Thoracic Stent Graft Shows Promise for High-Risk Patients

By Janice Rosenberg

CHICAGO -- A study of a vascular thoracic stent graft system for patients with thoracic aortic disease demonstrated highly favorable preliminary outcomes in a high-risk, nonsurgical population of patients historically managed with "watchful waiting," according to Ronald M. Fairman, M.D., at the Vascular Annual Meeting.

Dr. Fairman

The phase I prospective, nonrandomized, multicenter, observational trial was designed to evaluate the safety and efficacy of Medtronic Vascular Talent Thoracic Stent Graft system for patients with thoracic aortic disease who were high risk for open surgery (Society for Vascular Surgery score 3) and/or nonsurgical candidates not associated with SVS scoring. The study was sponsored by Medtronic Inc.

According to Dr. Fairman, chief of vascular surgery at the Hospital of the University of Pennsylvania, Philadelphia, this vascular stent graft system expands the treatment options for patients who face life-threatening conditions of the thoracic aorta, such as aneurysms, dissections, and trauma.

The stent graft is introduced through a small opening in the femoral artery and is advanced under fluoroscopic guidance to the site of the thoracic aortic aneurysm or dissection, where it is then deployed. Of 150 patients treated, 59% were male. The mean age was 75 years.

A variety of thoracic aortic pathologies was corrected. Mean maximum aneurysm diameter at treatment was 64 mm and mean aneurysm length was 108 mm. Because of device sizing constraints, 35% of patients treated in the trial had no other thoracic endograft options. Procedural success was 98%.

The primary safety end point was all-cause mortality, and the primary efficacy end point was the proportion of patients with successful aneurysm treatment. The secondary 30-day end points evaluated the percentage of patients who experienced successful deployment and delivery of the stent graft; death; paraplegia or paraparesis; secondary procedures resulting from endoleak; and one or more major adverse clinical events. End points beyond 30 days included secondary procedures, open conversion, device migration, loss of patency, rupture, endoleaks, and one or more major adverse clinical events.The 30-day all-cause mortality was 7.3% (10 patients). At a median follow-up of 8 months, mortality was approximately 25% (35 patients). The paraplegia rate was less than 1% at 1 month. A total of 14% of the procedures required a conduit for access. The 1-month endoleak rate was 9% and the 8-month rate was 6%. The 30-day stroke incidence was 7.3% (10 patients). After 8 months, there were no ruptures, late conversions to open surgery, device migration, or loss of graft patency. The second procedure rate at 8 months was 7%. The average length of hospital stay was 9 days.

"Long-term follow-up will be required to demonstrate the stent system's durability and its efficacy in preventing aneurysm-related mortality." Dr. Fairman stated.

Dr. Fairman disclosed a relationship with Medtronic and several other device companies.