Six years of clinical follow-up with endothelial cell-seeded small-diameter vascular grafts during coronary bypass surgery.

This clinical study was performed to investigate the patency rate of endothelial cell-seeded small-diameter expanded polytetrafluoroethylene grafts during coronary artery bypass surgery. Between September 1995 and December 1998, 14 patients (median age: 71 years, range: 61-79 years) received 21 endothelial cell-seeded small-diameter grafts. In all, 43% of the performed implantations were reoperations. Endothelial cells were harvested from a forearm vein, cultured and characterized in the laboratory until a sufficient number was available. After in vitro seeding, the grafts were allowed to mature for another 10 days, prior to implantation. Graft patency was investigated with angiography, angioscopy, and intravascular ultrasonography during follow-up. Cumulative data represented 58 patients' years and was 100% complete. The seeded autologous vascular endothelial cell density was 1.05 × 10(5) ± 0.12 × 10(5) cells/cm(2) with a cell viability of 95.5 ± 1.5%. Operative mortality was 7.1% (one patient). Patency rate at discharge was 95.2%, and at a mean follow-up of 27 months was 90.5%. The proven patency rate at up to 72 months was at least 50.0%, as five patients refused angiographic evaluation. None of these five patients suffered from angina pectoris and so the best scenario would have shown a patency rate of 85.7%. Angioscopy and intravascular ultrasonography showed absence of atheroma or stenosis in the investigated patent grafts. Autologous vascular endothelial cell seeding improves patency rate of small-caliber expanded polytetrafluoroethylene grafts in patients without suitable autologous graft material.