title: Active proximal sealing in the endovascular repair of abdominal aortic aneurysms: early results with a new stent-graft.
abstract: OBJECTIVE
  To investigate the performance of a new device that uses the STRATA polytetrafluoroethylene graft material and a mechanism that provides active proximal sealing in order to prevent type Ia endoleak during endovascular aneurysm repair (EVAR).
  
  
  METHODS
  Between April 2013 and July 2014, 21 consecutive patients (all men; median age 71 years, range 60-84 years) with abdominal aortic aneurysm (median diameter 5.9 cm, range 4.9-7.8 cm) and suitable anatomy were offered elective EVAR using the AFX endograft. These patients had an irregular, conical, tapered, or bulging proximal neck, for which this specific device was considered appropriate. Aneurysm exclusion and incidence of type Ia endoleak were the primary outcomes; secondary outcomes included mortality, morbidity, migration, and other graft-related complications.
  
  
  RESULTS
  Primary technical success was 90%; 2 intraoperative type Ia endoleaks due to low endograft deployment were treated with additional proximal cuffs. During a median follow-up of 10 months (range 2-15 months), no type I endoleak was observed. One type II endoleak was encountered, with no associated sac enlargement. There was no stent-graft migration or any other device-related complication. One patient had a nonfatal myocardial infarction and another developed renal failure requiring transient dialysis. No deaths occurred.
  
  
  CONCLUSIONS
  In this early experience, this newly available device appears to be safe and efficient in providing seal along irregularly shaped necks over the short term.
authors: Aristotle University of Thessaloniki, Papageorgiou General Hospital, Thessaloniki, Greece.
authors: Nikolaos
authors: N
authors: Melas
authors: Aristotle University of Thessaloniki, Papageorgiou General Hospital, Thessaloniki, Greece.
authors: Kyriakos
authors: K
authors: Stavridis
authors: Aristotle University of Thessaloniki, Papageorgiou General Hospital, Thessaloniki, Greece University of Leicester, Leicester, UK a_saratzis@yahoo.gr.
authors: Athanasios
authors: A
authors: Saratzis
authors: Aristotle University of Thessaloniki, Papageorgiou General Hospital, Thessaloniki, Greece.
authors: John
authors: J
authors: Lazarides
authors: Aristotle University of Thessaloniki, Papageorgiou General Hospital, Thessaloniki, Greece.
authors: Christos
authors: C
authors: Gitas
authors: Aristotle University of Thessaloniki, Papageorgiou General Hospital, Thessaloniki, Greece.
authors: Nikolaos
authors: N
authors: Saratzis
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D017544:Aortic Aneurysm, Abdominal / Q000000981:diagnostic imaging / Q000601:surgery*; D001027:Aortography / Q000379:methods; D001807:Blood Vessel Prosthesis; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation*; D057867:Endoleak / Q000209:etiology / Q000517:prevention & control; D057510:Endovascular Procedures / Q000009:adverse effects / Q000295:instrumentation*; D004869:Equipment Safety; D005548:Foreign-Body Migration / Q000209:etiology / Q000517:prevention & control; D006801:Humans; D008297:Male; D008875:Middle Aged; D011138:Polytetrafluoroethylene; D011474:Prosthesis Design; D012307:Risk Factors; D015607:Stents; D013997:Time Factors; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome
chemical_list: D011138:Polytetrafluoroethylene
keywords: abdominal aortic aneurysm; active sealing mechanism; conical neck; endograft; endoleak; endovascular aneurysm repair; hostile neck; proximal neck; proximal seal; stent-graft; tapered neck