The pEGASUS-HPC stent system for intracranial arterial stenosis: a single-center case series.

BACKGROUND: Intracranial arterial stenting is a technique for the treatment of symptomatic stenosis. In this single-center retrospective case series we evaluated a novel low profile laser-cut stent with an antithrombogenic hydrophilic polymer coating (pEGASUS-HPC, Phenox GmbH, Bochum, Germany) for the treatment of intracranial stenosis in the setting of acute ischemic stroke and elective cases. METHODS: All patients treated with pEGASUS-HPC for one or more intracranial arterial stenoses at our institution were retrospectively included. Clinical, imaging and procedural parameters as well as clinical and imaging follow-up data were collected. RESULTS: We performed 43 interventions in 41 patients with 42 stenoses in our neurovascular center between August 2021 and February 2024. Twenty-one patients (51.2%) were female and the mean±SD age was 71±10.8 years. Thirty-seven (86.1%) procedures were performed in the setting of endovascular acute ischemic stroke treatment. Technical or procedural complications occurred in seven patients (16.3%), six in the thrombectomy group and one in the elective group. One stent-related hemorrhagic complication (subarachnoid hemorrhage) occurred in emergency cases and symptomatic intracerebral hemorrhage occurred in one patient treated in an elective setting. Overall stenosis reduction following pEGASUS-HPC stent implantation was 53.0±18.0%. On follow-up imaging, which was available for 16 patients (37.2%) after an average of 32±58.6 days, 62.5% of the stents were patent. CONCLUSION: Our single-center case series demonstrates the feasibility of using the pEGASUS-HPC stent system, especially in emergency situations when thrombectomy fails.

The effect of actuation frequency on clot integration with the Tigertriever device: A preliminary in vitro study.

BACKGROUND: The Tigertriever stent retriever (Rapid Medical) can be actively expanded and contracted by the operator, which allows for several actuation-related parameters to be optimized to potentially improve device efficacy. These parameters have not yet been evaluated. We conducted a benchtop study to evaluate the effect of actuation frequency on clot integration within the stent. METHODS: A Tigertriever 17 device was deployed within a biological clot analog placed in a straight tube. The device was actuated between the maximally contracted and maximally expanded states with three different frequencies: passive (one-time opening, n = 6), slow (20 s/cycle, n = 6), and fast (5 s/cycle, n = 7). A flat-detector CT scan was acquired, the clot and stent wires were segmented, and the boundaries of the clot and stent wires were calculated on each axial slice. The intersection between the stent and clot boundaries throughout the volume was defined as the volume of clot integrated within the stent. The clot integration factor (ratio of integrated clot volume to total clot volume) was then statistically compared between the three frequencies as an estimate of clot capture efficiency. RESULTS: The clot integration factor was significantly higher (23% increase, p = 0.01) with the fast actuation as compared to the passive and slow actuations, with a post hoc test showing no difference (p > 0.05) between the passive and slow groups. CONCLUSIONS: Faster actuation frequencies may result in improved clot integration with the Tigertriever device. This effect needs to be validated by clinical data.

ARISE I Consensus Statement on the Management of Chronic Subdural Hematoma.

ARISE (Aneurysm/AVM/cSDH Roundtable Discussion With Industry and Stroke Experts) organized a one-and-a-half day meeting and workshop and brought together representatives from academia, industry, and government to discuss the most promising approaches to improve outcomes for patients with chronic subdural hematoma (cSDH). The emerging role of middle meningeal artery embolization in clinical practice and the design of current and potential future trials were the primary focuses of discussion. Existing evidence for imaging, indications, agents, and techniques was reviewed, and areas of priority for study and key questions surrounding the development of new and existing treatments for cSDH were identified. Multiple randomized, controlled trials have met their primary efficacy end points, providing high-level evidence that middle meningeal artery embolization is a potent adjunctive therapy to the standard (surgical and nonsurgical) management of neurologically stable cSDH patients in terms of reducing rates of disease recurrence. Pooled data analyses following the formal conclusion and publication of these trials will form a robust foundation upon which guidelines can be strengthened for cSDH treatment modalities and optimal patient selection, as well as delineate future lines of investigation.

The pEGASUS-HPC stent system for stent-assisted coiling of cerebral aneurysms: a multicenter case series.

