OBJECTIVE: The prospect of seeding endothelial cells to a prosthetic graft has been successful in the experimental setting, but less convincing in clinical studies in humans. This study was performed with the objective of evaluating endothelial cell seeding of aorto-bi-iliofemoral reconstructions with cells harvested at the same procedure. EXPERIMENTAL DESIGN: Randomized study with one graft limb seeded and with at least 5 year follow-up. SETTING: University Hospital. PATIENTS: 15 patients undergoing aorto-bi-ilio-femoral reconstruction. INTERVENTIONS: One graft limb (randomly determined) was seeded with autologous endothelial cells (median 5.2 x 10(5)) enzymatically (Dispase II) harvested from the saphenous vein (length 8-15 cm, diameter 4-8 mm). The other graft limb served as a control. MEASURES: Two months after surgery platelets were labelled with 111In and platelet activity registered over the graft. Long-term outcome were followed (median 5 years and 10 months). RESULTS: No difference in platelet activity was noted between the seeded and non-seeded graft limb. Different techniques of calculating graft wall activity showed large interindividual variations in the results. Long-term outcome showed that three patients died, two from myocardial infarction on postoperative day three and 60, and one patient died four years after surgery from a lung cancer. Grafts functioned well. In one non-seeded graft limb the patient had severe microembolisation postoperatively that required amputation 10 days after surgery. Of seeded graft limbs one occluded 42 months after surgery, intimal hyperplasia at the distal anastomosis was seen and in one patient progress of arteriosclerosis required additional surgery 12 months after initial operation with profundaplasty (partly due to intimal hyperplasia) and later two additional femoro-distal reconstructions were needed. CONCLUSION: In summary with our single-staged technique for seeding of endothelial cells to a graft limb in a high flow situation no effect on platelet activity at two months was found and long-term outcome was not obviously influenced.
RCT Entities:
OBJECTIVE: The prospect of seeding endothelial cells to a prosthetic graft has been successful in the experimental setting, but less convincing in clinical studies in humans. This study was performed with the objective of evaluating endothelial cell seeding of aorto-bi-iliofemoral reconstructions with cells harvested at the same procedure. EXPERIMENTAL DESIGN: Randomized study with one graft limb seeded and with at least 5 year follow-up. SETTING: University Hospital. PATIENTS: 15 patients undergoing aorto-bi-ilio-femoral reconstruction. INTERVENTIONS: One graft limb (randomly determined) was seeded with autologous endothelial cells (median 5.2 x 10(5)) enzymatically (Dispase II) harvested from the saphenous vein (length 8-15 cm, diameter 4-8 mm). The other graft limb served as a control. MEASURES: Two months after surgery platelets were labelled with 111In and platelet activity registered over the graft. Long-term outcome were followed (median 5 years and 10 months). RESULTS: No difference in platelet activity was noted between the seeded and non-seeded graft limb. Different techniques of calculating graft wall activity showed large interindividual variations in the results. Long-term outcome showed that three patients died, two from myocardial infarction on postoperative day three and 60, and one patient died four years after surgery from a lung cancer. Grafts functioned well. In one non-seeded graft limb the patient had severe microembolisation postoperatively that required amputation 10 days after surgery. Of seeded graft limbs one occluded 42 months after surgery, intimal hyperplasia at the distal anastomosis was seen and in one patient progress of arteriosclerosis required additional surgery 12 months after initial operation with profundaplasty (partly due to intimal hyperplasia) and later two additional femoro-distal reconstructions were needed. CONCLUSION: In summary with our single-staged technique for seeding of endothelial cells to a graft limb in a high flow situation no effect on platelet activity at two months was found and long-term outcome was not obviously influenced.