Section of Heart Failure, Cardiac Transplant, and Mechanical Circulatory Support, and Department of Medicine, Stanford University, Stanford, California; Ted Rogers Centre of Excellence in Heart Function, Peter Munk Cardiac Centre, University Health Network, Toronto, Ontario, Canada.
Ted Rogers Centre of Excellence in Heart Function, Peter Munk Cardiac Centre, University Health Network, Toronto, Ontario, Canada.
J Heart Lung Transplant. 2019 Jan;38(1):51-58. doi: 10.1016/j.healun.2018.09.004. Epub 2018 Sep 12.
Gene expression profiling (GEP) was developed for non-invasive surveillance of acute cellular rejection. Despite its widespread use, there has been a paucity in outcome data for patients managed with GEP outside of clinical trials.
The Outcomes AlloMap Registry (OAR) is an observational, prospective, multicenter study including patients aged ≥ 15 years and ≥ 55 days post-cardiac transplant. Primary outcome was death and a composite outcome of hemodynamically significant rejection, graft dysfunction, retransplantation, or death. Secondary outcomes included readmission rates and development of coronary allograft vasculopathy and malignancies.
The study included 1,504 patients, who were predominantly Caucasian (69%), male (74%), and aged 54.1 ± 12.9 years. The prevalence of moderate to severe acute cellular rejection (≥2R) was 2.0% from 2 to 6 months and 2.2% after 6 months. In the OAR there was no association between higher GEP scores and coronary allograft vasculopathy (p = 0.25), cancer (p = 0.16), or non-cytomegalovirus infection (p = 0.10). Survival at 1, 2, and 5 years post-transplant was 99%, 98%, and 94%, respectively. The composite outcome occurred in 103 patients during the follow-up period. GEP scores in dual-organ recipients (heart-kidney and heart-liver) were comparable to heart-alone recipients.
This registry comprises the largest contemporary cohort of patients undergoing GEP for surveillance. Among patients selected for GEP surveillance, survival is excellent, and rates of acute rejection, graft dysfunction, readmission, and death are low.
基因表达谱分析（GEP）是为非侵入性监测急性细胞排斥反应而开发的。尽管它被广泛应用，但在临床试验之外，使用 GEP 管理的患者的结果数据却很少。
Outcomes AlloMap 注册中心（OAR）是一项观察性、前瞻性、多中心研究，包括年龄≥15 岁和心脏移植后≥55 天的患者。主要结局是死亡和血液动力学显著排斥、移植物功能障碍、再次移植或死亡的复合结局。次要结局包括再入院率以及冠状动脉移植血管病和恶性肿瘤的发展。
该研究纳入了 1504 名患者，他们主要是白种人（69%）、男性（74%）和 54.1±12.9 岁。2 至 6 个月和 6 个月后中度至重度急性细胞排斥反应（≥2R）的患病率分别为 2.0%和 2.2%。在 OAR 中，较高的 GEP 评分与冠状动脉移植血管病（p=0.25）、癌症（p=0.16）或非巨细胞病毒感染（p=0.10）之间没有关联。移植后 1、2 和 5 年的生存率分别为 99%、98%和 94%。在随访期间，有 103 名患者发生复合结局。双器官受体（心脏-肾脏和心脏-肝脏）的 GEP 评分与心脏单独受体相当。
该注册中心包含了最大的接受 GEP 监测的当代患者队列。在接受 GEP 监测选择的患者中，生存率极好，急性排斥反应、移植物功能障碍、再入院和死亡的发生率较低。
