Long-Term Outcomes of Endovascular Repair Within and Outside the Instructions for Use in Korean Patients With Abdominal Aortic Aneurysm

Joonpyo Lee; Pyung Chun Oh; Albert Youngwoo Jang; Chul-Min Ahn; Donghoon Choi; Young-Guk Ko; Woong Chol Kang

doi:10.1177/15266028241232915

Long-Term Outcomes of Endovascular Repair Within and Outside the Instructions for Use in Korean Patients With Abdominal Aortic Aneurysm

J Endovasc Ther. 2024 Feb 27:15266028241232915. doi: 10.1177/15266028241232915. Online ahead of print.

Authors

Joonpyo Lee¹, Pyung Chun Oh¹, Albert Youngwoo Jang¹, Chul-Min Ahn², Donghoon Choi², Young-Guk Ko², Woong Chol Kang¹

Affiliations

¹ Department of Cardiology, Gil Medical Center, Gachon University College of Medicine, Incheon, Republic of Korea.
² Division of Cardiology, Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.

PMID: 38414229
DOI: 10.1177/15266028241232915

Abstract

Objective: Endovascular aneurysm repair (EVAR) has been used worldwide to treat abdominal aortic aneurysms (AAAs). Outcomes after EVAR within and outside the instruction for use (IFU) remain controversial. We analyzed long-term outcomes of EVAR within-the-IFU compared with that outside-the-IFU and baseline clinical/anatomical characteristics that influence outcomes of EVAR.

Methods: The study included 546 patients who underwent EVAR for infrarenal AAA from 1997 to 2021 at 2 Korean medical centers. The primary endpoint was graft-related adverse events (GRAEs), including type 1 or 3 endoleak, reintervention (included open conversion), aneurysm sac enlargement, aneurysm-related mortality (ARM), rupture, stent-graft migration, and stent thrombotic occlusion.

Results: The patients who underwent EVAR outside the IFU were 287 (52.6%). A neck angle of >60° was most common outside the IFU criteria (n=146, 50.9%). This study revealed that patients outside the IFU had a higher rate of GRAEs compared with patients within the IFU (hazard ratio [HR]: 1.879; 95% confidence interval [CI]: 1.045-2.386). A neck angle of >60° was a significant risk factor for GRAEs (adjusted HR: 2.229; 95% CI: 1.418-3.503), type 1 or 3 endoleak (adjusted HR: 2.640; 95% CI: 1.343-5.189), and reintervention (adjusted HR: 1.891; 95% CI: 1.055-3.388).

Conclusions: Our study revealed EVAR with outside the IFU was associated with increased GRAEs, mainly attributed to endoleak and ARM, compared with EVAR with within the IFU. In addition, severe neck angulation was an independent risk factor for GRAEs, type 1 or 3 endoleak, and reintervention.

Clinical impact: Our study revealed endovascular aneurysm repair (EVAR) with outside-the-instruction for use (IFU) was associated with increased graft-related adverse events (GRAEs) compared with EVAR with within-the-IFU. In the low-risk population, the incidence of GRAEs and Aneurysm related mortality were higher in the outside-the-IFU group rather than within-the-IFU group. In addition, severe neck angulation was an independent risk factor for GRAEs, type 1 or 3 endoleak and reintervention.

Keywords: abdominal aortic aneurysm; aneurysm neck; endoleak; endovascular aneurysm repair; reintervention.