Flow Modification of Cerebral Aneurysm by Flow Diverter (Pipeline) With Different Packing Densities

Author(s):  
Jianping Xiang ◽  
Ding Ma ◽  
Adnan Siddiqui ◽  
Hui Meng

Flow diverter, a braided fine mesh stent, is emerging as a novel device to treat wide-necked, fusiform, and giant cerebral aneurysms since these types of aneurysms are either untreatable otherwise or have high recurrence rate treated by endovascular coils. Flow diverter devices represent a major paradigm shift in the endovascular treatment of aneurysms from filling the aneurysm cavity to diverting blood flow away from aneurysm sac with parent vessel reconstruction. Due to its high flexibility, a flow diverter can be manipulated during deployment process to achieve better results; for example, an experienced neuro-interventionalist can manipulate the stent’s local metal coverage through coordinated movement of catheter pull-back, pusher advancement, and distal coil release to pack higher density for the aneurysm orifice region to divert more flow away from aneurysm, making aneurismal thrombosis quicker and easier. Pipeline embolization device is the first flow diverter approved by FDA. In this study, we investigate the flow modification of a wide-necked aneurysm by Pipeline with different packing densities.

2008 ◽  
Vol 108 (6) ◽  
pp. 1230-1240 ◽  
Author(s):  
Thomas R. Marotta ◽  
Thorsteinn Gunnarsson ◽  
Ian Penn ◽  
Donald R. Ricci ◽  
Ian Mcdougall ◽  
...  

Object The authors describe a novel device for the endovascular treatment of intracranial aneurysms, the endovascular clip system (eCLIPs). Descriptions of the device and its delivery system as well as the results of flow model tests and the treatment of experimental aneurysms are provided. Methods The eCLIPs comprises a flexible hybrid implantable device (an anchor and a covered leaf) and a balloon catheter delivery system, designed to be positioned and activated in the parent vessel in such a way that the covered portion will abut the aneurysm neck. The eCLIPs was subjected to testing in glass, elastomeric, and cadaveric flow models to determine its navigability, orientation, and activation compared with commercially available stents. In a second experiment, 8 carotid artery sidewall aneurysms in swine were treated using eCLIPs. The degree of occlusion was observed on angiography immediately following and 30 days after device activation, and a histological analysis was performed at 30 days. Results The device could navigate tortuous glass models and human cadaveric vessels. Compared with commercially available stents, the eCLIPs performed well. It could be navigated, oriented, and activated easily and reliably. With regard to the 8 porcine experimental aneurysms, immediate postactivation angiograms confirmed complete occlusion of 4 lesions and near occlusion of the other 4. Angiographic follow-up at 30 days postactivation showed occlusion of all 8 aneurysms and patency of all parent vessels. Histopathological analysis revealed aneurysm healing, with smooth-muscle cells growing across the lesion neck to allow reendothelialization. Conclusions Aneurysm occlusion with a single extrasaccular endovascular device has potential advantages. The authors believe that eCLIPs may prove to be a useful tool in the endovascular treatment of cerebral aneurysms. The system should reduce risks associated with coiling, procedure time, costs, and radiation exposure. The device satisfactorily occluded 8 experimental sidewall aneurysms. The observed healing pattern is similar to that seen after microsurgical clipping.


2018 ◽  
Vol 15 (6) ◽  
pp. 624-633 ◽  
Author(s):  
Fawaz Al-Mufti ◽  
Krishna Amuluru ◽  
Eric R Cohen ◽  
Vikas Patel ◽  
Mohammad El-Ghanem ◽  
...  

Abstract Flow diverting devices (FDDs) have revolutionized the treatment of morphologically complex intracranial aneurysms such as wide-necked, giant, or fusiform aneurysms. Although FDDs are extremely effective, they carry a small yet significant risk of intraprocedural complications. As the implementation of these devices increases, the ability to predict and rapidly treat complications, especially those that are iatrogenic or intraprocedural in nature, is becoming increasingly more necessary. Our objective in this paper is to provide a descriptive summary of the various types of intraprocedural complications that may occur during FDDs deployment and how they may best be treated. A systematic and qualitative review of the literature was conducted using electronic databases MEDLINE and Google Scholar. Searches consisted of Boolean operators “AND” and “OR” for the following terms in different combinations: “aneurysm,” “endovascular,” “flow diverter,” “intracranial,” and “pipeline.” A total of 94 papers were included in our analysis; approximately 87 of these papers dealt with periprocedural endovascular (mainly related to FDDs) complications and their treatment; 7 studies concerned background material. The main categories of periprocedural complications encountered during deployment of FDDs are failure of occlusion, parent vessel injury and/or rupture, spontaneous intraparenchymal hemorrhage, migration or malposition of the FDDs, thromboembolic or ischemic events, and side branch occlusion Periprocedural complications occur mainly due to thromboembolic events or mechanical issues related to device deployment and placement. With increasing use and expanding versatility of FDDs, the understanding of these complications is vital in order to effectively manage such situations in a timely manner.


