OBJECTIVES: To assess performance of a de-cellularised bovine ureter vascular graft for haemodialysis in patients for whom conventional access was not possible. METHODS: The Syner Graft Vascular Graft Model 100 (SGVG 100) is a bovine ureter modified by a tissue-engineering depopulation technology and uniquely it is not chemically cross-linked. SGVG 100 was implanted in patients with a failed fistula or vascular access grafts. Graft patency was the primary outcome; secondary outcomes included adverse events and associated treatments. RESULTS: 25 SGVG 100 were implanted in 23 patients; mean age was 59+/-14 years. Mean follow-up was 370 days. The mean time to occlusion (19 events) was 215+/-141 days with patency re-established in 14 of 18 surgical interventions. Thirty angioplasties were performed on 14 SGVG 100 for luminal/anastomotic stenosis. Two grafts demonstrated areas of dilation; however, both grafts continue to be usable at last reported follow-up (930 and 602 days) with no further changes in graft size. Primary patency, assisted primary patency, secondary patency, and freedom from infection were 29, 45, 81, and 95% at 1 year, respectively. CONCLUSIONS: This report demonstrates SGVG 100 is a stable vascular access conduit, providing a suitable graft alternative when autologous vein is not available.
OBJECTIVES: To assess performance of a de-cellularised bovine ureter vascular graft for haemodialysis in patients for whom conventional access was not possible. METHODS: The Syner Graft Vascular Graft Model 100 (SGVG 100) is a bovine ureter modified by a tissue-engineering depopulation technology and uniquely it is not chemically cross-linked. SGVG 100 was implanted in patients with a failed fistula or vascular access grafts. Graft patency was the primary outcome; secondary outcomes included adverse events and associated treatments. RESULTS: 25 SGVG 100 were implanted in 23 patients; mean age was 59+/-14 years. Mean follow-up was 370 days. The mean time to occlusion (19 events) was 215+/-141 days with patency re-established in 14 of 18 surgical interventions. Thirty angioplasties were performed on 14 SGVG 100 for luminal/anastomotic stenosis. Two grafts demonstrated areas of dilation; however, both grafts continue to be usable at last reported follow-up (930 and 602 days) with no further changes in graft size. Primary patency, assisted primary patency, secondary patency, and freedom from infection were 29, 45, 81, and 95% at 1 year, respectively. CONCLUSIONS: This report demonstrates SGVG 100 is a stable vascular access conduit, providing a suitable graft alternative when autologous vein is not available.