Noncoated Oxygenator Research Articles

Avecor Trillium Oxygenator Versus Noncoated Monolyth Oxygenator: A Prospective Randomized Controlled Study

The surface coating of a synthetic surface is currently investigated to decrease the harmful effects of cardiopulmonary bypass (CPB). This study was designed to study the effects of the surface coating of a hollow fiber membrane oxygenator on coagulation, inflammation markers, and clinical outcomes. The biomaterials used to coat the membrane include heparin, polyethylene oxide chains (PEO), and sulfate/sulfonate groups. The coated membrane was compared to an uncoated oxygenator made of polypropylene. Two hundred patients who were scheduled to undergo valve repair and/or replacement surgery with or without coronary surgery were enrolled in the study. The patients were randomized to undergo CPB with either the Avecor oxygenator with Trillium (Medtronic, Minneapolis, MN, USA), a biopassive surface, or the Monolyth (Sorin, Irvine, CA, USA) oxygenator without coating. The primary and secondary endpoints were the differences between these oxygenators in regard to patients' biochemistry, coagulation profiles, inflammatory mediators, and clinical outcomes, including blood loss and neurological events. There were no differences between the two groups in terms of biochemistry, coagulation profile, inflammatory mediator release, and blood loss. Five patients in the Avecor group showed clinical evidence of a stroke confirmed with computerized tomography (CT) scan imaging, and none in the noncoated oxygenator group. The oxygenator Avecor offers similar results in terms of inflammation and coagulation profiles and blood loss during valvular surgery compared to a standard uncoated control oxygenator. The rate of neurological events was unusually elevated in the former group of patients, with only speculative explanation at this point. Further studies are warranted to clarify this aspect.

Effect of Polymer Coating (Poly 2-Methoxyethylacrylate) of the Oxygenator on Hemostatic Markers During Cardiopulmonary Bypass in Children

Heparin and other oxygenator coatings have been used in attempts to reduce hemostatic activation during cardiopulmonary bypass (CPB). This study evaluated whether an oxygenator coated with poly 2-methoxyethylacrylate (PMEA) (X-coating; Terumo Corporation, Tokyo, Japan) would cause less activation of coagulation and fibrinolytic systems during CPB in children than a noncoated oxygenator. Observational study. University-affiliated children's hospital. Twenty-six patients, 3 months to 5 years old, who underwent congenital heart surgery for repair of a ventricular septal defect, atrial septal defect, or both. Patients were divided into 2 age-matched groups based on the type of oxygenator used: a noncoated oxygenator (group NC) versus a PMEA-coated oxygenator (group C). Blood samples for coagulation and fibrinolytic markers were compared before, during, and after CPB. Despite increases in thrombin generation markers (F1.2 and TAT) at certain times during CPB in group C compared to group NC, a comparison over all times during CPB were not statistically different between groups. Overall D-dimer concentrations during CPB were elevated in group C compared to group NC (p = 0.02). Active tPA and active PAI-1 were not different between groups during or after CPB. Group C had higher platelet counts (181,000 +/- 29,000) during CPB than group NC (155,000 +/- 57,000, p = 0.04) but not postoperatively. Twelve hours postoperatively, chest tube outputs were 8.8 +/- 3 mL/kg in group C and 19.1 +/- 12 mL/kg in group NC (p = 0.003). The corresponding outputs 24 hours after surgery were 12.4 +/- 3 mL/kg and 24 +/- 11 mL/kg, respectively (p = 0.005). Except for a somewhat higher platelet count during CPB, there was no indication that PMEA coating resulted in less activation of coagulation and fibrinolytic systems. The lower postoperative chest tube output observed after CPB with PMEA-coated oxygenators needs to be studied further.

