Division of Cardiology, Columbia University Irving Medical Center, New York, NY (E.M.D.).
Division of Cardiology, University of Minnesota, Minneapolis (M.M., V.M., R.C.).
Circ Heart Fail. 2023 Jun;16(6):e009946. doi: 10.1161/CIRCHEARTFAILURE.122.009946. Epub 2023 May 26.
While sex differences in heart transplantation (HT) waitlist mortality have been previously described, waitlist and HT outcomes by sex of patients in the highest urgency strata (Status 1) since implementation of the 2018 allocation system change in the United States are unknown. We hypothesized that women listed as Status 1 may have worse outcomes due to adverse events on temporary mechanical circulatory support.
The analysis included adult, single-organ HT waitlist candidates listed as Status 1 at any time while listed, after the HT allocation system change (from October 18, 2018 through March 31, 2022). The primary outcome was the rate of HT by sex, assessed using multivariable competing risk analysis where waitlist removal for death or clinical deterioration was the competing event. Post-HT survival by sex of waitlist candidates transplanted as a Status 1 was also compared.
Of 1120 Status 1 waitlist candidates (23.8% women), women had a lower rate of HT compared to men (adjusted hazard ratio, 0.74 [95% CI, 0.62-0.88]; <0.001) and a higher rate of delisting for death or medical unsuitability (adjusted hazard ratio, 1.48 [95% CI, 1.05-2.09]; =0.026). Calculated panel reactive antibody did not account for all the harm observed. Post-HT survival of Status 1 candidates by sex was similar (adjusted hazard ratio, 1.13 [95% CI, 0.62-2.06]; =0.70).
Women have a lower rate of HT and higher rate of delisting for death or clinical deterioration at the highest urgent status, which appears to be mediated but not fully explained by calculated panel reactive antibody levels. Further investigation into the safety profile of temporary mechanical circulatory support devices in women is needed.
尽管先前已经描述了心脏移植(HT)候补名单死亡率的性别差异,但自美国 2018 年分配系统变更实施以来,最高紧急状态(状态 1)下患者的候补名单和 HT 结果的性别差异尚不清楚。我们假设,由于临时机械循环支持的不良事件,列为状态 1 的女性可能会有更差的结果。
该分析包括成年、单一器官 HT 候补名单候选人,在任何时间被列为状态 1,在 HT 分配系统变更后(从 2018 年 10 月 18 日至 2022 年 3 月 31 日)。主要结果是根据多变量竞争风险分析评估的男女 HT 率,其中候补名单因死亡或临床恶化而被删除是竞争事件。还比较了作为状态 1 移植的候补名单候选人的 HT 后生存情况。
在 1120 名状态 1 候补名单候选人(23.8%为女性)中,女性的 HT 率低于男性(调整后的危险比,0.74[95%CI,0.62-0.88];<0.001),因死亡或医疗不适合而被除名的比率更高(调整后的危险比,1.48[95%CI,1.05-2.09];=0.026)。计算的面板反应性抗体并不能解释所有观察到的危害。按性别划分的状态 1 候选人的 HT 后生存情况相似(调整后的危险比,1.13[95%CI,0.62-2.06];=0.70)。
女性在最高紧急状态下的 HT 率较低,因死亡或临床恶化而被除名的比率较高,这似乎是由计算出的面板反应性抗体水平介导的,但并非完全解释。需要进一步调查女性临时机械循环支持设备的安全性概况。