Gunaydin Serdar, Farsak Bora, McCusker Kevin, Vijay Venkataramana, Sari Tamer, Onur M Ali, Gurpinar Aylin, Zorlutuna Yaman
University of Kirikkale, Kirikkale, Turkey.
J Cardiovasc Med (Hagerstown). 2009 Feb;10(2):135-42. doi: 10.2459/JCM.0b013e32831eef9d.
This prospective randomized study compares full and reduced heparinization on novel hyaluronan-based heparin-bonded circuits vs. uncoated controls under challenging clinical setting including biomaterial evaluation.
100 patients undergoing reoperation for coronary artery bypass grafting were allocated into two equal groups (n = 50): Group one was treated with hyaluronan-based heparin bonded preconnected circuits (Vision HFOGBS, Gish, California, USA) and Group two with identical uncoated controls (Vision HFO, Gish, USA). In the study group, half of the patients (n = 25) received low-systemic heparin (125 IU/kg, ACT >250 s) or full dose like control group. Blood samples were collected after induction of anesthesia (T1) and heparin administration before cardiopulmonary bypass (CPB) (T2), 15 min after initiation of CPB (T3), before cessation of CPB (T4), 15 min after reversal with protamine (T5), and the first postoperative day at 08: 00 h (T6).
Platelet counts were preserved significantly better at T5, T6 in hyaluronan groups (P < 0.05 vs. control). Serum IL-2 levels were significantly lower at T4, T5 in both hyaluronan groups and C3a levels at T4 and T5 only in low-dose group (P < 0.05). Troponin-T levels in coronary sinus blood demonstrated well preserved myocardium in hyaluronan groups. No significant differences in thrombin-antithrombin levels were observed between full and low-dose heparin groups at any time point. Amount of desorbed protein was 1.41 +/- 0.01 in full and 1.43 +/- 0.01 in low dose vs. 1.78 +/- 0.01 mg/dl in control (P < 0.05).
Hyaluronan-based heparin-bonded circuits provided better clinical outcome and less inflammatory response compared with uncoated surfaces. Reduced systemic heparinization combined with hyaluronan-based heparin-bonded circuits is feasible and clinically well tolerated.
本前瞻性随机研究在具有挑战性的临床环境(包括生物材料评估)中,比较新型基于透明质酸的肝素结合回路进行全量肝素化和减量肝素化与未涂层对照的效果。
100例行冠状动脉搭桥术再次手术的患者被分为两组,每组50例:第一组使用基于透明质酸的肝素结合预连接回路(Vision HFOGBS,Gish,加利福尼亚,美国)治疗,第二组使用相同的未涂层对照(Vision HFO,Gish,美国)。在研究组中,一半患者(n = 25)接受低剂量全身肝素(125 IU/kg,活化凝血时间>250秒)或与对照组相同的全剂量肝素。在麻醉诱导后(T1)和体外循环(CPB)前给予肝素后(T2)、CPB开始后15分钟(T3)、CPB停止前(T4)、用鱼精蛋白逆转后15分钟(T5)以及术后第一天08:00时(T6)采集血样。
在T5、T6时,透明质酸组的血小板计数保存明显更好(与对照组相比,P < 0.05)。在T4、T5时,两个透明质酸组的血清白细胞介素-2水平均显著降低,仅在低剂量组的T4和T5时C3a水平降低(P < 0.05)。冠状窦血中的肌钙蛋白-T水平表明透明质酸组心肌保存良好。在任何时间点,全量肝素组和低剂量肝素组之间的凝血酶-抗凝血酶水平均未观察到显著差异。全量组解吸蛋白量为1.41±0.01,低剂量组为1.43±0.01,而对照组为1.78±0.01 mg/dl(P < 0.05)。
与未涂层表面相比,基于透明质酸的肝素结合回路可提供更好的临床结果和更少的炎症反应。减量全身肝素化联合基于透明质酸的肝素结合回路是可行的,且临床耐受性良好。