title: Midterm Outcomes of the Nellix Endovascular Aneurysm Sealing System: A Dual-Center Experience.
abstract: To report midterm outcomes of the Nellix Endovascular Aneurysm Sealing (EVAS) System in the treatment of abdominal aortic aneurysm (AAA).
  
  
  
  Between September 2013 and July 2014, 64 AAA patients (mean age 76.6±6.8 years; 61 men) were treated with the EVAS system at 2 centers (only procedures performed at least 12 months prior to the analysis were included). Most patients were treated for a stable AAA, while 1 patient was treated for a ruptured aneurysm. Mean aneurysm diameter was 57.3±9.3 mm. The proximal neck measured a mean 21.5±3.3 mm in diameter and 27.0±12.1 mm long; the neck angle was 16.9°±19.3°. Eleven (17.2%) patients were treated outside the instructions for use (IFU).
  
  
  
  Technical success was achieved in 63 (98.4%) of 64 patients; 1 type Ia endoleak was treated intraoperatively. One (1.6%) aneurysm-related death occurred at 4 months due to a secondary aortoenteric fistula. Overall, endoleaks occurred in 3 (4.7%) patients (2 type Ia, 1 type II). The estimated rates for 18-month overall survival, freedom from aneurysm-related death, and freedom from secondary interventions were 92.7%, 98.4%, and 95.0%, respectively. Patients treated outside the IFU had a significantly higher incidence of device-related complications (p=0.03).
  
  
  
  The use of the Nellix device in everyday clinical practice is safe and offers promising midterm results. The risk of secondary aortoenteric fistula requires further analysis. Longer follow-up is needed to assess the actual efficacy of the device, although the risk of migration with late endoleak seems low.
authors.affiliation: Department of Vascular Surgery, Nuovo Ospedale Civile S. Agostino-Estense, Baggiovara, Modena, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Silingardi
authors.affiliation: Department of Vascular Surgery, Nuovo Ospedale Civile S. Agostino-Estense, Baggiovara, Modena, Italy giovanni.coppi@gmail.com.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Coppi
authors.affiliation: Vascular and Endovascular Surgery Unit, Mauriziano Umberto I Hospital, Turin, Italy.
authors.forename: Emanuele
authors.initials: E
authors.lastname: Ferrero
authors.affiliation: Department of Vascular Surgery, Nuovo Ospedale Civile S. Agostino-Estense, Baggiovara, Modena, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Lauricella
authors.affiliation: Vascular and Endovascular Surgery Unit, Mauriziano Umberto I Hospital, Turin, Italy.
authors.forename: Daniele
authors.initials: D
authors.lastname: Psacharopulo
authors.affiliation: Department of Vascular Surgery, Nuovo Ospedale Civile S. Agostino-Estense, Baggiovara, Modena, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Saitta
authors.affiliation: Vascular and Endovascular Surgery Unit, Mauriziano Umberto I Hospital, Turin, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Viazzo
authors.affiliation: Vascular and Endovascular Surgery Unit, Mauriziano Umberto I Hospital, Turin, Italy.
authors.forename: Michelangelo
authors.initials: M
authors.lastname: Ferri
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D017544:Aortic Aneurysm, Abdominal / Q000000981:diagnostic imaging / Q000401:mortality / Q000601:surgery*; D001019:Aortic Rupture / Q000000981:diagnostic imaging / Q000401:mortality / Q000601:surgery*; D001807:Blood Vessel Prosthesis; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D057510:Endovascular Procedures / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D005260:Female; D006801:Humans; D007558:Italy; D053208:Kaplan-Meier Estimate; D008297:Male; D011183:Postoperative Complications / Q000209:etiology; D011474:Prosthesis Design; D012189:Retrospective Studies; D012307:Risk Factors; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome
keywords: abdominal aortic aneurysm; balloon-expandable stent; endoleak; endovascular aneurysm sealing; sac anchoring stent-graft