Cardiovascular surgeons at the WVU Heart and Vascular Institute are the first in the state to implant the GORE Ascending Stent Graft as part of a new clinical trial to treat complex and potentially fatal aneurysms.
“This new device provides a lifesaving treatment of aneurysms of the ascending aorta in patients whose risk of open surgery is prohibitive,” Lawrence Wei, M.D., professor in the WVU Department of Cardiovascular and Thoracic Surgery and principal investigator of the ARISE II trial, said. “This novel treatment not only can treat the aneurysm, but it may even help the fear these patients have without treatment.”
The unique graft is designed for patients with conditions affecting the ascending aorta, the major large blood vessel that leaves the heart and supplies blood to the brain and the rest of the body. The stent graft is considered for patients who are not candidates for standard repair with open heart surgery. This new therapy potentially allows patients to avoid conventional surgery to repair aneurysms of the ascending aorta.
The ARISE II Study is the first multicenter pivotal study approved by the U.S. Food and Drug Administration investigating the use of a minimally invasive endovascular device to treat the ascending aorta. It will investigate how an endovascular stent graft, delivered via catheter, may be used to line the diseased portion of the ascending aorta as a potential alternative to open surgical repair that is performed using the heart-lung machine.
Endovascular technologies have been applied to other regions of the aorta to reduce the risk of complications and recovery times, but no endovascular device is currently approved for the ascending aorta. The WVU Heart and Vascular is one of only 41 sites in the United States selected to participate in the trial.
“Having access to this new technology is an exciting opportunity to provide a comprehensive endovascular or minimally invasive solution for patients most in need,” Pamela Zimmerman M.D., chief of Vascular Surgery and the vascular lead of the trial, said. “Collaborating with our cardiac surgical colleagues with this new therapy allows us to bring both of our unique skills to the table to provide the best care for our patients.”
The first patient at the WVU Heart and Vascular Institute was an 84-year-old female who presented with chest pain and pressure. The implant was successful and took less than an hour. She was discharged after five days. Her prognosis is very good, and she should be able to return to normal activities in two weeks.
“This new technology to treat our patients most in need with these complex aneurysms, showcases the ingenuity and innovation that is central to our mission in moving the field forward,” Vinay Badhwar, M.D., executive chair of the WVU Heart and Vascular Institute, said. “The teamwork of our heart and vascular surgeons epitomizes how we come together to solve critical problems for our patients and for our state.”
For more information on the WVU Heart and Vascular Institute, visit WVUMedicine.org/Heart.
