First Patient Treated in TRANSFIX Study for Blunt Thoracic Aortic Injury at Grady Memorial Hospital

February 2013

Dr. Ravi Rajani, director of the vascular and endovascular surgery program at Grady Memorial Hospital, has enrolled and treated the first patient in the TRANSFIX study for blunt thoracic aortic injury (BTAI). Dr. Rajani and his Grady team recently began participating in the FDA-approved, prospective, multicenter, nonrandomized study, which is assessing the safety and effectiveness of the Zenith® TX2® Low Profile Endovascular Graft in the treatment of patients with BTAI of the descending thoracic aorta. The study is sponsored by Cook Medical.

"The study is expected to enroll up to 50 participants in up to 30 institutions in the U.S., with approximately ten patients participating from Grady," says Dr. Rajani. "I'm honored to have implanted the first device nationally for this important trial."

After head injury, BTAI is the second most common cause of death in trauma patients and is often caused by motor vehicle accidents and falls from great heights. While open surgical repair had been the standard of care for patients with BTAI, it has been associated with high mortality and morbidity rates. In recent years, endovascular repair has emerged as a treatment option and has been reported to exhibit lower rates of mortality and morbidity compared to open repair in several meta-analyses. However, challenges also exist with currently available thoracic endovascular grafts in the treatment of patients with BTAI. On average these patients are much younger than those treated for other thoracic aortic diseases such as aneurysms, and require smaller diameter endovascular grafts with better arch conformability.

"The TX2 low-profile device may allow surgeons to treat patients with difficult or tortuous arterial access who might otherwise have been ineligible for endovascular aortic repair," says Dr. Rajani. "Trauma patients often include women and smaller-bodied adults with more narrow and angulated arteries that can impede the accurate positioning of an endovascular graft using currently available, larger-diameter delivery systems."