A Pilot Study of the Intracranial Multilayer Flow Modulator as a New Disruptive Technology in the Treatment of Cerebral Aneurysms

Main Article Content

Sherif Sultan Edel P Kavanagh Antoine Alves Isabel Wanke Sophia Goericke Daniel Ruefenacht Niamh Hynes

Abstract

The purpose of this study was to evaluate by histopathological analysis and Energy Dispersive X-ray analysis, the ability to occlude cerebral aneurysms with the Cardiatis (Isnes, Belgium) intracranial Multilayer Flow Modulator (MFM) device.

The devices were implanted in the subclavian artery distally to the brachiocephalic trunk proximally of 6 rabbit animal models, following induction of an aneurysm in the right carotid artery, collateral to the implanted segment of the subclavian. Device placement was performed 4 weeks after aneurysm creation, and for an implantation duration of 4 weeks. The aim of the study was to demonstrate local biocompatibility of the device as well as device integration without signs of complication.

Gross examination and histopathological analysis showed the aneurysmal areas of all six specimens were obturated with an old mixed thrombus, showing the lines of Zahn. The devices were also markedly integrated into the arterial wall with no evidence of local intolerance, and no aneurysm rupture or leakage was observed. Energy dispersive x-ray analysis of the specimens revealed that in all areas investigated in the tissues surrounding the device struts, there was an absence of metal release.

These results demonstrate the basic mechanism of the MFM, its ability to occlude a cerebral aneurysm, created using a rabbit model. Studies using a larger cohort and longer time period are necessary to assess the intracranial MFM’s long-term results.

Article Details

How to Cite
SULTAN, Sherif et al. A Pilot Study of the Intracranial Multilayer Flow Modulator as a New Disruptive Technology in the Treatment of Cerebral Aneurysms. Medical Research Archives, [S.l.], n. 3, june 2015. ISSN 2375-1924. Available at: <http://journals.ke-i.org/index.php/mra/article/view/157>. Date accessed: 19 nov. 2017.
Keywords
Intracranial aneurysm; aneurysm; Animal models; Prostheses and Implants
Section
Research Articles

References

Bouzeghrane F, Naggara O, Kallmes DF, Berenstein A, Raymond J, International Consortium of Neuroendovascular Centres. “In vivo experimental intracranial aneurysm models: a systematic review.” AJNR Am J Neuroradiol 31, no. 3 (2010): 418-423. doi: 10.3174/ajnr.A1853.

Brinjikji W, Murad MH, Lanzino G Cloft HJ, Kallmes DF. “Endovascular treatment of intracranial aneurysms with flow diverters: a meta-analysis.” Stroke 44, no. 2 (2013): 442-447. doi: 10.1161/STROKEAHA.

Brown RD, Broderick JP. “Unruptured intracranial aneurysms: epidemiology, natural history, management options, and familial screening.” Lancet Neurol 13, no. 4 (2014): 393-404. doi: 10.1016/S1474-4422(14)70015-8.

Byrne JV, Szikora I. “Flow Diverters in the Management of Intracranial Aneurysms: A Review.” EJMINT. (2012): 1225000057. Accessed February 11, 2014. url: http://www.ejmint.org/original-article/1225000057.

Chocron S, Vaislic C, Kaili D, Bonneville JF. “Multilayer stents in the treatment of thoraco-abdominal residual type B dissection.” Interact Cardiovasc Thorac Surg 12, no. 6 (2011): 1057-1059. doi: 10.1510/icvts.2010.257394.

Dinç H, Öztürk MH, Sari A, Çakir E, Gazioğlu G, Kuzeyli K. “Coil embolization in 481 ruptured intracranial aneurysms: angiographic and clinical results.” Diagn Interv Radiol 19, no. 2 (2013): 165-172. doi: 10.4261/1305-3825.DIR.6197-12.1.

Donath K, Brunner G. “A method for the study of nondecalcified bone and teeth with attached soft tissues.” J Oral Pathol Med 11, no. 4 (1982): 318-326. DOI: 10.1111/j.1600-0714.1982.tb00172.x.

Ferrero E, Ferri M, Viazzo A, Robaldo A, Carbonatto P, Pecchio A, Chiecchio A, Nessi F. “Visceral Artery Aneurysms, an Experience on 32 Cases in a Single Center: Treatment From Surgery to Multilayer Stent.” Ann Vasc Surg 25, no. 7 (2011): 923-35. doi: 10.1016/j.avsg.2011.04.006.

Gál G, Rudnicka S. “Mid term experiences with a new flow diverter, the Cardiatis Intracranial Multilayer System”, Presentation at the 12th congress of the World Federation of Interventional and Therapeutic Neuroradiology, Buenos Aires. November 9-13 2013.

Hackam DG, Redelmeier DA. “Translation of Research Evidence From Animals to Humans.” J Am Med Assoc 296, no. 14 (2006): 1731-1732. doi:10.1001/jama.296.14.1731.

