Localized kinking during deployment of a flow redirection lumen device (FRED) could be due to excessive pushing
- Department of Neurosurgery, Hyogo College of Medicine, Nishinomiya, Hyogo, Japan.
Mikiya Beppu, Department of Neurosurgery, Hyogo College of Medicine, Nishinomiya, Hyogo, Japan.
DOI:10.25259/SNI_1127_2021Copyright: © 2022 Surgical Neurology International This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-Share Alike 4.0 License, which allows others to remix, transform, and build upon the work non-commercially, as long as the author is credited and the new creations are licensed under the identical terms.
How to cite this article: Mikiya Beppu1, Yoji Kuramoto1, Soichiro Abe1, Satoshi Namitome1, Shinichi Yoshimura1. Localized kinking during deployment of a flow redirection lumen device (FRED) could be due to excessive pushing. 20-Jan-2022;13:22
How to cite this URL: Mikiya Beppu1, Yoji Kuramoto1, Soichiro Abe1, Satoshi Namitome1, Shinichi Yoshimura1. Localized kinking during deployment of a flow redirection lumen device (FRED) could be due to excessive pushing. 20-Jan-2022;13:22. Available from: https://surgicalneurologyint.com/?post_type=surgicalint_articles&p=11345
Background: The safety and efficacy analysis of flow redirection lumen device (FRED) demonstrated the excellent safety profile of FREDs for aneurysm treatment. We describe the first case in which FRED deployment for a paraclinoid aneurysm resulted in in-stent stenosis, necessitating balloon angioplasty, and an additional stent.
Case Description: A 50-year-old woman had a left paraclinoid aneurysm with a maximum diameter of 6.1 mm. We planned FRED deployment. We experienced in-stent stenosis just after the deployment of a FRED. Devices such as guidewires and catheters could not cross the lesion through the FRED because of an obstruction in the FRED. Balloon angioplasty and subsequent stenting resolved thrombosis and kinking. FRED has potential for kinking locally.
Conclusion: Surgeons should consider this possibility when treating cerebral aneurysm using FRED. Cone-beam computed tomography after deployment of FRED may be useful for evaluating the stent shape.
Keywords: Cone-beam computed tomography, Endovascular treatment, Flow diverter, Flow redirection lumen device, Kinking
The safety and efficacy of flow-diverting (FD) therapy using pipeline embolization devices; Medtronic, Irvine, Ca, USA have been proven in a number of studies.[
The safety and efficacy analysis of FRED embolic device in aneurysm treatment (SAFE) study demonstrated the excellent safety profile of FREDs for aneurysm treatment, with low morbidity and mortality rates, and their efficacy.[
We describe the first case in which FRED deployment for a paraclinoid aneurysm resulted in instent stenosis, necessitating balloon angioplasty, and an additional stent.
A 50-year-old woman visited another hospital for examination of forgetfulness. She had no relevant medical or family history related to her condition. A paraclinoid aneurysm was identified on magnetic resonance angiography. Therefore, she was referred to our department. Digital subtraction angiography (DSA) demonstrated a left paraclinoid aneurysm with a maximum diameter of 6.1 mm [
Digital subtraction angiography in the frontal (a) and lateral projections (b) demonstrating an internal carotid artery aneurysm located at the paraclinoid portion. The image shows good dilatation and no twisting of the flow redirection lumen device (FRED) (c). Digital subtraction angiography showing a contrast defect in the FRED (d).
Under local anesthesia, a 6-Fr shuttle sheath (Cook Medical, Bloomington, IN, USA), was inserted into the right femoral artery. Using a coaxial system consisting of 5-Fr Sofia select (Terumo Corporation, Aliso Viejo, CA, USA), Headway 27 (Terumo Corporation, Aliso Viejo, CA, USA), and ASAHI CHIKAI 18 (ASAHI INTECC CO., LTD. Aichi, Japan), the Sofia select was inserted into the petrous part of the internal carotid artery (ICA), and the Headway 27 was placed to the left middle cerebral artery (MCA). A 4.0 mm × 18 mm FRED was deployed from the orifice of the anterior choroidal artery to the cavernous portion of the ICA, fully covering the aneurysm neck [
After 5 min, the left ICA angiography showed slow flow and a contrast defect in the FRED [
A micro-guidewire could not cross the lesion through the flow redirection lumen device (FRED), indicating an obstruction in the FRED (a and b). The balloon was not fully dilated, consistent with the area of the contrast defect (c). Follow-up DSA after 3 days demonstrated improvement in the contrast defect (d).
