Adverse events and problems in therapeutic hemapheresis. A report from theSwedish registry

Background: Since 1996 adverse events (AE) in therapeutic apheresis (TA) ha ve been more extensively registered in Sweden. This report analyzes the ext ent and relation of AEs to procedures and diagnoses. Materials and methods: Reporting of TA performed in Sweden was centralized. A separate system for the registration of AE in TA was established and the data received were en tered into a central database for registration and analyses. Fifteen of all 35 apheresis units reported both TA and AE during 1996-1999. These centers performed 75% of all TA procedures. Adverse events included medical sympto ms, vascular access problems, technical and other problems. Results: More t han 14,000 procedures were registered during the observation period. No fat alities occurred. AEs occurred in 3.7% (1996), 4.6% (1997), 4.2% (1998) and 4.4% (1999) of procedures. Interventions during the adverse event were per formed in about 65% of the events. Apheresis procedures were interrupted du e to an adverse event in about 1%. Adverse events occurred in 5.6% of plasm a exchanges, 1.9% of plasma modulations and 6.8% of cytapheresis procedures . Paresthesia was registered in 22% and hypotensive events in 20.5%. Other more frequent symptoms were urticaria (14.4%), shivering (7.4%) and nausea (7.4%). AEs were most frequent in patients with Goodpasture's syndrome (12. 5%), TTP/HUS (10.5%) and GuillainBarre syndrome (11.0%). Conclusion: AEs ar e few, often mild and less common in plasma modulation than plasma exchange . AEs are more frequent during TA of patients with certain diagnoses such a s TTP/ HUS. (C) 2001 Elsevier Science Ltd. All rights reserved.