Outcomes and Complications After Fenestrated/Branched Endovascular Aortic Repair
Fernando Motta, MD, Jason Crowner, MD, Corey A. Kalbaugh, PhD, MS, William A. Marston, MD, Luigi Pascarella, MD, Katharine L. McGinigle, MD, Melina R. Kibbe, MD, Mark A. Farber, MD.
University of North Carolina, Chapel Hill, NC, USA.
Objectives: To report the outcomes of patients enrolled in a physician-sponsored investigational device exemption (PSIDE) trial for endovascular treatment of complex thoracoabdominal aortic aneurysms with fenestrated and/or branched devices.
Methods: This study represents a retrospective analysis of a prospectively maintained database of patients enrolled in a PSIDE trial for endovascular treatment of complex thoracoabdominal aneurysms between July 2012 and July 2017. Subjects included high risk patients for open repair, and patients with unsuitable anatomy for either standard endovascular aneurysm repair (EVAR) or a commercially available Zenith fenestrated device. Aneurysm classification was based upon extent of repair. The endografts implanted were custom manufactured devices (CMD) or "off-the-shelf" (OTS) devices based upon the Cook Zenith platform. Variables analyzed included pre-operative demographics and comorbidities, anatomic aneurysmal characteristics, procedural details, and peri-operative complications.
Results: A total of 150 patients with mean age of 71±7.9 years were treated, of which 69% were male. Tobacco use (93%) and hypertension (91%) were the most common risk factors (Table I). Fifty-seven patients (38%) had a history of previous aortic repair. Mean aneurysm diameter was 62±12 mm. Fourteen (9%) aneurysms were associated with chronic dissection. A total of 572 visceral vessels were incorporated and 539 were stented. Mesenteric arteries received a fenestrated design in 76.1%. Branch designs were used in the renal artery in only 13.2%. Spinal cord drainage was used in 50.7% (76/150) of patients. The mean operative time, fluoroscopy time, and EBL were 283±89 min, 83 ±38 min and 417±404 ml, respectively. There were 5 (3.3%) patients with intra-operative complications. The 30-day mortality was 2%(3/150). Thirty-nine percent of patients experience at least one complication. Major complications included: 7% (10/150) respiratory failure, 0.7%(1/150) of stroke and myocardial infarction each, 2.7%(4/150) paraplegia. Acute kidney injury occurred in 6%(9/150) of patients, two of which required temporary dialysis. Branch vessel patency was 99.8% (525/526) at 30 days.
Conclusion: Endovascular repair for complex aneurysms is safe and effective when performed in a high-volume center experienced in aortic disease management. Early branch vessel patency and the low incidence of paraplegia and mortality support its widespread use to treat most complex thoracoabdominal aortic aneurysms.
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