Postapproval outcomes of juxtarenal aortic aneurysms treated with the Zenith fenestrated endovascular graft

Objective: The objective of this study was to evaluate postapproval outcomes of patients with juxtarenal aortic aneurysms treated with the Zenith fenestrated endovascular graft (Cook Inc, Bloomington, Ind). Methods: We reviewed clinical data of consecutive patients treated with the Zenith fenestrated endovascular graft in the United States at seven institutions with early commercial access from July 2012 to December 2012. Clinical outcomes and compliance to anatomic guidelines were compared with results of the U. S. fenestrated trial (USFT). Results: Fifty-seven patients were treated. There were significantly more (P <.05) patients with coronary artery disease, myocardial infarction, and preoperative renal insufficiency than in the USFT. Thirty-six patients (63.2%) did not meet the USFT anatomic criteria of a >4-mm infrarenal neck, and there were significantly more mesenteric stents (13 vs 0; P <.05) used in this group than in the USFT, reflecting the higher anatomic complexity of these patients. The total operative time was 250.2 +/- 14.8 minutes, the fluoroscopy time was 68.9 +/- 4.47 minutes, and the average volume of contrast material was 108.6 +/- 5.6 mL. Technical success was 100% in regard to aneurysm exclusion, although the left renal fenestration was not able to be aligned in two patients, and one patient had a kinked renal stent that was successfully restented. During this time period, there were a total of 10 endoleaks, of which two were type III and eight were type II. Conclusions: Despite higher rates of comorbidities and more challenging anatomy, early 30-day outcomes of juxtarenal aortic aneurysms treated postapproval with the Zenith fenestrated endovascular graft compare well with USFT data. Future studies are needed to assess durability of this treatment modality as the technology diffuses and data mature.