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Data on the Acuseal Graft for Hemodialysis: An Interview With Marc Glickman, MD
At the 2013 VEITHsymposium, Marc Glickman, MD, presented “Early Cannulation Graft: Results of Acuseal Clinical Trial,” detailing results of a 138-patient study examining patency of the graft in hemodialysis patients.
The Acuseal Vascular Graft (W.L. Gore) is designed for early cannulation within 24 hours after implantation, which expands treatment options for earlier removal or possible avoidance of a central venous catheter, a major source of infection for hemodialysis patients. The Carmeda BioActive Surface heparin-coated surface (W.L. Gore) uses covalently bonded heparin technology that gives the graft thromboresistant properties. The device was approved by the FDA in April 2013. Vascular Disease Management spoke with Dr. Glickman about the study results at the VEITHsymposium meeting.
Q: Could you give a brief overview of the data that you presented on the AcuSeal Vascular Graft?
A: This is a multicenter prospective trial on patients who received the Acuseal graft for hemodialysis. Of the 138 patients, we found that we were able to cannulate the graft early—within 72 hours—without any increase in the complication rate, meaning infection or loss of patency. Also we were able to remove their dialysis catheters early, therefore reducing potential mortality, morbidity, and infection for these patients.
Q: What is most unique about the graft design?
A: The graft is unique in that it is trilayer, and its middle layer consists of proprietary silicone elastomer, which allows it to be a low-bleed and early-stick graft and the two other layers are polytetrafluoroethylene.
Q: What’s the biggest benefit that this graft provides for vascular specialists?
A: The graft will change the paradigm of what vascular specialists do now because utilizing this graft can really improve outcomes for our patients.
Q: What do you think are the most striking results of use of the device?
A: The most striking result of the study is that 50% of the patients were cannulated within 1 week, and no other study has ever demonstrated that without any increase in overall complication rate, meaning hematoma formation, infection, or loss of patency. Doing this allows for early catheter removal and reducing patient infection rate.
Q: Anything else you want to add about the device?
A:I think this has a unique design and allows ease in handling of this graft. It’s very soft, malleable, and easy to use, which will really be a welcome addition to the vascular surgeon’s armamentarium.
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Marc H. Glickman, MD, FACS, is the medical director of vascular services for Sentara Health in Norfolk, Virginia. Dr. Glickman reports consultancy, institutional grants, honoraria, and reimbursements from W.L. Gore.
