Abstract
Objectives: To evaluate the early experience of using the BYFix-innovative anastomotic device for creating suture-less vascular anastomosis in major and peripheral arteries surgery. Design: Uncontrolled prospective study. Materials: The BYFix anastomotic device for suture-less vascular anastomosis with surgical tools and standard vascular grafts. Methods: 7 patients, age 63.6 ± 9.2 years, with peripheral vascular occlusion above the knee scheduled for surgical repair were operared. They underwent the surgical procedure using the BYFix anastomotic device for creating proximal anastomosis and the conventional manual suturing for creating the distal anastomosis of the implantable vascular graft. Results: The anastomoses by using BYFix anastomotic device were successfully created in all patients. The duration of anastomosis creation was significantly shorter by using BYFix device, compared to conventional manual suturing, 5:10 ± 1:50 minutes compared to 33 ± 17:40 minutes respectively. No adverse events related to BYFix anastomotic device were observed, during the surgical procedure or recovery period. One year follow up revealed no complications related to BYFix anastomotic device. Conclusions: The BYFix anastomotic device enables the creation of efficient vascular anastomosis in peripheral vascular occlusions. It shortens the time needed for creating vascular anastomosis and thus reducing the operation time and might reduce distal complications related to the vascular procedure. Further clinical trials are needed to establish the results.
Highlights
Lower extremity peripheral arterial disease affects a large proportion of most adult populations worldwide [1]
They underwent the surgical procedure using the BYFix anastomotic device for creating proximal anastomosis and the conventional manual suturing for creating the distal anastomosis of the implantable vascular graft
The anastomoses by using BYFix anastomotic device were successfully created in all patients
Summary
Lower extremity peripheral arterial disease affects a large proportion of most adult populations worldwide [1]. As the presence of PAD is a red alert for the existence of widespread atherothrombosis it should provide a powerful stimulus for action. Despite these compelling statistics, PAD remains under diagnosed and patients often do not get proper care until the associated heart disease becomes evident. Severe PAD can result in tissue ischemia in the lower extremities, causing gangrene and requiring amputation in 3% to 8% of patients [5,6]. A small proportion of patients with severe disease require a major amputation
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