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OBJECTIVES: The Cook Fenestrated Endovascular Graft(Zfen) was approved by the FDA in April 2012. The present study reviews the outcomes of the first 38 post-approval Zfens placed at a single academic institution.
METHODS: A retrospective review was performed of a prospectively collected database containing Zfen cases performed between July 2012 and June 2015. Patient demographics, anatomic characteristics, perioperative morbidity/mortality, presence of endoleak and visceral branch patency were recorded.
RESULTS: A total of 38 Zfen cases were performed. The mean patient age was 75 years(range 61-91 years). The majority of the patients were male(76%), and had a history of hypertension(89%), smoking(80%) and CAD(68%). Other comorbidities included COPD(39%), DM(26%), and CRI(5%). Mean preoperative AAA size was 59±9mm(range 50-91mm) with a mean infrarenal neck length of 3.1±2.5mm(range 0-11mm). Eighteen cases(47%) fell within the Zfen IFU guidelines. The mean number of stented fenestrations was 2.0±0.3mm. Technical success was 97%. In one patient, the case was aborted due to diminutive and heavily calcified iliac vessels; he subsequently underwent a successful open repair. There was no perioperative or 30 day mortality. Post-operative complications included two groin seromas, one groin hematoma, and one urinary tract infection. One patient reported buttock claudication following intentional coverage of an internal iliac artery. One additional patient experienced transient unilateral leg weakness and was diagnosed with a mild spinal cord infarction. At a mean follow up of 8.5 months (range 1-36 months), there was a statistically significant decrease in mean maximal aneurysm diameter to 53±11 mm(p=0.01). All stented branch vessels were patent, and no patient exhibited renal/visceral ischemia. There was one persistent type I endoleak in a patient with unfavorable anatomy(no infrarenal neck, and <15mm proximal seal zone). The patient is presently refusing further treatment. There were no type III endoleaks. There was no incidence of AAA rupture or aneurysm related death. Outcomes were similar between those patients who were within IFU criteria and those who were not.
CONCLUSIONS: These early results support the safe and effective use of the Zfen device for the treatment of juxtarenal AAA patients. In our early experience with the Zfen device following FDA approval, we have found that relaxation of strict IFU guidelines(infrarenal neck≥4mm), based upon the judgment of the operating surgeon, does not appear to have adversely affected outcomes.