Early North American experience with the INCRAFT device

Area of Science:

• Vascular Surgery
• Endovascular Interventions
• Medical Devices

Background:

• Low-profile grafts are crucial for endovascular aneurysm repair (EVAR) in patients with small or difficult-to-access vessels.
• The INCRAFT device is a low-profile graft designed for such challenging anatomies.
• Evaluating its real-world performance in North America is essential.

Purpose of the Study:

• To assess the safety and effectiveness of the INCRAFT device for EVAR in a North American patient cohort.
• To identify perioperative and long-term outcomes associated with INCRAFT implantation.
• To provide procedural recommendations based on observed complications.

Main Methods:

• A prospective registry of 61 patients undergoing INCRAFT implantation between March 2015 and December 2016 was analyzed.
• Clinical characteristics and perioperative outcomes were recorded.
• Anatomic measurements and complication assessments were performed using computed tomography angiograms and intraoperative angiograms.

Main Results:

• The study included 61 patients with a median follow-up of 363 days; minimum access vessel sizes were approximately 7.5 mm.
• High rates of same-day discharge (57.3%) and reintervention-free survival (95%) were observed.
• Procedural complications included type II endoleaks (77% endoleak-free rate), inadvertent gate cannulation, and one graft limb thrombosis.

Conclusions:

• The INCRAFT device is safe and effective for EVAR in a real-world North American setting, with a low rate of perioperative complications.
• Recommendations include deploying the entire ipsilateral limb before contralateral limb cannulation to prevent early issues.
• Further long-term data are required to fully establish the device's sustained effectiveness.