Comparison Of Fenestrated Stent-graft Designs Using Proximal Bare-metal Or Non-bare Metal Fixation
Guilherme B. Lima, MD, PhD1, Ying Huang, MD, PhD2, Emanuel R. Tenorio, MD, PhD2, Andrea Vacirca, MD, PhD2, Aidin Baghbani-Oskouei, MD, PhD2, Bernardo C. Mendes, MD1, Aleem Mirza, MD2, Naveed Saqib, MD2, Gustavo S. Oderich, MD2.
1Mayo Clinic, Rochester, MN, USA, 2McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, TX, USA.
Purpose: Fenestrated stent-grafts with proximal bare-metal fixation stent (BMFS) may provide better rotational movement to facilitate vessel catheterization, but novel designs without BMFS have a lower profile. The aim of this study was to evaluate procedural metrics and outcomes of fenestrated endovascular repair (FEVAR) using devices with and without BMFS. Methods: The clinical data of 502 consecutive patients enrolled in a prospective, non-randomized investigational device exemption (IDE) study was reviewed. Patients with 4-vessel fenestrated stent-grafts with or without BMFS indicated for the treatment of complex abdominal aortic aneurysms (CAAAs) and Extent IV thoracoabdominal aortic aneurysms (TAAA) were included in the analysis. 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, and 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 (n=79) or without BMFS (n=68). Patients treated with BMFS designs had significantly (P<.05) more cigarette smoking and peripheral artery disease, and less Extent IV TAAAs. The use of BMFS designs decreased from 88% (64/73) to 20% (15/74) after 2018 (P<.001). Technical success was similar in patients treated with or without BMFS designs (99% vs. 100%, P=.47), but total operating time and cumulative air karma were significantly lower (P<.05) in patients without BMFS designs (Table). 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=.59), respectively. At 1-year, there was no difference in patient survival (97±1.8 vs 93±3.7%, P=.51), freedom from secondary intervention (88±3.6 vs 86±4.6%, P=.71), and TAI (99±0.9 vs 94±2.0%, P=.07) between patients treated with or without BMFS. 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.
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