title: Real-world performance of the new C3 Gore Excluder stent-graft: 1-year results from the European C3 module of the Global Registry for Endovascular Aortic Treatment (GREAT).
abstract: OBJECTIVE
  The European C3 module of the Global Registry for Endovascular Aortic Treatment (GREAT) provides "real-world" outcomes for the new C3 Gore Excluder stent-graft, and evaluates the new deployment mechanism. This report presents the 1-year results from 400 patients enrolled in this registry.
  
  
  METHODS
  Between August 2010 and December 2012, 400 patients (86.8% male, mean age 73.9 ± 7.8 years) from 13 European sites were enrolled in this registry. Patient demographics, treatment indication, case planning, operative details including repositioning and technical results, and clinical outcome were analyzed.
  
  
  RESULTS
  Technical success was achieved in 396/400 (99%) patients. Two patients needed intraoperative open conversion, one for iliac rupture, the second because the stent-graft was pulled down during a cross-over catheterization in an angulated anatomy. Two patients required an unplanned chimney renal stent to treat partial coverage of the left renal artery because of upward displacement of the stent-graft. Graft repositioning occurred in 192/399 (48.1%) patients, most frequently for level readjustment with regard to the renal arteries, and less commonly for contralateral gate reorientation. Final intended position of the stent-graft below the renal arteries was achieved in 96.2% of patients. Thirty-day mortality was two (0.5%) patients. Early reintervention (≤30 days) was required in two (0.5%) patients. Mean follow-up duration was 15.9 ± 8.8 months (range 0-37 months). Late reintervention (>30 days) was required in 26 (6.5%) patients. Estimated freedom from reintervention at 1 year was 95.2% (95% CI 92.3-97%), and at 2 years 91.5% (95% CI 86.8-94.5%). Estimated patient survival at 1 year was 96% (95% CI 93.3-97.6%) and at 2 years 90.6% (95% CI 85.6-93.9%).
  
  
  CONCLUSIONS
  Early real-world experience shows that the new C3 delivery system offers advantages in terms of device repositioning resulting in high deployment accuracy. Longer follow-up is required to confirm that this high deployment accuracy results in improved long-term durability.
authors.affiliation: Department of Vascular and Endovascular Surgery, Paracelsus Medical University, Nuremberg, Germany. Electronic address: Eric.Verhoeven@klinikum-nuernberg.de.
authors.forename: E L G
authors.initials: EL
authors.lastname: Verhoeven
authors.affiliation: Department of Vascular and Endovascular Surgery, Paracelsus Medical University, Nuremberg, Germany.
authors.forename: A
authors.initials: A
authors.lastname: Katsargyris
authors.affiliation: Department of Vascular Surgery, Aberdeen Royal Infirmary, Aberdeen, UK.
authors.forename: P
authors.initials: P
authors.lastname: Bachoo
authors.affiliation: Department of Cardiothoracic and Vascular Surgery, Örebro University Hospital, Örebro, Sweden.
authors.forename: T
authors.initials: T
authors.lastname: Larzon
authors.affiliation: Liverpool Vascular and Endovascular Service, Royal Liverpool University Hospital, Liverpool, UK.
authors.forename: R
authors.initials: R
authors.lastname: Fisher
authors.affiliation: Department of Radiology, Hull Royal Infirmary, Hull, UK.
authors.forename: D
authors.initials: D
authors.lastname: Ettles
authors.affiliation: Department of Vascular Surgery, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.
authors.forename: J R
authors.initials: JR
authors.lastname: Boyle
authors.affiliation: Department of Vascular and Endovascular Surgery, University Clinics, University of Cologne, Cologne, Germany.
authors.forename: J
authors.initials: J
authors.lastname: Brunkwall
authors.affiliation: Department of Vascular and Endovascular Surgery, University Hospital Heidelberg, Heidelberg, Germany.
authors.forename: D
authors.initials: D
authors.lastname: Böckler
authors.affiliation: Department of Vascular and Endovascular Surgery, Weisseritztal Kliniken, Freital, Germany.
authors.forename: H-J
authors.initials: HJ
authors.lastname: Florek
authors.affiliation: Vascular Surgery Department, University of Bologna, Policlinico S. Orsola-Malpighi, Bologna, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Stella
authors.affiliation: Department of Surgery, Vascular Surgery and Endovascular Surgery, University Hospital, University of Regensburg, Germany.
authors.forename: P
authors.initials: P
authors.lastname: Kasprzak
authors.affiliation: Department of Vascular Surgery, Erasmus University Medical Center, Rotterdam, The Netherlands.
authors.forename: H
authors.initials: H
authors.lastname: Verhagen
authors.affiliation: Vascular Surgery Division, Department of Cardiovascular Surgery, Thorax Institute, Hospital Clinic, University of Barcelona, Spain.
authors.forename: V
authors.initials: V
authors.lastname: Riambau
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D017544:Aortic Aneurysm, Abdominal / 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; D005060:Europe; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D011183:Postoperative Complications / Q000401:mortality / Q000601:surgery; D011474:Prosthesis Design; D012042:Registries; D012086:Reoperation; D012307:Risk Factors; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome
keywords: Abdominal aortic aneurysm; Endovascular aneurysm repair; Gore Excluder; Proximal deployment; Repositioning