Comparison of commercially available versus customized branched-fenestrated devices in the treatment of complex...

To evaluate and compare the early outcomes of patients treated for complex aortic aneurysms using a commercially available Zenith fenestrated endograft (ZFEN) or an advanced customized fenestrated-branched endovascular repair, which includes custom-made device or off-the-shelf p-branch devices available for use in a physician-sponsored investigational device exemption (PSIDE).

Between July 2012 and July 2015, patients who underwent to complex aortic aneurysms repair at University of North Carolina-Chapel Hill were retrospectively analyzed using data prospectively collected in electronically maintained aortic database. Patients were separated in two groups: ZFEN and PSIDE (custom-made device and p-branch). Demographics data, cardiac risk factors, comorbidities, computed tomography angiography anatomic measurements (aneurysm diameter, length of aortic coverage above the celiac artery), procedural data (operative time, estimated blood loss, intraoperative complications), and 30-day outcomes (mortality, major adverse cardiac events, stroke/transient ischemic attack, paraplegia, gastrointestinal complications, visceral branch complications, and endoleak) were analyzed.

Among the 131 repairs for complex aortic aneurysms (juxtarenal or thoracoabdominal), there were 60 ZFEN and 71 PSIDE devices. Demographics and risk factors had similar distribution between groups, except that PSIDE patients more commonly had a history of previous aortic surgery (33% vs 5% [ZFEN]; P = .0001). PSIDE patients had a greater number of stented vessels (3.4 vs 2.2; P < .001) and length of aortic coverage (72 mm vs -13.4 mm) than ZFEN; however, no differences were seen in operative time, estimated blood loss or fluoroscopic time. Early outcomes were similar between groups, except for duration of hospital stay, which was significantly longer in PSIDE cohort (4.4 days vs 3.3 days; P = .05).

More advanced fenestrated-branched endovascular repair does not seem to increase the complications associated with repair compared with patients receiving a ZFEN device in an experienced treatment center. Although mortality and morbidity were comparable between the groups, further studies evaluating long-term outcomes are needed.