Clinical and Morphological Outcomes in Endovascular Aortic Repair of Abdominal Aortic Aneurysm Using GORE C3 EXCLUDER: Comparison between Patients Treated within and Outside Instructions for Use.

Abstract

BACKGROUND:

The goals of this study were to evaluate mid-term outcome in endovascular aortic repair (EVAR) of abdominal aortic aneurysm (AAA) using a GORE C3 EXCLUDER and compare results between patients treated within and outside the instructions for use (IFU).

METHODS:

Over a 3-year period spanning October 2013 to September 2016, consecutive patients undergoing EVAR for AAA using the C3 EXCLUDER at Tokyo Medical University Hospital were registered on a prospectively maintained database. The data thus obtained were retrospectively analyzed.

RESULTS:

A total of 109 AAA patients underwent EVAR using the C3 EXCLUDER. The median follow-up duration was 729 days (interquartile range, 542-1,069 days). Technical success was achieved in 98.2% of cases. Adjunctive, unplanned proximal cuff-extender implantation was required in 8 patients (9.2%). Of the total number, 29 (24.8%) were categorized as being treated outside the IFU. No significant difference was observed in freedom from overall mortality or aneurysm-related mortality between patients treated within and outside the IFU. Freedom from reintervention tended to be lower in patients treated outside the IFU. There was aneurysm sac shrinkage (≥5 mm) in 30.3% and 39.1%; stable aneurysm sac in 69.7% and 56.3%; and aneurysm sac expansion (≥5 mm) in 0% and 4.7% of cases at 1 and 2 years, respectively. No significant difference was observed in aneurysm sac shrinkage between patients treated within and outside the IFU.

CONCLUSIONS:

The C3 EXCLUDER showed good clinical performance and aneurysm sac shrinkage, regardless of whether the patient was treated within or outside the IFU. The results suggest, however, that in those treated outside the IFU, precise planning, careful operative procedure, and subsequent follow-up are required to obtain short-term and mid- to long-term success in EVAR for AAA using the C3 EXCLUDER.

• Authors: Toshiya Nishibe, Toru Iwahashi, Kentaro Kamiya, Masaki Kano, Keita Maruno, Toshiki Fujiyoshi, Akinari Iwahori, Shun Suzuki, Koji Kawago, Satoshi Takahashi, Hitoshi Ogino, Jun Koizumi, Alan Dardik
• Journal: Annals of vascular surgery (Ann Vasc Surg) Vol. 59 Pg. 54-62 (Aug 2019) ISSN: 1615-5947 [Electronic] Netherlands
• PMID: 30802590 (Publication Type: Comparative Study, Journal Article)
• Copyright: Copyright © 2019 Elsevier Inc. All rights reserved.

Topics

• Aged
• Aged, 80 and over
• Aortic Aneurysm, Abdominal (diagnostic imaging, mortality, surgery)
• Blood Vessel Prosthesis (standards)
• Blood Vessel Prosthesis Implantation (adverse effects, instrumentation, mortality, standards)
• Databases, Factual
• Endovascular Procedures (adverse effects, instrumentation, mortality, standards)
• Female
• Guideline Adherence
• Humans
• Male
• Postoperative Complications (etiology)
• Practice Guidelines as Topic
• Product Labeling
• Progression-Free Survival
• Prosthesis Design
• Retrospective Studies
• Risk Assessment
• Risk Factors
• Stents (standards)
• Time Factors
• Tokyo