Universität zu Köln

Verhoeven, E. L. G., Katsargyris, A., Bachoo, P., Larzon, T., Fisher, R., Ettles, D., Boyle, J. R., Brunkwall, J., Boeckler, D., Florek, H-J, Stella, A., Kasprzak, P., Verhagen, H. and Riambau, V. (2014). 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). S. 131 - 138. LONDON: W B SAUNDERS CO LTD. ISSN 1532-2165

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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. (C) 2014 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Verhoeven, E. L. G. UNSPECIFIED UNSPECIFIED UNSPECIFIED Katsargyris, A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Bachoo, P. UNSPECIFIED UNSPECIFIED UNSPECIFIED Larzon, T. UNSPECIFIED UNSPECIFIED UNSPECIFIED Fisher, R. UNSPECIFIED UNSPECIFIED UNSPECIFIED Ettles, D. UNSPECIFIED UNSPECIFIED UNSPECIFIED Boyle, J. R. UNSPECIFIED UNSPECIFIED UNSPECIFIED Brunkwall, J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Boeckler, D. UNSPECIFIED UNSPECIFIED UNSPECIFIED Florek, H-J UNSPECIFIED UNSPECIFIED UNSPECIFIED Stella, A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Kasprzak, P. UNSPECIFIED UNSPECIFIED UNSPECIFIED Verhagen, H. UNSPECIFIED UNSPECIFIED UNSPECIFIED Riambau, V. UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-433272
DOI:	10.1016/j.ejvs.2014.04.009
Journal or Publication Title:	Eur. J. Vasc. Endovasc. Surg.
Volume:	48
Number:	2
Page Range:	S. 131 - 138
Date:	2014
Publisher:	W B SAUNDERS CO LTD
Place of Publication:	LONDON
ISSN:	1532-2165
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language ANEURYSM REPAIR; EXPERIENCE; ANATOMY Multiple languages Surgery; Peripheral Vascular Disease Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/43327