Clampless 2 Device: Experimental Study of a Lateral Aorto-Prosthetic Anastomosic Device Without Clamping or Suturing

To offer an alternative to conventional techniques of lateral prosthetic anastomosis on arteries which require a long training, and impose an extensive open surgery, we are proposing the clampless 2 device (C2D) implanted by a simple arterial puncture and allows a lateral implantation of a polytetrafluoroethylene (PTFE) vascular graft in an artery, without arterial clamping or suture.

C2D is a "T" shaped 25-mm long and 8-mm diameter Nitinol stent with a 6-mm PTFE graft prosthesis mounted laterally on the stent, and implanted in an artery, via a 21-French sheath, and a compliant balloon inflation. In vitro testing of the C2D was first performed on a bench including a segment of a 7-mm internal diameter pig abdominal aorta. A series of 5 consecutive C2D implantation was analyzed with evaluation of the implantation time and the fluid losses at a fluid pressure of 80 and 150 mm Hg. The C2D implantation was finally controlled by angioscopy. An aorto-iliac bypass was then secondly performed on 8 living sows, with a side-to-end C2D implantation in the infrarenal abdominal aorta, followed by a conventional end-to-end prosthetic left iliac trunk anastomosis. The C2D and distal conventional anastomotic times were evaluated, as well as the total operative time and blood loss. A postoperative angiogram was systematically performed.

The C2D was successfully implanted in all 5 in vitro tests, with an average implantation time of 2'58 (range: 2'25-3'22). The mean value of fluid losses was 84 ml (range: 67-94 ml), with no fluid leakage occurring at 80- and 150-mm Hg pressure. All anastomoses were patent after macroscopic study by angioscopy with a perfect application of the stent in the aortic wall. In 8 living sows (mean weight: 42 kg, 37-50 kg), an aorto-left iliac bypass was successfully implanted in all cases, with a total mean procedure time of 101 min (range: 90-130 min), and an average fluid loss of 77 ml (range:20-120 ml). The mean implantation time was 4'39 (range 3'29-5'52) for C2D and 16 min (range 12-17 min) to perform the conventional distal prosthetic-iliac anastomosis. Systematic arteriographic and angioscopy control showed perfect patency of the C2D implantations.

Preliminary in vitro and acute in vivo testing of C2D implantation show good early results, allowing further long-lasting pig experiments on the way to human homologation.