title: Prospective, nonrandomized study to evaluate endovascular repair of pararenal and thoracoabdominal aortic aneurysms using fenestrated-branched endografts based on supraceliac sealing zones.
abstract: To investigate outcomes of manufactured fenestrated and branched endovascular aortic repair (F-BEVAR) endografts based on supraceliac sealing zones to treat pararenal aortic aneurysms and thoracoabdominal aortic aneurysms (TAAAs).
  
  
  
  A total of 127 patients (91 male; mean age, 75 ± 10 years old) were enrolled in a prospective, nonrandomized single-center study using manufactured F-BEVAR (November 2013-March 2015). Stent design was based on supraceliac sealing zone in all patients with ≥ four vessels in 111 (89%). Follow-up included clinical examination, laboratory studies, duplex ultrasound, and computed tomography imaging at discharge, 1 month, 6 months, and yearly. End points adjudicated by 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, and branch-related instability (occlusion, stenosis, endoleak or disconnection requiring reintervention), target vessel patency, sac aneurysm enlargement, and aneurysm rupture.
  
  
  
  There were 47 pararenal, 42 type IV, and 38 type I-III TAAAs with 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). There were no 30-day or in-hospital deaths, dialysis, ruptures or conversions to open surgical repair. Major adverse events occurred in 27 patients (21%). Paraplegia occurred in two patients (one type IV, one type II TAAAs). Follow-up was >30 days in all patients, >6 months in 79, and >12 months in 34. 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), 4 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.
  
  
  
  Endovascular repair of pararenal aortic aneurysms and TAAAs, using manufactured F-BEVAR 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.
authors.affiliation: Advanced Endovascular Aortic Research Program, Division of Vascular and Endovascular Surgery, Mayo Clinic, Rochester, Minn. Electronic address: oderich.gustavo@mayo.edu.
authors.forename: Gustavo S
authors.initials: GS
authors.lastname: Oderich
authors.affiliation: Advanced Endovascular Aortic Research Program, Division of Vascular and Endovascular Surgery, Mayo Clinic, Rochester, Minn; Division of Vascular and Endovascular Surgery, Department of Surgery and Anatomy, University of São Paulo School of Medicine of Ribeirão Preto, Ribeirão Preto, Brazil.
authors.forename: Mauricio
authors.initials: M
authors.lastname: Ribeiro
authors.affiliation: Advanced Endovascular Aortic Research Program, Division of Vascular and Endovascular Surgery, Mayo Clinic, Rochester, Minn.
authors.forename: Jan
authors.initials: J
authors.lastname: Hofer
authors.affiliation: Advanced Endovascular Aortic Research Program, Division of Vascular and Endovascular Surgery, Mayo Clinic, Rochester, Minn.
authors.forename: Jean
authors.initials: J
authors.lastname: Wigham
authors.affiliation: Department of Epidemiology and Biostatistics, Mayo Clinic, Rochester, Minn.
authors.forename: Stephen
authors.initials: S
authors.lastname: Cha
authors.affiliation: Advanced Endovascular Aortic Research Program, Division of Vascular and Endovascular Surgery, Mayo Clinic, Rochester, Minn.
authors.forename: Julia
authors.initials: J
authors.lastname: Chini
authors.affiliation: Department of Radiology, Mayo Clinic, Rochester, Minn.
authors.forename: Thanila A
authors.initials: TA
authors.lastname: Macedo
authors.affiliation: Advanced Endovascular Aortic Research Program, Division of Vascular and Endovascular Surgery, Mayo Clinic, Rochester, Minn.
authors.forename: Peter
authors.initials: P
authors.lastname: Gloviczki
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D017544:Aortic Aneurysm, Abdominal / Q000000981:diagnostic imaging / Q000401:mortality / Q000503:physiopathology / Q000601:surgery*; D017545:Aortic Aneurysm, Thoracic / Q000000981:diagnostic imaging / Q000401:mortality / Q000503:physiopathology / Q000601:surgery*; D001027:Aortography / Q000379:methods; D001807:Blood Vessel Prosthesis; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D000072226:Computed Tomography Angiography; D057510:Endovascular Procedures / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008910:Minnesota; D011183:Postoperative Complications / Q000209:etiology / Q000503:physiopathology / Q000628:therapy; D011474:Prosthesis Design; D019233:Retreatment; D012307:Risk Factors; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome; D018616:Ultrasonography, Doppler, Duplex; D014654:Vascular Patency