Neurosurgery ◽  
2012 ◽  
Vol 71 (2) ◽  
pp. E509-E513 ◽  
Author(s):  
Adnan H. Siddiqui ◽  
Peter Kan ◽  
Adib A. Abla ◽  
L. Nelson Hopkins ◽  
Elad I. Levy

Abstract BACKGROUND AND IMPORTANCE: The Pipeline Embolization Device (PED) is a flow diverter designed to treat intracranial aneurysms through endoluminal parent vessel reconstruction. The role of adjunctive coil embolization is unknown. CLINICAL PRESENTATION: This report details the authors' experience with the PED in 2 patients with symptomatic, giant distal intracranial aneurysms (1 basilar artery and 1 M1 segment middle cerebral artery). Both patients had successful parent vessel reconstruction. In the first patient, the basilar artery aneurysm was treated with PEDs alone, and the patient experienced early fatal brainstem hemorrhage from aneurysm rupture. In the second patient, the M1 aneurysm was treated with 2 PEDs along with dense coil embolization, with a good initial angiographic result. This patient experienced acute thrombosis of the PED post-procedure, likely related to mass effect and thrombogenicity of the dense coil mass. CONCLUSION: Flow diversion is an evolutionary step in the treatment of giant intracranial aneurysms. However, complete aneurysm occlusion occurs over a delayed period. The authors recommend placement of coils in addition to PED in the treatment of large or giant distal intracranial aneurysms in an attempt to protect the dome. However, robust packing is to be avoided because it can lead to acute PED thrombotic or compressive occlusion.


2019 ◽  
Author(s):  
Thomas J Sorenson ◽  
Jon P Klein ◽  
Leonardo Rangel-Castilla ◽  
Giuseppe Lanzino

Abstract Fusiform aneurysms involving the M2 branches of the middle cerebral artery are often dissecting, identified by a characteristic diseased adjacent segment, and location not at a branch point. Herein, we present the case of a 38-yr-old man with a symptomatic, dissecting M2 aneurysm that was previously incompletely treated with stent-assisted coiling. In our experience, symptomatic fusiform aneurysms in this location tend to recur unless the involved segment is completely trapped or reconstructed with flow diversion. We successfully treated this patient with a vessel reconstruction using a Pipeline Flex Embolization Device (Medtronic). Deployment of a flow diverter inside a previously placed stent can pose potential challenges, as the original stent may constrain complete expansion of the flow diverter and prevent perfect apposition against the parent vessel wall. In this operative video, we demonstrate this technique and provide a brief discussion of the potential pitfalls.


2021 ◽  
Vol 12 ◽  
Author(s):  
Helge Winters ◽  
Marie-Sophie Schüngel ◽  
Cordula Scherlach ◽  
Dirk Mucha ◽  
Jörg Thalwitzer ◽  
...  

