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)

E L G Verhoeven; A Katsargyris; P Bachoo; T Larzon; R Fisher; D Ettles; J R Boyle; J Brunkwall; D Böckler; H-J Florek; A Stella; P Kasprzak; H Verhagen; V Riambau; GREAT European C3 Module Investigators

doi:10.1016/j.ejvs.2014.04.009

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)

Eur J Vasc Endovasc Surg. 2014 Aug;48(2):131-7. doi: 10.1016/j.ejvs.2014.04.009. Epub 2014 May 28.

Authors

E L G Verhoeven¹, A Katsargyris², P Bachoo³, T Larzon⁴, R Fisher⁵, D Ettles⁶, J R Boyle⁷, J Brunkwall⁸, D Böckler⁹, H-J Florek¹⁰, A Stella¹¹, P Kasprzak¹², H Verhagen¹³, V Riambau¹⁴; GREAT European C3 Module Investigators

Affiliations

¹ Department of Vascular and Endovascular Surgery, Paracelsus Medical University, Nuremberg, Germany. Electronic address: [email protected].
² Department of Vascular and Endovascular Surgery, Paracelsus Medical University, Nuremberg, Germany.
³ Department of Vascular Surgery, Aberdeen Royal Infirmary, Aberdeen, UK.
⁴ Department of Cardiothoracic and Vascular Surgery, Örebro University Hospital, Örebro, Sweden.
⁵ Liverpool Vascular and Endovascular Service, Royal Liverpool University Hospital, Liverpool, UK.
⁶ Department of Radiology, Hull Royal Infirmary, Hull, UK.
⁷ Department of Vascular Surgery, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.
⁸ Department of Vascular and Endovascular Surgery, University Clinics, University of Cologne, Cologne, Germany.
⁹ Department of Vascular and Endovascular Surgery, University Hospital Heidelberg, Heidelberg, Germany.
¹⁰ Department of Vascular and Endovascular Surgery, Weisseritztal Kliniken, Freital, Germany.
¹¹ Vascular Surgery Department, University of Bologna, Policlinico S. Orsola-Malpighi, Bologna, Italy.
¹² Department of Surgery, Vascular Surgery and Endovascular Surgery, University Hospital, University of Regensburg, Germany.
¹³ Department of Vascular Surgery, Erasmus University Medical Center, Rotterdam, The Netherlands.
¹⁴ Vascular Surgery Division, Department of Cardiovascular Surgery, Thorax Institute, Hospital Clinic, University of Barcelona, Spain.

PMID: 24878234
DOI: 10.1016/j.ejvs.2014.04.009

Abstract

Objectives: 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.

Keywords: Abdominal aortic aneurysm; Endovascular aneurysm repair; Gore Excluder; Proximal deployment; Repositioning.

Publication types

Multicenter Study
Research Support, Non-U.S. Gov't

MeSH terms

Aged
Aged, 80 and over
Aortic Aneurysm, Abdominal / mortality
Aortic Aneurysm, Abdominal / surgery*
Blood Vessel Prosthesis Implantation / adverse effects
Blood Vessel Prosthesis Implantation / instrumentation*
Blood Vessel Prosthesis Implantation / mortality
Blood Vessel Prosthesis*
Endovascular Procedures / adverse effects
Endovascular Procedures / instrumentation*
Endovascular Procedures / mortality
Europe
Female
Humans
Kaplan-Meier Estimate
Male
Postoperative Complications / mortality
Postoperative Complications / surgery
Prosthesis Design
Registries
Reoperation
Risk Factors
Stents*
Time Factors
Treatment Outcome