Department of Medicine, Division of Cardiology, Center for Structural Heart Disease, Henry Ford Hospital, Detroit, MI (P.A.V., C.-y.S., M.H.E., D.D.W., T.M.F., J.C.L., G.K., A.L., W.W.O.).
Duke Clinical Research Institute, Durham, NC (S.V., A.S., D.D.).
Circ Cardiovasc Interv. 2021 Nov;14(11):e009374. doi: 10.1161/CIRCINTERVENTIONS.120.009374. Epub 2021 Nov 16.
Women have a higher rate of adverse events after mitral valve surgery. We sought to evaluate whether outcomes after transcatheter edge-to-edge repair intervention by sex have similar trends to mitral valve surgery.
The primary outcome was 1-year major adverse events defined as a composite of all-cause mortality, stroke, and any bleeding in the overall study cohort. Patients who underwent transcatheter edge-to-edge repair for mitral regurgitation with the MitraClip system in the Society of Thoracic Surgery/American College of Cardiology Transcatheter Valve Therapy registry were evaluated. Linked administrative claims from the Centers for Medicare and Medicaid Services were used to evaluate 1-year clinical outcomes. Associations between sex and outcomes were evaluated using a multivariable logistic regression model for in-hospital outcomes and Cox model for 1-year outcomes.
From November 2013 to March 2017, 5295 patients, 47.6% (n=2523) of whom were female, underwent transcatheter edge-to-edge repair. Females were less likely to have >1 clip implanted (<0.001) and had a lower adjusted odds ratio of device success (adjusted odds ratio, 0.78 [95% CI, 0.67-0.90]), driven by lower odds of residual mitral gradient <5 mm Hg (adjusted odds ratio, 0.54 [CI, 0.46-0.63]) when compared with males. At 1-year follow-up, the primary outcome did not differ by sex. Female sex was associated with lower adjusted 1-year risk of all-cause mortality (adjusted hazard ratio, 0.80 [CI, 0.68-0.94]), but the adjusted 1-year risk of stroke and any bleeding did not differ by sex.
No difference in composite outcome of all-cause mortality, stroke, and any bleeding was observed between females and males. Adjusted 1-year all-cause mortality was lower in females compared with males.
女性在接受二尖瓣手术后出现不良事件的比率更高。我们试图评估经导管缘对缘修复干预后的结局是否与二尖瓣手术具有相似的趋势。
主要终点为 1 年主要不良事件，定义为全因死亡率、卒中和整个研究队列中任何出血的综合结果。评估了在胸外科医师学会/美国心脏病学会经导管瓣膜治疗注册研究中接受 MitraClip 系统治疗二尖瓣反流的经导管缘对缘修复患者。使用医疗保险和医疗补助服务中心的关联行政索赔来评估 1 年的临床结局。使用多变量逻辑回归模型评估院内结局，使用 Cox 模型评估 1 年结局，以评估性别与结局之间的关联。
从 2013 年 11 月至 2017 年 3 月，共有 5295 例患者（47.6%[n=2523]为女性）接受了经导管缘对缘修复。女性更不可能植入>1 个夹子（<0.001），并且设备成功率的校正优势比较低（校正优势比，0.78[95%CI，0.67-0.90]），这是由于与男性相比，残留二尖瓣梯度<5mm Hg 的几率较低（校正优势比，0.54[CI，0.46-0.63]）。在 1 年随访时，性别与主要结局无差异。女性性别与较低的 1 年全因死亡率校正风险相关（校正危险比，0.80[CI，0.68-0.94]），但 1 年卒中和任何出血的校正风险无性别差异。
女性和男性之间未观察到全因死亡率、卒中和任何出血的复合结局存在差异。与男性相比，女性的 1 年全因死亡率校正后较低。
