Justyna Kozik-Jaromin1, Eberhard Röseler2, Franz Heigl3, Ralf Spitthöver4, Jens Ringel5, Gerd Schmitz6, Rainer Heinzler7, Nadim Abdul-Rahman8, Frank Leistikow9, Frido Himmelsbach10, Volker Schettler11, Ingrid Uhlenbusch-Körwer1, Wolfgang Ramlow12. 1. Clinical and Epidemiological Research, Fresenius Medical Care, Daimlerstraße 15, Bad Homburg, Germany. 2. Zentrum für Nieren-, Hochdruck und Stoffwechselerkrankungen, Heidering 31, Hannover, Germany. 3. Dres. Heigl, Hettich & Partner Medizinisches Versorgungszentrum, Robert Weixler-Straße 19, Kempten, Germany. 4. Nephrologische Gemeinschaftspraxis Dialysezentrum/Lipidzentrum Dr. med. Ralf Spitthöver, Dr. med. Johann Knee, Dr. med. Alexandra Gröschel, Hindenburgstraße 27, Essen, Germany. 5. Dialysezentrum Potsdam, Allee nach Sanssouci 7, Potsdam, Germany. 6. Universitätsklinikum Regensburg Institut für Klinische Chemie und Laboratoriumsmedizin, Franz-Josef-Strauß-Allee 11, Regensburg, Germany. 7. Dr. med. Detlef Gysan, Dr- med. Rainer Heinzler, Dr. med. Erik May Fachärzte für Innere Medizin/Kardiologie, Rolshover Straße 526, Köln, Germany. 8. Dialysezentrum Fachpraxis für Nieren-und Hochdruckkrankheiten & Lipid-Apherese, Liebknechtstraße 36a, Magdeburg, Germany. 9. Apherese- und Nierenzentrum Mannheim, Dornheimer Ring 92, Mannheim, Germany. 10. Apheresezentrum Ingelheim, Carolinenstraße 6, Ingelheim, Germany. 11. Nephrologisches Zentrum Göttingen, An der Lutter 24, Göttingen, Germany. 12. Apherese Centrum Rostock (ACR), Nobelstraße 53, Rostock, Germany. Electronic address: ramlow@apherese.de.
Abstract
BACKGROUND: Lipidapheresis was introduced for intractable hyperlipidemia as a more selective therapy than plasma exchange aiming to enhance efficacy and limit side-effects. Although this therapy is regarded safe, multicenter data from routine application are limited. We investigated direct adsorption of lipoproteins (DALI) and lipofiltration (MONET) regarding the short and the long-term safety aspects. METHODS: This multicenter observational study prospectively evaluated 2154 DALI and 1297 MONET sessions of 122 patients during a period of 2 years. Safety parameters included clinical side-effects (adverse device effects, ADEs), technical complications, blood pressure and pulse rate. Also routinely performed laboratory parameters were documented. Analysis of laboratory parameters was not corrected for blood dilution. RESULTS: Overall 0.4% DALI and 0.5% MONET treatments were affected by ADE. Technical complications occurred in 2.1% and in 0.8% DALI and MONET sessions, respectively. The most frequent ADE was hypotension, and the majority of technical problems were related to vascular access. Both types of treatments led to a drop of thrombocytes in the range of 7-8%. Hematocrit and erythrocytes decreased only during the DALI treatments by about 6%. Leucocytes decreased during the DALI therapy (∼15%), whereas they increased during the MONET application (∼11%). MONET treatment was associated with a higher reduction of proteins (fibrinogen: 58% vs. 23%, albumin: 12% vs. 7%, CRP: 33% vs. 19% for MONET and DALI, respectively). Apart from severe thrombocytopenia in two DALI patients, changes of other parameters were typically transient. CONCLUSIONS: Under routine use the frequency of side-effects was low. Still, monitoring of blood count and proteins in chronic apheresis patients is recommended.
BACKGROUND: Lipidapheresis was introduced for intractable hyperlipidemia as a more selective therapy than plasma exchange aiming to enhance efficacy and limit side-effects. Although this therapy is regarded safe, multicenter data from routine application are limited. We investigated direct adsorption of lipoproteins (DALI) and lipofiltration (MONET) regarding the short and the long-term safety aspects. METHODS: This multicenter observational study prospectively evaluated 2154 DALI and 1297 MONET sessions of 122 patients during a period of 2 years. Safety parameters included clinical side-effects (adverse device effects, ADEs), technical complications, blood pressure and pulse rate. Also routinely performed laboratory parameters were documented. Analysis of laboratory parameters was not corrected for blood dilution. RESULTS: Overall 0.4% DALI and 0.5% MONET treatments were affected by ADE. Technical complications occurred in 2.1% and in 0.8% DALI and MONET sessions, respectively. The most frequent ADE was hypotension, and the majority of technical problems were related to vascular access. Both types of treatments led to a drop of thrombocytes in the range of 7-8%. Hematocrit and erythrocytes decreased only during the DALI treatments by about 6%. Leucocytes decreased during the DALI therapy (∼15%), whereas they increased during the MONET application (∼11%). MONET treatment was associated with a higher reduction of proteins (fibrinogen: 58% vs. 23%, albumin: 12% vs. 7%, CRP: 33% vs. 19% for MONET and DALI, respectively). Apart from severe thrombocytopenia in two DALI patients, changes of other parameters were typically transient. CONCLUSIONS: Under routine use the frequency of side-effects was low. Still, monitoring of blood count and proteins in chronic apheresis patients is recommended.