Effect of poly(2-methoxyethyl acrylate)-coated oxygenators on haemolysis

Blood contact with artificial device surfaces and mechanical trauma are two major factors for haemolysis. Poly(2-methoxyethyl acrylate) (PMEA) is an amphiphilic polymer with a polyethylene chain that is hydrophobic and a mildly hydrophilic tail. PMEA coating has showed positive effects on protein adsorption, platelet loss, platelet aggregation and post-operative bleeding in previous studies. In this study, effects of poly(2-metoxyethyl acrylate) (PMEA)-coated oxygenators on haemolysis was investigated. PMEA-coated (SX18-Capiox) oxygenators were used. Desorbed erythrocyte, free haemoglobin indirect bilirubin and total bilirubin quantities from fibre samples of oxygenators were studied. Erythrocyte, total bilirubin and direct bilirubin values were measured from blood aliquots taken in five different times during cardiopulmonary by-pass (CPB); baseline (T1), during CPB (T2), at the end of CPB (T3), after protamine injection (T4) and in intensive care (T5). In both coated and non-coated oxygenators haemolysis rate was in clinically acceptable safety range. Average desorbed free haemoglobin was 6663 mg/dl from coated and 29.405 mg/dl from non-coated fibres. Average desorbed total bilirubin was 0.0068 mg/dl from coated and 0.023 mg/dl from non-coated fibres. We observed less haemolysis, as reflected by lower desorbed free haemoglobin and indirect bilirubin from coated oxygenators and less decrease in blood erythrocyte number. Blood bilirubin concentration was low in the coated group when compared to the control group. This study describes the relationship between PMEA coating and haemolysis at the blood contacting surface. PMEA coating reduces red blood cell damage during extracorporeal circulation.

Evaluation of coated oxygenators in cardiopulmonary bypass systems and their impact on neurocognitive function

Coronary artery bypass graft surgery (CABG) using cardiopulmonary bypass (CPB) is assumed to be associated with a decline of neurocognitive functions. This study was designed to analyse the neurocognitive function of patients with coronary heart disease before and after CABG and to determine possible protective effects of oxygenator surface coating on neurological outcome. Forty patients scheduled for selective CABG were prospectively randomized into two groups of 20 patients each according to the type of hollow-fibre membrane oxygenator used. Non-coated oxygenators (Group A) were compared to phosphorylcholine (PC)coated oxygenators (Group B). A battery of six neurological tests was administered preoperatively, 7-10 days and 4-6 months after surgery. One patient of Group A suffered from a perioperative stroke and died on postoperative day 3, presumably because of sudden heart failure. Two patients of Group A (10%) developed a symptomatic transitory delirious psychotic syndrome (STPT) on postoperative days 3 and 5. None of the patients of Group B had perioperative complications. The test analysis revealed a trend of declined neurocognitive function early after CABG, but did not show any difference in neurocognitive outcome between the two groups. PC coating of the oxygenators did not show any significant benefit on neurocognitive function after CABG using CPB.

Clinical performance and biocompatibility of poly(2-methoxyethylacrylate)—coated extracorporeal circuits

