Language
English
Publication Date
11-10-2025
Journal
Journal of Endovascular Therapy
DOI
10.1177/15266028251388749
PMID
41211656
Abstract
Purpose: Fenestrated stent-grafts with proximal bare-metal fixation stent (BMFS) may provide better rotational movement to facilitate vessel catheterization, but novel designs with covered fixation stents (CFSs) have been increasingly utilized with lower profile fabric. This study aimed to evaluate procedural metrics and outcomes of fenestrated endovascular repair (FEVAR) using BMFS and CFS devices.
Methods: Clinical data of 502 consecutive patients enrolled in a prospective, non-randomized investigational device exemption (IDE) study were reviewed. Patients with 4-vessel fenestrated stent-grafts with BMFS or CFS for treatment of complex abdominal aortic aneurysms (CAAAs) and Extent IV thoracoabdominal aortic aneurysms (TAAAs) were included. Patients with Extent I-III TAAAs and stent-grafts designed with < 4 fenestrations or scallops were excluded. Endpoints were technical success, radiation exposure, major adverse events (MAEs), patient survival, freedom from secondary interventions, and target artery instability (TAI).
Results: There were 147 patients (29%; 85% male, median 75 years old) treated by FEVAR using 4-vessel fenestrated stent-grafts with BMFS in 79 patients or CFS in 68 patients. Patients treated with BMFS designs had significantly (p< 0.05) higher prevalence of cigarette smoking and peripheral artery disease and less often had Extent IV TAAAs. Use of BMFS designs decreased from 88% (64/73) to 20% (15/74) after 2018 (p< 0.001). Technical success was similar in patients treated with or without BMFS designs (99% vs 100%, p=0.47), but total operating time and cumulative air karma were significantly lower (p< 0.05) in patients with CFS designs. Overall 30-day mortality was 1%, with no difference in mortality and MAEs among patients treated with or without BMFS (1% vs 1%, p=1.0 and 15% vs 12%, p=0.59), respectively. Patient survival at 1 and 3 years was 95%±2%, and 85%±4% for all patients with no difference between groups (p=0.51). Freedom from secondary interventions was 88%±3.6% for patients with BMFS and 86%±4.6% for those with CFS at 1 year (p=0.71), with also no difference at 3 years (p=0.55).
Conclusion: FEVAR for CAAAs and Extent IV TAAAs was performed with high technical success, low mortality, and MAEs, independent of the use of BMFS. There is no difference in patient survival and freedom from secondary interventions in patients treated with or without BMFS.Clinical ImpactOne hundred forty-seven patients were treated with bare-metal fixation-stent (79) or covered fixation stents (68). Technical success was similar (p=.47). Overall 30-day mortality was 1%, with no difference in major adverse events (MAEs; p=.59). At 1- and 3-year, there was no difference in patient survival (p=.51), freedom from secondary intervention (p=.71). In conclusion, FEVAR for CAAAs and Extent IV TAAAs was performed with high technical success, low mortality and MAEs, independent of the use of bare-metal fixation stent.
Keywords
bare-metal stent, branched endovascular aortic repair, complex abdominal aortic aneurysm, endovascular aortic aneurysm repair, fenestrated endovascular aortic repair, fenestrated-branched endovascular aortic repair, thoracoabdominal aortic aneurysm
Published Open-Access
yes
Recommended Citation
Lima, Guilherme B; Huang, Ying; Ruiter Kanamori, Lucas; et al., "Comparison of Bare Metal vs Covered Proximal Stent Fixation During Fenestrated Endovascular Aortic Repair of Complex Abdominal Aortic Aneurysms" (2025). Faculty, Staff and Students Publications. 6169.
https://digitalcommons.library.tmc.edu/baylor_docs/6169