Background. The use of DEHP plasticised poly-vinyl-chloride (DEHPPPVC)) in medical devices persists despite evidence suggesting that DEHP migration can be harmful. Researchers have shown that a simple surface sulfonation process can retard the migration of DEHP, which may reduce the associated inflammatory response. The present study is designed to investigate the effects of surface sulfonation on DEHP migration and blood contact activation using in-vitro and rodent models. Methods. The study was carried out in two phases; Phase 1 in which the migration rate of DEHP from DEHPPPVC and sulfonated DEHP plasticised PVC (SDEHPPPVC) was measured. In phase 2 of the study the materials were incorporated into a rat recirculation biomaterial test model and blood samples taken to assess CD11b expression on neutrophils, IL-6 and Factor XIIa. Results. The initial DEHP concentration washed from the surface after storage was 37.19 ± 1.17 mg/l in the PPVC group and 5.89 ± 0.81 mg/l in the SPPVC group (P<0.0001). The post-wash migration rate was 3.07 ± 0.32 mg/l/hour in the PPVC group, compared to 0.46 ± 0.038 mg/l/hour in the SPPVC group (P<0.0001). In phase 2 of the study CD11b expression increased by 228.9% ± 37% over the test period in the PPVC group compared to 118.3% ± 46% in the SPPVC group (p<0.01). IL-6 levels rose from 3.1 ± 1.4 pg/ml to 263 ± 26 pg/ml in the PPVC group and 2.2 ± 1.6 pg/ml to 161 ± 29 pg/ml in the SPPVC group (p<0.01). Factor FXIIa levels rose from 0.22 ± 0.13 ug/ml to 3.7 ± 0.32 ug/ml and 0.28 ± 0.09 to 2.71 ± 0.21 ug/ml in the PPVC and SPPVC groups respectively (p<0.05 at 90 minutes). Conclusions. The simple sulfonation process significantly retards the migration of DEHP and is associated with the moderation of contact activation processes
This study was to compare the impact of different biocompatible coated circuits on inflammatory response and oxidative stress induced during cardiopulmonary bypass (CPB). Seventy-eight patients undergoing elective coronary artery bypass grafting (CABG) with CPB were randomly assigned to five groups with different biocompatible coated circuits: Trillium, Bioline, Phosphorylcholine, Polymethoxyethyl acrylate (PMEA), and the uncoated control group. Blood was drawn at three different time points: before CPB, 6 and 72 hours post CPB. Unlike the Trillium group, serum levels of TNF-alpha in the Bioline and Phosphorylcholine groups significantly increased only at 72 hours post CPB (p < 0.05). Serum levels of IL-6 significantly increased at 6 and 72 hours post CPB in all groups (p < 0.01). The Trillium group showed a significant increase of IL-10 compared to the control group at 72 hours post CPB (p < 0.05). Serum levels of NOx in the Phosphorylcholine group significantly decreased at 6 hours post CPB compared to baseline (p < 0.05). Both the Bioline and Phosphorylcholine groups showed statistical decreases in serum NOx levels compared with other groups at 6 hours post CPB (p < 0.05). A significant difference in NOx levels between the Bioline and the control group was also observed at 72 hours post CPB. Myeloperoxidase levels were significantly elevated at 6 and 72 hours post CPB in all groups (p < 0.05). Inflammatory response and oxidative stress are elevated during CABG with CPB. Heparin-coated and the Phosphorylcholine-coated circuits induce less inflammatory responses and oxidative stress compared to other circuits.
Monitoring of these markers could help to determine implementation of protective interventions during CABG with CPB to prevent myocardial deterioration and to predict the risk and prognosis.
We compared all 5 coated circuits approved for clinical use in Canada against an uncoated control circuit. Three of the 5 coated circuits (Trillium, Phisio and Bioline BCC) were found to improve ventilator and ICU time compared to Control. Further studies are indicated to validate these results and their impact upon approval criteria, purchasing choices and safe clinical practice, especially as applied to higher risk diabetic patients.
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