Purpose

The prevalence of end stage heart failure and patients that could benefit from heart transplantation requires an expansion of the donor pool, relying on the transplant community to continually re-evaluate and expand the use of extended criteria donor organs. Introduction of new technologies such as the Paragonix SherpaPak Cardiac Transport System aids in this shift. We seek to analyze the impact of the SherpaPak system on recipient outcomes who receive extended criteria organs in the GUARDIAN Heart Registry.

Methods

Between October 2015-December 2022, 1,113 adults from 15 US centers receiving donor hearts utilizing either SherpaPak (N=560) or conventional ice storage (Ice, N=453) were analyzed from the GUARDIAN-Heart registry using summary statistics. A previously published set of criteria was used to identify extended criteria donors, which included 193 SherpaPak and 137 ice.

Results

There were a few baseline differences among recipients in the 2 cohorts, most notably IMPACT Scores, distance traveled and total ischemic time were significantly greater in SherpaPak, and significantly more donor hearts in the SherpaPak cohort had >4 hours total ischemia time. Post-transplant MCS utilization (SherpaPak 22.3% vs. ice 35.0%, p=0.012) and new ECMO/VAD (SherpaPak 7.8% vs. ice 15.3%, p=0.033) was significantly reduced, and the rate of severe PGD (SherpaPak 6.2% vs. ice 13.9%, p=0.022) was significantly reduced by over 50% in hearts preserved using SherpaPak. One-year survival between cohorts was similar (SherpaPak 92.9% vs. ice 89.6%, p=0.27).

Conclusion

This subgroup analysis demonstrates that SherpaPak can be safely used to utilize extended criteria donors, with low severe PGD rates.

中文翻译：

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使用高级心脏保存的扩展标准捐赠者的受者结果：对 GUARDIAN 心脏登记的分析

目的

终末期心力衰竭的患病率和可以从心脏移植中受益的患者需要扩大供体库，依靠移植界不断重新评估和扩大扩展标准供体器官的使用。Paragonix SherpaPak 心脏运输系统等新技术的引入有助于实现这一转变。我们试图分析 SherpaPak 系统对在 GUARDIAN 心脏登记处接受扩展标准器官的受者结果的影响。

方法

2015 年 10 月至 2022 年 12 月期间，来自 15 个美国中心的 1,113 名成年人使用 SherpaPak（N = 560）或传统冰储存（Ice，N = 453）接收捐赠心脏，并使用汇总统计数据从 GUARDIAN-Heart 登记处进行了分析。之前发布的一套标准用于识别扩展标准捐赠者，其中包括 193 个 SherpaPak 和 137 个ice。

结果

2 个队列中的受者之间存在一些基线差异，最显着的是 SherpaPak 中的 IMPACT 评分、移动距离和总缺血时间明显更长，并且 SherpaPak 队列中更多的供体心脏的总缺血时间 >4 小时。移植后 MCS 利用率（SherpaPak 22.3% 对比冰 35.0%，p=0.012）和新 ECMO/VAD（SherpaPak 7.8% 对比冰 15.3%，p=0.033）显着降低，严重 PGD 发生率（SherpaPak）使用 SherpaPak 保存的心脏中，（6.2% 与冰 13.9%，p=0.022）显着降低了 50% 以上。队列之间的一年生存率相似（SherpaPak 92.9% vs.ice 89.6%，p=0.27）。

结论

该亚组分析表明，SherpaPak 可以安全地用于利用扩展标准供体，且严重 PGD 率较低。