Wiersum-Osselton Johanna C, Whitaker Barbee, Grey Sharran, Land Kevin, Perez Gabriela, Rajbhandary Srijana, Andrzejewski Chester, Bolton-Maggs Paula, Lucero Harriet, Renaudier Philippe, Robillard Pierre, Santos Matilde, Schipperus Martin
Transfusion and Transplantation Reactions in Patients Hemovigilance and Biovigilance Office, Leiden, Netherlands.
Office of Biostatistics and Epidemiology, US Food and Drug Administration, Center for Biologics Evaluation and Research, Silver Spring, MD, USA.
Lancet Haematol. 2019 Jul;6(7):e350-e358. doi: 10.1016/S2352-3026(19)30080-8. Epub 2019 May 9.
Transfusion-associated circulatory overload (TACO) is a major cause of transfusion-related morbidity and mortality in countries with well developed transfusion services. The International Society of Blood Transfusion, the International Haemovigilance Network, and AABB (formerly American Association of Blood Banks), have developed and validated a revised definition of TACO.
International Haemovigilance Network-member haemovigilance systems (Australia, Austria, Denmark, Finland, Greece, India, Ireland, Italy, Japan, Malta, Netherlands, New Zealand, Norway, Slovenia, United Kingdom and United States) provided cases of respiratory complications categorised by their systems, including clinical parameters listed in the 2017 draft definition (part 1). Individual transfusion professionals were then invited to assess 24 case descriptions according to the draft definition (part 2). Positive and negative agreement and inter-rater agreement (κ) were calculated. Based on validation results, cases were reanalysed and slight adjustments made to yield the final 2018 TACO definition.
In part 1, 16 (44%) of 36 haemovigilance systems provided 178 cases, including 126 TACO cases. By use of the 2018 definition, 96 (76%) of 126 cases of TACO were in positive agreement. 19 (37%) of 52 cases were recognised as non-TACO respiratory complications. In part 2 (47 experts from 20 countries), moderate all-case agreement (κ=0·43) and TACO-specific agreement (κ=0·54) were observed. Excluding cases missing some clinical information (eg, N terminal pro-brain natriuretic peptide, distinctive chest x-ray findings, and relationship with existing respiratory co-morbidities like pneumonia and chronic obstructive pulmonary disease) improved all-case agreement to κ=0·50 (moderate) and κ=0·65 (good) for TACO cases.
The two-part validation exercise showed that the revised 2018 TACO surveillance case definition captures 76% of cases endorsed as TACO by participating haemovigilance systems. This definition can become the basis for internationally consistent surveillance reporting and contribute towards increased awareness and mitigation of TACO. Further research will require reporting more complete clinical information to haemovigilance systems and should focus on improved distinction between TACO and other transfusion respiratory complications.
International Society of Blood Transfusion, International Haemovigilance Network, and AABB.
在输血服务发达的国家，输血相关循环超负荷（TACO）是输血相关发病和死亡的主要原因。国际输血协会、国际血液警戒网络和美国血库协会（原美国血库协会）已制定并验证了TACO的修订定义。
国际血液警戒网络成员的血液警戒系统（澳大利亚、奥地利、丹麦、芬兰、希腊、印度、爱尔兰、意大利、日本、马耳他、荷兰、新西兰、挪威、斯洛文尼亚、英国和美国）提供了按其系统分类的呼吸并发症病例，包括2017年定义草案（第1部分）中列出的临床参数。然后邀请个体输血专业人员根据定义草案（第2部分）评估24例病例描述。计算阳性和阴性一致性以及评分者间一致性（κ）。根据验证结果，对病例进行重新分析并进行轻微调整，以得出最终的2018年TACO定义。
在第1部分中，36个血液警戒系统中的16个（44%）提供了178例病例，包括126例TACO病例。使用2018年定义，126例TACO病例中有96例（76%）呈阳性一致。52例病例中有19例（37%）被认定为非TACO呼吸并发症。在第2部分（来自20个国家的47名专家）中，观察到中等的全病例一致性（κ=0.43）和TACO特异性一致性（κ=0.54）。排除一些临床信息缺失（如N末端脑钠肽前体、独特的胸部X线表现以及与肺炎和慢性阻塞性肺疾病等现有呼吸合并症的关系）的病例后，全病例一致性提高到κ=0.50（中等），TACO病例的一致性提高到κ=0.65（良好）。
两部分验证工作表明，修订后的2018年TACO监测病例定义涵盖了参与血液警戒系统认可为TACO的76%的病例。该定义可成为国际一致监测报告的基础，并有助于提高对TACO的认识和减轻其影响。进一步的研究将需要向血液警戒系统报告更完整的临床信息，并应侧重于改善TACO与其他输血相关呼吸并发症之间的区分。
国际输血协会、国际血液警戒网络和美国血库协会。
