title: Treatment of abdominal aortic aneurysm with a new type of polymer-filled low profile device.
abstract: OBJECTIVE
  To evaluate the mid-term safety and effectiveness of a novel stent graft for treatment of abdominal aortic aneurysm (AAA).
  
  
  METHODS
  Thirty-three patients with AAA (20 males and 13 females; mean age: 71.3 y) were treated with the Ovation™ Abdominal Stent Graft System (TriVascular, Inc., Santa Rosa, CA, USA). Indications for endovascular aneurysm repair: AAA ≥ 5.5 cm, neck ≥ 7 mm, angulation ≤ 60° and with an inner wall diameter of no less than 16 mm and no greater than 30 mm; the presence of neck calcification and thrombosis is not much of a problem in this device because aortic seal is achieved with 2 polymer-filled sealing rings and the fixation by means of a suprarenal stent with 8 pairs of anchors. Patients were followed through discharge and returned for follow-up visits. The follow-up protocol included a CT-A exam at 1 and 12 months after the intervention; the mid-term follow up was performed at 3 and 6 months with contrast-enhanced ultrasound (CEUS). Mean follow-up duration was 18.6 months (range: 3-25 months).
  
  
  RESULTS
  Technical success was 100%. Mean implantation procedure time was 31.1 minutes, and median hospital stay was 4.6 days. None of the patients required conversion to open surgery, and no aneurysm enlargement, rupture, fracture, or migration were observed. No type I, III or IV endoleaks were observed. Hospitalization death rate was 0%. Death rate at 30 days was 0%. No major complications were observed.
  
  
  CONCLUSIONS
  The first results from this 3-center study with the Ovation stent graft are promising with high technical success and excellent safety and effectiveness.
authors.affiliation: Department of Radiology, University of Insubria, Varese, Italy.
authors.forename: Gianpaolo
authors.initials: G
authors.lastname: Carrafiello
authors.affiliation: Department of Radiology, University of Insubria, Varese, Italy.
authors.forename: Annamaria
authors.initials: A
authors.lastname: Ierardi
authors.affiliation: Department of Surgical Sciences, University of Insubria, Varese, Italy.
authors.forename: Gabriele
authors.initials: G
authors.lastname: Piffaretti
authors.affiliation: Department of Surgical Sciences, University of Insubria, Varese, Italy.
authors.forename: Nicola
authors.initials: N
authors.lastname: Rivolta
authors.affiliation: Department of Radiology, University of Insubria, Varese, Italy.
authors.forename: Chiara
authors.initials: C
authors.lastname: Floridi
authors.affiliation: Al Qassimi Hospital, Sharjah, UAE.
authors.forename: Adel
authors.initials: A
authors.lastname: Aswad
authors.affiliation: Al Qassimi Hospital, Sharjah, UAE.
authors.forename: Francesco
authors.initials: F
authors.lastname: Della Valle
authors.affiliation: Cardiovascular Diseases Department, "M. Mellini" Hospital, Chiari, Italy.
authors.forename: C V
authors.initials: CV
authors.lastname: Ioannou
authors.affiliation: Al Qassimi Hospital, Sharjah, UAE.
authors.forename: Claudio
authors.initials: C
authors.lastname: Gentilini
authors.affiliation: Cardiovascular Diseases Department, "M. Mellini" Hospital, Chiari, Italy.
authors.forename: Dimitrious
authors.initials: D
authors.lastname: Tsetis
authors.affiliation: Department of Surgical Sciences, University of Insubria, Varese, Italy.
authors.forename: Patrizio
authors.initials: P
authors.lastname: Castelli
authors.affiliation: Department of Surgical Sciences, University of Insubria, Varese, Italy.
authors.forename: Renzo
authors.initials: R
authors.lastname: Dionigi
mesh_terms: D000368:Aged; D017544:Aortic Aneurysm, Abdominal / Q000000981:diagnostic imaging / Q000601:surgery*; D001807:Blood Vessel Prosthesis; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D005260:Female; D006801:Humans; D008297:Male; D011108:Polymers / Q000737:chemistry / Q000627:therapeutic use*; D014057:Tomography, X-Ray Computed
chemical_list: D011108:Polymers
keywords: Abdominal; Aneurysm; Aortic; Endovascular; Ovation; Stent graft