SAN DIEGO – A novel, minimally invasive approach appears safe for treating life-threatening aneurysms that occur in the farthest part of the aorta, making it easier for cardiothoracic surgeons to repair the aorta and easier for patients to recover.
The approach was described today at the 51st Annual Meeting of The Society of Thoracic Surgeons.
The aorta is the major blood vessel that carries blood from the heart to the body. A thoracic aortic aneurysm occurs along the part of the aorta that travels through the chest cavity. If a thoracic aortic aneurysms bursts, it can lead to death in a matter of minutes.
“Currently, thoracic aortic aneurysms that reach into the left subclavian artery are very difficult to treat, leaving physicians no choice but to use more invasive surgical techniques,” says Himanshu J. Patel, M.D., a cardiothoracic surgeon at the University of Michigan Frankel Cardiovascular Center, who led the study. “During these procedures, we have to re-route blood flow to eliminate the risk of a fatal rupture while still protecting the brain. It’s pretty complicated.”
Patel and colleagues participated in a multicenter clinical feasibility trial, sponsored by the U.S. Food and Drug Administration, using a new stent graft that can repair the aortic aneurysm without the need to open the chest. The U-M Cardiovascular Center was the first heart center in the world to use the investigational device -- the W.L. Gore Thoracic Single Side Branch Endograft.
Ten patients were enrolled and underwent branched thoracic endovascular aortic repair (B-TEVAR). The surgeons performed the entire procedure using only a small incision in the leg.
Results were positive; after 30 days, all patients were alive and did not experience a stroke or spinal cord ischemia, an inadequate blood supply to the spinal cord that can lead to severe back pain.
“Our study is one of the first in-human feasibility trials, which is an important development in scientific research,” says co-author Joseph E. Bavaria, M.D., from the Hospital of the University of Pennsylvania. “This is one of the first branched TEVAR procedures into the arch vessels. While our study only addressed aneurysms, the results have implications for cardiothoracic surgeons who perform procedures to repair tears in the ascending aorta (type A dissection), as well as for patients, because our approach eliminates an open procedure.”
Patel cautions that the study demonstrates only the first step in the process.
“Future studies should evaluate whether this treatment will be safe and effective in aneurysms that extend a little closer to the heart within the aorta, and the next extension would be development of a newer device that could be used to treat the entire arch aorta with a pure endovascular graft,” Patel says
Regulatory Disclosure: This study uses the W.L. Gore Thoracic Single Side Branch Endograft, which has an FDA status of investigational. Patel has an outside consulting relationship with W.L. Gore & Associates.
For a copy of the abstract contact Cassie McNulty at 312-202-5865 or firstname.lastname@example.org.