BACKGROUND: Stent-assisted coiling (SAC) is a well-established method for treatment of wide-necked intracranial aneurysms. In this multicenter, retrospective case series we evaluated SAC with a new low-profile, laser-cut stent with an antithrombogenic hydrophilic polymer coating (pEGASUS-HPC) for the treatment of intracranial aneurysms. METHODS: Patients treated with pEGASUS-HPC SAC for one or more intracranial aneurysms were retrospectively included. Clinical, imaging, and procedural parameters as well as clinical and imaging follow-up data were recorded. RESULTS: We treated 53 aneurysms in 52 patients in six neurovascular centers between August 2021 and November 2022. Thirty-seven patients (69.8%) were female. Mean age was 57 (±11.7) years. Twenty-nine patients were treated electively, 23 in the acute phase (22 with aneurysmal subarachnoid hemorrhage (SAH), and 1 with a partially thrombosed aneurysm causing ischemic events). One intraprocedural thromboembolic event and three postprocedural ischemic complications occurred in two (8.7 %) of the SAH patients and in one of the elective patients (3.45%). Overall aneurysm occlusion was Raymond Roy (RR) I in 36 (69.2%), RR II in 9, and RR III in 9 cases. Follow-up imaging was available for 23 patients after an average of 147.7 (±59.6) days demonstrating RR I occlusion in 22 (95.5%) and RR II in 1 patient. CONCLUSION: SAC with the pEGASUS-HPC stent system demonstrates rates of periprocedural safety and effectiveness that are comparable with previously reported series for stent-assisted coil embolization.

In vitro flow diversion effect of the ReSolv stent with the shelf technique in a bifurcation aneurysm model.

BACKGROUND: Flow-diverting stents are not currently indicated for the treatment of bifurcation aneurysms, and some case series have demonstrated low occlusion rates, possibly due to a lack in neck coverage. The ReSolv stent is a unique hybrid metal/polymer stent that can be deployed with the shelf technique in order to improve neck coverage. METHODS: A Pipeline, unshelfed ReSolv, and shelfed ReSolv stent were deployed in the left-sided branch of an idealized bifurcation aneurysm model. After determining stent porosity, high-speed digital subtraction angiography runs were acquired under pulsatile flow conditions. Time-density curves were created using two region of interest (ROI) paradigms (total aneurysm and left/right), and four parameters were extracted to characterize flow diversion performance. RESULTS: The shelfed ReSolv stent demonstrated better aneurysm outflow alterations compared to the Pipeline and unshelfed ReSolv stent when using the total aneurysm as the ROI. On the left side of the aneurysm, there was no significant difference between the shelfed ReSolv stent and the Pipeline. On the right side of the aneurysm, however, the shelfed ReSolv stent had a significantly better contrast washout profile than the unshelfed ReSolv stent and the Pipeline stent. CONCLUSIONS: The ReSolv stent with the shelf technique demonstrates the potential to improve flow diversion outcomes for bifurcation aneurysms. Further in vivo testing will help to determine whether the additional neck coverage leads to better neointimal scaffolding and long-term aneurysm occlusion.

In vitro comparison of middle meningeal artery embolization with Squid liquid embolic agent and Contour polyvinyl alcohol particles.

BACKGROUND: Liquid embolic agents and polyvinyl alcohol (PVA) particles have been used for the embolization of the middle meningeal artery (MMA) for the treatment of chronic subdural hematomas. However, the vascular penetration and distribution of these embolic agents have not yet been compared. The current study compares distribution of a liquid embolic agent (Squid) to PVA particles (Contour) in an in vitro model of the MMA. METHODS: MMA models were embolized with Contour PVA particles 45-150 µm, Contour PVA particles 150-250 µm, and Squid-18 liquid embolic agent (n=5 each). The models were scanned and every vascular segment with embolic agent was manually marked on the images. Embolized vascular length as a percentage of control, average embolized vascular diameter, and embolization time were compared between the groups. RESULTS: The 150-250 µm Contour particles primarily accumulated close to the microcatheter tip, yielding proximal branch occlusions. The 45-150 µm Contour particles achieved a more distal distribution, but in a patchy segmental pattern. However, the models embolized with Squid-18 had a consistently distal, near-complete and homogenous distribution. Embolized vascular length was significantly higher (76±13% vs 5±3%, P=0.0007) and average embolized vessel diameter was significantly smaller (405±25 µm vs 775±225 µm, P=0.0006) with Squid than with Contour. Embolization time with Squid was also lower (2.8±2.4 min vs 6.4±2.7 min, P=0.09). CONCLUSIONS: Squid-18 liquid results in a considerably more consistent, distal and homogeneous pattern of embolysate distribution than Contour PVA particles in an anatomical model of the MMA tree.