Background: In the last decade, flow diversion (FD) has been established as hemodynamic treatment for cerebral aneurysms arising from proximal and distal cerebral arteries. However, two significant limitations remain—the need for 0.027” microcatheters required for delivery of most flow diverting stents (FDS), and long-term dual anti-platelet therapy (DAPT) in order to prevent FDS-associated thromboembolism, at the cost of increasing the risk for hemorrhage. This study reports the experience of three neurovascular centers with the p64MW-HPC, a FDS with anti-thrombotic coating that is implantable via a 0.021” microcatheter.Materials and methods: Three neurovascular centers contributed to this retrospective analysis of patients that had been treated with the p64MW-HPC between March 2020 and March 2021. Clinical data, aneurysm characteristics, and follow-up results, including procedural and post-procedural complications, were recorded. The hemodynamic effect was assessed using the O'Kelly–Marotta Scale (OKM).Results: Thirty-two patients (22 female, mean age 57.1 years) with 33 aneurysms (27 anterior circulation and six posterior circulation) were successfully treated with the p64MW-HPC. In 30/32 patients (93.75%), aneurysmal perfusion was significantly reduced immediately post implantation. Follow-up imaging was available for 23 aneurysms. Delayed aneurysm perfusion (OKM A3: 8.7%), reduction in aneurysm size (OKM B1-3: 26.1%), or sufficient separation from the parent vessel (OKM C1-3 and D1: 65.2%) was demonstrated at the last available follow-up after a mean of 5.9 months. In two cases, device thrombosis after early discontinuation of DAPT occurred. One delayed rupture caused a caroticocavernous fistula. The complications were treated sufficiently and all patients recovered without permanent significant morbidity.Conclusion: Treatment with the p64MW-HPC is safe and feasible and achieves good early aneurysm occlusion rates in the proximal intracranial circulation, which are comparable to those of well-established FDS. Sudden interruption of DAPT in the early post-interventional phase can cause in-stent thrombosis despite the HPC surface modification. Deliverability via the 0.021” microcatheter facilitates treatment in challenging vascular anatomies.


2016 ◽  
Vol 9 (1) ◽  
pp. 70-76 ◽  
Author(s):  
Francesco Briganti ◽  
Giuseppe Leone ◽  
Lorenzo Ugga ◽  
Mariano Marseglia ◽  
Antonio Macera ◽  
...  

BackgroundExperience with the endovascular treatment of cerebral aneurysms using the p64 Flow Modulation Device is still limited. This study discusses the results and complications of this new flow diverter device.Methods40 patients (30 women, 10 men) with 50 cerebral aneurysms treated in six Italian neurointerventional centers with the p64 Flow Modulation Device between April 2013 and September 2015 were retrospectively reviewed.ResultsComplete occlusion was obtained in 44/50 aneurysms (88%) and partial occlusion in 3 (6%). In the other three aneurysms (6%), two cases of asymptomatic in-stent thrombosis and one intraprocedural occlusion of the parent vessel occurred. Technical complications were observed in eight procedures (16%). Permanent morbidity due to acute in-stent thrombosis and consequent ischemic stroke occurred in one patient (2.5%). No delayed aneurysm rupture, subarachnoid or intraparenchymal hemorrhage, or ischemic complications occurred and there were no deaths.ConclusionsEndovascular treatment with the p64 Flow Modulation Device is a safe treatment for unruptured cerebral aneurysms, resulting in a high rate of occlusion. As with other flow diverter devices, we recommend this treatment mainly for large-necked aneurysms of the internal carotid artery siphon. However, endovascular treatment with the p64 device should also be encouraged in difficult cases such as aneurysms of the posterior circulation and beyond the circle of Willis.


Author(s):  
V. L. Rayz ◽  
G. Acevedo-Bolton ◽  
M. T. Lawton ◽  
V. Halbach ◽  
J. R. Leach ◽  
...  

Giant intracranial aneurysms present a grave danger of hemorrhage, cerebral compression, and thromboembolism. Fusiform aneurysms present a particular challenge for interventional treatment since these lesions cannot be completely removed from the circulation by clipping or coiling without sacrificing flow to the distal vasculature. In some cases, these lesions can be treated by interventions eliminating pathological hemodynamics, such as indirect aneurysm occlusion or deployment of a flow diverter stent (FDS). The first approach consists of proximal occlusion, distal occlusion, or trapping, sometimes performed with a bypass supplying flow from collateral circulation. In the second approach, a flow diverter device is used to reconstruct the parent vessel geometry and redirect the flow away from the aneurysmal sac. This is achieved due to the denser struts of an FDS relative to a standard stent, which provide resistance to the flow across its walls. Both interventional approaches often result in thrombus deposition (TD) in the aneurysm sac that is considered protective. Despite their advantages, these treatments introduce complications related to thrombotic occlusion of vital perforators or branch arteries. A virtual model, that could predict TD regions that result from flow alteration could help evaluate various treatment options. In addition to biochemical factors, an important role in the TD process may be played by hemodynamics. Previous studies demonstrated that flow regions with elevated TD potential are characterized by low velocities and near-wall shear stresses as well as increased flow residence time [1, 2]. The current study extends this patient-specific CFD methodology to predict TD regions following vascular interventions, such as proximal vessel occlusion and FDS deployment.


