Division of Cardiac Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.
Division of Cardiology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.
JAMA Cardiol. 2021 Feb 1;6(2):159-167. doi: 10.1001/jamacardio.2020.4909.
The US heart allocation policy was changed on October 18, 2018. The association of this change with recipient and donor selection and outcomes remains to be elucidated.
To evaluate changes in patient characteristics, wait list outcomes, and posttransplant outcomes after the recent allocation policy change in heart transplant.
DESIGN, SETTING, AND PARTICIPANTS: In this cohort study, all 15 631 adults undergoing heart transplants, excluding multiorgan transplants, in the US as identified by the United Network for Organ Sharing multicenter, national registry were reviewed. Patients were stratified according to prepolicy change (October 1, 2015, to October 1, 2018) and postpolicy change (October 18, 2018 or after). Follow-up data were available through March 31, 2020.
Heart transplants after the policy change.
Competing risk regression for wait list outcomes was performed. Posttransplant survival was compared using the Kaplan-Meier method, and risk adjustment was performed using multivariable Cox proportional hazards regression analysis.
In this cohort study, of the 15 631 patients undergoing transplant, 10 671 (mean [SD] age, 53.1 [12.7] years; 7823 [73.3%] male) were wait listed before and 4960 (mean [SD] age, 52.7 [13.0] years; 3610 [72.8%] male) were wait listed after the policy change. Competing risk regression demonstrated reduced likelihood of mortality or deterioration (subhazard ratio [SHR], 0.60; 95% CI, 0.52-0.69; P < .001), increased likelihood of transplant (SHR, 1.38; 95% CI, 1.32-1.45; P < .001), and reduced likelihood of recovery (SHR, 0.54; 95% CI, 0.40-0.73; P < .001) for wait listed patients after the policy change. A total of 6078 patients underwent transplant before and 2801 after the policy change. Notable changes after the policy change included higher frequency of bridging with temporary mechanical circulatory support and lower frequency of bridging with durable left ventricular assist devices. Posttransplant survival was reduced after the policy change (1-year: 92.1% vs 87.5%; log-rank P < .001), a finding that persisted after risk adjustment (HR, 1.29; 95% CI, 1.07-1.55; P = .008).
Substantial changes have occurred in adult heart transplant in the US after the policy change in October 2018. Wait list outcomes have improved, although posttransplant survival has decreased. These data confirm findings from earlier preliminary analyses and demonstrate that these trends have persisted to 1-year follow-up, underscoring the importance of continued reevaluation of the new heart allocation policy.
美国心脏分配政策于 2018 年 10 月 18 日发生变更。这种变化与受体和供体的选择以及结果的关联仍有待阐明。
评估最近心脏移植分配政策变化后患者特征、等待名单结果和移植后结局的变化。
设计、地点和参与者:在这项队列研究中,回顾了美国器官共享联合网络多中心国家登记处确定的所有 15631 例成人心脏移植患者(不包括多器官移植)。患者根据术前(2015 年 10 月 1 日至 2018 年 10 月 1 日)和术后(2018 年 10 月 18 日或之后)分组。随访数据截至 2020 年 3 月 31 日。
政策变更后的心脏移植。
采用竞争风险回归进行等待名单结果分析。采用 Kaplan-Meier 方法比较移植后生存率,并采用多变量 Cox 比例风险回归分析进行风险调整。
在这项队列研究中,在接受移植的 15631 例患者中,有 10671 例(平均[SD]年龄为 53.1[12.7]岁;7823[73.3%]为男性)在政策变更前等待,4960 例(平均[SD]年龄为 52.7[13.0]岁;3610[72.8%]为男性)在政策变更后等待。竞争风险回归表明等待名单患者的死亡率或病情恶化的可能性降低(亚危险比[SHR],0.60;95%置信区间[CI],0.52-0.69;P<0.001),移植的可能性增加(SHR,1.38;95%CI,1.32-1.45;P<0.001),以及恢复的可能性降低(SHR,0.54;95%CI,0.40-0.73;P<0.001)。共有 6078 例患者在政策变更前接受移植,2801 例在政策变更后接受移植。政策变更后的显著变化包括使用临时机械循环支持进行桥接的频率更高,而使用耐用左心室辅助设备进行桥接的频率更低。政策变更后移植后生存率降低(1 年:92.1%比 87.5%;对数秩检验 P<0.001),风险调整后仍然存在这种情况(HR,1.29;95%CI,1.07-1.55;P=0.008)。
2018 年 10 月美国心脏分配政策变更后,美国成人心脏移植发生了重大变化。虽然等待名单结果有所改善,但移植后生存率下降。这些数据证实了早期初步分析的结果,并表明这些趋势持续到 1 年随访,这强调了需要继续重新评估新的心脏分配政策。