Background. Poly(2-methoxyethylacrylate) is an amphiphilic organic polymer consisting of a hydrophobic backbone with pendant hydrophilic groups that has been reported to reduce protein and platelet adsorption in in vitro and ex vivo studies. Methods. Sixty patients undergoing three-vessel coronary artery bypass grafting were divided into two equal groups. Group 1 had operation with Capiox poly(2-methoxyethylacrylate) coated SX18R oxygenators with noncoated circuits, and group 2 had operation with all noncoated circuits. Hemodynamic variables, blood and urine test results, hematologic variables, complement fractions, C3a and C4d, and interleukin-6 levels were documented preoperatively (T1), on cardiopulmonary bypass (T2), before cessation of cardiopulmonary bypass (T3), after protamine sulfate reversal (T4), and on the first postoperative day (T5). Protein electrophoresis was performed at T1 and T5. Blood cell adhesion and aggregation on fibers were analyzed with optical microscopy, and desorbed protein was evaluated quantitatively by a spectrophotometer using samples obtained when the oxygenators were dismantled after cardiopulmonary bypass. Results. Platelet counts in group 1 demonstrated significant differences at T3, T4, and T5 ( p < 0.05) versus group 2 and white blood cell counts in group 1 versus group 2, at counts T4 and T5. Albumin levels were significantly better preserved in group 1 at T4, and T5 and fibrinogen levels, at T3 and T5 ( p < 0.05). On electrophoresis, the postoperative albumin level was 57.9% ± 3% in group 1 versus 50.2% ± 3% in group 2 ( p < 0.05). Postoperative hemorrhage was 452 ± 35 mL in group 1 and 612 ± 35 mL in group 2 ( p < 0.05). Duration of intubation was significantly lower ( p < 0.05) in group 1, as was need of blood transfusion ( p < 0.01). More platelet adhesion and aggregation were demonstrated on noncoated oxygenator fibers. The amount of desorbed protein was 0.13 ± 0.01 mg/dL versus 0.012 ± 0.001 mg/dL ( p < 0.001) on noncoated versus coated fibers, respectively. Conclusions. Poly(2-methoxyethylacrylate)—coated oxygenators reduce platelet adhesion, platelet aggregation and protein adsorption. This surface provides a better perioperative clinical status through platelet-, albumin-, and fibrinogen-sparing effects.

A Comparative Study of Heparin-coated and Non-coated Oxygenators for Cardiopulmonary Bypass in Small Animals

A Comparative Study of Heparin-coated and Non-coated Oxygenators for Cardiopulmonary Bypass in Small Animals

Haemocompatibility of paediatric membrane oxygenators with heparin-coated surfaces.

Extracorporeal circulation (ECC) in paediatric patients with heparin-coated oxygenation systems is rarely investigated. The objective of this study was to evaluate, preclinically, the haemocompatibility of paediatric membrane oxygenators with heparin-coated surfaces. We compared 16 paediatric membrane oxygenators (Minimax, Medtronic) in an in vitro heart-lung machine model with fresh human blood. Eight of these oxygenation systems had a covalent heparin coating (Carmeda bioactive surface). After 90 min simulated ECC, the heparin-coated systems showed significantly higher platelet count, lower platelet-factor 4 release, reduced contact activation (factor XIIa and kallikrein), and lower neutrophil elastase levels (p < 0.05), compared to the noncoated oxygenator group. More biocompatible materials for paediatric operations may ameliorate the various postperfusion syndromes arising from ECC procedures, particularly unspecific inflammation, hyperfibrinolysis and blood loss.

Heparin-coated oxygenators significantly reduce contact system activation in an in vitro cardiopulmonary bypass model.

Over the past decade our group has shown that the contact system of blood is activated in cardiopulmonary bypass (CPB), that heparins enhance this activation and that aprotinin reduces both this activation and blood loss in CPB. We have developed an in vitro CPB model to assess the effects of added components to blood and new components in the artificial devices of CPB. In the present study we have compared membrane oxygenators with or without heparin-coated surfaces under identical conditions in the CPB model. Recalcified ACD blood was circulated in a closed system for 90 min at 28 degrees C. Blood samples were taken at various times during circulation. 4 IU/ml heparin was used with the non-coated oxygenators; no heparin was used in the coated system. Heparin levels were measured in the plasma together with various contact system components. Haemolysis, platelet count, platelet factor 4 and alpha 1-proteinase inhibitor-PMN elastase complexes, were also determined. No heparin was detected during the period of recirculation in samples from the coated oxygenators, showing the excellent adhesive quality of the heparin coating. In keeping with a significant greater fall in the platelet count in non-coated vs coated oxygenators (mean [+/- SD] final counts of 170 +/- 50 x 10(9)/l and 97 +/- 34.2 x 10(9)/l respectively after 90 min circulation), platelet factor 4 levels were significantly higher (682.9 +/- 187.3% and 95.8 +/- 46.5% of the initial value respectively).(ABSTRACT TRUNCATED AT 250 WORDS)