Frank A. Arko, MD
Led by Frank R. Arko, MD, Carolinas HealthCare System's Sanger Heart & Vascular Institute implanted the first branched stent graft specifically designed to restore branch vessel repair of thoracic aortic aneurysms (TAAs). Sanger was one of two sites in the country to be part of this clinical trial to test the device.
The branched stent graft is based on an FDA-approved design that could fill the need for repairing TAAs in patients whose aneurysms are inaccessible by traditional surgical methods.
The device is designed to repair TAAs encroaching on the left subclavian artery (LSA). The stent is implanted with two catheters. One enters through the femoral artery in the leg and implants the device in the aorta near the LSA. The second catheter enters from the brachial artery in the left arm and snares the branch of the device, guiding it into the LSA. This catheter-based approach is less invasive than thoracic surgical options, which can include multi-graft bypasses of the LSA. It is hoped that this device and approach will lead to fewer complications, such as clots and spinal ischemia, as well as shorter hospital stays and better outcomes for patients.
"This endovascular treatment for aortic aneurysms provides an important alternative to open-chest operations," said Dr. Arko, who also helped design the device. "By eliminating the need for invasive surgeries, we should be able to reduce certain complications and hopefully improve outcomes for patients facing a life-threatening illness."
Additionally, this trial is one of nine chosen by the Food and Drug Administration (FDA) for a pilot program to encourage and facilitate feasibility studies of innovative medical devices for first-in-human trials in the United States. Carolinas HealthCare System is the first site to perform the surgery as part of the pilot program.
"This is an important milestone for Carolinas HealthCare System as well as the U.S. medical community," said Paul G. Colavita, MD, president of Sanger Heart & Vascular Institute. "Typically, these studies occur outside the United States, but the FDA has recognized a need to keep important medical trials and technologies in the country. We are excited to be a part of this program to help lead medical innovations in the U.S. as well as helping to lead the advancement of cardiovascular care through the trial and development of this new device."
According to the Society for Vascular Surgeons, an estimated 40 percent of patients with descending thoracic aneurysms are not candidates for endovascular repair and this approach could apply to those patients. Approximately 45,000 people die from aortic diseases every year in the U.S., and up to 25 percent of aortic aneurysms are thoracic. Aneurysms along the aortic arch are the most complex to treat because of the key arteries that branch off from the aortic arch. TAAs are the most lethal type of aortic aneurysms – as many as one out of every five people die within five years if TAA is left untreated.