Safety aspects of lipidapheresis using DALI and MONET - Multicenter observational study

Atheroscler Suppl. 2017 Nov:30:225-231. doi: 10.1016/j.atherosclerosissup.2017.05.036.

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.

Keywords: Apheresis; DALI; Lipids; MONET.

Publication types

  • Comparative Study
  • Multicenter Study
  • Observational Study

MeSH terms

  • Adsorption
  • Adult
  • Biomarkers / blood
  • Blood Component Removal / adverse effects
  • Blood Component Removal / methods*
  • Cholesterol, HDL / blood
  • Cholesterol, LDL / blood
  • Databases, Factual
  • Down-Regulation
  • Female
  • Filtration
  • Germany
  • Humans
  • Hyperlipidemias / blood
  • Hyperlipidemias / diagnosis
  • Hyperlipidemias / therapy*
  • Lipids / blood*
  • Male
  • Middle Aged
  • Prospective Studies
  • Risk Factors
  • Time Factors
  • Treatment Outcome
  • Triglycerides / blood

Substances

  • Biomarkers
  • Cholesterol, HDL
  • Cholesterol, LDL
  • Lipids
  • Triglycerides