Abstract
ObjectiveThis 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.MethodsEighteen 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).ResultsOf 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 (p < 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.ConclusionsThe 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.
Highlights
Surgical procedures for mitral valve repair and replacement under cardiopulmonary bypass (CPB) remain a superior treatment option for patients with severe valvular heart disease (VHD) [1]
CPB remains unavoidable for the vast majority of cardiac surgery and prolonged CPB time and aortic cross-clamp (ACC) time are reported to be independently associated with postoperative morbidity and mortality [2,3,4]
We mainly focused on the evaluation of firmness of knots, mitral valve integrity, biocompatibility, thrombosis, local reactions, and other aspects, providing a reference evaluation system for an automated titanium suture fastener or similar devices in cardiac valvular surgery
Summary
Surgical procedures for mitral valve repair and replacement under cardiopulmonary bypass (CPB) remain a superior treatment option for patients with severe valvular heart disease (VHD) [1]. It is well-established that the surgical procedure could be extremely complicated and with potential ensued complications of CPB. Among the new adjunct devices, an automated titanium suture fastener is the most widely accepted by cardiac surgeons [5]. This device is designed to enable quick, reliable, and easy suture fastening with a single squeeze. The use of fastener translating to the improved patient outcome remains debatable [15, 16]
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