Apheresis with different procedures and devices are used for a variety of indications that may have different adverse events (AEs). The aim of this study was to clarify the extent and possible reasons of various side effects based on data from a multinational registry. The WAA-apheresis registry data focus on adverse events in a total of 50846 procedures in 7142 patients (42% women). AEs were graded as mild, moderate (need for medication), severe (interruption due to the AE) or death (due to AE). More AEs occurred during the first procedures versus subsequent (8.4 and 5.5%, respectively). AEs were mild in 2.4% (due to access 54%, device 7%, hypotension 15%, tingling 8%), moderate in 3% (tingling 58%, urticaria 15%, hypotension 10%, nausea 3%), and severe in 0.4% of procedures (syncope/hypotension 32%, urticaria 17%, chills/fever 8%, arrhythmia/asystole 4.5%, nausea/vomiting 4%). Hypotension was most common if albumin was used as the replacement fluid, and urticaria when plasma was used. Arrhythmia occurred to similar extents when using plasma or albumin as replacement. In 64% of procedures with bronchospasm, plasma was part of the replacement fluid used. Severe AEs are rare. Although most reactions are mild and moderate, several side effects may be critical for the patient. We present side effects in relation to the procedures and suggest that safety is increased by regular vital sign measurements, cardiac monitoring and by having emergency equipment nearby.

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Abstract:The aim of this study was to evaluate the safety, tolerability, technical performance and clinical efficacy of a novel adsorptive-type cytapheresis module in patients with active ulcerative colitis. Ten patients with ulcerative colitis (clinical activity index 6-10) were recruited. The new adsorber (Nikkiso, Tokyo, Japan) was specifically designed to remove platelets, granulocytes and monocytes from peripheral blood using an extracorporeal circulation. Cytapheresis treatments were performed weekly for five consecutive weeks (each with a 60-min duration). Safety and tolerability were evaluated by investigating vital parameters, routine laboratory tests, adverse event reporting and a questionnaire. Disease activity was evaluated by assessing the clinical activity index as well as the endoscopic index, according to Rachmilewitz. Technical performance and biocompatibility were investigated by repeated measurements of cellular blood count, complement factor C3a and cell surface markers before, during and after the apheresis treatments. The cytapheresis treatments were "well" to "very well" tolerated by the patients. All measured safety parameters remained essentially unchanged. Performance data showed that platelets, monocytes and neutrophil granulocytes were effectively reduced during the cytapheresis treatments. Apheresis treatment was associated with high remission rates (80% at week 10). Clinical remission was accompanied by the reduction of the endoscopic index in four out of the nine eligible patients. Levels of C3a did not significantly increase during cytapheresis treatments. The novel device has been shown to be safe, well tolerated and clinically efficient. It offered a very good biocompatibility and platelet elimination capacity.

Endocrine ophthalmopathy (EO) is a severe disease entity that is characterized by retrobulbar swelling due to accumulation of glycosaminoglycans on an autoimmune basis. This disorder can lead to the loss of vision and often is resistant to conventional therapy. There is a relation to Graves' hyperthyroidism, but probably no close association. Two patients with severe EO that was resistant to usual therapeutic approaches including steroids and radiological and surgical measures underwent a 20 session course of intensive immunoadsorption therapy (Plasmaselect/Therasorb Anti-IgG) with a mean 2-to 3-fold plasma volume treated. After the first sessions, both patients voiced an impressive relief of their major symptoms, which was confirmed by ophthalmological investigation. Throughout the time of therapy until present, these patients have remained at their respective levels of improvement. We consider immunoadsorption an effective therapeutic opportunity in severe EO resistant to conventional treatment.