2010-21 年法国捐献者的心脏严重不良反应 Évènements indésirables graves donneurs de type cardiaque en France 2010-21.

IF 1.4 4区医学 Q4 HEMATOLOGY

Transfusion Clinique et Biologique Pub Date : 2025-05-01 DOI:10.1016/j.tracli.2025.02.002

Karim Boudjedir , Monique Carlier , Isabelle Hervé , Paul-Michel Mertes , Sophie Somme , Anne-Marine Lenzotti , Gilles Folléa

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引用次数: 0

摘要

目的研究法国全血（WBD）或单采（AD）献血者心脏严重不良反应（CSARD）报告。尽管可能很严重，但迄今为止对它们的研究很少。方法对2010年至2021年间报道的125例CSARD（心肌梗死- mi、急性冠状动脉综合征- acs、心绞痛- ap、心律失常- rd）进行回顾性描述性研究。研究参数为年龄、性别、捐献类型、诊断、发病时间、归咎性、严重程度（分级）、心血管危险因素（CVRF）。由5位专家在报告中进行审查，他们独立记录了他们对每个参数（年龄、性别、捐赠类型除外）的意见。然后，对所有案件的意见进行合议分析，得出了一致意见。发生CSARD和捐赠之间的时间被延长到48小时。对于非捐赠原因（如冠状动脉粥样硬化）但因捐赠而加重或引发的CSARD，增加了一个附加的归责标准：AT1可能（捐赠后24-48小时），AT2可能（捐赠后12-24小时）或AT3肯定（捐赠前12小时或开始）。结果125例报告中，排除了50例：SARD心脏鉴定无效（8例），资料缺乏（2例），未捐献（1例），捐献后48小时以上发生（39例）。75例CSARD患者（包括5例死亡）包括58例冠状动脉事件（38例MI， 13例ACS， 7例AP）和17例RD，其互补归责标准（AT）分别为1(20%),2(24%),3（56%）。CSARD/106捐献的累积发生率估计为2.1，AD（5.3）明显高于WBD (1.6)；p

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Cardiac serious adverse reactions in donors in France 2010–21

Aim

To study cardiac serious adverse reactions in blood donors (CSARD) reported in the context of whole blood donation (WBD) or apheresis donation (AD) in France. Although potentially serious, they have been poorly studied so far.

Methods

Retrospective descriptive study of the 125 CSARD (myocardial infarction-MI, acute coronary syndrome-ACS, angina pectoris-AP, rhythm disorder-RD) reported between 2010 and 2021. The studied parameters were age, gender, type of donation, diagnosis, time to onset, imputability, severity (grade), cardiovascular risk factors (CVRF). They were reviewed within the reports by 5 experts, who independently recorded their opinions on each parameter (except age, gender, type of donation). The collegial analysis of the opinions then resulted in a consensus for all cases. The time between the occurrence of CSARD and donation has been extended and limited to 48 h. An additional criterion of imputability was added for the CSARD attributed to causes other than the donation (e.g., coronary atheroma) but Aggravated or Triggered by the donation: AT1 possibly (>24–48 h post-donation), AT2 probably (>12–24 h post-donation) or AT3 certainly (within 12 h or pre-donation start).

Results

Out of 125 reports, 50 were excluded: cardiac qualification of SARD invalidated (8), lack of data (2), absence donation (1), occurrence more than 48 h after the donation (39). The 75 included CSARD (including 5 deaths) comprised 58 coronary events (38 MI, 13 ACS, 7 AP) and 17 RD, and their complementary imputability criterion (AT) was classified respectively as follows 1 (20%), 2 (24%), 3 (56%). The estimated cumulative incidence of CSARD/106 donations is 2.1, significantly higher for AD (5.3) than for WBD (1.6; p < 0.001). The male (M) and female (F) percentages are 81% vs 19%, significantly different from the ones of the standard donor population over 2010–21: 48% M vs 52% F. The median ages, 55 years (30–70) in men, and 47 years (23–68) in women, were significantly higher than the ones of standard donor population 2010–21, respectively 46 (p < 0,001) and 41 (p = 0,04). In the 58 coronary accidents, at least 3 CVRF were noted in 38 cases (66%) and at least 4 CVRF in 20 cases (34%), including 5 with 5 CVRF. In 6/75 cases (8%) pre-existing signs not detected during the pre-donation interview (PDI) would have permanently contraindicated donation.

Conclusions

A complementary study should assess whether a more formalised consideration of CVRF in the PDI could reduce the frequency of CSARD of coronary type.

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来源期刊

Transfusion Clinique et Biologique 医学-免疫学

CiteScore

2.50

自引率

11.80%

发文量

234

审稿时长

36 days

期刊介绍： Transfusion Clinique et Biologique, the official journal of the French Society of Blood Transfusion (SFTS): - an aid to training, at a European level - the only French journal indexed in the hematology and immunology sections of Current Contents Transfusion Clinique et Biologique spans fundamental research and everyday practice, with articles coming from both sides. Articles, reviews, case reports, letters to the editor and editorials are published in 4 editions a year, in French or in English, covering all scientific and medical aspects of transfusion: immunology, hematology, infectious diseases, genetics, molecular biology, etc. And finally, a convivial cross-disciplinary section on training and information offers practical updates. Readership: "Transfusers" are many and various: anesthetists, biologists, hematologists, and blood-bank, ICU and mobile emergency specialists...