Early North American experience with the INCRAFT device.

Background: Several low-profile grafts have been created for use in endovascular aneurysm repair in patients with small or difficult to access vessels. Our objective was to evaluate the outcomes of patients undergoing endovascular aneurysm repair with the INCRAFT device in a real-world North American setting.

Methods: Consecutive patients undergoing INCRAFT implantation between March 2015 and December 2016 at two McGill University teaching hospitals were enrolled in a prospectively maintained registry. Clinical characteristic and perioperative outcomes were entered into the registry. Two authors performed anatomic measurements from preoperative and postoperative computed tomography angiograms and intraoperative angiograms independently. In cases of disagreement a consensus was reached.

Results: We included 61 patients with a median follow-up of 363 days (mean, 344 ± 244 days). Minimum left and right access vessel sizes were 7.5 ± 1.7 mm and 7.4 ± 1.5 mm, respectively. More than 90% of grafts were implanted for aneurysm size or growth. Vessel access was percutaneous in 95% of cases. We had a mean length of stay of 0.88 ± 1.8 days with 57.3% of patients discharged the same day. There were 14 procedural type II endoleaks, 10 new type II leaks that were discovered during follow-up, and 11 that resolved for 77% of patients remaining endoleak free during follow-up. There were no 30-day mortalities. Three cancer-related deaths occurred during follow-up. Early complications included one access site repair for bleeding, one access site repair for dissection, and two aortounilateral conversions with femoral-femoral bypass owing to inadvertent ipsilateral gate cannulation. Long-term complications included one graft limb thrombosis, one intervention for type II endoleak with sac expansion that subsequently became infected and was explanted, and one intervention for a type III endoleak for an intervention. During follow-up, 95% of patients remained reintervention free.

Conclusions: Use of the INCRAFT device in a real-world North American setting is relatively safe and effective, and is associated with a low rate of perioperative complications. However, we experienced early issues with inadvertent cannulation and deployment of the contralateral limb in the ipsilateral gate. Therefore, we recommend deploying the entire ipsilateral limb before cannulating the contralateral limb. Data with additional follow-up are needed to assess the long-term effectiveness of the INCRAFT device.