A University of Michigan Health System team including Himanshu Patel, M.D., cardiothoracic surgeon, David M. Williams, M.D., vascular interventional radiologist, and Jon Eliason, M.D., vascular surgeon, have performed the first ever implantation of the GORE® TAG® Thoracic Branch Endoprosthesis.
The device treats thoracic aortic aneurysms, which generally occur in the elderly and can lead to a life-threatening rupture of the aorta, the largest artery in the body. Designed to seal-off a hard-to-treat section of the aorta, the device potentially provides a safe and less invasive alternative to open heart surgery.
The first human recipient of the GORE® TAG® Thoracic Branch Endoprosthesis is an 84-year-old woman who underwent the procedure Jan. 21 at the University of Michigan Frankel Cardiovascular Center. The device had previously only been used in laboratory studies.
"As the first hospital in the world to implant the device, the University of Michigan is demonstrating its commitment to providing innovative care to patients with cardiovascular diseases," says Ora Hirsch Pescovitz, M.D., chief executive officer of the U-M Health System.
The procedure marks the beginning of Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis in the Treatment of Proximal Descending Thoracic Aortic Aneurysms, a U.S.-based, multi-center feasibility study sponsored by W.L. Gore & Associates.
Through thoracic branch technology and design, the Gore device fits the unique characteristics of the descending aorta, allowing physicians to treat a subset of patients that could not be considered for total endovascular repair in the past.
Endovascular repair uses real-time x-ray and guidewires to help deliver a graft, inserted via catheter, to exclude the lesion inside the diseased aorta, making a new path for blood to flow. Through this less invasive technique, physicians can treat conditions through small incisions in the groin that might otherwise require open chest surgery.
Thoracic aortic aneurysms are less common than abdominal aortic aneurysms, but a TAA rupture remains a fatal event. The risk of rupture and a patient's overall health determines whether the patient has surgery.
"Thoracic aortic aneurysms that encroach on the aortic arch make treating these challenging anatomies very difficult, leaving physicians no choice but to use more invasive surgical techniques or to cover the branch vessel," says Dr. Patel. "Using GORE® TAG® Thoracic Branch Endoprosthesis, we were able to successfully treat the first patient in the study using endovascular means only. These results demonstrate the feasibility of using branched stent-grafts to treat aortic aneurysms that involve the left subclavian artery."
Patel leads a multidisciplinary team that will coordinate the GORE® TAG® Thoracic Branch Endoprosthesis study at the University of Michigan, one of only six hospitals in the country using the investigational device.
"With this study, we hope to demonstrate that the Gore device allows physicians to safely treat aortic aneurysms near the aortic arch while maintaining blood flow to all branch vessels using endovascular techniques," says Michael Dake, M.D., national principal investigator and Thelma and Henry Doelger Professor of Cardiovascular Surgery at Stanford School of Medicine.
"Gore's device will reduce the need for invasive surgical procedures commonly required today, thus reducing the complications associated with treatment of this complex disease."
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