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

Abstract

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. Invitro 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 150mm 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 invitro tests, with an average implantation time of 2'58 (range: 2'25-3'22). The mean value of fluid losses was 84ml (range: 67-94ml), 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: 42kg, 37-50kg), an aorto-left iliac bypass was successfully implanted in all cases, with a total mean procedure time of 101min (range: 90-130min), and an average fluid loss of 77ml (range:20-120ml). The mean implantation time was 4'39 (range 3'29-5'52) for C2D and 16min (range 12-17min) to perform the conventional distal prosthetic-iliac anastomosis. Systematic arteriographic and angioscopy control showed perfect patency of the C2D implantations. Preliminary invitro and acute invivo testing of C2D implantation show good early results, allowing further long-lasting pig experiments on the way to human homologation.