Icahn School of Medicine at Mount Sinai, New York, New York.
Icahn School of Medicine at Mount Sinai, New York, New York; Prince of Wales Hospital, Sydney, Australia.
J Am Coll Cardiol. 2016 Dec 27;68(25):2733-2744. doi: 10.1016/j.jacc.2016.10.041.
A differential impact of sex has been observed in transcatheter aortic valve replacement (TAVR) outcomes from small observational studies and subgroup analyses of randomized trials.
The goal of this study was to compare the in-hospital and 1-year outcomes in male and female subjects from the U.S. nationwide TAVR registry.
National data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry were used for in-hospital outcomes, and data linked from the Centers for Medicare & Medicaid Services were used to provide 1-year events. Multivariable logistic regression adjustment was performed for in-hospital outcomes. Fine-Gray models were used for nonfatal 1-year outcomes to account for the competing risk of death.
From 2011 to 2014, a total of 11,808 (49.9%) women and 11,844 (51.1%) men underwent TAVR. Compared with male patients, female patients were older, with a lower prevalence of coronary artery disease, atrial fibrillation, and diabetes but a higher rate of porcelain aorta, lower glomerular filtration rate, and higher mean Society of Thoracic Surgeons score (9.0% vs. 8.0%; all p < 0.001). Women were treated more often by using nontransfemoral access than men (45.0% vs. 34.0%). Despite using smaller device sizes, women achieved valve cover index ≥8% more often than men (66% vs. 54%). In-hospital vascular complications were higher in women (8.27% vs. 4.39%; adjusted hazard ratio [HR]: 1.70; 95% CI: 1.34 to 2.14; p < 0.001) and a trend toward higher bleeding (8.01% vs 5.96%; adjusted HR: 1.19; 95% CI: 0.99 to 1.44; p = 0.06) was observed; however, 1-year mortality was lower (21.3% vs. 24.5%; adjusted HR: 0.73; 95% CI: 0.63 to 0.85; p < 0.001) in women than in men.
Female patients undergoing TAVR had a different risk profile compared with male patients. Notwithstanding a greater adjusted risk for in-hospital vascular complications, 1-year adjusted survival was superior in female patients.
来自小型观察性研究和随机试验亚组分析的结果表明，经导管主动脉瓣置换术（TAVR）的结果存在性别差异。
本研究旨在比较美国全国性 TAVR 注册中心男性和女性患者的住院和 1 年结局。
采用胸外科医师学会/美国心脏病学会经导管瓣膜治疗登记处的全国数据评估住院期间的结果，采用医疗保险和医疗补助服务中心的相关数据提供 1 年的事件数据。对住院期间的结果进行多变量逻辑回归调整。使用 Fine-Gray 模型评估非致命性 1 年结局，以考虑死亡的竞争风险。
2011 年至 2014 年，共有 11808 名（49.9%）女性和 11844 名（51.1%）男性接受了 TAVR 治疗。与男性患者相比，女性患者年龄较大，冠心病、心房颤动和糖尿病的患病率较低，但主动脉瓷化、肾小球滤过率较低和较高的胸外科医生协会评分的发生率较高（9.0% vs. 8.0%；均 P<0.001）。女性患者更多地通过非经股动脉入路进行治疗（45.0% vs. 34.0%）。尽管使用了较小的器械尺寸，但女性患者的瓣膜覆盖指数≥8%的比例高于男性（66% vs. 54%）。女性患者的院内血管并发症发生率较高（8.27% vs. 4.39%；校正后的危险比[HR]：1.70；95%置信区间[CI]：1.34 至 2.14；P<0.001），且出血风险有增高趋势（8.01% vs. 5.96%；校正 HR：1.19；95% CI：0.99 至 1.44；P=0.06），但女性患者 1 年死亡率较低（21.3% vs. 24.5%；校正 HR：0.73；95% CI：0.63 至 0.85；P<0.001）。
与男性患者相比，接受 TAVR 的女性患者具有不同的风险特征。尽管院内血管并发症的调整后风险较高，但女性患者 1 年的调整后生存率更高。
