Cardiac serious adverse reactions in donors in France 2010-21.

Abstract

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.