2022 ◽  
Vol 12 ◽  
Author(s):  
Stefan Schob ◽  
Richard Brill ◽  
Eberhard Siebert ◽  
Massimo Sponza ◽  
Marie-Sophie Schüngel ◽  
...  

Background: Treatment of cerebral aneurysms using hemodynamic implants such as endosaccular flow disruptors and endoluminal flow diverters has gained significant momentum during recent years. The intended target zone of those devices is the immediate interface between aneurysm and parent vessel. The therapeutic success is based on the reduction of aneurysmal perfusion and the subsequent formation of a neointima along the surface of the implant. However, a subset of aneurysms–off-centered bifurcation aneurysms involving the origin of efferent branches and aneurysms arising from peripheral segments of small cerebral vessels–oftentimes cannot be treated via coiling or implanting a hemodynamic implant at the neck level for technical reasons. In those cases, indirect flow diversion–a flow diverter deployed in the main artery proximal to the parent vessel of the aneurysm–can be a viable treatment strategy, but clinical evidence is lacking in this regard.Materials and Methods: Five neurovascular centers contributed to this retrospective analysis of patients who were treated with indirect flow diversion. Clinical data, aneurysm characteristics, anti-platelet medication, and follow-up results, including procedural and post-procedural complications, were recorded.Results: Seventeen patients (mean age: 60.5 years, range: 35–77 years) with 17 target aneurysms (vertebrobasilar: n = 9) were treated with indirect flow diversion. The average distance between the flow-diverting stent and the aneurysm was 1.65 mm (range: 0.4–2.4 mm). In 15/17 patients (88.2%), perfusion of the aneurysm was reduced immediately after implantation. Follow-ups were available for 12 cases. Delayed opacification (OKM A3: 11.8%), reduction in size (OKM B1-3: 29.4%) and occlusion (D1: 47.1%) were observable at the latest investigation. Clinically relevant procedural complications and adverse events in the early phase and in the late subacute phase were not observed in any case.Conclusion: Our preliminary data suggest that indirect flow diversion is a safe, feasible, and effective approach to off-centered bifurcation aneurysms and distant small-vessel aneurysms. However, validation with larger studies, including long-term outcomes and optimized imaging, is warranted.


Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Nikolaos Mouchtouris ◽  
David Hasan ◽  
Fadi Al Saiegh ◽  
Ahmad Sweid ◽  
Mario Zanaty ◽  
...  

Introduction: Wide-neck bifurcation cerebral aneurysms have always posed a treatment challenge and have historically required either clip ligation, or stent vs. balloon-assisted coil embolization. This predicament led to the development of the newly FDA-approved Woven EndoBridge (WEB) aneurysm embolization system (Sequent Medical Inc, Aliso Viejo, CA) Which is a self-expanding mesh that achieves intrasaccular flow disruption and does not require antithrombotic medications. In this study, we report our experience with the first 64 consecutive aneurysms treated via WEB embolization at two high-volume institutions. Methods: We reviewed our first 61 consecutive patients with 64 cerebral aneurysms who underwent WEB embolization from February-August 2019. We collected data on patient demographics and clinical presentation, aneurysm characteristics, device and procedural details, and functional outcomes. Results: A total of 64 aneurysms were included in our study. Fifteen patients (24.1%) presented with acutely ruptured aneurysm while the rest were unruptured. The majority of patients (82.8%) required only one attempt for successful device deployment, while a stent was necessary as an adjunct treatment in 4 patients (6.3%) due to WEB herniation. Two patients had residual aneurysm that had to undergo additional treatment; one of them underwent second WEB embolization and one underwent clip ligation. One patient with a PICA aneurysm had device dislodgment with injury to the parent vessel—Onyx and coils were used to deconstruct the vertebral artery. Conclusions: The advent of the WEB device has significantly impacted the surgical decision-making for the treatment of bifurcation, wide-neck aneurysms. We discuss in detail the lessons learned from patient selection, device size selection, technique, and complications from two institutions with high-volume endovascular and microsurgical aneurysm treatment experience.


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