Ted Rogers Centre for Heart Research, University of Toronto, Toronto, Ontario, Canada.
UT Southwestern Medical Center, Dallas, Texas, USA.
J Card Fail. 2024 Jun;30(6):805-815. doi: 10.1016/j.cardfail.2023.09.018. Epub 2023 Oct 30.
Primary graft dysfunction (PGD) is the leading cause of morbidity and mortality early after heart transplantation (HT). The International Consortium on PGD is a multicenter collaboration dedicated to identifying the clinical risk factors for PGD in the contemporary era of HT. The objectives of the current report were (1) to assess the incidence of severe PGD in an international cohort; (2) to evaluate the performance of the most strongly validated PGD risk tool, the RADIAL score, in a contemporary cohort; and (3) to redefine clinical risk factors for severe PGD in the current era of HT.
This is a retrospective, observational study of consecutive adult HT recipients between 2010 and 2020 in 10 centers in the United States, Canada and Europe. Patients with severe PGD were compared to those without severe PGD (comprising those with no, mild and moderate PGD). The RADIAL score was calculated for each transplant recipient. The discriminatory power of the RADIAL score was evaluated using receiver operating characteristic (ROC) analysis, and its calibration was assessed by plotting the percentage of PGD predicted vs that which was observed. To identify clinical risk factors associated with severe PGD, we performed multivariable mixed-effects logistic regression modeling to account for among-center variability.
A total of 2746 patients have been enrolled in the registry to date, including 2015 (73.4%) from North America, and 731 (26.6%) from Europe; 215 participants (7.8%) met the criteria for severe PGD. There was an increase in the incidence of severe PGD over the study period (P value for trend by difference sign test = 0.004). The Kaplan-Meier estimate for 1-year survival was 75.7% (95% CI 69.4-80.9%) in patients with severe PGD as compared to 94.4% (95% CI 93.5-95.2%) in those without severe PGD (log-rank P value < 0.001). The RADIAL score performed poorly in our contemporary cohort and was not associated with severe PGD; it had an AUC of 0.53 (95% CI 0.48-0.58). In the multivariable regression model, acute preoperative dialysis (OR 2.41, 95% CI 1.31-4.43), durable left ventricular assist device support (OR 1.77, 95% CI 1.13-2.77), and total ischemic time (OR 1.20 for each additional hour, 95% CI 1.02-1.41) were associated with an increased risk of severe PGD.
Our consortium has identified an increasing incidence of PGD in the modern transplant era. We identified contemporary risk factors for this early post-transplant complication, which confers a high mortality risk. These results may enable the identification of patients at high risk for developing severe PGD in order to inform peri-transplant donor and recipient management practices.
原发性移植物功能障碍（PGD）是心脏移植（HT）后早期发病率和死亡率的主要原因。PGD 国际联合会是一个多中心合作组织，致力于确定当代 HT 中 PGD 的临床危险因素。本报告的目的是：（1）评估国际队列中严重 PGD 的发生率；（2）评估最有力验证的 PGD 风险工具 RADIAL 评分在当代队列中的表现；（3）重新定义当代 HT 中严重 PGD 的临床危险因素。
这是一项回顾性、观察性研究，纳入了 2010 年至 2020 年期间美国、加拿大和欧洲 10 个中心的连续成年 HT 受者。将发生严重 PGD 的患者与未发生严重 PGD 的患者（包括无、轻度和中度 PGD 患者）进行比较。为每个移植受者计算 RADIAL 评分。通过接受者操作特征（ROC）分析评估 RADIAL 评分的判别能力，并通过绘制预测 PGD 的百分比与观察到的百分比来评估其校准情况。为了确定与严重 PGD 相关的临床危险因素，我们进行了多变量混合效应逻辑回归建模，以解释中心间的变异性。
迄今为止，该登记处共纳入了 2746 名患者，其中 2015 年（73.4%）来自北美，731 名（26.6%）来自欧洲；215 名患者（7.8%）符合严重 PGD 的标准。在研究期间，严重 PGD 的发生率呈上升趋势（差异符号检验的趋势检验 P 值=0.004）。与无严重 PGD 的患者相比，发生严重 PGD 的患者 1 年生存率的 Kaplan-Meier 估计值为 75.7%（95%CI 69.4-80.9%）（对数秩检验 P 值<0.001）。在我们的当代队列中，RADIAL 评分表现不佳，与严重 PGD 无关；其 AUC 为 0.53（95%CI 0.48-0.58）。在多变量回归模型中，术前急性透析（OR 2.41，95%CI 1.31-4.43）、持久左心室辅助装置支持（OR 1.77，95%CI 1.13-2.77）和总缺血时间（每增加 1 小时的 OR 为 1.20，95%CI 1.02-1.41）与严重 PGD 的风险增加相关。
我们的联合会已经确定了在现代移植时代 PGD 发生率的增加。我们确定了这种早期移植后并发症的当代危险因素，这会带来高死亡率风险。这些结果可能能够识别出发生严重 PGD 风险较高的患者，以便为移植前供体和受者管理实践提供信息。
