Early Experience with Patient-Specific Unibody Bifurcated Fenestrated-Branched Devices for Complex Endovascular Aortic Aneurysm Repair
Mira T Tanenbaum1, Andres V Figueroa1, Lucas R Kanamori2, Marilisa Soto Gonzalez1, Titia Sulzer2, Thomas Mesnard2, Ying Huang2, Mirza S Baig1, Gustavo S Oderich2, Carlos H Timaran1
1University of Texas Southwestern Medical Center, Dallas, TX;2The University of Texas Health Science Center at Houston, Houston, TX
INTRODUCTION: A short distance between the lowest visceral/renal artery and the aortic bifurcation represents a technical challenge for fenestrated-branched endovascular aortic aneurysm repair (FBEVAR), particularly after previous infrarenal repair. Traditionally, inverted limb bifurcated devices have been used in addition to fenestrated-branched (FB) endografts, but short overlap, difficult cannulation and potential crushing of bridging stents are limitations for their use. This study reviews the early experience of patient-specific unibody bifurcated FB-devices for complex abdominal aortic aneurysms.
METHODS: Consecutive FBEVAR procedures over a 34-month period with unibody bifurcated FB-devices as part of physician-sponsored investigational device exemption studies at two institutions were reviewed. Unibody bifurcated FB-designs included fenestrated bifurcated (Fig 1), fenestrated inverted limbs or bifurcated FB-devices. Fenestrations/branches were selectively preloaded for access from above and/or below. End points were technical success, survival, frequency of type I or III endoleaks, limb occlusion, and secondary interventions.
RESULTS: Among 168 patients undergoing FBEVAR during the study period. 33 (29.6%) patients (78.7% male; mean age 77) received unibody bifurcated FB-devices. Fenestrated bifurcated, fenestrated inverted limb, and bifurcated FB-devices were used in 24 (72.7%), 2 (6.06%), and 7 (21.2%) patients, respectively. The median maximum aneurysm diameter was 61 mm (55-69). Prior endovascular aneurysm repair was reported by 29 (87.9 %) patients, of which 2 (6.06%) had suprarenal stents. A short distance between the lowest renal artery and aortic bifurcation was demonstrated in 30 (90.9%) patients, with mean distance of 49.1±4.2 mm. A total of 128 fenestrations were planned, 22 (17.2%) were preloaded with a guidewire, and 5 (3.9%) with catheters. Preloaded devices were used in 23 patients (69.7%). The median operative time was 238 min (226-300), with a median fluoroscopy time of 65.5 min (56.0-77.7) and a median dose area product of 147 mGy cm2 (105-194) (Table I). Exclusive femoral access was used in 14 (42.4%) procedures. Technical success was 100%. Target vessel primary patency was 100% at median follow-up time of 11.7 months (3.5-18.6). Two (6.06%) patients required reintervention for iliac occlusion; one patient required stenting and other a femoral-femoral bypass. Two (6.06%) patients died from causes unrelated to their aortic aneurysm or repair. During follow-up, 11 (33.3 %) type II endoleaks and one (3.03%) type Ib endoleak were detected; the latter was treated with leg extension. No type I or III endoleaks occurred. CONCLUSIONS: FBEVAR using unibody bifurcated FB-devices is a simple, safe, and cost-effective alternative for the treatment of patients with short distances between the renal arteries and the aortic bifurcation. Further studies are required to assess benefits and durability of unibody bifurcated FB-devices.
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