UMMC Performs First Thoracic Side Branch Graft Surgery in Maryland
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Continuing its long-established leadership in cardiac and vascular care, the University of Maryland Medical Center (UMMC) recently became the first center in Maryland to perform surgery using a novel device to repair life-threatening problems affecting the aortic arch.
The co-directors of UMMC’s Center for Aortic Disease, Shahab Toursavadkohi, MD, and Brad Taylor, MD, MPH, also both faculty members at the University of Maryland School of Medicine, completed the inaugural thoracic side branch graft procedure in November 2016. The operation was part of a national pivotal trial for the device, which can repair lesions of the aortic arch such as aneurysm, dissection or trauma, using endovascular methods. This new device has a branch that allows treatment of lesions that encroach or involve arch vessels.
Notoriously difficult to treat, aortic arch disease has traditionally required open surgery or a hybrid approach blending open and endovascular techniques. Having the thoracic branch device increases surgeons’ options to treat patients with purely endovascular options, Dr. Toursavadkohi says.
The University of Maryland is the only site in Maryland participating in the national feasibility trial for the device, which is manufactured by W. L. Gore & Associates Inc., and is being tested in up to 40 centers around the United States. The tube-shaped device is made of GORE-TEX and held open with a scaffolding of alloy metal. The device has a portal for a side branch that can be used to allow flow into subclavian or carotid arteries, depending on the aneurysm anatomy.
“We were chosen to participate because we’re recognized as a high-volume center for conditions affecting the thoracic aorta,” says Dr. Toursavadkohi.
Great Need Projected for Device
“Patients in need of repair from aortic lesions are often elderly and suffer from co-existing health problems, making open surgery far riskier than a minimally invasive endovascular procedure,” explains Dr. Taylor.
Nearly half of the approximately 80 UMMC patients who undergo thoracic endovascular surgery each year might benefit from the new thoracic side branch device, which Dr. Toursavadkohi notes will likely take a few years to be approved by the U.S. Food and Drug Administration. Until then, the device will be available at UMMC for the trial and later through a continued access phase.
The aortic arch is considered highly challenging to reconstruct if diseased or damaged, and one of the concerns is maintaining proper oxygenation of blood flow to the brain. The device has received an FDA Expedited Access Pathway designation — among the first devices to do so in the nation — since it demonstrates the potential to address an unmet medical need for life-threatening diseases.
“With a side branch, we can extend the potential for being able to use endovascular techniques in the aortic arch because we have a graft to perfuse the branches of the brain,” says Dr. Taylor.
Patients undergoing endovascular techniques such as side branch graft surgery typically experience much quicker recoveries than when undergoing open surgery, which involves cutting the chest or abdomen and may require the use of a heart-lung bypass machine.
“These endovascular surgeries can be completed with a small incision in the groin, much less than a big thoracotomy,” Dr. Toursavadkohi explains. “It’s really night and day for patients — they go home in a few days and feel back to normal in about a week.”
New Procedure Highlights UMMC’s Expertise
This scenario held true for UMMC’s first thoracic side branch patient, an 81-year-old man for whom the device was used to repair two aneurysms: one in his thoracic aorta and the other in his subclavian artery, one of three problems from which he suffered, Dr. Toursavadkohi says. The patient recovered well and went home after a four-day hospital stay.
“We are aiming to do this surgery in 20 patients over the duration of this trial,” Dr. Toursavadkohi explains. “There are going to be a lot more of these patients, because many of the cases involving the aortic arch are done with open surgery. This will open the options to do this endovascularly.”
The new thoracic side branch graft procedure augments UMMC’s already robust offerings at the Center for Aortic Disease and highlights the faculty’s well-recognized experience, Dr. Toursavadkohi says. The Center will also be involved in upcoming clinical trials using branch devices to repair vessels in the abdominal aorta.
“We have a technology that’s not available to anyone else in Maryland, and it offers an endovascular option to patients who otherwise might have to undergo open surgery,” he says.
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