A prospective, double-blind study on the efficacy of the bioline surface-heparinized extracorporeal perfusion circuit.
BACKGROUND
We evaluated the newly introduced Bioline heparin coating and tested the hypothesis that surface heparinization limited to the oxygenator and the arterial filter will ameliorate systemic inflammation and preserve platelets during cardiopulmonary bypass (CPB).


METHODS
In a prospective double-blind study, 159 patients underwent coronary revascularization using closed-system CPB with systemic heparinization, mild hypothermia (33 degrees C), a hollow-fiber oxygenator, and an arterial filter. The patients were randomly divided in three groups. In group A (controls, n = 51), surface heparinization was not used. In group B (n = 52), the extracorporeal circuits were totally surface-heparinized with Bioline coating. In group C (n = 56), surface heparinization was limited to oxygenator and arterial filter.


RESULTS
No significant difference was noted in patient characteristics and operative data between groups. Operative (30-day) mortality was zero. Platelet counts dropped by 12.3% of pre-CPB value among controls at 15 minutes of CPB, but were preserved in groups B and C throughout perfusion (p = 0.0127). Platelet factor 4, plasmin-antiplasmin levels, and tumor necrosis factor-alpha increased more in controls during CPB than in groups B or C (p = 0.0443, p = 0.0238 and p = 0.0154 respectively). Beta-thromboglobulin, fibrinopeptide-A, prothrombin fragments 1 + 2, factor XIIa levels, bleeding times, blood loss, and transfusion requirements were similar between groups. Intensive care unit stay was shorter in groups B and C than in controls (p = 0.037).


CONCLUSIONS
Surface heparinization with Bioline coating preserves platelets, ameliorates the inflammatory response and is associated with a reduced fibrinolytic activity during CPB. Surface heparinization limited to the oxygenator and the arterial filter had similar results as totally surface-heparinized circuits.
Palatianos
George M
GM
Third Department of Cardiac Surgery, Onassis Cardiac Surgery Center, Athens, Greece. palatianos@otenet.gr
Foroulis
Christophoros N
CN
Vassili
Maria I
MI
Astras
George
G
Triantafillou
Konstantinos
K
Papadakis
Emmanuel
E
Lidoriki
Angela A
AA
Iliopoulou
Eugenia
E
Melissari
Efthimia N
EN
D000368:Aged; D000704:Analysis of Variance; D001760:Bleeding Time; D001779:Blood Coagulation Factors; D001780:Blood Coagulation Tests; D002315:Cardiopulmonary Bypass / Q000295:instrumentation* / Q000379:methods; D020099:Coated Materials, Biocompatible; D003327:Coronary Disease / Q000175:diagnosis / Q000601:surgery*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006493:Heparin / Q000494:pharmacology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010107:Oxygenators, Membrane; D010979:Platelet Function Tests; D019106:Postoperative Hemorrhage / Q000175:diagnosis* / Q000453:epidemiology; D011336:Probability; D011446:Prospective Studies; D012016:Reference Values; D012680:Sensitivity and Specificity; D015996:Survival Rate; D016896:Treatment Outcome
D001779:Blood Coagulation Factors; D020099:Coated Materials, Biocompatible; D006493:Heparin