Liquid embolic surface area as a predictor of chronic subdural hematoma resolution in middle meningeal artery embolization.

BACKGROUND: Liquid embolic agents (LEAs) such as ethylene vinyl alcohol (EVOH) are utilized for middle meningeal artery embolization (MMAE) for chronic subdural hematomas (cSDH). LEAs may be advantageous for MMAE as they are permanent and can penetrate the microvasculature of the subdural membranes. LEA surface area (SA) can quantify this penetration. The segmentation of LEA SA is not described in the literature and may be of interest in refining MMAE technique. METHODS: We retrospectively collected computerized tomography (CT) scans from 74 patients (with 95 cSDH) who underwent first-line MMAE with EVOH. Non-contrast head CTs were acquired pre-embolization, immediately post-embolization and at 1-, 3-, and 6 month follow-up. A 3D-Slicer was used to segment hematoma volumes and the liquid embolic cast. We hypothesized that greater LEA SA would be correlated with greater improvements in cSDH volumetric resolution. RESULTS: There was significant resolution in cSDH volumes over the follow-up period compared to preoperative volume (p<0.0001). The LEA SA was significantly correlated with the rate of cSDH resolution at 3 months (R2=0.08, p=0.03), and 6 months (R2=0.14, p=0.01). CONCLUSIONS: The correlation of LEA surface area with hematoma resolution at 3-months and 6-months suggests greater LEA penetration may improve radiographic outcomes. This study uniquely provides a quantitative radiological perspective on the effect of LEA penetration on cSDH resolution.

Braid stability after flow diverter treatment of intracranial aneurysms: a systematic review and meta-analysis.

BACKGROUND: The aim of this study was to evaluate the overall rates of braid changes associated with flow diverter (FD) treatment for intracranial aneurysms (IAs). Additionally, we sought to provide an overview of the currently reported definitions related to these complications. METHODS: A systematic search was conducted from the inception of relevant literature up to April 2023, encompassing six databases. The included studies focused on patients with IAs treated with FDs. We considered four main outcome measures as FD braid changes: (1) fish-mouthing, (2) device braid narrowing, (3) device braid collapsing, and (4) device braid deformation. The data from these studies were pooled using a random-effects model. RESULTS: A total of 48 studies involving 3572 patients were included in the analysis. Among them, 14 studies (39%) provided definitions for fish-mouthing. However, none of the included studies offered specific definitions for device braid narrowing, collapsing, or deformation, despite reporting rates for these complications in six, five, and three studies, respectively. The pooled rates for braid changes were as follows: 3% (95% CI 2% to 4%, I2=27%) for fish-mouthing, 7% (95% CI 2% to 20%, I2=85%) for narrowing, 1% (95% CI 0% to 3%, I2=0%) for collapsing, and 1% (95% CI 1% to 4%, I2=0%) for deformation. CONCLUSION: The findings of this study suggest that FD treatment for IAs generally exhibits low rates of fish-mouthing, device braid narrowing, collapsing, and deformation. However, the lack of standardized definitions hinders the ability to compare device outcomes objectively, emphasizing the need for uniform definitions for FD braid changes in future prospective studies on FD.

Active drug-coated flow diverter in a preclinical model of intracranial stenting.

BACKGROUND: Flow diverters carry the risk of thromboembolic complications (TEC). We tested a coating with covalently bound heparin that activates antithrombin to address TEC by locally downregulating the coagulation cascade. We hypothesized that the neuroimaging evidence of TEC would be reduced by the coating. METHODS: 16 dogs were implanted with overlapping flow diverters in the basilar artery, separated into two groups: heparin-coated (n=9) and uncoated (n=7). Following implantation, high-frequency optical coherence tomography (HF-OCT) was acquired to quantify acute thrombus (AT) formation on the flow diverters. MRI was performed postoperatively and repeated at 1, 2, 3, 4, and 8 weeks, consisting of T1-weighted imaging, time-0f-flight (ToF), diffusion weighted imaging (DWI), susceptibility weighted imaging (SWI), and fluid attenuated inversion recovery (FLAIR) sequences. Neurological examinations were performed throughout the 8-week duration of the study. RESULTS: The mean AT volume on coated devices was lower than uncoated (0.014 vs 0.018 mm3); however, this was not significant (P=0.3). The mean number of foci of magnetic susceptibility artifacts (MSAs) on SWI was significantly different between the uncoated and coated groups at the 1-week follow-up (P<0.02), and remained statistically different throughout the duration of the study. The AT volume showed a direct linear correlation with the MSA count and 80% of the variance in the MSA could be explained by the AT volume (P<0.001). Pathological analysis showed evidence of ischemic injury at locations of MSA. CONCLUSIONS: Heparin-coated flow diverters significantly reduced the number of new MSAs after 1 week follow-up, showing the potential to reduce TEC.

