Prospective, multicenter experience with the Ventana Fenestrated System for juxtarenal and pararenal aortic aneurysm endovascular repair.

OBJECTIVE: This study assessed preliminary results of the Ventana Fenestrated System (Endologix, Irvine, Calif) as an off-the-shelf integrated device for juxtarenal aortic aneurysm (JAA) or pararenal aortic aneurysm (PAA) endovascular repair.

METHODS: From November 2010 to April 2012, seven centers enrolled 31 patients with JAAs or PAAs in an international clinical trial of the Ventana Fenestrated System. Clinical and laboratory evaluations were done predischarge and at 1 month, with continuing follow-up through 5 years. Core laboratory computed tomography imaging assessments were performed at 1 month and at each subsequent follow-up.

RESULTS: Patients (mean age, 73 years; 90% male) presented with mean aneurysm sac diameter of 6.0 cm. One patient with a short, reversed tapered infra-superior mesenteric artery (SMA) neck was enrolled under a protocol waiver. Among the 31 patients, one of five Ventana device models was used to preserve main renal arteries, the SMA, and celiac arteries; 20 patients (65%) received the same Ventana device (aligned fenestrations, 28-mm diameter). Median fluoroscopy and procedure times were 49 and 197 minutes, respectively; median hospital length of stay was 3.0 days. The 1-month clinical success rate was 94% (29 of 31), with no perioperative mortality. One intervention on day 26 was done to resolve limb kink/occlusion. A type IA endoleak and renal occlusion secondary to procedural device damage led to a reintervention on day 52 and dialysis at 5 months. During follow-up to 23 months, three non-aneurysm-related deaths occurred. No aneurysm rupture or conversion to open repair has occurred. One late migration with endoleak and covered renal stent fracture/occlusion occurred at 8 months in the patient with a short, reverse tapered infra-SMA neck performed under a protocol waiver, which was managed successfully with bilateral renal bypasses and endovascular repair of the endoleak. Another patient underwent late endovascular interventions to resolve bilateral renal stenosis.

CONCLUSIONS: The multicenter experience of the Ventana Fenestrated System supports its safety and early-term to midterm effectiveness for the endovascular repair of JAAs and PAAs. This off-the-shelf integrated system permits endovascular treatment of JAAs or PAAs; however, further expanded clinical experience and longer-term follow-up are needed to more fully assess this device system.