本文由小咖机器人翻译整理

期刊来源：JAMA

原文链接：https://doi.org/10.1001/jama.2023.27029

摘要内容如下：

重要性

美国心脏分配系统（US Heart Allocation System）优先考虑不进行移植就有很高死亡风险的医学紧急候选人。当前基于治疗的6-状态系统易受操纵并且具有有限的等级排序能力。

目的

开发并验证结合了当前临床、实验室和血液动力学数据的候选风险评分。

设计、设置和参与者

2019年1月1日至2022年12月31日期间，美国心脏分配系统（US Heart Allocation System）对成人心脏移植候选人（年龄≥18岁）进行了一项基于登记的观察研究，按中心分为训练（70%）和测试（30%）数据集。2019年1月1日至2022年12月31日期间列入成人候选人名单。

主要成果和措施

通过向当前的法国候选风险评分（French-CRS）模型添加一组预定义的预测因子，开发了美国候选风险评分（US-CRS）模型。对US-CRS短期机械循环支持（MCS）的定义进行了敏感性分析，其中包括主动脉内球囊反搏泵（IABP）和经皮心室辅助装置（VAD）。US-CRS模型、French-CRS模型和6-状态模型在测试数据集中的性能通过6周内无移植死亡的时间依赖性受试者工作特征曲线下面积（AUC）和总生存一致性（C指数）与综合AUC进行评估。

结果

共列出16905名成人心脏移植候选人（平均[SD]年龄:53[13]岁；73%为男性；58%为白人）；796名患者（4.7%）在没有移植的情况下死亡。最终的US-CRS包括随时间变化的短期MCS（心室辅助-体外膜氧合或临时外科VAD）、胆红素的对数、估计的肾小球滤过率、B型利钠肽的对数、白蛋白、钠和耐用的左心室辅助装置。在测试数据集中，美国CRS模型上市后6周内死亡的AUC为0.79（95%CI，0.75-0.83），法国CRS模型为0.72（95%CI，0.67-0.76），6-状态模型为0.68（95%CI，0.62-0.73）。美国CRS模型的总体C指数为0.76（95%CI，0.73-0.80），法国CRS模型为0.69（95%CI，0.65-0.73），6-状态模型为0.67（95%CI，0.63-0.71）。将IABP和经皮VAD归类为短期MCS可将效应大小降低54%。

结论和相关性

在这项基于登记的美国心脏移植候选人研究中，连续多变量分配评分在按医疗紧急程度对心脏移植候选人进行排序方面优于6状态系统，并且可能对心脏分配的医疗紧急部分有用。

英文原文如下：

Abstracts

Importance  The US heart allocation system prioritizes medically urgent candidates with a high risk of dying without transplant. The current therapy-based 6-status system is susceptible to manipulation and has limited rank ordering ability.

Objective  To develop and validate a candidate risk score that incorporates current clinical, laboratory, and hemodynamic data.

Design, Setting, and Participants  A registry-based observational study of adult heart transplant candidates (aged ≥18 years) from the US heart allocation system listed between January 1, 2019, and December 31, 2022, split by center into training (70%) and test (30%) datasets. Adult candidates were listed between January 1, 2019, and December 31, 2022.

Main Outcomes and Measures  A US candidate risk score (US-CRS) model was developed by adding a predefined set of predictors to the current French Candidate Risk Score (French-CRS) model. Sensitivity analyses were performed, which included intra-aortic balloon pumps (IABP) and percutaneous ventricular assist devices (VAD) in the definition of short-term mechanical circulatory support (MCS) for the US-CRS. Performance of the US-CRS model, French-CRS model, and 6-status model in the test dataset was evaluated by time-dependent area under the receiver operating characteristic curve (AUC) for death without transplant within 6 weeks and overall survival concordance (c-index) with integrated AUC.

Results  A total of 16 905 adult heart transplant candidates were listed (mean [SD] age, 53 [13] years; 73% male; 58% White); 796 patients (4.7%) died without a transplant. The final US-CRS contained time-varying short-term MCS (ventricular assist-extracorporeal membrane oxygenation or temporary surgical VAD), the log of bilirubin, estimated glomerular filtration rate, the log of B-type natriuretic peptide, albumin, sodium, and durable left ventricular assist device. In the test dataset, the AUC for death within 6 weeks of listing for the US-CRS model was 0.79 (95% CI, 0.75-0.83), for the French-CRS model was 0.72 (95% CI, 0.67-0.76), and 6-status model was 0.68 (95% CI, 0.62-0.73). Overall c-index for the US-CRS model was 0.76 (95% CI, 0.73-0.80), for the French-CRS model was 0.69 (95% CI, 0.65-0.73), and 6-status model was 0.67 (95% CI, 0.63-0.71). Classifying IABP and percutaneous VAD as short-term MCS reduced the effect size by 54%.

Conclusions and Relevance  In this registry-based study of US heart transplant candidates, a continuous multivariable allocation score outperformed the 6-status system in rank ordering heart transplant candidates by medical urgency and may be useful for the medical urgency component of heart allocation.

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