A 4.5-mm FRED was deployed with intentional excessive pushing and this shape was verified. The results showed localized kinking of the FRED [
We present our first experience of in-stent stenosis just after the deployment of a FRED. Devices such as guidewires and catheters could not cross the lesion through the FRED because of an obstruction in the FRED. Cone-beam CT showed some space between the two stents, consistent with the contrast defect on 3DRA. This might have occurred due to kinking of the FRED. We considered that excessive pushing of the system during deployment may have led to kinking.
In the FRED Italian registry, follow-up angiography at 3–6 months showed complete or nearly complete occlusion of the aneurysm in 94% of the cases.[
As a complication related to FRED deployment, Guimaraens et al. reported that in-stent thrombus or in-stent stenosis was observed in 9 (4.9%) cases.[
In the present case, we confirmed in-stent stenosis just after deployment of FRED. Cone-beam CT showed some space between FRED and CERENOVUS ENTERPRISE 2 VRD [
Murakami et al. reported that a carotid open-cell stent could be folded inward under specific circumstances wherein the stent does not expand enough to be placed in the stenosis with a device that has a relatively larger diameter outside of the stent.[
The findings based on the aneurysm model suggested that the localized kinking could have been caused by excessive pushing during FRED deployment. Kinking rates of 15–30% have been reported in stents that are near pulsatile structures such as the myocardium or the great vessels.[
Since our experience indicated that FRED stent can undergo kinking, surgeons should avoid pushing excessively during FRED deployment. Furthermore, we should confirm the regular shape of tantalum wire of FRED. We also recommend performing cone-beam computed tomography after FRED deployment to evaluate the shape of the stent.
We first experienced and treated a case of thrombus formation due to kinking of a FRED. Surgeons should avoid pushing excessively and confirm the regular shape of tantalum wire of FRED.
The authors certify that they have obtained all appropriate patient consent.
Dr. Yoshimura reported research grants from Medtronic, Medicos Hirata, Termo, Bristol-Myers Squibb, and Otsuka; lecturer’s fees from Daiichi Sankyo, Pfizer, BoehringerIngelheim, Otsuka, Bayer, Pfizer, Bristol-Myers Squibb, Stryker, Medtronic, and Mitsubishi Tanabe. Other authors have no conflicts of interest to declare.
1. Becske T, Brinjikji W, Potts M, Kallmes D, Shapiro M, Moran C. Long-term clinical and angiographic outcomes following pipeline embolization device treatment of complex internal carotid artery aneurysms: Five-year results of the pipeline for uncoilable or failed aneurysms trial. Neurosurgery. 2016. 80: 40-8
2. Becske T, Potts M, Shapiro M, Kallmes D, Brinjikji W, Saatci I. Pipeline for uncoilable or failed aneurysms: 3-year follow-up results. J Neurosurg. 2017. 127: 81-8
3. Caroff J, Iacobucci M, Rouchaud A, Mihalea C, de Carvalho F, Jocson V. The occurrence of neointimal hyperplasia after flow-diverter implantation is associated with cardiovascular risks factors and the stent design. J Neurointerv Surg. 2018. 11: 610-3
4. Guimaraens L, Vivas E, Saldaña J, Llibre J, Gil A, Balaguer E. Efficacy and safety of the dual-layer flow-diverting stent (FRED) for the treatment of intracranial aneurysms. J Neurointerv Surg. 2019. 12: 521-5
5. Murakami T, Shigematsu T, Kadono Y, Ima H, Kidani T, Asai K. Stent folding deformation in carotid artery stenting with open-cell stent: A case report. J Neuroendovasc Ther. 2015. 9: 260-5
6. Nakanishi T, Kondoh C, Nishikawa T, Satomi G, Nakazawa M, Imai Y. Intravascular stents for management of pulmonary artery and right ventricular outflow obstruction. Heart Vessels. 1994. 9: 40-8
7. Perry SB, Lock JE. Intracardiac stent implantation to relieve muscular and non-muscular obstruction. J Am Coll Cardiol. 1993. 21: 261A
8. Piano M, Valvassori L, Lozupone E, Pero G, Quilici L, Boccardi E. FRED Italian registry: A multicenter experience with the flow re-direction endoluminal device for intracranial aneurysms. J Neurosurg. 2020. 133: 174-81
9. Pierot L, Spelle L, Berge J, Januel A, Herbreteau D, Aggour M. SAFE study (Safety and efficacy Analysis of FRED Embolic device in aneurysm treatment): 1-year clinical and anatomical results. J Neurointerv Surg. 2018. 11: 184-9