Prospective Adjudicated Long Term Results of Fenestrated and p-Branch Endografts for the Treatment of Juxtarenal Abdominal Aortic Aneurysms
James F. McKinsey, MD1, Zachary Dawson, PhD2.
1Mount Sinai Medical Center, New York, NY, USA, 2Cook Research Incorporated, West Lafayette, IN, USA.
OBJECTIVES: Under IDE# G070023, patients with juxtarenal abdominal aortic aneurysms (AAAs) were evaluated and treated with fenestrated or p-Branch endografts. Study follow up is scheduled over 5 years; mortality, adverse events, graft complications including thrombosis, endoleak, stenosis, reintervention and stent fracture or migration were prospectively evaluated.METHODS: Twenty-three patients (mean age 72±10 years; 78% male) were treated with a Zenith Fenestrated Endovascular Graft (9 patients with 24 visceral/renal fenestrations; 17 small renal fenestrations, 1 large SMA fenestration and 6 SMA scallop) or off-the-shelf Zenith p-Branch (14 patients; 28 pivot renal branches and 14 SMA fenestrations and 14 celiac scallop) between July 2008 and April 2014, with a mean follow-up of 27±15 months (range, 2-61 months). All imaging was analyzed by a core laboratory and major clinical events were adjudicated by an independent CEC. RESULTS: Device implantation success rate was 100% and 30-day mortality was 0%. 3 late deaths occurred, two unrelated to AAA repair and one unable to be adjudicated. AAA rupture or conversion to open repair was 0%.There was no main body graft thrombosis or deformation. Renal artery/stent patency at 30 days was 96%(43/45). No late renal artery occlusion was noted. One fenestrated patient had intraoperative renal artery dissection and despite stenting resulted in renal occlusion; and one p-Branch patient developed renal stent occlusion within 30 days and underwent successful thrombolysis, angioplasty, and additional stent placement. Renal failure requiring dialysis was 0%. During late follow-up, one fenestrated patient required reintervention after 2 years years to resolve stenosis of a stented accessory renal artery. Of the 21 SMAs targeted with fenestration or scallop, one SMA (p-Branch patient) was treated for symptomatic stenosis at 3 years with complete symptom resolution. Additionally reintervention was performed in one fenestrated patient for type1b endoleak, and one p-Branch patient underwent multiple reinterventions for a persistent type IIb endoleak and aneurysm growth. Graft migration and device integrity fracture were 0% by core lab analysis.
CONCLUSIONS: This prospective CEC adjudicated study reveals excellent acute technical success and long term patency of aortic endografts as well as patency of the fenestration and branched grafts for the renal and visceral vessels. This study supports the primary use of fenestrated and when available p-Branched off the shelf stent-grafts for the treatment of patients with juxtarenal AAAs.
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