Surgery

Artery

Clinical trial

Perioperative

Investigational device exemption

Celiac artery

Superior mesenteric artery

Abdominal aortic aneurysm

Radiology

Endovascular aneurysm repair

Dissection (medical)

Aortic aneurysm

Internal medicine

Medicine

Inferior mesenteric artery

Aneurysm

Journal of Vascular Surgery

<h2>Abstract</h2><h3>Objective</h3> To report the outcomes of patients enrolled in a physician-sponsored investigational device exemption trial for endovascular treatment of complex thoracoabdominal aortic aneurysms with fenestrated and/or branched devices. <h3>Methods</h3> This study represents a retrospective analysis of a prospectively maintained database of patients enrolled in a physician-sponsored investigational device exemption 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 or Zenith (Cook Medical, Bloomington, Ind) fenestrated device. Aneurysm classification was based upon Crawford classification. We included the pararenal and paravisceral aneurysms in the type IV aneurysm group, because the repair of these aneurysms usually involved treatment of all four visceral branches. The endografts implanted were custom manufactured devices or off-the-shelf devices based on the Cook Zenith platform. Variables analyzed included preoperative demographics and comorbidities, anatomic aneurysmal characteristics, procedural details, and perioperative complications. <h3>Results</h3> One -hundred fifty patients with a mean age of 71 ± 7.9 years were treated; 69% were male. Tobacco use (93%) and hypertension (91%) were the most common risk factors. Fifty-seven patients (38%) had a history of previous aortic repair. The mean aneurysm diameter was 62 ± 12 mm and 14 (9%) aneurysms were associated with chronic dissection. A total of 573 visceral vessels were incorporated (celiac artery/superior mesenteric artery [287 vessels], renal arteries [275 vessels], and 11 additional vessels) and 539 were stented. The celiac artery/superior mesenteric artery received a fenestrated design in 76.1% of cases. Branch designs were used in the renal artery in 13.2%, with the remainder treated with fenestrations. Spinal cord drainage was used in 51% of patients (76/150). The mean operative time, fluoroscopy time, and estimated blood loss were 283 ± 89 minutes, 83 ± 38 minutes, and 417 ± 404 mL, respectively. There were five patients (3.3%) with intraoperative complications, resulting in one intraoperative death. The early mortality was 2.7% (4/150). Major complications included respiratory failure in 7% (10/150), stroke and myocardial infarction in 0.7% each (1/150), and paraplegia in 2.7% (4/150). Acute kidney injury occurred in 4.7% of patients (7/150), two of whom required temporary dialysis. Thirty-nine percent of patients experienced at least one complication. Early branch vessel patency was 99.8% (525/526). Survival, primary, and primary-assisted branch patency at 2 years of follow-up were 79%, 97%, and 99%, respectively. <h3>Conclusions</h3> Endovascular repair of complex aneurysms is safe and effective when performed in a high-volume center experienced in aortic disease management. Branch vessels patency and the low incidence of paraplegia and mortality support expanded use to treat most complex thoracoabdominal aortic aneurysms.

Outcomes and complications after fenestrated-branched endovascular aortic repair