Long-term reduction of medial and intimal thickening in porcine saphenous vein grafts with a polyglactin biodegradable external sheath.

OBJECTIVES: The development of neointimal hyperplasia with subsequent atherosclerotic deposition has been proposed to cause most late vein graft failures. Our unit has previously demonstrated that placement of a macroporous, loose-fitting polyester external stent prevents neointimal thickening in porcine vein grafts, and has been proposed as a therapeutic strategy to prevent late vein graft failure. To reduce any potential long-term complications of the permanent polyester stent, a study was undertaken to investigate the effect of a biodegradable external stent on porcine vein graft thickening at 1 month and to identify its longer term effects at 6 months.
METHODS: Bilateral saphenous vein to common carotid artery interposition grafting was performed in Large White pigs (25-32 kg; n = 6 per time course group) according to UK Home Office guidelines. A commercially constructed loose-fitting 8-mm-diameter polyglactin stent was placed externally around the vein graft on one side, and the contralateral side remained unstented to serve as control. The external stent was designed to biodegrade and hence disappear within 90 days. Grafts were left in situ for 1 month in 1 group of animals, and for up to 6 months in the other group, before explantation. Graft morphometric features were assessed with computer-aided planimetry.
RESULTS: At 1 month the vein grafts fitted with the polyglactin stent demonstrated a statistically significant decrease in neointimal thickening (0.038 mm; interquartile range [IQR], 0.035-0.039 mm) compared with the unstented control grafts (0.13 mm; IQR; 0.11-0.19; P = .0012), and also in medial thickening (0.09 mm; IQR, 0.086-0.093) compared with unsheathed control grafts (0.302 mm; IQR, 0.272-0.414; P = .0012). The 6-month polyglactin stented grafts also demonstrated a statistically significant reduction in neointimal thickening (0.049 mm; IQR, 0.047-0.07; P = .0012) compared with control grafts (0.178 mm; IQR, 0.164-0.19), and also in medial thickening (0.105 mm; IQR, 0.095-0.143) compared with unstented grafts (0.421 mm; IQR, 0.35-0.44; P = .0012, Mann-Whitney U test).
CONCLUSION: The loose-fitting biodegradable polyglactin external stent reduces porcine vein graft thickening at 1 month, which persists in the long term, even after degradation of the stent itself. This effective removal of the stent may therefore reduce the long-term risks for infection and mechanical complications associated with implanted prosthetic material while still eliciting the primary objective of preventing graft thickening over the long term. Biodegradable external stents therefore have potential advantages over permanent stent material in clinical application. CLINICAL RELEVANCE: Arteriovenous bypass graft failure has a huge economic effect on health care resources, and a devastating effect o the patient. The attenuation of vein wall thickening, with subsequent luminal narrowing and occlusion, is a major goal in improving the longevity of the venous graft, to reduce secondary percutaneous and surgical interventions. The biodegradable external stent demonstrated in this study has possible clinical applications in bypass procedures with autogenous venous tissue, and represents a novel approach to ameliorating the problem of intimal hyperplasia that plagues these grafts.