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Safety and Functionality of a Guidewire Fixator: Clinical Investigation of a New Endovascular Tool

Liungman, Krister; Mani, Kevin; Wanhainen, Anders; Bosaeus, Linus; Lachat, Mario (2018). Safety and Functionality of a Guidewire Fixator: Clinical Investigation of a New Endovascular Tool. Innovations : Technology And Techniques In Cardiothoracic And Vascular Surgery, 13(1):51-53.

Abstract

OBJECTIVE A new endovascular tool, the Liungman Guidewire Fixator, has been developed to simplify endovascular treatment in complex aortic aneurysms. The device has been extensively tested in bench models and animal trials. To verify the safety and functionality demonstrated in the porcine model, the device was tested in ten patients undergoing endovascular aortic repair (EVAR) or fenestrated endovascular aortic repair (f-EVAR) treatment for abdominal aortic aneurysm.
METHODS The Liungman Guidewire Fixator consists of a braided stent-like, cylindrical structure with conical ends and a central channel for a 0.035″ guidewire. When in use, it is slid along the guidewire and positioned in the target artery, where the Liungman Guidewire Fixator interacts with the arterial wall by anchoring the guidewire to the wall through a radial force. The Liungman Guidewire Fixator allows for uninterrupted blood flow passed the point of fixation. In this study, the Liungman Guidewire Fixator was tested in ten patients undergoing EVAR or f-EVAR treatment for abdominal aortic aneurysm. The device was deployed and retrieved crossover into the hypogastric artery, and the occurrence of thrombotic occlusion, arterial dissection, and vascular rupture or trauma was studied using angiography, as well as device ability to withstand guidewire tension.
RESULTS There were no instances of occlusion, dissection, or vascular trauma detected using angiography. In all cases, deployment and retrieval were successful, and the devices could withstand an applied tension of 3 N. In one instance, retrieval was challenging because of significant tortuosity, which was resolved by a coaxial catheterization.
CONCLUSIONS Deployment was uneventful in all ten patients. Retrieval according to the intended instruction for use was performed in nine of the patients. In one patient, a coaxial catheterization was necessary. All devices withstood a retention force of 3 N.

Additional indexing

Item Type:Journal Article, refereed, original work
Communities & Collections:04 Faculty of Medicine > University Hospital Zurich > Clinic for Cardiac Surgery
Dewey Decimal Classification:610 Medicine & health
Scopus Subject Areas:Health Sciences > Surgery
Health Sciences > Pulmonary and Respiratory Medicine
Health Sciences > Cardiology and Cardiovascular Medicine
Language:English
Date:1 January 2018
Deposited On:05 Mar 2019 13:45
Last Modified:29 Aug 2024 03:33
Publisher:Lippincott Williams & Wilkins
ISSN:1556-9845
OA Status:Hybrid
Free access at:PubMed ID. An embargo period may apply.
Publisher DOI:https://doi.org/10.1097/IMI.0000000000000468
PubMed ID:29465630
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