Clinical Studies Target Fewer Complications, Better Outcomes for Vascular Surgery

Two studies at the Jefferson Vascular Center (JVC) are assessing innovative methods to reduce risk of complications — and increase positive outcomes — for vascular surgery patients. Here, Paul DiMuzio, MD, FACS, William M. Measey Professor of Surgery and Co-Director, Jefferson Vascular Center, reviews what both studies mean for patient care. ‘Game-changer’ for groin wounds As Dr. DiMuzio explains, groin incisions in vascular surgery are a source of significant morbidity and healthcare costs. When groin wounds become infected, patients may have to be readmitted and undergo additional surgery. Some patients are at greater risk because of diabetes and obesity, others because of the surgical technique required for their treatment. In exploring ways to decrease groin wound infections in high-risk patients, the JVC identified a possible solution in PrevenaTM — a sponge covered in adhesive that attaches to a small suction device. The suction device removes fluids from the region, helping reduce the risk of infection. Already FDA-approved, Prevena is used by cardiac surgeons for sternal incisions and by orthopedic surgeons in total joint replacements. “No one had conducted a prospective randomized trial to determine if Prevena is a viable option for highrisk groin wounds,” he says. “We were the first.” The results of Jefferson’s two-year study — which will be presented later this Spring at the 2017 Annual Meeting of the Society for Vascular Surgery in San Diego — showed a significant reduction in infections and re-admissions. Hospital costs declined by an average of $6,000 per patient. “We are now using this device for every patient with high-risk groin incisions, and we expect it to become a standard of care everywhere once the findings are published,” he adds. “It’s a game changer.” In February, Megan Lundgren, MD, a third-year General Surgery resident and Sidney Kimmel Medical College alumna, presented the study at the Philadelphia Academy of Surgery’s Annual Surgical Research Competition. Dr. Lundgren, who helped enroll and care for trial participants, won the inaugural Chris Tzarnas Surgical Research Award for the work. Follow-up trial of new treatment for carotid artery disease Following the promising multi-center ROADSTER trial, the ROADSTER 2 trial is observing and evaluating real-world results of a newly approved procedure for treating carotid artery disease. The most widely used treatment for carotid artery disease has been the carotid endarterectomy (CEA) procedure, in which plaque is surgically removed from the blocked artery. For patients who may be at high medical or anatomic risk for carotid endarterectomy, carotid stenting may be a better option. Though both procedures are generally safe, heart attack risk is higher with CEA, while stroke risk is higher with stenting. Trans-carotid Artery Revascularization (TCAR) is designed to lower both risks, and the initial ROADSTER trial demonstrated its success. “The TCAR procedure is a hybrid of the other two treatments,” Dr. DiMuzio says. “It places a carotid stent through a minimally invasive incision in the carotid artery at the level of the neck. Blood flow in the artery is temporarily reversed to protect the brain from plaque fragments that may come loose during the procedure. A stent is then inserted into the blood vessel to support the artery walls and prevent blockage or collapse.” Dr. DiMuzio adds that stent deployment via access directly through the common carotid artery avoids the need to traverse the aortic arch with catheters, which can lead to embolic stroke. Though approved by the FDA, the TCAR procedure will not be marketed until the ROADSTER 2 trial is completed. To date, Jefferson is the first and only study location in the Philadelphia area. Dr. DiMuzio and his team have already performed the TCAR procedure and are actively enrolling more patients. “Nationally, the study is more than halfway to completion — and the TCAR procedure is on its way to becoming an exciting new standard of care for carotid artery disease,” he says. For more information, contact the Jefferson Vascular Center at 215-955-8304 or visit Jefferson.edu/JV