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Initial Pilot Study Outcomes of the Ventana Fenestrated Stent Graft
System for Endovascular Repair of Juxtarenal and Pararenal Aortic Aneurysms

Daniel Clair, M.D.1, Andrew Holden, M.D.2, Andrew Hill, M.D.2, Renato Mertens, M.D.3, Leopoldo Marine, M.D.4.
1Cleveland Clinic, Cleveland, OH, USA, 2Auckland City Hospital, Auckland, New Zealand, 3Catholic University Hospital, Santiago, Chile, 4Catholic University, Santiago, Chile.

Objectives: Customized endovascular stent grafts have been investigated as an alternative to open surgery for repair of more complex juxtarenal aortic aneurysms. The substantial time required to design and manufacture these devices has led to the desire for a more standardized endovascular system. The Ventana stent graft system was designed as a potential off-the-shelf endografting option with the intent to fit the majority of juxtarenal or pararenal aneurysm morphologies. It includes the anatomically-fixed bifurcated stent graft, a proximal extension with a fenestrated, oversized mid-section and proximal scallop to accommodate the renal arteries, superior mesenteric artery (SMA) and celiac axis, and covered renal stent grafts. We report the initial Pilot Study results to assess the initial safety and feasibility of this potential “off-the-shelf” system approach. Methods: Following Ethics Committee approvals at two centers, consenting patients were evaluated for eligibility. Patients with aneurysms abutting or including the renal artery orifices who were not candidates for standard infrarenal endograft placement due to proximal aortic neck morphology were further assessed for anatomic suitability, including: stable infra-SMA aortic neck ≥15mm; renal artery orifices within 35mm from SMA origin and within 30mm of each other axially; absence of severe renal occlusive disease (>70% stenosis); and adequate distal anatomy for device placement. Results: Among 15 patients with juxtarenal or pararenal aneurysms having mean age of 77 years (87% male), mean vascular measurements include sac diameter 5.9cm; infrarenal neck length 6.9mm; infra-SMA neck length 25mm; and renal artery spacing 6.9mm axially and 147° radially (clockface). All devices were successfully implanted, and all renal and visceral arteries were preserved. Mean procedure time was 108 minutes with a mean fluoroscopy time of 55 minutes utilizing 254cc of contrast. Five patients received blood products. Mean time to hospital discharge is 3.3 days. Among all patients reaching one month follow-up and three patients reaching six month follow-up, no Type I/III endoleak, migration, renal artery loss/damage, or renal infarcts is observed. One late non-aneurysm related death occurred secondary to accidental fall. One secondary procedure for limb kinking/occlusion has been performed. Conclusions: Initial Pilot Study experience with the Ventana fenestrated stent graft system for juxtarenal and pararenal aneurysms is feasible and safe. More extensive evaluation to assess efficacy over the mid and long-term is warranted.

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