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
; 48(2): 131-7, 2014 Aug.
Article
in En
| MEDLINE
| ID: mdl-24878234
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.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Blood Vessel Prosthesis
/
Stents
/
Aortic Aneurysm, Abdominal
/
Blood Vessel Prosthesis Implantation
/
Endovascular Procedures
Type of study:
Clinical_trials
/
Etiology_studies
/
Risk_factors_studies
Limits:
Aged
/
Aged80
/
Female
/
Humans
/
Male
Country/Region as subject:
Europa
Language:
En
Journal:
Eur J Vasc Endovasc Surg
Journal subject:
ANGIOLOGIA
Year:
2014
Document type:
Article