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欧洲多中心研究:体外光化学疗法在心脏移植后的真实世界应用及临床影响。

European multicenter study on the real-world use and clinical impact of extracorporeal photopheresis after heart transplantation.

机构信息

Department of Cardiovascular Surgery, University Heart and Vascular Center Hamburg, Hamburg, Germany.

Heart and Vascular Center, Semmelweis University Budapest, Budapest, Hungary.

出版信息

J Heart Lung Transplant. 2023 Aug;42(8):1131-1139. doi: 10.1016/j.healun.2023.03.005. Epub 2023 Mar 15.

Abstract

BACKGROUND

Aim of this study was to describe the real-world use of extracorporeal photopheresis (ECP) and assess its impact on clinical outcomes in the modern era of heart transplantation.

METHODS

Seven transplant centers from 5 European countries participated in this retrospective, observational, single-arm chart review study. All patients received ECP after heart transplantation in 2015 or later. Data were extracted from medical records between November 2020 and December 2021.

RESULTS

Overall, 105 patients were enrolled and followed for an average of 2 years after initiation of ECP. Reasons to start ECP were acute cellular rejection (35.2%), rejection prevention (32.4%), mixed rejection (18.1%), and antibody-mediated rejection (14.3%). Rejection ISHLT grades improved from start to end of ECP treatment in 92% of patients treated with ECP for rejection. Of patients who started ECP to prevent rejection, 88% remained free from any rejection despite a reduction of calcineurin inhibitors. Overall survival was 95%, and no deaths were related to ECP. Safety events occurred in 18 patients, of which 13 experienced complications with venous access.

CONCLUSIONS

This study, the largest European ECP study in heart transplantation, demonstrates that ECP can effectively be used to treat different rejection types and to prevent rejection in the modern era of immunosuppression. Patients with rejections who have received ECP have shown high response as measured by histological improvements in ISHLT classification. A high percentage of patients in the prevention group remained free from rejection despite reduction in immunosuppression, in particular calcineurin inhibitors.

摘要

背景

本研究旨在描述体外光化学疗法(ECP)的实际应用,并评估其在心脏移植的现代时代对临床结果的影响。

方法

来自 5 个欧洲国家的 7 个移植中心参与了这项回顾性、观察性、单臂图表回顾研究。所有患者均在 2015 年或之后接受心脏移植后接受 ECP。数据从 2020 年 11 月至 2021 年 12 月的病历中提取。

结果

共有 105 名患者入组,并在开始 ECP 后平均随访 2 年。开始 ECP 的原因是急性细胞排斥(35.2%)、预防排斥(32.4%)、混合排斥(18.1%)和抗体介导的排斥(14.3%)。接受 ECP 治疗排斥的患者中,92%的患者在开始 ECP 治疗后,ISHLT 排斥等级得到改善。开始 ECP 预防排斥的患者中,尽管钙调神经磷酸酶抑制剂减少,仍有 88%的患者无任何排斥反应。总生存率为 95%,无死亡与 ECP 相关。18 名患者发生了安全事件,其中 13 名患者静脉通路并发症。

结论

这项研究是心脏移植中最大的欧洲 ECP 研究,表明 ECP 可有效用于治疗不同类型的排斥反应,并在现代免疫抑制时代预防排斥反应。接受 ECP 治疗的排斥患者在 ISHLT 分类方面显示出高反应,组织学改善明显。预防组中有很大比例的患者尽管减少了免疫抑制,特别是钙调神经磷酸酶抑制剂,仍无排斥反应。

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