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. 1. Department of Vascular and Endovascular Surgery, Paracelsus Medical University, Nuremberg, Germany. Electronic address: Eric.Verhoeven@klinikum-nuernberg.de. 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.
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.
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.
Authors: Raman Uberoi; Carlo Setacci; Mario Lescan; Antonio Lorido; David Murray; Zoltán Szeberin; Tomasz Zubilewicz; Vincent Riambau; Angsu Chartrungsan; Jörg Tessarek Journal: J Endovasc Ther Date: 2018-10-03 Impact factor: 3.487