Back to 2016 Annual Symposium Abstacts

Introduction: Commercially available fenestrated aortic devices typically involve incorporation of the renal arteries and sometimes the superior mesenteric artery. A few institutions have established FDA approved Physician Sponsored Investigational Device Exemption(PSIDE) trials to evaluate fenestrated repair. Perception exists that more advanced repairs are associated with higher risks and complication rates in the perioperative period. We aimed to compare and evaluate the early outcomes and complication rates of commercially available fenestrated devices(ZFEN) and more complex fenestrated designs(PSIDE).
Methods: All patients treated with a commercially available fenestrated graft [Cook Zenith Fenestrated(ZFEN) Device(Cook Medical, Bloomington, IN)] or a PSIDE with a more complex design(Cook Zenith p-Branch and other custom manufactured devices) involving the visceral vessels between 7/2012 and 7/2015 at our institution were included in the study. Enrollment into the PSIDE included all patients with < 4 mm infrarenal neck as well as patients with anatomy not accommodated with a commercially available ZFEN device. Outcomes evaluated included target vessel patency, mortality, MACE, renal insufficiency, paraplegia and device related events. Demographics, comorbidities, and crude outcomes were compared using chi-square, fishers exact, or t-tests.
Results: There were 60 zFEN devices and 71 PSIDE devices implanted during the study. Average number of target vessels stented was 2.2 ± 0.6 for ZFEN group and 3.4±0.6 for PSIDE cohort.(p<0.001) There was no significant difference in age, gender, SVS summary score, or comorbid factors. The PSIDE group did have a higher percentage of patients with previous aortic surgery(5%:33%,p80 years old.
There was no statistical difference in length of operation or blood loss but PSIDE patients had a longer LOS(4.4 ±4 vs. 3.3±2.5,p<0.05). Target vessel patency was 99.7% with one renal artery rupturing during branched vessel stent implantation in a PSIDE patient. Thirty-day mortality for ZFEN was 1.7% and for PSIDE was 1.4%(p=NS). There was no significant difference in MACE, renal insufficiency, paraparesis or device related events. No patients were placed on hemodialysis.
Conclusion: More advanced designs for fenestrated devices incorporating the mesenteric vessels are effective in treating patients with more complex aortic disease with no increase in mortality or significant increase in complication rates at a high volume center. Long-term follow-up of advanced designs is needed to determine the impact on durability especially concerning the visceral branches.