BACKGROUND: Delayed, large-volume bacterial culture and amotosalen/ultraviolet-A light pathogen reduction are effective at reducing the risk of bacterial proliferation in platelet concentrates (PCs). Hemovigilance programs continue to receive reports of suspected septic transfusion reactions, most with low imputability. Here, we compile national hemovigilance data to determine the relative efficacy of these interventions. STUDY DESIGN AND METHODS: Annual reports from the United Kingdom, France, Switzerland, and Belgium were reviewed between 2005 and 2016 to assess the risk of bacterial contamination and septic reactions. RESULTS: Approximately 1.65 million delayed, large-volume bacterial culture-screened PCs in the United Kingdom and 2.3 million amotosalen/ultraviolet-A-treated PCs worldwide were issued with no reported septic fatalities. One definite, one possible, and 12 undetermined/indeterminate septic reactions and eight contaminated "near misses" were reported with delayed, large-volume bacterial cultures between 2011 and 2016, for a lower false-negative culture rate than that in the previous 5 years (5.4 vs. 16.3 per million: odds ratio, 3.0; 95% confidence interval, 1.4-6.5). Together, the Belgian, Swiss, and French hemovigilance programs documented zero probable or definite/certain septic reactions with 609,290 amotosalen/ultraviolet-A-treated PCs (<1.6 per million). The rates were significantly lower than those reported with concurrently transfused, nonpathogen-reduced PCs in Belgium (<4.4 vs. 35.6 per million: odds ratio, 8.1; 95% confidence interval,1.1-353.3) and with historic septic reaction rates in Switzerland (<6.0 vs. 82.9 per million: odds ratio, 13.9; 95% confidence interval, 2.1-589.2), and the rates tended to be lower than those from concurrently transfused, nonpathogen-reduced PCs in France (<4.7 vs. 19.0 per million: odds ratio, 4.1; 95% confidence interval, 0.7-164.3). CONCLUSION: Pathogen reduction and bacterial culture both reduced the incidence of septic reactions, although under-reporting and strict imputability criteria resulted in an underestimation of risk.
BACKGROUND: Delayed, large-volume bacterial culture and amotosalen/ultraviolet-A light pathogen reduction are effective at reducing the risk of bacterial proliferation in platelet concentrates (PCs). Hemovigilance programs continue to receive reports of suspected septic transfusion reactions, most with low imputability. Here, we compile national hemovigilance data to determine the relative efficacy of these interventions. STUDY DESIGN AND METHODS: Annual reports from the United Kingdom, France, Switzerland, and Belgium were reviewed between 2005 and 2016 to assess the risk of bacterial contamination and septic reactions. RESULTS: Approximately 1.65 million delayed, large-volume bacterial culture-screened PCs in the United Kingdom and 2.3 million amotosalen/ultraviolet-A-treated PCs worldwide were issued with no reported septic fatalities. One definite, one possible, and 12 undetermined/indeterminate septic reactions and eight contaminated "near misses" were reported with delayed, large-volume bacterial cultures between 2011 and 2016, for a lower false-negative culture rate than that in the previous 5 years (5.4 vs. 16.3 per million: odds ratio, 3.0; 95% confidence interval, 1.4-6.5). Together, the Belgian, Swiss, and French hemovigilance programs documented zero probable or definite/certain septic reactions with 609,290 amotosalen/ultraviolet-A-treated PCs (<1.6 per million). The rates were significantly lower than those reported with concurrently transfused, nonpathogen-reduced PCs in Belgium (<4.4 vs. 35.6 per million: odds ratio, 8.1; 95% confidence interval,1.1-353.3) and with historic septic reaction rates in Switzerland (<6.0 vs. 82.9 per million: odds ratio, 13.9; 95% confidence interval, 2.1-589.2), and the rates tended to be lower than those from concurrently transfused, nonpathogen-reduced PCs in France (<4.7 vs. 19.0 per million: odds ratio, 4.1; 95% confidence interval, 0.7-164.3). CONCLUSION: Pathogen reduction and bacterial culture both reduced the incidence of septic reactions, although under-reporting and strict imputability criteria resulted in an underestimation of risk.
Authors: Richard R Gammon; Rita A Reik; Marc Stern; Ralph R Vassallo; Dan A Waxman; Pampee P Young; Richard J Benjamin Journal: Transfusion Date: 2021-12-20 Impact factor: 3.337
Authors: Roberta Z Horth; Jefferson M Jones; Janice J Kim; Bert K Lopansri; Sarah J Ilstrup; Joy Fridey; Walter E Kelley; Susan L Stramer; Ashok Nambiar; Lynn Ramirez-Avila; Amy Nichols; Wendy Garcia; Kelly F Oakeson; Nicholas Vlachos; Gillian McAllister; Robert Hunter; Allyn K Nakashima; Sridhar V Basavaraju Journal: MMWR Morb Mortal Wkly Rep Date: 2018-06-29 Impact factor: 17.586
Authors: Katherine M Prioli; Julie Katz Karp; Nina M Lyons; Vera Chrebtow; Jay H Herman; Laura T Pizzi Journal: Appl Health Econ Health Policy Date: 2018-12 Impact factor: 2.561
Authors: A M Hashem; A M Hassan; A M Tolah; M A Alsaadi; Q Abunada; G A Damanhouri; S A El-Kafrawy; M Picard-Maureau; E I Azhar; S I Hindawi Journal: Transfus Med Date: 2019-11-06 Impact factor: 2.019
Authors: Marion C Lanteri; Felicia Santa-Maria; Andrew Laughhunn; Yvette A Girard; Marcus Picard-Maureau; Jean-Marc Payrat; Johannes Irsch; Adonis Stassinopoulos; Peter Bringmann Journal: Transfusion Date: 2020-04-24 Impact factor: 3.157