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Ten Years of Experience with the GORE EXCLUDER® Stent-Graft for the Treatment of Aortic and Iliac Aneurysms: Outcomes from a Single Center Study

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Abstract

Purpose

This study was designed to assess the long-term outcome of selected patients with aortic, aortoiliac, and isolated common iliac aneurysms treated with the GORE EXCLUDER® stent-graft.

Methods

Between December 1998 and June 2010, 121 nonconsecutive patients underwent insertion of a GORE EXCLUDER® stent-graft to treat an aortic (n = 80; 66%), aortoiliac (n = 25; 21%), or isolated common iliac (n = 16; 13%) aneurysm. Procedural and follow-up data were collected prospectively. Primary endpoints are overall survival, intervention-free survival, and freedom from aneurysm rupture. Secondary endpoints are device- and procedure-related complications, including all types of endoleaks or endotension, and reintervention.

Results

The mean follow-up is 4.98 years (standard deviation, 3.18; median follow-up, 4.05 years). The estimated percentage overall survival (with 95% confidence interval) after respectively 5 and 10 years of follow-up is 74.5% (65.8; 81.3) and 57.8% (47.7; 66.7). The estimated intervention-free survival after respectively 5 and 10 years is 90% (84.3; 96.1) and 77.7% (67; 88.4). There was no aneurysm rupture during follow-up. Early postoperative complications occurred in 16 patients (13%); none were fatal. Late reinterventions were performed in 18 patients (15%). Finally, throughout the follow-up period, endoleaks were identified: type I (n = 4; 3%); type II (n = 39; 32%); type III (n = 0; 0%); endotension was seen in 11 patients (9%).

Conclusions

Aneurysm exclusion with use of the GORE EXCLUDER® stent-graft is durable through a mean follow-up of nearly 5 years. There was no postprocedural aneurysm rupture. Complications occurred throughout the follow-up period, requiring continued clinical and radiological surveillance.

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Conflict of interest

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Authors and Affiliations

  1. Department of Radiology, University Hospitals Leuven, Herestraat 49, 3000, Leuven, Belgium

    G. Maleux, H. Claes, A. Van Holsbeeck & S. Heye

  2. Department of Vascular Surgery, University Hospitals Leuven, Herestraat 49, 3000, Leuven, Belgium

    R. Janssen, S. Houthoofd & I. Fourneau

  3. Department of Biostatistics and Statistical Bioinformatics, Catholic University of Leuven, Kapucijnenvoer 35 Blok d - Bus 7001, 3000, Leuven, Belgium

    A. Laenen

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  1. G. Maleux
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  2. H. Claes
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  3. A. Van Holsbeeck
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  4. R. Janssen
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  5. A. Laenen
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  6. S. Heye
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  7. S. Houthoofd
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  8. I. Fourneau
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Corresponding author

Correspondence to G. Maleux.

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The authors state that they haven’t received any funding for research from any of the following organizations: National Institutes of Health (NIH), Wellcome Trust, Howard Hughes Medical Institute (HHMI).

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Maleux, G., Claes, H., Van Holsbeeck, A. et al. Ten Years of Experience with the GORE EXCLUDER® Stent-Graft for the Treatment of Aortic and Iliac Aneurysms: Outcomes from a Single Center Study. Cardiovasc Intervent Radiol 35, 498–507 (2012). https://doi.org/10.1007/s00270-011-0235-6

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  • DOI: https://doi.org/10.1007/s00270-011-0235-6

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