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一种新型合成密封剂抑制心脏粘连的评估及心脏手术程序的临床经验

Evaluation of a novel synthetic sealant for inhibition of cardiac adhesions and clinical experience in cardiac surgery procedures.

作者信息

Marc Hendrikx M, Mees U, Hill A C, Egbert B, Coker G T, Estridge T D

机构信息

Faculty of Medicine, Limburgs Universitair Centrum, Diepenbeek, Belgium.

出版信息

Heart Surg Forum. 2001;4(3):204-9; discussion 210.

PMID:11673138
Abstract

BACKGROUND

Pericardial adhesions subject patients requiring reoperation to potential injuries to the heart, great vessels, and cardiac grafts during the re-sternotomy. These adhesions can severely complicate re-operations by making re-entry hazardous, impeding orientation and visibility, increasing the amount of blood loss, and prolonging the operation time. The efficacy of an in situ-forming polyethylene glycol (PEG) material, CoSeal surgical sealant (CoSeal), for inhibiting cardiac adhesions in an animal model is reported. It is currently estimated that 10-20% of patients undergoing aortic valve replacement and coronary artery bypass grafting (CABG) will require a second operation later in their lives. Successful clinical experience using CoSeal for sealing suture lines of the aorta and CABGs with the data reported here suggest that CoSeal may have multiple applications in cardiac surgery.

METHODS

In rabbits, a sternotomy and pericardiotomy were performed to expose the heart and the epicardium of the left ventricular surface. The epicardium was abraded for five minutes with dry gauze and cotton to develop punctate bleeding. In treated animals, CoSeal(R) or Tissucol(R) was applied directly to the abraded bleeding epicardium while retracting the pericardium. The pericardium was released, and the material over-sprayed to the cut edges of the pericardium. No material was applied in control animals.

RESULTS

At necropsy, CoSeal(R) was found to significantly reduce the formation of adhesions, the tenacity of the adhesions, and the percent of the abraded site with adhesions as compared to surgical control and Tissucol. Tissucol showed no significant difference from the surgical control in any adhesion parameter. CoSeal treated hearts showed re-establishment of the mesothelial layer and tissue morphology similar to a normal un-operated heart. During the clinical cardiac procedures, CoSeal was easily mixed and applied to the suture lines of the aorta and coronary artery grafts. No bleeding was found at the suture lines.

CONCLUSIONS

In the rabbit cardiac adhesion model, CoSeal significantly reduced the formation of adhesions as compared to surgical control and Tissucol, and demonstrated good biocompatibility. In CoSeal treated patients undergoing cardiopulmonary bypass or vessel repair, sealing was achieved comparable to previous cases using Tissucol fibrin sealant. CoSeal effectively sealed the suture lines of the aorta and coronary artery bypass grafts.

摘要

背景

心包粘连会使需要再次手术的患者在再次开胸手术过程中面临心脏、大血管和心脏移植物受损的风险。这些粘连会使再次进入手术区域变得危险,妨碍手术定位和视野,增加失血量并延长手术时间,从而使再次手术严重复杂化。据报道,一种原位形成的聚乙二醇(PEG)材料——CoSeal手术密封剂(CoSeal)在动物模型中对抑制心脏粘连有效。目前估计,接受主动脉瓣置换术和冠状动脉旁路移植术(CABG)的患者中有10% - 20%在其后期生活中需要再次手术。此处报告的使用CoSeal密封主动脉和CABG缝线的成功临床经验表明,CoSeal可能在心脏手术中有多种应用。

方法

在兔子身上,进行开胸术和心包切开术以暴露心脏和左心室表面的心外膜。用干纱布和棉球在心外膜上摩擦五分钟以形成点状出血。在治疗组动物中,将CoSeal或Tissucol直接应用于有出血的摩擦心外膜,同时牵拉心包。松开心包,并将材料喷洒到心包的切缘。对照组动物不应用任何材料。

结果

尸检时发现,与手术对照组和Tissucol相比,CoSeal能显著减少粘连的形成、粘连的强度以及有粘连的心外膜磨损部位的百分比。Tissucol在任何粘连参数方面与手术对照组均无显著差异。经CoSeal处理的心脏显示间皮细胞层重新形成,组织形态与正常未手术的心脏相似。在临床心脏手术过程中,CoSeal易于混合并应用于主动脉和冠状动脉移植物的缝线处。缝线处未发现出血。

结论

在兔子心脏粘连模型中,与手术对照组和Tissucol相比,CoSeal显著减少了粘连的形成,并显示出良好的生物相容性。在接受体外循环或血管修复的CoSeal治疗患者中,实现的密封效果与先前使用Tissucol纤维蛋白密封剂的病例相当。CoSeal有效地密封了主动脉和冠状动脉旁路移植术的缝线。

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