Department of Vascular Surgery, University Hospital, Toulouse-Rangueil, Toulouse, France.
J Vasc Surg. 2012 Jan;55(1):210-5. doi: 10.1016/j.jvs.2011.07.082. Epub 2011 Dec 3.
This study assessed the feasibility and efficacy of a new sutureless connector for end-to-end arterial anastomosis.
The anastomotic device is a connector consisting of a bare-metal stent with spikes covering its outer surface, which is introduced through the prosthesis. The seal of the anastomosis is obtained by inflating a balloon anchoring the stent with the spikes in the prosthesis and in the receiving artery. This experiment was conducted in three phases: (1) A feasibility study was done on four cadaveric femoral arteries using a polytetrafluoroethylene prosthesis, with measurement of the penetration of the spikes into the layers of the arterial wall. (2) Bench tests were conducted in seven automated and in seven sutured anastomoses. Anastomosis sealing was tested using a pump system (≤250 mm Hg) in a water-filled closed circuit. (3) The infrarenal aorta of seven pigs was replaced with a 6- to 8-mm diameter prosthesis, using this automated device for the proximal anastomosis. The distal anastomosis was handsewn on the aortic bifurcation. After completion angiography, animals were euthanized for macroscopic and histologic studies of the aorta, connector, and prosthesis. Explantations were done immediately (2 pigs), and at 15 (2 pigs), at 30 (2 pigs), and 42 days (1 pig). Study end points were the automated anastomosis time compared with manual suturing, leakage, mechanical strength, and patency of the anastomosis together with the histologic changes of the aortic wall in contact with the spiked stent.
Tests performed on four cadaveric arteries showed complete penetration of the spikes into the arterial wall layers without metal fracture. Tests of traction showed that the median force needed to rupture the automated anastomosis was 18.3 N (interquartile range [IQR], 17.7-19.9 N), with no significant difference from the handmade anastomosis (19.5 N; IQR, 17.9-20.2 N, P = .33). No leakage was demonstrated in vitro with a pulsatile flow and a pressure up to 250 mm Hg. The median automated anastomosis time on pig aorta was 2.4 minutes (IQR, 1.4-3.3 min) vs 17.0 minutes (IQR, 15.1-17.2 minutes) for the handmade aortic anastomosis performed on the same animals (P = .002). There was no anastomotic leak. Histology showed incorporation of the connector spikes in the aortic wall, without intimal hyperplasia or false aneurysm.
This preliminary study confirms the feasibility of this sutureless system, suggesting its usefulness for a faster and simpler anastomosis in hybrid arterial surgery.
本研究评估了一种新的无缝线连接器用于端对端动脉吻合的可行性和疗效。
吻合装置是一种连接器，由带有覆盖其外表面的刺的裸金属支架组成，通过假体引入。通过充气将支架锚固在假体和接受动脉中的刺来获得吻合的密封。该实验分三个阶段进行：（1）在四个尸体股动脉上进行了一项可行性研究，使用聚四氟乙烯假体，测量刺穿透动脉壁各层的情况。（2）在七个自动吻合和七个缝合吻合的情况下进行了台架试验。使用泵系统（≤250mmHg）在充满水的闭路中测试吻合密封。（3）用 6 至 8 毫米直径的假体替换七头猪的肾下主动脉，近端吻合采用这种自动装置。在主动脉分叉处手工缝合远端吻合。完成血管造影后，处死动物进行主动脉、连接器和假体的大体和组织学研究。立即进行了 2 只猪的取出，15 只猪（2 只）、30 只猪（2 只）和 42 天（1 只）进行了取出。研究终点是与手动缝合相比，自动吻合的时间、渗漏、机械强度以及与带刺支架接触的主动脉壁的通畅性和组织学变化。
在四个尸体动脉上进行的测试显示，刺完全穿透动脉壁各层，没有金属断裂。牵引测试表明，破裂自动吻合所需的中位数力为 18.3N（四分位距[IQR]，17.7-19.9N），与手工吻合无显著差异（19.5N；IQR，17.9-20.2N，P=.33）。在体外脉动流和高达 250mmHg 的压力下未发生渗漏。在同一动物上进行的手工主动脉吻合时间中位数为 17.0 分钟（IQR，15.1-17.2 分钟），而猪主动脉上的自动吻合时间中位数为 2.4 分钟（IQR，1.4-3.3 分钟）（P=.002）。吻合无渗漏。组织学显示连接器刺嵌入主动脉壁，无内膜增生或假性动脉瘤。
这项初步研究证实了这种无缝线系统的可行性，表明它可用于更快、更简单的杂交动脉手术吻合。
