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Title: Early and midterm outcomes of endovascular aneurysm repair with an ultra-low-profile endograft from the Triveneto Incraft Registry.
Author: Zavatta M, Squizzato F, Balestriero G, Bonvini S, Perkmann R, Milite D, Veraldi GF, Antonello M, Triveneto Incraft Registry Collaborators.
Journal: J Vasc Surg; 2021 Jun; 73(6):1950-1957.e2. PubMed ID: 33248119.
Abstract:
OBJECTIVE: We evaluated the early and midterm outcomes of the Incraft (Cordis Corp, Bridgewater, NJ) ultra-low-profile endograft by analyzing data from the Triveneto Incraft Registry (TIR). METHODS: TIR is an independent multicenter cohort registry of 10 vascular surgery units in the Triveneto area (Northeast Italy). A prospective analysis of patients electively treated with Incraft from September 2014 to June 2019 was performed. The main outcomes were technical success, major 30-day complications, 30-day aneurysm-related death, freedom from reintervention, and mortality rate during follow-up and were analyzed using Kaplan-Meier curves. Univariable Cox regression was used to evaluate the associations between anatomic complexity factors and reintervention. RESULTS: During the study period, 209 patients were included in the registry. Their mean age was 76.9 ± 7.7 years and the Society for Vascular Surgery comorbidity score was 0.97 ± 0.52. Most patients (n = 181; 86.6%) had presented with at least one complex anatomic factor: aortic neck angle α <135° in 31 patients (14.8%), conic neck in 17 patients (8.2%), iliac tortuosity index τ >1.5 in 102 (48.8%), iliac artery calcification >50% in 106 (50.7%), and external iliac artery <6 mm in 45 (21.5%). The concurrent presence of two or more complex iliac anatomic factors was present in 67 patients (32.1%). The technical success rate was 99.5%, and the early major complication rate was 1.5% (one limb occlusion, one iliac branch stenosis, one type III endoleak [EL]). No 30-day mortality was recorded. The mean follow-up period was 18.5 ± 13.2 months. The overall mortality was 9.5% (n = 18), none related to the aneurysm. The freedom from reintervention rate was 92.1%. Of these patients, six (3.2%) had been treated for type II EL embolization, one (0.5%) for type IA EL, four (2.1%) for iliac branch occlusion, and one (0.5%) for flow-limiting external iliac artery dissection. None of the single anatomic factors analyzed were predictive of reintervention. However, the association of two or more complex iliac anatomic factors was predictive of related reintervention (hazard ratio, 7.25; P = .014). The crude reintervention rate in this complex subgroup of patients was low (4 of 67; 6%). CONCLUSIONS: Data from the TIR have demonstrated excellent early and midterm outcomes of endovascular aneurysm repair using the Incraft stent graft in patients with complex anatomy. The concurrent presence of two or more complex iliac anatomic factors still represent an issue for endovascular aneurysm repair success. However, the technical characteristics of this device resulted in low intervention rates, even for patients with these challenging issues.

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