January 28, 2016
ROUND ROCK, Texas—Heart Hospital of Austin at St. David’s Round Rock, in collaboration with members of Cardiothoracic and Vascular Surgeons, P.A. (CTVS), has been chosen as a site for a new clinical study to compare and evaluate current stent graft devices for the repair of abdominal aortic aneurysms, or AAA. As part of the LEOPARD study—which stands for Looking at EVAR Outcomes by Primary Analysis of Randomized Data—Heart Hospital of Austin at St. David’s Round Rock recently performed its first percutaneous endovascular aortic repair (EVAR) in the facility’s newly opened Hybrid Operating Room (OR)—the first Hybrid OR in Williamson County. The facility is the first in the Greater Austin area to enroll patients and perform this procedure as part of this study. Bradley Boone, M.D., medical director of vascular surgery at Heart Hospital of Austin at St. David’s Round Rock, performed the procedure.
Approximately 4.5 million people are living with AAA, and more than 500,000 cases are diagnosed each year. AAA is a swelling that occurs in part of the aorta—the main vessel that carries blood from the heart to the rest of the body—and is the result of a progressive weakening in the arterial wall. Over time, the aneurysm will grow larger, leading to a potentially fatal rupture. Many patients benefit from minimally invasive, EVAR procedures using special stents that create a new pathway for blood flow away from the aneurysm.
Dr. Boone and his partner, Jeffrey Apple, M.D., both members of CTVS, recently began treating patients enrolled in the study using a percutaneous approach to the endovascular repair, which reduces operation time, blood loss, wound complications and length of hospital stay. Through this approach, small skin incisions (less than one centimeter in length) are made in each groin to reach the femoral arteries to facilitate endograft repair of an aortic aneurysm, and special artery closure devices are used to complete the surgery. The endograft repairs the aneurysm by relining it on the inside of the aorta, without the need for open surgery through the abdomen or chest. This repair is done to prevent future rupture of the aneurysm, which is a life-threatening situation. Due to the minimally invasive nature of the procedure, most patients may be able to return home the following day. In comparison, open surgical repair frequently requires up to a one-week hospital stay.
“This innovative technology is a significant advancement for patients suffering from AAA, as it offers a less-invasive alternative to traditional open surgery with a faster recovery time and shorter hospital stay,” Dr. Boone said. “The addition of this research study and technology underscores our commitment to bringing the most effective and innovative cardiovascular care possible to our patients in Williamson County.”
All devices used in the study have been approved by the FDA as safe and effective for the treatment of AAA. Patients who participate in the study are randomly chosen to receive one of the following devices: AFX® Endovascular AAA System from Endologix, Inc., Endurant® AAA Stent Graft System from Medtronic, Excluder® AAA Endoprosthesis from Gore and the Zenith® Fenestrated AAA Endovascular Graft from Cook.
The LEOPARD study is sponsored by Endologix, Inc.