Initial experience with the Ventana fenestrated system for endovascular repair of juxtarenal and pararenal aortic aneurysms.

OBJECTIVE: Customized fenestrated endovascular stent grafts have been investigated as an alternative to open surgery for repair of more complex juxtarenal aortic aneurysms (JAAs). The substantial time required to design and manufacture these devices has led to the desire for a standardized fenestrated endovascular system. We report the initial pilot study results of a potential "off-the-shelf" fenestrated device system to assess its initial safety and feasibility for endovascular repair of JAAs and pararenal aortic aneurysms (PAAs).

METHODS: Following ethics committee approvals, 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 because of proximal aortic neck morphology were further assessed for anatomic suitability for this "off-the-shelf" device. There were a number of anatomic requirements, the most important being a stable infra-superior mesenteric artery aortic neck length ≥ 15 mm. Patients are assessed in-hospital and in follow-up at 1, 6, and 12 months, and annually thereafter to 5 years for adverse events and using contrast-enhanced computed tomography angiography with Core Laboratory interpretation of renal perfusion, device integrity, migration, endoleak, and aneurysm morphology.

RESULTS: Fifteen patients (87% male) with JAAs (93%) or PAAs (6.7%) presented at mean age of 77 years (range, 66-85 years) and with mean sac diameter of 5.9 cm (range, 5.1-7.9 cm). Four Ventana fenestrated stent graft models having aligned fenestrations (three models) or offset fenestrations (one model) and renal stent grafts were successfully implanted among the patients, and all renal and visceral arteries were preserved. Mean endovascular procedure time was 108 minutes (range, 71-212 minutes) with mean contrast usage and fluoroscopy time of 254 mL (range, 67-420 mL) and 55 minutes (range, 27-104 minutes), respectively. Five patients received blood products. Mean time to hospital discharge was 3.3 days (range, 2-9 days). In follow-up to 6 months and 1 year, no rupture, conversion to open repair, migration, type I/III endoleak, or renal loss/infarcts were observed. Two late nonaneurysm-related deaths have occurred. One secondary procedure for iliac limb kinking/occlusion and one secondary procedure for renal artery stenosis have been performed.

CONCLUSIONS: Early experience supports procedural and initial postprocedural safety and demonstrates proof of concept for the off-the-shelf Ventana fenestrated system for the endovascular repair of JAAs and PAAs in selected patients. Continued follow-up and expanded multicenter clinical experience is warranted.