Henry M, Polydorou A, Frid N, Gruffaz P, Cavet A, Henry I, Hugel M, Rüfenacht DA, Augsburger L, De Beule M, Verdonck P, Bonneau M, Kang C, Ouared R, Chopard B. “Treatment of Renal Artery Aneurysm With the Multilayer Stent.” J Endovasc Ther 15, no. 2 (2008): 231-236. doi: 10.1583/07-2222.1.

Ionita CN, Paciorek AM, Dohatcu A, Hoffmann KR, Bednarek DR, Kolega J, Levy EI, Hopkins LN, Rudin S, Mocco JD. “The Asymmetric Vascular Stent: Efficacy in a rabbit aneurysm model.” Stroke 40, no. 3 (2009): 959-965. doi: 10.1161/STROKEAHA.108.524124.

Kallmes DF, Ding YH, Dai D, Kadirvel R, Lewis DA, Cloft HJ. “A Second-Generation, Endoluminal, Flow-Disrupting Device for Treatment of Saccular Aneurysms.” Am J Neuroradiol 30, no. 6 (2009): 1153-1158. doi: 10.3174/ajnr.A1530.

Kelly AG. “Unruptured Intracranial Aneurysms: Screening and Management.” Continuum (Minneap Minn) 20, no. 2 Cerebrovascular Disease (2014): 387-398. doi: 10.1212/01.CON.0000446108.12915.65.

Lubicz B, Collignon L, Raphaeli G, Pruvo JP, Bruneau M, De Witte O, Leclerc X. “Flow-Diverter Stent for the Endovascular Treatment of Intracranial Aneurysms - A Prospective Study in 29 Patients With 34 Aneurysms.” Stroke 41, no. 10 (2010): 2247-2253. doi: 10.1161/STROKEAHA.110.589911.

Meyer C, Verrel F, Weyer G, Wilhelm K. “Endovascular Management of Complex Renal Artery Aneurysms Using the Multilayer Stent.” Cardiovasc Intervent Radiol 34, no. 3 (2011): 637-641. doi: 10.1007/s00270-010-0047-0.

Piotin M, Blanc R, Spelle L, Mounayer C, Piantino R, Schmidt PJ, Moret J. “Stent-assisted coiling of intracranial aneurysms: clinical and angiographic results in 216 consecutive aneurysms.” Stroke 41, no. 1 (2010): 110-115. doi: 10.1161/STROKEAHA.109.558114.

Polydorou A, Henry M, Bellenis I, Kiskinis D, Bolos K, Athanasiadou K, Portinos A, Dedeilias P, Kokotsakis I, Anthopoulos P, Chondros G, Testempasi E, Farsaris D, Kratimenos T, Tsiakouri C, Papapavlou P, Rammos S, Perdikides T, Polydorou A, Polydorou V, Stavrou G, Megalooikonomos P, Moutiris J, Fotis T. “Endovascular treatment of arterial aneurysms with side branches - a simple method. Myth or reality?” Hospital Chronicles 5, no. 2 (2010): 88-94. url: http://www.hospitalchronicles.gr/index.php/hchr/article/view/214

Rajpal G, Kadzioloka K, Estrade L, Pierot L. “Flow diverter neuroendovascular stents-Reconstructive endovascular treatment of intracranial aneurysms-Single centre experience” Indian J Neurosurg 2, no. 2 (2013): 182-188. url: http://www.ijns.in

Sultan S, Hynes N. “Disruptive Endovascular Technology with Multilayer Flow Modulator Stents as a Therapeutic Option in the Management of Thoracoabdominal Aortic Aneurysms. Early Results From the Global Independent MFM Registry.” Italian J Vasc Endovasc Surg 19, no. 4 (2012): 215-228. url: http://www.minervamedica.it/en/journals/vascular-endovascular-surgery/article.php?cod=R46Y2012N04A0215

“Understanding: Brain Aneurysm Statistics and Facts.” Brain Aneurysm Foundation. Last modified, 2015. http://www.bafound.org/Statistics_and_Facts.

Williams SM, Haines JL, Moore JH. “The use of animal models in the study of complex disease: all else is never equal or why do so many human studies fail to replicate animal findings?” Bioessays 26, no. 2 (2004): 170-179. doi: 10.1002/bies.10401

Wong GK, Kwan MC, Ng RY, Yu SC, Poon WS. “Flow diverters for treatment of intracranial aneurysms: current status and ongoing clinical trials.” J Clin Neurosci 18, no. 6 (2011): 737-740. doi: 10.1016/j.jocn.2010.10.011.

Most read articles by the same author(s)

Obs.: This plugin requires at least one statistics/report plugin to be enabled. If your statistics plugins provide more than one metric then please also select a main metric on the admin's site settings page and/or on the journal manager's settings pages.