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UNOS 政策变化和例外状态请求对使用主动脉内球囊泵桥接心脏移植患者结局的影响。

Effect of UNOS policy change and exception status request on outcomes in patients bridged to heart transplant with an intra-aortic balloon pump.

机构信息

Division of Cardiovascular Medicine, Keck School of Medicine of the University of Southern California, Los Angeles, California, USA.

Department of Medicine, Keck School of Medicine of the University of Southern California, Los Angeles, California, USA.

出版信息

Artif Organs. 2022 May;46(5):838-849. doi: 10.1111/aor.14109. Epub 2021 Nov 17.

DOI:10.1111/aor.14109
PMID:34748232
Abstract

BACKGROUND

Intra-aortic balloon pumps (IABP) are used to bridge select end-stage heart disease patients to heart transplant (HT). IABP use and exception requests both increased dramatically after the UNOS policy change (PC). The purpose of this study was to evaluate the effect of PC and exception status requests on waitlist and post-transplant outcomes in patients bridged to HT with IABP support.

METHODS

We analyzed adult, first-time, single-organ HT recipients from the UNOS Registry either on IABP at the time of registration for HT or at the time of HT. We compared waitlist and post-HT outcomes between patients from the PRE (October 18, 2016 to May 30, 2018) and POST (October 18, 2018 to May 30, 2020) eras using Kaplan-Meier curves and time-to-event analyses.

RESULTS

A total of 1267 patients underwent HT from IABP (261 pre-policy/1006 post-policy). On multivariate analysis, PC was associated with an increase in HT (sub-distribution hazard ratio (sdHR): 2.15, p < .001) and decrease in death/deterioration (sdHR: 0.55, p = .011) on the waitlist with no effect on 1-year post-HT survival (p = .8). The exception status of patients undergoing HT was predominantly seen in the POST era (29%, 293/1006); only four patients in the PRE era. Exception requests in the POST era did not alter patient outcomes.

CONCLUSIONS

In patients bridged to heart transplant with an IABP, policy change is associated with decreased rates of death/deterioration and increased rates of heart transplantation on the waitlist without affecting 1-year post-transplant survival. While exception status use has markedly increased post-PC, it is not associated with patient outcomes.

摘要

背景

主动脉内球囊泵(IABP)用于桥接选择的终末期心脏病患者进行心脏移植(HT)。在 UNOS 政策变更(PC)后,IABP 的使用和例外请求都急剧增加。本研究的目的是评估 PC 和例外请求对 IABP 支持下桥接 HT 的患者的等待名单和移植后结果的影响。

方法

我们分析了 UNOS 登记处的成年、首次、单器官 HT 受者,他们要么在登记 HT 时正在使用 IABP,要么在 HT 时正在使用 IABP。我们使用 Kaplan-Meier 曲线和时间事件分析比较了 PRE(2016 年 10 月 18 日至 2018 年 5 月 30 日)和 POST(2018 年 10 月 18 日至 2020 年 5 月 30 日)两个时期患者的等待名单和移植后的结果。

结果

共有 1267 名患者接受了 IABP 支持的 HT(261 例在政策前/1006 例在政策后)。多变量分析显示,PC 与 HT 的增加相关(亚分布危险比(sdHR):2.15,p<.001),与等待名单上的死亡/恶化减少相关(sdHR:0.55,p=.011),但对 1 年后 HT 存活率无影响(p=.8)。接受 HT 的患者的例外情况主要出现在 POST 时期(29%,293/1006);在 PRE 时期只有 4 例。POST 时期的例外请求并没有改变患者的结局。

结论

在接受 IABP 桥接 HT 的患者中,政策变化与等待名单上的死亡率/恶化率降低和 HT 移植率增加相关,而不影响 1 年后的移植存活率。虽然 PC 后例外情况的使用明显增加,但与患者结局无关。

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