Department of Medicine, University of Chicago, Chicago, Illinois.
MacLean Center for Clinical Medical Ethics, University of Chicago, Chicago, Illinois.
JAMA. 2019 Nov 12;322(18):1789-1798. doi: 10.1001/jama.2019.15686.
In the United States, the number of deceased donor hearts available for transplant is limited. As a proxy for medical urgency, the US heart allocation system ranks heart transplant candidates largely according to the supportive therapy prescribed by transplant centers.
To determine if there is a significant association between transplant center and survival benefit in the US heart allocation system.
DESIGN, SETTING, AND PARTICIPANTS: Observational study of 29 199 adult candidates for heart transplant listed on the national transplant registry from January 2006 through December 2015 with follow-up complete through August 2018.
Transplant center.
The survival benefit associated with heart transplant as defined by the difference between survival after heart transplant and waiting list survival without transplant at 5 years. Each transplant center's mean survival benefit was estimated using a mixed-effects proportional hazards model with transplant as a time-dependent covariate, adjusted for year of transplant, donor quality, ischemic time, and candidate status.
Of 29 199 candidates (mean age, 52 years; 26% women) on the transplant waiting list at 113 centers, 19 815 (68%) underwent heart transplant. Among heart transplant recipients, 5389 (27%) died or underwent another transplant operation during the study period. Of the 9384 candidates who did not undergo heart transplant, 5669 (60%) died (2644 while on the waiting list and 3025 after being delisted). Estimated 5-year survival was 77% (interquartile range [IQR], 74% to 80%) among transplant recipients and 33% (IQR, 17% to 51%) among those who did not undergo heart transplant, which is a survival benefit of 44% (IQR, 27% to 59%). Survival benefit ranged from 30% to 55% across centers and 31 centers (27%) had significantly higher survival benefit than the mean and 30 centers (27%) had significantly lower survival benefit than the mean. Compared with low survival benefit centers, high survival benefit centers performed heart transplant for patients with lower estimated expected waiting list survival without transplant (29% at high survival benefit centers vs 39% at low survival benefit centers; survival difference, -10% [95% CI, -12% to -8.1%]), although the adjusted 5-year survival after transplant was not significantly different between high and low survival benefit centers (77.6% vs 77.1%, respectively; survival difference, 0.5% [95% CI, -1.3% to 2.3%]). Overall, for every 10% decrease in estimated transplant candidate waiting list survival at a given center, there was an increase of 6.2% (95% CI, 5.2% to 7.3%) in the 5-year survival benefit associated with heart transplant.
In this registry-based study of US heart transplant candidates, transplant center was associated with the survival benefit of transplant. Although the adjusted 5-year survival after transplant was not significantly different between high and low survival benefit centers, compared with centers with survival benefit significantly below the mean, centers with survival benefit significantly above the mean performed heart transplant for recipients who had significantly lower estimated expected 5-year waiting list survival without transplant.
在美国,可用于移植的已故供体心脏数量有限。作为医疗紧迫性的替代指标,美国心脏分配系统主要根据移植中心开出的支持性治疗方案对心脏移植候选人进行排名。
确定在美国心脏分配系统中,移植中心与生存获益之间是否存在显著关联。
设计、地点和参与者:这是一项观察性研究,纳入了 2006 年 1 月至 2015 年 12 月期间在国家移植登记处登记的 29199 名成年心脏移植候选者,随访至 2018 年 8 月。
移植中心。
心脏移植的生存获益定义为心脏移植后与等待名单上未接受移植的患者相比的 5 年生存率差异。使用混合效应比例风险模型,将移植作为时间依赖性协变量,调整了移植年份、供体质量、缺血时间和候选者状态,估算每个移植中心的平均生存获益。
在 113 个中心的 29199 名等待移植的候选者中(平均年龄为 52 岁,26%为女性),19815 名(68%)接受了心脏移植。在心脏移植受者中,5389 名(27%)在研究期间死亡或接受了另一次移植手术。在未接受心脏移植的 9384 名候选者中,5669 名(60%)死亡(2644 名在等待名单上死亡,3025 名在被除名后死亡)。移植受者的 5 年估计生存率为 77%(四分位距[IQR],74%至 80%),而未接受心脏移植的候选者的生存率为 33%(IQR,17%至 51%),这意味着生存率提高了 44%(IQR,27%至 59%)。中心之间的生存获益范围为 30%至 55%,31 个中心(27%)的生存获益明显高于平均值,30 个中心(27%)的生存获益明显低于平均值。与低生存获益中心相比,高生存获益中心为预计等待名单上无移植生存获益较低的患者进行了心脏移植(高生存获益中心为 29%,低生存获益中心为 39%;生存差异,-10%[95%CI,-12%至-8.1%]),尽管高生存获益中心和低生存获益中心之间的移植后 5 年生存率无显著差异(分别为 77.6%和 77.1%;生存差异,0.5%[95%CI,-1.3%至 2.3%])。总体而言,在给定中心,估计的移植候选者等待名单上的生存率每降低 10%,与心脏移植相关的 5 年生存获益就会增加 6.2%(95%CI,5.2%至 7.3%)。
在这项基于美国心脏移植候选者的注册研究中,移植中心与移植的生存获益相关。尽管高生存获益中心和低生存获益中心之间的调整后 5 年生存率无显著差异,但与生存获益明显低于平均值的中心相比,生存获益明显高于平均值的中心为预计 5 年等待名单上无移植生存获益较低的患者进行了心脏移植。