Early Postapproval Data Support Cook's Zenith Fenestrated Graft to Treat Juxtarenal Aortic Aneurysms

August 7, 2014—Findings from an evaluation of postapproval outcomes of patients with juxtarenal aortic aneurysms treated with the Zenith fenestrated endovascular graft (Cook Medical) were published by Chandu Vemuri, MD, et al in the Journal of Vascular Surgery (2014;69:295–300). Cook Medical announced US Food and Drug Administration approval of the Zenith device in April 2012.

As summarized in the Journal of Vascular Surgery, the investigators reviewed clinical data on 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 United States fenestrated trial (USFT).

The investigators reported that 57 patients were treated and that there were significantly more (P < .05) patients with coronary artery disease, myocardial infarction, and preoperative renal insufficiency than in the USFT. Additionally, 36 patients (63.2%) did not meet the USFT anatomic criteria of a < 4-mm infrarenal neck. There were also significantly more mesenteric stents (13 vs 0; P < .05) used in this group than in the USFT, reflecting the greater anatomic complexity found in these patients. 

The total operative time was 250.2 ± 14.8 minutes, the fluoroscopy time was 68.9 ± 4.47 minutes, and the average contrast material volume was 108.6 ± 5.6 mL. Technical success was 100% in regard to aneurysm exclusion, although the left renal fenestration could not 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, the investigators found.

The investigators concluded that 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 the durability of this treatment modality as the technology diffuses and data mature, advised the investigators in the Journal of Vascular Surgery.