A prospective randomized trial of Duraflo II heparin-coated circuits in cardiac reoperations.

BACKGROUND: Heparin-coated circuits in cardiopulmonary bypass have been shown to decrease the systemic inflammatory responses associated with cardiopulmonary bypass. Previous clinical studies on low-risk patients who had coronary artery bypass grafting (CABG) and received full-dose systemic heparin did not have clearly improved clinical outcomes. We hypothesized that the beneficial effects of heparin-coated circuits might be seen in patients who had cardiac reoperations. METHODS: Three hundred fifty patients who had reoperation with CABG only (58%), or with valve operations (42%) were randomly assigned to receive either a heparin-coated (Duraflo II; study group) or uncoated (control group) circuit. Clinical outcomes were compared and the variables were analyzed using the following three groups: entire populations of study group and control group, subgroup of patients who had CABG reoperation only, and a subgroup who had valve reoperation or combined valve and CABG reoperation. RESULTS: Preoperative variables were the same in both groups. No difference in clinical outcomes could be demonstrated except that the percentage of patients with major bleeding episodes was significantly lower in the study group (1.2% versus 5.4%, p = 0.035). In the subgroup analysis of patients who had valve reoperations, lower blood transfusion requirements in the intensive care unit (p = 0.013) were found in the study group. When the subgroup of patients who had CABG reoperations was analyzed separately, there was a trend toward less reoperation for bleeding in the study group (0% versus 4.0%, p = 0.058). CONCLUSIONS: We conclude that the use of heparin-coated circuits was safe and imparted protection from reoperations for bleeding and major bleeding episodes. Material-independent blood activation (eg, blood-air interface and cardiotomy suction) blunted the total effect of the heparin-coated surface.

Advances in perfusion technology--an overview.

The introduction of minimally invasive approaches to cardiac surgery offered the opportunity to reduce patient's pain associated with median stemotomy as well as infection and postoperative bleeding. This technique required the use of one small venous cannula necessitating the implementation of kinetic assisted venous drainage (KAVD). However, KAVD proved costly due to the use of a centrifugal pump and could be de-primed if air was introduced into the venous line. Vacuum assisted venous drainage (VAVD), an easy to learn technique, was proved to be a better, safe and less expensive alternative as it required lower prime and small cannulae. Blunt trauma could also be avoided as large cannulae were not used.

Biocompatibility of heparin-coated extracorporeal bypass circuits: a randomized, masked clinical trial.

Cardiopulmonary bypass circuits cause morbidity during cardiac operations. Plasma proteins and cellular components are stimulated by contact with the cardiopulmonary bypass circuit and can cause bleeding and postperfusion syndrome. This is especially true in patients undergoing reoperative cardiac procedures, which carries a higher risk of postoperative bleeding and prolonged ventilation compared with primary cardiac surgical procedures. Recently, cardiopulmonary bypass circuit surfaces have been coated with antithrombotic agents to improve their biocompatibility. This study evaluated the effect of a heparin-coated cardiopulmonary bypass system (Duraflo II, Baxter Bentley Healthcare Systems, Irvine, Calif.) on thrombin formation, platelet stimulation, and leukocyte activation in patients undergoing reoperative coronary artery bypass grafting or valve operation. Fifty patients were selected and randomly assigned to a standard noncoated control system (n = 26) or the Duraflo heparin-coated system (n = 24). Similar heparin doses were used in both groups (3 mg/kg). The heparin-coated group used a completely heparin-coated bypass circuit including the cardiotomy reservoir; arterial filters were heparin-coated in both groups. Samples were obtained before cardiopulmonary bypass, 30 minutes into cardiopulmonary bypass, 5 minutes after crossclamp removal, and 5 minutes after protamine administration. Thrombin formation (thrombin-antithrombin III by enzyme-linked immunosorbent assays) and platelet activation (beta-thromboglobulin by enzyme-linked immunosorbent assays; P-selectin expression by flow cytometry) were assayed. Leukocyte activation was determined by quantitative and qualitative analysis of arterial filters by scanning electron microscopy in six patients from each group. In both circuits, thrombin values increased markedly 30 minutes into cardiopulmonary bypass compared with baseline values (p < 0.001) (heparin-coated, 7 +/- 5 to 96 +/- 115 ng/ml; noncoated, 10 +/- 9 to 115 +/- 125 ng/ml). Platelet activation as measured by beta-thromboglobulin (heparin-coated, 104 +/- 100 to 284 +/- 166 IU/ml; noncoated, 81 +/- 74 to 288 +/- 277 IU/ml) and P-selectin expression (heparin-coated, 1.5% +/- 1.5% to 6.4% +/- 6.1%; noncoated, 1.4% +/- 1.1% to 6.2% +/- 4.3%) also significantly increased 30 minutes into cardiopulmonary bypass compared with baseline values (p < 0.001). Platelet activation and thrombin generation did not differ between the two circuits at any time. Granulocyte activation and platelet deposition did not differ between the two circuits when arterial filters were evaluated. Both groups had similar heparin and protamine administration, blood transfusions, postoperative alveolar-arterial oxygen gradient, time to extubation, length of intensive care unit stay, and overall morbidity and mortality. Clinical outcome and blood loss did not differ between the groups. We conclude that heparin-coated cardiopulmonary bypass circuits did not improve biochemical or clinical markers of biocompatibility in a reoperative patient population.

