Biodegradable Flow Diverter for the Treatment of Intracranial Aneurysms: A Pilot Study Using a Rabbit Aneurysm Model

Nishi, Hidehisa; Ishii, Akira; Ono, Isao; Abekura, Yu; Ikeda, Hiroyuki; Arai, Daisuke; Yamao, Yukihiro; Okawa, Masakazu; Kikuchi, Takayuki; Nakakura, Akiyoshi; Miyamoto, Susumu

doi:10.1161/jaha.119.014074

Cited by 13 publications

(19 citation statements)

References 31 publications

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“…If the neointimal layer does not cover the bioabsorbable struts evenly, either the stent itself or small segments of PLLA fibers can potentially migrate during fragmentation of polymer in the absorption process, increasing the chance of stroke. The delivery conditions reported in our animal studies resulted in a significant temporary stent diameter reduction of more than four times, yet did not require angioplasty to obtain good wall apposition as opposed to other studies 10. We have since been using 0.027” catheters (as shown in figure 1B) to deploy the stents in our studies and achieving good self-expansion without the need for angioplasty.…”

Section: Discussionmentioning

confidence: 77%

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A novel self-expanding primarily bioabsorbable braided flow-diverting stent for aneurysms: initial safety results

Jamshidi

Rajabian

Avery

et al. 2019

J NeuroIntervent Surg

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IntroductionThe advent of metal flow-diverting stents has provided neurointerventionalists with an option for treating aneurysms without requiring manipulations within the aneurysm sac. The large amount of metal in these stents, however, can lead to early and late thrombotic complications, and thus requires long-term antiplatelet agents. Bioabsorbable stents have been postulated to mitigate the risk of these complications. Here we present early data on the first self-expandable primarily bioabsorbable stent for aneurysms.MethodsBraided stents were developed using poly-L-lactic acid fibers with material surface area similar to metal flow diverters. Crush resistance force, hemolysis, and thrombogenicity were determined and compared with existing commercial devices. Stents were deployed in infra-renal rabbit aortas to determine angiographic side branch patency and to study neointima formation for a 1-month follow-up period.ResultsCrush resistance force was determined to be on the order of existing commercial devices. Hemolytic behavior was similar to existing metal devices, and thrombogenicity was lower than metal flow-diverting stents. A smooth neointimal layer was found over the absorbable stent surface and all covered side branches were patent at follow-up.ConclusionThe design of self-expanding primarily bioabsorbable flow-diverting stents is possible, and preliminary safety data is consistent with a favorable profile in terms of mechanical behavior, hemocompatibility, side branch patency, and histological effects. Additional in vitro and long-term in vivo studies are in progress and will help determine aneurysm occlusion rates and absorption characteristics of the stent.

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Section: Discussionmentioning

confidence: 77%

“…In 2019, our group described the first self-expanding bioabsorbable flow-diverting stent for brain aneurysms, which was presented at the 2019 Joint Cerebrovascular Section Meeting 9. More recently, Nishi et al published their pilot data on a biodegradable flow-diverting PLLA stent requiring angioplasty for proper deployment 10…”

Section: Introductionmentioning

confidence: 99%

A novel self-expanding primarily bioabsorbable braided flow-diverting stent for aneurysms: initial safety results

Jamshidi

Rajabian

Avery

et al. 2019

J NeuroIntervent Surg

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“…The New Zealand rabbit elastase-induced aneurysm of the RCCA is one of the most common experiment models in testing the safety and efficacy of new endovascular devices in the field of interventional neuroradiology and biomaterial engineering (1)(2)(3)(4)(5)(6). However, the configurations of the aneurysm, especially neck width, still remain randomized and uncontrollable.…”

Section: Discussionmentioning

confidence: 99%

“…The preclinical experiment studies play an important role in helping practitioners and device developers improve techniques and tools for endovascular treatment (EVT) of intracranial aneurysms. Elastase-induced aneurysm of the right common carotid artery (RCCA) in rabbits has been widely used to test the safety and efficacy of new endovascular devices prior to use in humans (1)(2)(3)(4)(5)(6). The previous preclinical studies have indicated that the elastase-induced aneurysm model has similar hemodynamic, morphological, and histologic characteristics to human unruptured aneurysms, and demonstrated similar healing responses and biologic characteristics to treat with coils, stents, and flow diverters as human aneurysms (7)(8)(9)(10).…”

Section: Introductionmentioning

confidence: 99%

An Improved Surgical Technique to Increase Neck Width of Elastase-Induced Aneurysm Model in Rabbits: A Prospective Study

Zhang

He²,

Tang³

et al. 2022

Front. Neurol.

