Background

Extended criteria donor (ECD) hearts available with donation after brain death (DBD) are underutilized for transplantation due to limitations of cold storage.

Objectives

This study evaluated use of an extracorporeal perfusion system on donor heart utilization and post-transplant outcomes in ECD DBD hearts.

Methods

In this prospective, single-arm, multicenter study, adult heart transplant recipients received ECD hearts using an extracorporeal perfusion system if hearts met study criteria. The primary outcome was a composite of 30-day survival and absence of severe primary graft dysfunction (PGD). Secondary outcomes were donor heart utilization rate, 30-day survival, and incidence of severe PGD. The safety outcome was the mean number of heart graft–related serious adverse events within 30 days. Additional outcomes included survival through 2 years benchmarked to concurrent nonrandomized control subjects.

Results

A total of 173 ECD DBD hearts were perfused; 150 (87%) were successfully transplanted; 23 (13%) did not meet study transplantation criteria. At 30 days, 92% of patients had survived and had no severe PGD. The 30-day survival was 97%, and the incidence of severe PGD was 6.7%. The mean number of heart graft–related serious adverse events within 30 days was 0.17 (95% CI: 0.11-0.23). Patient survival was 93%, 89%, and 86% at 6, 12, and 24 months, respectively, and was comparable with concurrent nonrandomized control subjects.

Conclusions

Use of an extracorporeal perfusion system resulted in successfully transplanting 87% of donor hearts with excellent patient survival to 2 years post-transplant and low rates of severe PGD. The ability to safely use ECD DBD hearts could substantially increase the number of heart transplants and expand access to patients in need. (International EXPAND Heart Pivotal Trial [EXPANDHeart]; NCT02323321; Heart EXPAND Continued Access Protocol; NCT03835754)

中文翻译：

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增加用于移植的扩展标准供体心脏的利用率：OCS Heart EXPAND 试验

背景

由于冷藏的限制，脑死亡（DBD）后可捐献的扩展标准供体（ECD）心脏未充分用于移植。

目标

本研究评估了体外灌注系统对 ECD DBD 心脏供体心脏利用率和移植后结果的影响。

方法

在这项前瞻性、单臂、多中心研究中，如果心脏符合研究标准，成年心脏移植受者将使用体外灌注系统接受 ECD 心脏。主要结局是 30 天生存率和不存在严重原发性移植物功能障碍 (PGD) 的综合结果。次要结局是供体心脏利用率、30 天生存率和严重 PGD 发生率。安全性结果是 30 天内心脏移植相关严重不良事件的平均数量。其他结果包括以同时进行的非随机对照受试者为基准的 2 年生存率。

结果

总共对173颗ECD DBD心脏进行了灌注；150例（87%）移植成功；23 例 (13%) 不符合研究移植标准。30 天时，92% 的患者存活并且没有进行严重的 PGD。30天生存率为97%，严重PGD发生率为6.7%。30 天内心脏移植相关严重不良事件的平均数量为 0.17（95% CI：0.11-0.23）。6、12 和 24 个月时患者的生存率分别为 93%、89% 和 86%，与同时进行的非随机对照受试者相当。

结论

使用体外灌注系统成功移植了 87% 的供体心脏，患者在移植后 2 年存活率极好，并且严重 PGD 发生率低。安全使用 ECD DBD 心脏的能力可以大大增加心脏移植的数量并扩大有需要的患者的移植机会。（国际 EXPAND Heart Pivotal 试验 [EXPANDHeart]；NCT02323321；Heart EXPAND 持续访问协议；NCT03835754）