Reintervention Rate after Treatment with the INCRAFT AAA Ultra–Low-Profile Stent Graft System

BackgroundThe INCRAFT stent graft system is an ultra–low-profile endograft for the exclusion of infrarenal aortic aneurysms. In the market approval studies, an increased rate of device-related complications was observed and the endograft was approved with mandated postmarketing investigations. Our aim was to analyze mid-term outcomes of a real-world patient cohort treated with the INCRAFT endograft.MethodsConsecutive patients treated with the INCRAFT endograft between February 2015 and December 2022 at a single institution were included. In accordance with the Society for Vascular Surgery reporting standards, safety endpoints were reported and outcome endpoints included reinterventions, technical success, aortic-related and overall-mortality, endoleak, stent fracture, and endograft migration >5 mm.ResultsEighty patients (85% male) with a mean age of 76 ± 7 years were included. Fifty-two patients (65%) were treated within the endograft's instruction for use. Mean aortic diameter was 59 ± 10 mm and 91% of the procedures were performed percutaneously. Mean follow-up (FU) was 37 ± 25 months and there was no aortic- or procedure-related mortality. Reinterventions occurred in 25 patients (31%) with a freedom from reintervention at 1, 3, and 5 years of 84%, 66%, and 55%. The most frequent reinterventions were limb graft stenting (23%) and type II endoleak embolization (14%). Limb occlusion rate was 9% and in 3 patients (4%) distal endograft migrations >5 mm occurred. Persisting type II endoleaks were observed in 29% and aneurysm diameter was stable in 41% and had shrunk in 38%. Three type III endoleaks (4%) developed during FU and 4 open conversions (5%) were necessary. No known risk factors, including treatment outside instruction for use, were predictive for reinterventions.ConclusionsTreatment of infrarenal aortic aneurysms with the INCRAFT stent graft system was safe and successful. Nevertheless, a substantial rate of reinterventions was necessary during FU to maintain endograft patency and prevent aneurysm growth. The INCRAFT stent graft system is an ultra–low-profile endograft for the exclusion of infrarenal aortic aneurysms. In the market approval studies, an increased rate of device-related complications was observed and the endograft was approved with mandated postmarketing investigations. Our aim was to analyze mid-term outcomes of a real-world patient cohort treated with the INCRAFT endograft. Consecutive patients treated with the INCRAFT endograft between February 2015 and December 2022 at a single institution were included. In accordance with the Society for Vascular Surgery reporting standards, safety endpoints were reported and outcome endpoints included reinterventions, technical success, aortic-related and overall-mortality, endoleak, stent fracture, and endograft migration >5 mm. Eighty patients (85% male) with a mean age of 76 ± 7 years were included. Fifty-two patients (65%) were treated within the endograft's instruction for use. Mean aortic diameter was 59 ± 10 mm and 91% of the procedures were performed percutaneously. Mean follow-up (FU) was 37 ± 25 months and there was no aortic- or procedure-related mortality. Reinterventions occurred in 25 patients (31%) with a freedom from reintervention at 1, 3, and 5 years of 84%, 66%, and 55%. The most frequent reinterventions were limb graft stenting (23%) and type II endoleak embolization (14%). Limb occlusion rate was 9% and in 3 patients (4%) distal endograft migrations >5 mm occurred. Persisting type II endoleaks were observed in 29% and aneurysm diameter was stable in 41% and had shrunk in 38%. Three type III endoleaks (4%) developed during FU and 4 open conversions (5%) were necessary. No known risk factors, including treatment outside instruction for use, were predictive for reinterventions. Treatment of infrarenal aortic aneurysms with the INCRAFT stent graft system was safe and successful. Nevertheless, a substantial rate of reinterventions was necessary during FU to maintain endograft patency and prevent aneurysm growth.