高。来自高质量、严格的随机试验数据，这些发现可以指导需要MVR的年轻患者的决策。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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

查看原文本刊更多论文

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

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.

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来源期刊

Journal of Thoracic and Cardiovascular Surgery 医学-呼吸系统

CiteScore

11.20

自引率

10.00%

发文量

1079

审稿时长

68 days

期刊介绍： The Journal of Thoracic and Cardiovascular Surgery presents original, peer-reviewed articles on diseases of the heart, great vessels, lungs and thorax with emphasis on surgical interventions. An official publication of The American Association for Thoracic Surgery and The Western Thoracic Surgical Association, the Journal focuses on techniques and developments in acquired cardiac surgery, congenital cardiac repair, thoracic procedures, heart and lung transplantation, mechanical circulatory support and other procedures.