Charlotte Fernandez-Canal1, Pierre-Gabriel Pinta2, Teuta Eljezi3, Virginie Larbre3, Sophie Kauffmann1, Lionel Camilleri4, Bernard Cosserant1, Lise Bernard3, Bruno Pereira5, Jean-Michel Constantin1, Gael Grimandi2,6, Valérie Sautou3. 1. a Département de médecine périopératoire , CHU Clermont-Ferrand , Clermont-Ferrand , France. 2. b LIOAD INSERM UMR_S 791 , Université de Nantes , Nantes , France. 3. c CHU Clermont-Ferrand, CNRS, SIGMA Clermont, Institut de Chimie de Clermont-Ferrand , Université Clermont Auvergne , Clermont-Ferrand , France. 4. d Chirurgie cardio-vasculaire , CHU Clermont-Ferrand , Clermont-Ferrand , France. 5. e Direction à la recherche clinique et l'innovation , CHU Clermont-Ferrand , Clermont- Ferrand , France. 6. f Pôle Pharmacie , CHU Nantes , Nantes , France.
Abstract
BACKGROUND: ECMO is a therapeutic act with a high risk of exposure to diethylhexylphthalate (DEHP), plasticizer from PVC tubings. The replacement of this plasticizer with alternative compounds is recommended but the risks associated with the use of new plasticizers have not been evaluated in ECMO situations. METHODS: Ex vivo ECMO models were performed with different flow rates over 6 days to evaluate the migration of plasticizers and their potential toxic risk for patient. The release of plasticizers during ECMO was measured and compared to reference value (derived no effect level, DNEL) and to cytotoxic concentration carried out with MTT test. RESULTS: Trioctyltrimellitate (TOTM), main plasticizer present in circuit (44% w/w), is weakly released during ECMO. Concentrations are not cytotoxic and exposure doses are lower than DNEL. In contrast, DEHP doses are higher than the DNEL despite a lower presence of DEHP in the circuit (0.2%). We have shown that DEHP is not coming from the circuit but from the priming bag. Replacing this bag with a multilayer one avoids the exposure to DEHP. CONCLUSION: Our study shows that circuits made of PVC plasticized with TOTM against DEHP improves the safety of ECMO.
BACKGROUND: ECMO is a therapeutic act with a high risk of exposure to diethylhexylphthalate (DEHP), plasticizer from PVC tubings. The replacement of this plasticizer with alternative compounds is recommended but the risks associated with the use of new plasticizers have not been evaluated in ECMO situations. METHODS: Ex vivo ECMO models were performed with different flow rates over 6 days to evaluate the migration of plasticizers and their potential toxic risk for patient. The release of plasticizers during ECMO was measured and compared to reference value (derived no effect level, DNEL) and to cytotoxic concentration carried out with MTT test. RESULTS:Trioctyltrimellitate (TOTM), main plasticizer present in circuit (44% w/w), is weakly released during ECMO. Concentrations are not cytotoxic and exposure doses are lower than DNEL. In contrast, DEHP doses are higher than the DNEL despite a lower presence of DEHP in the circuit (0.2%). We have shown that DEHP is not coming from the circuit but from the priming bag. Replacing this bag with a multilayer one avoids the exposure to DEHP. CONCLUSION: Our study shows that circuits made of PVC plasticized with TOTM against DEHP improves the safety of ECMO.
Entities:
Keywords:
Extracorporeal membrane oxygenation; cytotoxicity; medical devices; migration; plasticizers