Dr. Duwayri Leading Study of New Branched Aortic Graft
Since joining Emory in 2011, vascular and endovascular surgeon Dr. Yazan Duwayri has been heavily involved with developing Emory's use of customized fenestrated aortic endografts for treating juxtarenal aortic aneurysms. In 2012, he and Dr. Ravi Veeraswamy successfully implanted Georgia's first FDA-approved fenestrated aortic endograft as a minimally invasive treatment for patients with complex abdominal aortic aneurysms (AAA). Since then, this team has performed approximately forty implants on patients referred from Georgia and neighboring states.
An aortic aneurysm is a swelling in the aorta that can stretch to the point of bursting, causing fatal bleeding. Repairing the enlargement with an endovascular, minimally invasive approach avoids the large abdominal or chest cavity incisions that are part of the traditional open method. However, certain patients with extensive AAA are not appropriate candidates for conventional endovascular repair. For them, the implantation of fenestrated and branched endografts, which have reinforced openings (fenestrations) or branches that attach to arteries that lead to other organs affected by the aneurysm, are an effective treatment. Using specialized imaging software, the fenestrations are customized to accommodate the anatomical specifications of each individual patient. The endograft is delivered to the site of the aneurysm using a catheter inserted through the skin in the groin area and threaded through a blood vessel.
"These customized grafts have been a great advance, since they have eliminated the need for open surgery for some complex aortic aneurysms," says Dr. Duwayri. "However, the design and production times can pose problems in patients requiring urgent or emergent repair. The current fenestrated technology also does not allow for treatment of aneurysms above the level of the renal arteries."
Working with others towards a solution to this problem, Dr. Duwayri has become the Principal Investigator of the Emory site in a multi-center trial to evaluate the safety and effectiveness of the Zenith® p-Branch™ device for the treatment of pararenal aortic aneurysms, which could be the next generation of fenestrated graft. Unlike the current fenestrated graft, the Zenith p-Branch device does not need to be customized for the patient. Instead, it has two distinct designs that feature different locations for the pivoting renal windows, allowing it to fit more patients without delaying treatment. It can also treat aneurysms that extend to the level of the superior mesenteric artery.
During the study, once the stent graft is in place, its orientation and configuration will be evaluated with respect to kidney function and device performance. Detailed imaging will be performed prior to and after endovascular repair so important data concerning the stent graft can be studied.
"Due to the large number of patients referred to us with complex aortic pathology, I expect that participation in the trial will potentially benefit a significant portion of them," says Dr. Duwayri.
The P-branch endograft trial began enrolling patients in October 2015. Dr. Ravi Veeraswamy is Co-Investigator. For more information about the trial and for enrollment consideration, patients and physicians can contact Carole Seeley or Kim Baio.