Endovascular Aneurysmal Repair With the INCRAFT Stent Graft System for Abdominal Aortic Aneurysms: A Combined Korean Multi-Center and Single-Center Registry Analysis

Abstract

Introduction:

The INCRAFT™ Stent Graft System is a trimodular, bifurcated, ultra-low-profile endovascular device designed for endovascular aneurysm repair in patients with abdominal aortic aneurysm (AAA).

Materials and Methods:

The study population comprised a prospective multi-center cohort (n = 85) and a single-center retrospective cohort (n = 61) of Korean AAA patients treated with INCRAFT. Postprocedural follow-up involved computed tomography (CT) imaging at 1 and 12 months post-procedure to monitor aneurysm dimensions and detect any endoleak.

Results:

The mean age of participants was 72.0 ± 7.1 years, with the majority being male (91.8%). The average maximal aortic sac diameter was 54.7 ± 8.6 mm. Technical success was achieved in 82.9%, primarily due to the relatively high incidence of type I endoleak (17.1%) observed on immediate angiographical assessment. The rate of 30-day major vascular complication was 0.7%. For the hemostasis of bilateral femoral access arteries, 57.5% required only 2 ProGlides. At the 30-day follow-up CT, the prevalence of endoleaks was 30.4% including type I (1.4%), type II (26.1%), and undermined type (2.8%). At the 12-month follow-up, the major adverse event rate was 6.2% attributed to noncardiovascular mortality. Aneurysm-related events included 3 cases (2.1%) of re-interventions due to graft occlusion (n = 2) and type II endoleak with sac expansion (n = 1). Aneurysm shrinkage and enlargement occurred in 37.8% and 3.4% of patients, respectively. At the 12-month follow-up, type II endoleak was the most frequent type, with a prevalence of 22.7%. Type I endoleak and undetermined type were found in 0.8% and 17.8% of cases, respectively, with no instances of type III endoleak.

Conclusion:

INCRAFT demonstrated favorable early and 12-month clinical efficacy and safety profiles for treating Korean patients with AAA.

Trial Registration:

K-INCRAFT; www.clinicaltrials.gov Identifier: NCT03952780

Clinical Impact

Endovascular aneurysmal repair (EVAR) is effective treatment option for unruptured abdominal aortic aneurysm (AAA) in patients with high perioperative risk and suitable anatomy. The INCRAFT stent graft system is an ultra-low-profile endovascular graft designed for EVAR, and its efficacy and safety have been demonstrated in multi-center European and U.S. trials. Our study found that the INCRAFT stent graft system has favorable early and 12-month clinical efficacy and safety profiles in treating AAAs within Korean population, with a 30-day major vascular complications rate of 0.7% and no cases of aneurysmal-related mortality or rupture.

Keywords

abdominal aortic aneurysm endovascular aneurysm repair stent graft clinical outcome endoleak

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