低温氧合机器灌注可减少延长标准供肝来源肝移植术后早期移植物损伤并改善移植结局：来自多中心随机对照试验（HOPE ECD-DBD）的结果。

Hypothermic Oxygenated Machine Perfusion Reduces Early Allograft Injury and Improves Post-transplant Outcomes in Extended Criteria Donation Liver Transplantation From Donation After Brain Death: Results From a Multicenter Randomized Controlled Trial (HOPE ECD-DBD).

机构信息

Department of Surgery and Transplantation, University Hospital RWTH Aachen, Aachen, Germany.

Department of Surgery, Campus Charité Mitte | Campus Virchow-Klinikum, Charité-Universitätsmedizin Berlin, Germany.

出版信息

Ann Surg. 2021 Nov 1;274(5):705-712. doi: 10.1097/SLA.0000000000005110.

DOI:10.1097/SLA.0000000000005110

PMID:34334635

Abstract

OBJECTIVE

The aim of this study was to evaluate peak serum alanine aminotransferase (ALT) and postoperative clinical outcomes after hypothermic oxygenated machine perfusion (HOPE) versus static cold storage (SCS) in extended criteria donation (ECD) liver transplantation (LT) from donation after brain death (DBD).

BACKGROUND

HOPE might improve outcomes in LT, particularly in high-risk settings such as ECD organs after DBD, but this hypothesis has not yet been tested in a randomized controlled clinical trial (RCT).

METHODS

Between September 2017 and September 2020, 46 patients undergoing ECD-DBD LT from four centers were randomly assigned to HOPE (n = 23) or SCS (n = 23). Peak-ALT levels within 7 days following LT constituted the primary endpoint. Secondary endpoints included incidence of postoperative complications [Clavien-Dindo classification (CD), Comprehensive Complication Index (CCI)], length of intensive care- (ICU) and hospital-stay, and incidence of early allograft dysfunction (EAD).

RESULTS

Demographics were equally distributed between both groups [donor age: 72 (IQR: 59-78) years, recipient age: 62 (IQR: 55-65) years, labMELD: 15 (IQR: 9-25), 38 male and 8 female recipients]. HOPE resulted in a 47% decrease in serum peak ALT [418 (IQR: 221-828) vs 796 (IQR: 477-1195) IU/L, P = 0.030], a significant reduction in 90-day complications [44% vs 74% CD grade ≥3, P = 0.036; 32 (IQR: 12-56) vs 52 (IQR: 35-98) CCI, P = 0.021], and shorter ICU- and hospital-stays [5 (IQR: 4-8) vs 8 (IQR: 5-18) days, P = 0.045; 20 (IQR: 16-27) vs 36 (IQR: 23-62) days, P = 0.002] compared to SCS. A trend toward reduced EAD was observed for HOPE (17% vs 35%; P = 0.314).

CONCLUSION

This multicenter RCT demonstrates that HOPE, in comparison to SCS, significantly reduces early allograft injury and improves post-transplant outcomes in ECD-DBD liver transplantation.

摘要

目的

本研究旨在评估低温氧合机器灌注（HOPE）与静态冷保存（SCS）在脑死亡供体（DBD）来源的扩展标准捐赠（ECD）肝移植（LT）中对血清丙氨酸氨基转移酶（ALT）峰值和术后临床结局的影响。

背景

HOPE 可能改善 LT 的结局，特别是在 ECD 器官等高风险环境中，但这一假设尚未在随机对照临床试验（RCT）中得到验证。

方法

2017 年 9 月至 2020 年 9 月，来自四个中心的 46 例行 ECD-DBD LT 的患者被随机分配至 HOPE 组（n = 23）或 SCS 组（n = 23）。LT 后 7 天内的血清 ALT 峰值为主要终点。次要终点包括术后并发症发生率[Clavien-Dindo 分级（CD），综合并发症指数（CCI）]、重症监护病房（ICU）和住院时间、以及早期移植物功能障碍（EAD）的发生率。

结果

两组患者的人口统计学特征无差异[供体年龄：72（IQR：59-78）岁，受体年龄：62（IQR：55-65）岁，labMELD：15（IQR：9-25），38 名男性和 8 名女性受体]。HOPE 使血清 ALT 峰值降低了 47%[418（IQR：221-828）vs 796（IQR：477-1195）IU/L，P = 0.030]，90 天并发症显著减少[44% vs 74% CD 分级≥3，P = 0.036；32（IQR：12-56）vs 52（IQR：35-98）CCI，P = 0.021]，ICU 和住院时间缩短[5（IQR：4-8）vs 8（IQR：5-18）天，P = 0.045；20（IQR：16-27）vs 36（IQR：23-62）天，P = 0.002]。与 SCS 相比，HOPE 组 EAD 发生率呈降低趋势（17% vs 35%；P = 0.314）。