Early Results Presented at STS for Gore's Thoracic Single Side Branch Endograft

January 27, 2015—A novel approach for treating thoracic aortic aneurysms was presented at the 51st Annual Meeting of the Society of Thoracic Surgeons (STS), the society announced. Himanshu J. Patel, MD, and colleagues conducted a multicenter phase 2 trial on Gore & Associates’ thoracic single side branch endograft, which was sponsored by the US Food and Drug Administration.

Ten patients were enrolled in the study and underwent branched thoracic endovascular aortic repair. After 30 days, 100% of patients were alive and did not experience stroke nor spinal cord ischemia, reported the investigators.

Dr. Patel, who is with the University of Michigan Health System in Ann Arbor, commented in the STS press release, “Currently, thoracic aortic aneurysms that reach into the aortic arch are very difficult to treat with minimally invasive endovascular methods because critical blood vessels branch emanate off the aorta in the arch and supply blood to the arms, head, and brain.” 

He explained, “When critical branches come off the broken down pipe, the endografts currently available do not permit blood to flow into these branches. To keep blood flowing into these important branches, we often have to perform complex and more invasive rerouting procedures. The new, specially designed endograft tested in this study allows us to perform the minimally invasive endovascular procedure without the complex rerouting.”

Dr. Patel advised, “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.”

Investigator Joseph E. Bavaria, MD, from the Hospital of the University of Pennsylvania in Philadelphia, added “Our study is one of the first-in-human feasibility trials, which is an important development in scientific research. This is one of the first branched thoracic endovascular aortic repair 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.”