Study Evaluates EVAR Using Fenestrated-Branch Endografts Based on Supraceliac Sealing Zones
April 20, 2017—Gustavo S. Oderich, MD, et al conducted a prospective, nonrandomized study to evaluate manufactured fenestrated-branched endovascular aortic repair (EVAR) endografts for the treatment of pararenal and thoracoabdominal aortic aneurysms (TAAAs) based on supraceliac sealing zones. The investigators published the findings of the study in Journal of Vascular Surgery (2017;65:1249–1259).
The investigators reported that a total of 127 patients (91 men; mean age, 75 ± 10 years ) were enrolled in a prospective, nonrandomized, single-center study using manufactured fenestrated-branched EVAR devices from November 2013 to March 2015. Stent design was based on the supraceliac sealing zone in all patients with four or more vessels in 111 patients (89%). Follow-up included clinical examination, laboratory studies, duplex ultrasound, and CT imaging at discharge, 1 month, 6 months, and yearly.
Endpoints adjudicated by an independent clinical event committee included mortality, major adverse events (any mortality, myocardial infarction, stroke, paraplegia, acute kidney injury, respiratory failure, bowel ischemia, blood loss > 1 L), freedom from reintervention, branch-related instability (occlusion, stenosis, endoleak, or disconnection requiring reintervention), target vessel patency, sac aneurysm enlargement, and aneurysm rupture.
As summarized in Journal of Vascular Surgery, there were 47 pararenal, 42 type IV, and 38 type I to III TAAAs with a mean diameter of 59 ± 17 mm. A total of 496 renal-mesenteric arteries were incorporated by 352 fenestrations, 125 directional branches, and 19 celiac scallops, with a mean of 3.9 ± 0.5 vessels per patient. Technical success of target vessel incorporation was 99.6% (n = 493/496).
The investigators reported that there was no 30-day or in-hospital death, dialysis, rupture, or conversion to open surgical repair. Major adverse events occurred in 27 patients (21%). Paraplegia occurred in two patients (one type IV and one type II TAAAs). Follow-up was > 30 days in all patients, > 6 months in 79 patients, and > 12 months in 34 patients. No patients were lost to follow-up. After a mean follow-up of 9.2 ± 7 months, 23 patients (18%) had reinterventions (15 aortic, 8 nonaortic), four renal artery stents were occluded, five patients had type Ia or III endoleaks, and none had aneurysm sac enlargement.
Primary and secondary target vessel patency was 96% ± 1% and 98% ± 0.7% at 1 year. Freedom from any branch instability and any reintervention was 93% ± 2% and 93% ± 2% at 1 year, respectively. Patient survival was 96% ± 2% at 1 year for the entire cohort.
The investigators concluded that endovascular repair of pararenal aortic aneurysms and TAAAs using manufactured fenestrated-branched EVAR devices with supraceliac sealing zones is safe and efficacious. Long-term follow-up is needed to assess the impact of four-vessel designs on device-related complications and progression of aortic disease, advised the investigators in Journal of Vascular Surgery.