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DOI: 10.1055/s-2006-925730
The Holly Graft™ first clinical experience with a novel, drug eluting and heparin coated artificial bypass graft
Aims: Various attempts to generate alternative, other than autologous grafts for CABG surgery have been reported. Here we introduce, for the first time in a clinical series, a high flow, large diameter artificial graft, which could replace autologous veins and arteries in CABG surgery.
Methods: Nine patients (35 intended), (three pts with 2-vessel coronary artery disease and 6 pts with 3-vessel coronary artery disease). The Holly Graft™ is a 6mm thin walled ePTFE conduit with a flow limiter at the distal end to maintain pressure in the graft. The anastomosis to the coronary artery is being fashioned using a vessel connector.
The vessel connector is coated with Paclitaxel and an eluting polymer to prevent intimal hyperplasia. All blood contacting titanium components, including the vessel connector and the flow limiter, are coated with a covalent layer of heparin to prevent thrombotic occlusion.
Results: In all cases a single anastomosis was fashioned (PLA in 8, RCA in 1, LAD in 1). In the early postoperative phase, no adverse events were observed. A 64 slice CT scan revealed patency of the Holly Graft and no kinking was observed.
Conclusion: Early experience with the Holly Graft System indicates a safe and efficient device for facilitating CABG procedures. Long term patency rates will determine its place among all sources of coronary artery bypass conduits.