Experimental Study of a Novel Suture-less Aortic Anastomotic Device

Objectives To assess the suitability and safety of a novel suture-less hermetic docking head (HDH) device for aortic anastomosis, and to test it in vitro, on cadavers, and in animals. Design Uncontrolled prospective studies. Materials HDH device with commercial vascular grafts. Methods Two experimental series were conducted in vitro to test the hermetic seal of the anastomosis and the fixation of the device. Another series was performed in 6 cadavers with atherosclerotic aortas. Two in vivo trials tested the HDH device when implanted in ten and five pigs, respectively, with follow-up of 22 weeks. Pathological, histological and radiographic studies of the aorta were performed. Results The in vitro and cadaveric studies demonstrated the resilience of the device under physiological and extreme conditions (up to 1200 mmHg pulsatile flow on the bench and up to 270 mmHg in cadaveric studies). These studies also established the safety and ease of application of the device in both normal and atherosclerotic aortas. Insertion was easy and rapid. There was no indication of leakage, narrowing or stenosis at the anastomotic sites. The implants' position was maintained without distal or proximal migration. Reliable fixation was observed despite significant increase (up to 112%) in the weight of the animals. Histologically, normal tissue reaction of the lamina was observed. Conclusions The suture-less HDH device's behavior in vitro and in vivo suggests that this implant is useful for aortic anastomosis, and its use is faster and simpler than common suturing techniques.