Li Bin, Bai Shanshan, Yue Guangxin, Zhu Jinyan, Zhang Min, Yang Baiqing, Luo Jiafei, Sun Yang, Zhang Leisheng, Wang Xin
Beijing Key Laboratory of Preclinical Research and Evaluation for Cardiovascular Implant Materials, State Key Laboratory of Cardiovascular Disease, Animal Experimental Centre, National Centre for Cardiovascular Disease, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Department of Blood Products and Substitutes, Beijing Institute of Transfusion Medicine, Beijing, China.
Front Cardiovasc Med. 2022 Feb 11;9:783208. doi: 10.3389/fcvm.2022.783208. eCollection 2022.
This study was designed to evaluate the operability, effectiveness, and safety of the automated titanium suture fastener in a preclinical ovine model in comparison with manual tying in a mitral valve annuloplasty ring implantation surgery.
Eighteen adult Small-tailed Han sheep were prepared for the surgery of mitral valve annuloplasty ring implantation through lateral thoracotomy under cardiopulmonary bypass (CBP). A total of 12 stitches were performed to secure an annuloplasty ring, with 6 stitches done with the automated fastener and the other 6 by manual tying. The knotting time for the automated fastener or manual tying was recorded, respectively. The firmness of knots, mitral valve integrity, biocompatibility, thrombosis, local reactions, and other aspects were also compared at follow-up time (Days 30, 60, 90, and 180).
Of the 18 sheep, 16 survived to the designated endpoints and were enrolled for further analysis. Compared with the control group, the knotting time was significantly reduced with the automated fastener ( < 0.01). All the annuloplasty rings were tightly secured by 6 fastener clips and 6 hand-made knots without any disengagement or displacement. All the mitral valves were intact without any defect, stenosis, prolapse, valve insufficiency, or perforation. Endothelialization was comparable between the two groups by Day 60. Small red thrombi formed at the thread end of the suture in both groups. No thrombus was found on the surface of the titanium clip. All the thrombi were within the acceptable range for the antithrombotic property. Thrombosis showed no significant difference by Day 60. No significant differences in the inflammatory response and pathological lesions were observed by Day 60. One case of diffuse renal infarction (area ratio = 20%) and 1 case of small focal renal infarction (area ratio < 5%) were caused by thromboembolism.
The automated fastener significantly shortened the procedure time of tying knots for the implantation of the annuloplasty ring in the ovine model, with comparable safety and effectiveness as manual tying.
本研究旨在评估在二尖瓣瓣环成形环植入手术的临床前绵羊模型中，与手工打结相比，自动钛缝合钉的可操作性、有效性和安全性。
18只成年小尾寒羊通过体外循环（CBP）下的侧胸壁切开术准备进行二尖瓣瓣环成形环植入手术。总共进行12针缝合以固定瓣环成形环，其中6针使用自动缝合钉完成，另外6针通过手工打结完成。分别记录自动缝合钉或手工打结的打结时间。在随访时间（第30、60、90和180天）还比较了结的牢固程度、二尖瓣完整性、生物相容性、血栓形成、局部反应等方面。
18只绵羊中，16只存活至指定终点并纳入进一步分析。与对照组相比，自动缝合钉显著缩短了打结时间（<0.01）。所有瓣环成形环均通过6个缝合钉夹和6个手工打结紧密固定，无任何松开或移位。所有二尖瓣均完整，无任何缺陷、狭窄、脱垂、瓣膜关闭不全或穿孔。到第60天时，两组之间的内皮化情况相当。两组在缝线末端均形成小的红色血栓。在钛夹表面未发现血栓。所有血栓均在抗血栓性能的可接受范围内。到第60天时，血栓形成无显著差异。到第60天时，炎症反应和病理病变无显著差异。1例弥漫性肾梗死（面积比=20%）和1例小灶性肾梗死（面积比<5%）由血栓栓塞引起。
在绵羊模型中，自动缝合钉显著缩短了瓣环成形环植入时的打结操作时间，其安全性和有效性与手工打结相当。
