Clinical and economic impacts of large volume delayed sampling and pathogen reduction technology platelet processing strategies in the United States

Abstract

Background: Large volume delayed sampling (LVDS) and pathogen reduction technology (PRT) are strategies for platelet processing to minimize transfusion of contaminated platelet components (PCs). This study holistically compares the economic and clinical impact of LVDS and PRT in the United States. Study Design and Methods: A decision model was constructed to simulate collection, processing, and use of PCs and to compare processing strategies: PRT with 5-day shelf life, LVDS with 7-day shelf life (LVDS7), and LVDS with 5-day shelf life extended to 7 days with secondary testing (LVDS5/2). Target population was adults requiring two or more transfusions. Collection, processing, storage, and distribution data were obtained from the National Blood Collection and Utilization Survey and published literature. Patient outcomes associated with transfusions were obtained from AABB guidelines, meta-analyses, and other published clinical studies. Costs were obtained from reimbursement schedules and other published sources.Results: Given 10,000 donated units, 9512, 9511, and 9651 units of PRT, LVDS5/2, and LVDS7 PCs were available for transfusion, respectively. With these units, 1502, 2172, and 2329 transfusions can be performed with similar levels of adverse events. Assuming 30 transfusions a day, a hospital would require 69,325, 47,940, and 45,383 units of PRT, LVDS5/2, and LVDS7 platelets to perform these transfusions. The mean costs to perform transfusions were significantly higher with PRT units.Conclusions: Compared with PRT, LVDS strategies were associated with lower costs and higher PC availability while patients experienced similar levels of adverse events. Increased utilization of LVDS has the potential to improve efficiency, expand patient access to platelets, and reduce health care costs.

Increased frequency of false‐positive bacterial detection after implementation of new guidelines for large‐volume delayed sampling of platelets

“…Overall, LVDS platelets remain a popular choice amongst transfusion services, particularly due to the lower costs of production in comparison to PR. 30,31 The increased need for equipment and technical expertise has led to the increased average cost of LVDS APs, 31 with those costs being passed onto the transfusion service. The overall utility of testing all split product bags and additional use of BPNs has thus far led to the increased discard of inventory, in a "back to the future" repeat model of the PASSPORT study, without an increase in detection of clinically relevant pathogens.…”

Ten Days Storage of Platelets: Analysis of Quality and Safety

“…Therefore, other methods may need to be explored when prolonging the shelflife of PC to keep a balance between safety and efficacy. For instance, large volume delayed sampling (LVDS) was found to be more appropriate when prolonging the storage life by up to 7 days and is more cost-effective than pathogen reduction methods [35,50,51]. Consequently, even though there is increased bacterial proliferation during prolonged storage, the risk of a TTBI or STR between Day 5 and Day 10 is analogous to the detection or reduction of bacterial contamination [36,[52][53][54].…”

New Approaches in Strategy to Evaluate the Risk of Microbial Contamination of Donor Blood Components

“…После опубликования рекомендации FDA в сентябре 2019 г. и дополнений в декабре 2020 г. рядом зарубежных авторов была проведена оценка эффективности предлагаемых стратегий, в том числе с учетом финансовых затрат на внедрение стратегии [3,4,6,12]. Lu W. и соавторами по результатам проведенного анкетирования учреждений, заготавливающих и использующих компоненты крови, наиболее эффективной была признана LVDS-стратегия (максимальное количество баллов по результатам анкетирования по пяти разработанным критериям: возможность реализации, логистика компонентов, удобство использования в учреждении) [6].…”

“…Scientific publications LVDS-стратегии выше, чем при использовании 100%-ной патогенредукции, но LVDSстратегия позволяет переливать более «молодые» по сроку хранения компоненты, чем при использовании патогенредукции [12]. Earnshow S. и соавторами также была подтверждена эффективность LVDS-стратегии в сравнении с патогенредукцией, а также отмечена более высокая доступность для пациентов компонентов крови при использовании данной стратегии [4].…”

“…Scientific publications компонента до момента реализации, методологических подходов по оценке риска бактериальной контаминации компонентов крови. Полученные результаты микробиологического анализа сильно зависят и от времени, прошедшего от момента заготовки до поступления образца для проведения испытаний, а также объема исследуемого образца [3][4][5]. Поэтому актуальной задачей службы крови является анализ и определение оптимальной стратегии мониторинга рисков микробной контаминации в процессе заготовки и хранения компонентов крови до их реализации [6,7].…”