Incidence and Management of the Failing Nellix Endovascular Aneurysm Sealing System

Abstract

Objective: Fenestrated and branched endovascular aneurysm repair (F/ B-EVAR) is increasingly performed to treat complex aortic aneurysms (juxtarenal abdominal aortic aneurysms [AAAs], pararenal AAAs, thoracoabdominal aortic aneurysms [TAAAs]); however, the outcome of the procedures is usually reported separately by each single center, and a wider overview is lacking. The aim of this study was therefore to report the experience of four high-volume centers nationwide to evaluate predictors of outcome.Methods: Between 2008 and 2019, all consecutive patients undergoing F/B-EVAR in four Italian university centers were prospectively recorded and retrospectively analyzed. Preoperative comorbidities and postoperative complications were classified according to the Society for Vascular Surgery reporting standards. Postoperative complications and perioperative mortality were assessed as early outcomes. Survival, freedom from reintervention, and target visceral vessel patency were assessed as follow-up outcomes by Kaplan-Meier analysis. Risk factors for perioperative mortality and spinal cord ischemia (SCI) were determined by multivariate analysis. Risk factors for late mortality were evaluated by Cox regression model.Results: Overall, 596 patients underwent F/B-EVAR for 124 (21%) juxtarenal AAAs, 112 (19%) pararenal AAAs, and 360 (60%) TAAAs. Elective and urgent procedures were performed in 520 (87%) and 76 (13%) cases, respectively. Postoperative cardiac, pulmonary, and renal complications were reported in 41 (7%), 50 (8%), and 80 (13%) patients, respectively. Seven cases (1%) of bowel ischemia and 13 (2%) cerebrovascular complications occurred. Thirty-nine (7%) patients suffered SCI, with 16 (3%) cases of permanent paraplegia. Crawford extent I to extent III TAAAs (odds ratio [OR], 13.41; 95% confidence interval [CI], 1.77-101.65; P ¼ .012) and postoperative renal complications (OR, 3.84; 95% CI, 1.70-8.69; P ¼ .001) independently predicted SCI. Thirty-two (5%) patients died in the perioperative period. Preoperative chronic renal failure (