Longitudinal analysis of annual national hemovigilance data to assess pathogen reduced platelet transfusion trends during conversion to routine universal clinical use and 7‐day storage

Abstract

Background: France converted to universal pathogen reduced (PR; amotosalen/UVA) platelets in 2017 and extended platelet component (PC) shelf-life from 5-to 7-days in 2018 and 2019. Annual national hemovigilance (HV) reports characterized longitudinal PC utilization and safety over 11 years, including several years prior to PR adoption as the national standard of care. Methods: Data were extracted from published annual HV reports. Apheresis and pooled buffy coat [BC] PC use was compared. Transfusion reactions (TRs) were stratified by type, severity, and causality. Trends were assessed for three periods: Baseline (2010-14; $7% PR), Period 1 ([P1] 2015-17; 8%-21% PR), and Period 2 ([P2] 2018-20; 100% PR). Results: PC use increased by 19.1% between 2010 and 2020. Pooled BC PCproduction increased from 38.8% to 68.2% of total PCs. Annual changes in PCs issued averaged 2.4% per year at baseline, À0.02% (P1) and 2.8% (P2). The increase in P2 coincided with a reduction in the target platelet dose and extension to 7-day storage. Allergic reactions, alloimmunization, febrile nonhemolytic TRs, immunologic incompatibility, and ineffective transfusions accounted for >90% of TRs. Overall, TR incidence per 100,000 PCs issued declined from 527.9 (2010) to 345.7 (2020). Severe TR rates declined 34.8% between P1-P2. Forty-six transfusion-transmitted bacterial infections (TTBI)

How do we use the National Healthcare Safety Network for Hemovigilance in Massachusetts?

“…With the increase in PRT use for platelets, along with implementation of universal screening of products for Babesia microti , Massachusetts has seen a decrease in all TTIs, and specifically babesiosis, with zero TTI cases reported in 2021 (compared to an average of three per year from 2017 to 2020). This is comparable to data collected in France, where the HV system detected a similar decrease in TTIs after the universal adoption of PRT products 17 . AR data from Massachusetts are also comparable to what the United Kingdom reports annually.…”

Biochemical and functional characteristics of stored (double‐dose) buffy‐coat platelet concentrates treated with amotosalen and a prototype UVA light‐emitting diode illuminator

“…Randomized clinical trials and post-marketing studies measuring the posttransfusion increments in platelet counts, time between platelet transfusion, and numbers of PC units transfused remain essential to evaluate their clinical efficacy. 32,33 Overall, these new findings should allow improved procedures for the preparation and storage of PCs, so as to ensure transfusion safety and transfuse platelets with better and longer lasting functional properties.…”

“…Since 7‐day stored LED‐treated platelets displayed identical in vitro quality to those of 7‐day stored UVA lamp‐treated platelets, it is reasonable to anticipate that 7‐day stored LED‐treated platelets would survive in vivo at similar levels. Randomized clinical trials and post‐marketing studies measuring the posttransfusion increments in platelet counts, time between platelet transfusion, and numbers of PC units transfused remain essential to evaluate their clinical efficacy 32,33 . Overall, these new findings should allow improved procedures for the preparation and storage of PCs, so as to ensure transfusion safety and transfuse platelets with better and longer lasting functional properties.…”