A critical approach for longitudinal clinical trial of stretch PTFE aortic grafts.

Adaptation of new clinical products should be based upon thorough scientific evaluation of properties and performance in vitro and in vivo. Developmental animal research experimentation is classically carried out by the manufacturer with eventual government approval. However, objective data needs to be recorded during clinical trials including handling characteristics, bleeding, tensile strength, kinking, seamline break, dilatation, anastomotic deterioration, patency, and incorporation. Since April 1991, 1010 stretch polytetrafluoroethylene (PTFE) aortic grafts have been implanted at our institution and data were recorded prospectively. Six hundred and seven were for elective abdominal aortic aneurysms, 46 for symptomatic abdominal aortic aneurysms, 58 for ruptured abdominal aortic aneurysms, 17 for elective thoracoabdominal aneurysms, 3 for ruptured thoracoabdominal aneurysms and the remainder were for various aortoiliac pathology. Average age of the patients was 69 (range: 10-95), 66% were males, 25% were diabetics. Overall operative mortality was 5.8% (2.9% in elective cases and 26.6% in emergent cases). There were 23 occlusions; 21 were revised and 2 were replaced with axillofemoral bypasses. Estimated blood loss was 784 cc in elective cases and 1918 cc in emergent cases. Grafts were followed by duplex ultrasound or CT scan every 3 months during the first year and every 6 months thereafter. There were no graft dilatations or false aneurysms in this series. There was one graft infection and no perigraft seromas or anastomotic deteriorations during this follow up. Follow up was complete in 94% of these patients. In conclusion, stretch PTFE graft has acceptable handling characteristics, no excessive bleeding at the suture line and had no anastomotic or graft dilatation. This graft material was suitable for thoracic, visceral, renal and abdominal aortic reconstructions.