The Journal of thoracic and cardiovascular surgery · 2024
Midterm survival, clinical, and hemodynamic outcomes of a novel mechanical mitral valve prosthesis.
СтатьяМногоцентровое исследованиеРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
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, PROACT Mitral Investigators
Аннотация
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.
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.