Klein Doron, Heller Lior, Sorkin Alex, Zeltzer Assaf A
Department of Plastic and Reconstructive Surgery, Shamir Medical Center, Zerifin 70300, Israel.
Department of Plastic and Reconstructive Surgery, Shamir Medical Center, Zerifin 70300, Israel.
J Plast Reconstr Aesthet Surg. 2023 Oct;85:479-487. doi: 10.1016/j.bjps.2023.07.025. Epub 2023 Jul 20.
A novel device was designed to assist with microvascular arterial anastomoses. This study compares the safety and efficacy of the anastomosis-assisting device with manual suturing in an ovine model.
Arteries with a diameter ranging from 2 to 4 mm were transected and anastomosed at four locations. A comparison was done between manual anastomoses and anastomoses performed with a novel anastomotic device in seven sheep. All the device-assisted anastomoses were performed by a single surgeon. At day 45 ± 7, anastomotic sites were dissected to determine patency, and samples were obtained for pathology.
Thirteen of 13 (100%) samples from the Vesseal™ group demonstrated patency both on the day the anastomoses were performed and after the 45-day follow-up period. All four additional anastomoses performed using the Vesseal™ were found patent. In the hand-suturing group, six of six (100%) samples demonstrated patency on the day of the anastomoses and five of six (83%) were patent after the follow-up period. No thromboses or adverse events were observed in the anastomoses in either group. No difference in histopathology of the anastomoses was observed between the groups.
The anastomosis-assisting device is a safe and efficacious alternative to hand suturing. The patency rates of device-assisted anastomoses were greater than those of manual suturing and pose no additional risk, as demonstrated by clinical observation, histopathology, and macroscopic evaluation. The Vesseal™ anastomosis-assisting device may be a viable alternative to manual suturing, with an ergonomic and intuitive design, short learning curve, and consistent results.
设计了一种新型装置以辅助微血管动脉吻合。本研究在绵羊模型中比较了吻合辅助装置与手工缝合的安全性和有效性。
将直径为2至4毫米的动脉在四个部位横断并进行吻合。在七只绵羊中对手工吻合和使用新型吻合装置进行的吻合进行了比较。所有装置辅助的吻合均由一名外科医生完成。在45±7天时，解剖吻合部位以确定通畅情况，并获取样本进行病理学检查。
Vesseal™组的13个样本中有13个（100%）在吻合当天和45天随访期后均显示通畅。使用Vesseal™进行的另外四个吻合均被发现通畅。在手工缝合组中，六个样本中有六个（100%）在吻合当天显示通畅，六个中有五个（83%）在随访期后通畅。两组吻合中均未观察到血栓形成或不良事件。两组之间吻合的组织病理学未观察到差异。
吻合辅助装置是一种安全有效的手工缝合替代方法。临床观察、组织病理学和宏观评估表明，装置辅助吻合的通畅率高于手工缝合，且无额外风险。Vesseal™吻合辅助装置可能是手工缝合的可行替代方法，具有符合人体工程学且直观的设计、较短的学习曲线和一致的结果。