Extracorporeal membrane oxygenation for postcardiotomy cardiogenic shock.

BACKGROUND: Extracorporeal membrane oxygenation circuits have recently been introduced for extracorporeal life support (ECLS) in adult patients in cardiogenic shock and have been shown to provide excellent oxygenation and hemodynamic support. Heparin coating of the extracorporeal circuit provides a more biocompatible surface, which has been shown to minimize early surface-induced complement activation and platelet dysfunction and hence may improve patient survival. This report reviews our experience with extracorporeal membrane oxygenation to treat postcardiotomy cardiogenic shock using minimal to no systemic heparinization in 23 patients. METHODS: During the 22-month period September 1992 through July 1994, 23 patients in cardiogenic shock were placed on venoarterial ECLS using a heparin-bonded circuit. These patients' charts were retrospectively reviewed. A logistic regression analysis of the variables collected was performed to identify clear-cut predictors of ability to be weaned from ECLS. RESULTS: Average patient age was 47.3 +/- 16.4 years (range, 5 to 72 years). There were 17 male patients. Average time on ECLS was 58.4 +/- 35.1 hours (range, 0.5 to 144 hours). Statistical analysis revealed that patients unable to be weaned from ECLS were more likely to have a critically dilated left ventricle on echocardiography and were female. Ten patients (43.5%) died while on ECLS. Four patients were transferred to an implantable left ventricular assist device, and 3 underwent successful transplantation. The 9 other patients were successfully weaned from ECLS, and 4 were discharged home from the hospital. Overall, 7 patients (30.4%) who were placed on ECLS were successfully discharged home. CONCLUSIONS: Extracorporeal life support using an extracorporeal membrane oxygenation system provides excellent cardiac support with similar hospital survival rates as centrifugal mechanical support. Extracorporeal life support has complications unique to itself, but with time, these are likely to be overcome. Women and patients with persistent left ventricular dilatation are less likely to be weaned.

Complications of extracorporeal life support systems using heparin-bound surfaces. The risk of intracardiac clot formation.

Extracorporeal life support with heparin-coated extracorporeal membrane oxygenation circuits are being used with increased frequency in patients who have cardiogenic shock. We report our experience in 30 patients with cardiogenic shock, looking specifically at the complications associated with this form of life support. Thirty patients with a mean age of 46.5 +/- 16.6 years received extracorporeal life support for a mean of 62.8 +/- 41.1 hours (range 0.5 to 159 hours). Twenty-three patients had postcardiotomy cardiogenic shock, five had acute myocardial infarction, and one each had acute cardiac deterioration after a balloon coronary angioplasty and another after pulmonary artery balloon angioplasty. Peripheral (femoral vein to femoral artery) cannulation was used in 24 patients. Limb ischemia developed in 21 patients (70%), renal failure in 17 patients (57%), oxygenator failure requiring change in 13 patients (43%), bleeding requiring reexploration in 12 (40%), and infection in 9 patients (30%). Transesophageal echocardiography revealed intracardiac thrombus formation in 6 patients (20%) and clot was visualized grossly in the pump head in 2 patients (6%) necessitating pump-head change. Nine patients (30%) were discharged home. We conclude that the use of heparin-coated extracorporeal life support without systemic heparinization, especially after protamine has been used to reverse systemic heparinization in patients having postcardiotomy cardiogenic shock, may be dangerous. Extracorporeal life support has introduced new complications unique to itself specifically limb ischemia, oxygenator failure, and pump-head thrombus.