Open: Precannulated Fenestrated Endovascular Aneurysm Repair using Guidewire Fixator

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.

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Section: Discussionmentioning

confidence: 99%

“… 3 A simplistic case of a single fenestration f-EVAR in a pig model under anesthesia has been previously published. 4 …”

mentioning

confidence: 99%

Safety and Functionality of a Guidewire Fixator

Liungman

Mani

Wanhainen

et al. 2018

Innovations�(Phila)

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“…Furthermore, distal fixation allows repositioning of the proximal end of the guidewire, which can be used, e.g., during fenestrated and branched aortic repair to access angled target artery takeoff. 4 The force of fixation tested in this study was 3 N. This force was chosen as the necessary retaining force needed to hold the guidewire during an endovascular procedure was anticipated to be limited and of this magnitude.…”

Section: Discussionmentioning

confidence: 99%

“…3 A simplistic case of a single fenestration f-EVAR in a pig model under anesthesia has been previously published. 4 Guidewire stability is also valuable in other endovascular procedures because distal fixation enables tension on the guidewire and thereby better procedure guidance, e.g., for crossover treatment of peripheral arterial disease.…”

mentioning

confidence: 99%

Safety and Functionality of a Guidewire Fixator

et al. 2018

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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 stentlike, 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.

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Open: Precannulated Fenestrated Endovascular Aneurysm Repair using Guidewire Fixator

Cited by 2 publications

References 5 publications

Safety and Functionality of a Guidewire Fixator

Safety and Functionality of a Guidewire Fixator

Safety and Functionality of a Guidewire Fixator

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