Endurant Stent Graft for AAA Safe, Effective at 2 Years

Two-year outcomes with a bifurcated stent graft show the device to be safe and effective for the treatment of abdominal aortic aneurysm (AAA), according to a study presented at TCT 2012.

Brij Maini, MD, of PinnacleHealth Cardiovascular Institute in Wormleysburg, Pa., led the prospective, single-arm study of 150 patients with AAA who received the Endurant Stent Graft System (Medtronic CardioVascular). Patients were treated at 26 sites in the United States between April 2008 and May 2009. One-year results were presented previously.

The procedural success rate was 99.3%, with the lone failure occurring due to an inability to cannulate the contralateral gate. The average hospital stay was 2.1 days. Mean estimated blood loss was 185 mL, and 1 patient required a blood transfusion.

At 2 years, there were no reported endoleaks or deaths. In addition there were no ruptures, migrations or conversions to open repair. However, there were 2 (1.5%) stent graft occlusions.

Overall, aneurysm sac diameter decreased more than 5 mm in 60.8% of patients. Sac diameter remained stable in 36.9% and increased more than 5 mm in 2.3%.

Two-year data mirror first-year results

“The Endurant stent endograft continues to perform as a safe, durable and effective device for the treatment of AAA,” Maini told TCT Daily. He added that the 2-year results were not surprising in that they mirrored the success seen at 1-year follow-up.

The latest generation of endografts for AAA has improved on previous treatment options with regard to “accurate controlled deployment, active fixation, and flexible limbs to treat challenging anatomy,” Maini said. “Patient selection and preplanning is important to reduce complications such as external compression of the limbs.”

Maini observed that data from the international ENGAGE registry show similar short-term results, adding that “Additional data are needed to address long-term outcomes.”

Study details

The trial included primarily male patients (91.3%) with a mean age of 73.1 years. All patients had an AAA diameter of more than 5 cm, proximal neck length of at least 10 mm, bilateral iliac fixation length of at least 15 mm, and a neck angulation of no more than 60°.

Disclosures:

·         Dr. Maini reports serving on the speakers bureau for Medtronic.