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BackgroundRabbit elastase-induced aneurysms have widely been used to test various endovascular materials over the past two decades. However, wide-necked aneurysms cannot be stably constructed.ObjectiveThe purpose of the study was to increase the neck width of the elastase-induced aneurysm model in rabbits via an improved surgical technique with two temporary clips.Materials and MethodsFifty-four elastase-induced aneurysms in rabbits were successfully created. Group 1 was (n = 34) composed of cases in which two temporary aneurysm clips were placed closely medially and laterally to the origin of the right common carotid artery (RCCA), respectively. Group 2 (n = 20) included cases in which a single temporary aneurysm clip was placed crossed the origin of RCCA. Digital subtraction angiography (DSA) was performed before and immediately after elastase incubation and 3 weeks later. The diameter of the origin of RCCA before and immediately after elastase incubation and aneurysm sizes of the two groups were measured and compared. Moreover, the correlation analysis was performed between the diameter of the origin of RCCA immediately after elastase incubation and aneurysm neck width.ResultsThe mean aneurysm neck and dome width of group 1 were both significantly larger than that of group 2 (p-value < 0.001 and p-value = 0.005, respectively). Moreover, the proportion of wide-necked aneurysms (neck width ≥4 mm) in group 1 was significantly larger than that in group 2 (p-value = 0.004) and the mean dome to neck ratio (D/N) of group 1 was smaller than that of group 2 (p-value = 0.008). Furthermore, there was a positive correlation between the diameter of the origin of RCCA immediately after elastase incubation and aneurysm neck width.ConclusionThe improved surgical technique with two temporary clips, focusing on the direct contact of elastase with the origin of RCCA, could increase the neck width of elastase-induced aneurysm models in rabbits.

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“…[ 169 ] 2019 X Surgical Rabbits Saccular X X Grüter B.E. [ 170 ] 2019 X Surgical Rats Saccular X Nishi H. [ 171 ] 2019 X Surgical Rabbits Saccular X X Iseki S. [ 172 ] 2019 X Surgical Swines Saccular X King R.M. [ 173 ] 2019 X Surgical Dogs Saccular X X …”

Section: Methodsmentioning

confidence: 99%

Imaging of intracranial aneurysms in animals: a systematic review of modalities

et al. 2023

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Intracranial aneurysm (IA) animal models are paramount to study IA pathophysiology and to test new endovascular treatments. A number of in vivo imaging modalities are available to characterize IAs at different stages of development in these animal models. This review describes existing in vivo imaging techniques used so far to visualize IAs in animal models. We systematically searched for studies containing in vivo imaging of induced IAs in animal models in PubMed and SPIE Digital library databases between 1 January 1945 and 13 July 2022. A total of 170 studies were retrieved and reviewed in detail, and information on the IA animal model, the objective of the study, and the imaging modality used was collected. A variety of methods to surgically construct or endogenously induce IAs in animals were identified, and 88% of the reviewed studies used surgical methods. The large majority of IA imaging in animals was performed for 4 reasons: basic research for IA models, testing of new IA treatment modalities, research on IA in vivo imaging of IAs, and research on IA pathophysiology. Six different imaging techniques were identified: conventional catheter angiography, computed tomography angiography, magnetic resonance angiography, hemodynamic imaging, optical coherence tomography, and fluorescence imaging. This review presents and discusses the advantages and disadvantages of all in vivo IA imaging techniques used in animal models to help future IA studies finding the most appropriate IA imaging modality and animal model to answer their research question.

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Biodegradable Flow Diverter for the Treatment of Intracranial Aneurysms: A Pilot Study Using a Rabbit Aneurysm Model

Cited by 13 publications

References 31 publications

A novel self-expanding primarily bioabsorbable braided flow-diverting stent for aneurysms: initial safety results

A novel self-expanding primarily bioabsorbable braided flow-diverting stent for aneurysms: initial safety results

An Improved Surgical Technique to Increase Neck Width of Elastase-Induced Aneurysm Model in Rabbits: A Prospective Study

Imaging of intracranial aneurysms in animals: a systematic review of modalities

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