Multicenter Mid-term Results After Endovascular Aortic Aneurysm Repair with the Incraft® Device.

OBJECTIVES

Durability after endovascular aortic aneurysm repair (EVAR) is considered an ongoing topic of investigation and was always a point of concern with smaller profile devices. Recently released five-year clinical trial results using the Incraft® ultralow profile device are encouraging. However, additional real-life experience will need to assist these initial findings. Herein, we investigated the outcomes after EVAR, in real world practice using the Incraft® endograft (EG).

MATERIAL AND

METHODS

Seventy-seven patients with infrarenal abdominal aortic aneurysms (AAA) ≥50 mm in diameter treated with the Incraft® device in three vascular centers were enrolled from November 2015 to July 2018. Follow-up was completed in August 2020. Selection of EVAR using the Incraft® device was individualized according to aorto-iliac morphologic features, comorbidities, history of previous abdominal surgery and preference of the patient. At the early phase of the study, we specifically opted for preferential use of this low profile EG mainly in cases of small and tortuous iliac vessels (more challenging access routes). At later stages, it was used according to surgeon preference and not specifically in complex anatomies (real-world conditions). End-points included technical success, perioperative complications, 30-day survival, endoleg patency, presence of endoleaks, sac enlargement >5 mm and clinical success.

RESULTS

The primary technical success rate was 97.4% before the addition of an aortic cuff and iliac extension for a type Ia and type Ib endoleak respectively, and the repair of a maldeployment iliac component (primary-assisted and secondary technical success, 100%). Intraoperative small type II endoleaks (visible in final angiogram) were noted in 19 patients (24.7%). There were no intraoperative deaths from AAA rupture, primary conversions or conversions to aortounilateral grafts. Two complications occurred, necessitating hybrid techniques for repair (replaced of a dislodged endoleg and distal external iliac artery hemostasis). No deaths were reported within 30 days. Occlusion of an endoleg, was observed in two patients, 6 and 14 months respectively after implantation (2.6%), and were treated by femoral-femoral PTFE bypass after unsuccessful endovascular recanalization. The latter required open conversion, 3 mo later, to repair compromised flow to the inflow iliac axis. Three patients (3.9%) experienced sac enlargement >5 mm in diameter compared with the 1-month CT scan. All of these had type II endoleaks and two received embolization procedures. Eleven patients died from causes unrelated to AAA repair. Clinical success was 97.3%, 92.8% and 89.4% through 1, 2 and 3 years respectively.

CONCLUSIONS

EVAR with the Incraft® device might be considered a reliable option in real-world conditions and not specifically only in complex iliac anatomies.