EARLY AND MID-TERM OUTCOMES OF EVAR WITH AN ULTRA LOW-PROFILE ENDOGRAFT FROM THE TRIVENETO INCRAFT REGISTRY

OBJECTIVE To evaluate early and mid-term outcomes of Incraft (Cordis Corporation, Bridgewater, NJ) ultra-low-profile endograft analysing data from the Triveneto Incraft Registry (TIR). METHODS TIR is an independent multicentre cohort registry of 10 Vascular Surgery Units of Triveneto area (North-East Italy). A prospective analysis of patients electively treated with Incraft between September 2014 and June 2019 was carried out. Main outcomes were technical success, major 30-day complications and aneurysm-related deaths; freedom from reinterventions and mortality rate during follow-up were analysed with Kaplan-Meier curves. Univariable Cox regression was used to evaluate association between anatomic complexity factors and reinterventions. RESULTS During the study period, 209 patients were included in the registry. Mean age was 76.9 ± 7.7 years; SVS comorbidity score was 0.97 ± 0.52. The majority of patients (n=181; 86.6%) presented with at least one complex anatomic factor: aortic neck angle α 1.5 in 48.8% (n=102), iliac artery calcifications > 50% in 50.7% (n=106), external iliac artery <6 mm in 21.5% (n=45). Contemporary presence of ≥2 complex iliac anatomic factors was present in 32.1% of cases (n=67).Technical success was 99.5%; early major complications rate was 1.5% (1 limb occlusion, 1 iliac branch stenosis, 1 type III endoleak); no 30-days mortality was recorded. Mean follow-up was 18.5 months ± 13.2; overall mortality was 9.5% (n=18), all non aneurysm-related. Freedom from reinterventions was 92.1%; of these, 6 patients (3.2%) were treated for type II endoleak embolization, 1 (0.5%) for type IA endoleak, 4 (2.1%) for iliac branch occlusion and 1 (0.5%) for flow-limiting external iliac artery dissection. None of the single anatomic factors analysed but the association of ≥2 complex iliac anatomic factors came out to be predictor of related reinterventions (HR 7.25, .P .014); noteworthy the crude reintervention rate in this complex subgroup of patients was low (n=4/67; 6%). CONCLUSIONS Data from TIR demonstrated excellent early and mid-term outcomes of EVAR using Incraft stent graft also in cases with complex anatomy. The contemporary presence of ≥2 complex iliac anatomic factors still represent an issue for EVAR success; however the technical characteristics of this device provides low intervention rates even in these challenging cases.