Treatment of abdominal aortic aneurysm with a new type of polymer-filled low profile device.

PURPOSE OF THE STUDY: To evaluate the mid-term safety and effectiveness of a novel stent graft for treatment of abdominal aortic aneurysm (AAA).

METHODS

Thirty-three patients with AAA (20 males and 13 females; mean age: 71.3 y) were treated with the Ovation™ Abdominal Stent Graft System (TriVascular, Inc., Santa Rosa, CA, USA). Indications for endovascular aneurysm repair: AAA ≥ 5.5 cm, neck ≥ 7 mm, angulation ≤ 60° and with an inner wall diameter of no less than 16 mm and no greater than 30 mm; the presence of neck calcification and thrombosis is not much of a problem in this device because aortic seal is achieved with 2 polymer-filled sealing rings and the fixation by means of a suprarenal stent with 8 pairs of anchors. Patients were followed through discharge and returned for follow-up visits. The follow-up protocol included a CT-A exam at 1 and 12 months after the intervention; the mid-term follow up was performed at 3 and 6 months with contrast-enhanced ultrasound (CEUS). Mean follow-up duration was 18.6 months (range: 3-25 months).

MAIN FINDINGS: Technical success was 100%. Mean implantation procedure time was 31.1 minutes, and median hospital stay was 4.6 days. None of the patients required conversion to open surgery, and no aneurysm enlargement, rupture, fracture, or migration were observed. No type I, III or IV endoleaks were observed. Hospitalization death rate was 0%. Death rate at 30 days was 0%. No major complications were observed.

CONCLUSIONS

The first results from this 3-center study with the Ovation stent graft are promising with high technical success and excellent safety and effectiveness.