Safety and effectiveness of the Woven EndoBridge (WEB) system for the treatment of wide necked bifurcation aneurysms: final 5 year results of the pivotal WEB Intra-saccular Therapy study (WEB-IT).

INTRODUCTION: The US Woven EndoBridge Intra-saccular Therapy (WEB-IT) study is a pivotal, prospective, single arm, investigational device exemption study to evaluate the safety and effectiveness of the WEB device for the treatment of wide neck bifurcation aneurysms (WNBAs). We present complete 5 year data for the cohort of 150 patients. METHODS: 150 patients with WNBAs were enrolled at 21 US and six international centers. Imaging from the index procedure, 6 month, 1 year, 3 year, and 5 year follow-up were reviewed by a core laboratory. Adverse events were reviewed and adjudicated by a clinical events adjudicator. RESULTS: 83 patients had 5 year follow-up imaging and 123 had clinical follow-up. No ruptured (0/9) or unruptured aneurysm (0/141) rebled or bled during follow-up. No new device or procedure related adverse events or serious adverse events were reported after 1 year. At 5 years, using the LOCF method, complete occlusion was observed in 58.1% and adequate occlusion in 87.2% of patients. For patients with both 1 year and 5 year occlusion statuses available, 76.8% (63/82) of aneurysms remained stable or improved with no retreatment. After 1 year, 18 aneurysms were retreated, 11 of which were adequately occluded at 1 year, and 15 of which were retreated in the absence of any deterioration in occlusion grade. CONCLUSIONS: Five year follow-up data from the WEB-IT study demonstrated that the WEB device was safe and effective when used in the treatment of WNBAs. Aneurysm occlusion rates achieved at 1 year follow-up were durable, with rates of progressive thrombosis far exceeding rates of recurrence over time.

Development of an in-vitro model based on patient vessel geometry for simulated use testing in neurointerventional surgery.

BACKGROUND: Neurointerventionalists use in-vitro vascular models to train for worst-case scenarios and test new devices in a simulated use environment to predict clinical performance. According to the Food and Drug Administration (FDA), any neurovascular navigation device should be able to successfully navigate two 360-degree turns and two 180-degree turns at the distal portion of the anatomical model. Here, we present a device benchmarking vascular model that complies with FDA recommendations. METHODS: Our vascular model was assembled from quantitative characterization of 49 patients who underwent CT angiography either for acute ischemic stroke caused by large vessel occlusion or for aneurysm treatment. Following complete characterization of these data, the vascular segments were 3D reconstructed from CT angiograms of 6 selected patients that presented with challenging anatomy. The curvature and total rotational angle were calculated for each segment and the anatomical parts that complied with FDA recommendations were fused together into a single in-vitro model. RESULTS: The model was constructed containing two common carotid branches arising from a type two aortic arch and the dimensions of the overall model exceeded the recommendations of the FDA. Two experienced neurointerventionalists tested the model for navigation difficulty using several devices on an in-vitro perfusion system and concluded that the model provided a realistic, challenging scenario. CONCLUSIONS: This model provides a first prototype designed according to FDA recommendations of cumulative angle while also integrating an aggregation of actual patient-specific anatomy. The availability of this clinically relevant benchmark model presents a potential standardized approach for neurovascular device testing.

First-line thrombectomy strategy for distal and medium vessel occlusions: a systematic review.

BACKGROUND: The benefit of mechanical thrombectomy (MT) and efficacy of different first-line MT techniques remain unclear for distal and medium vessel occlusions (DMVOs). In this systematic review, we aimed to compare the performance of three first-line MT techniques in DMVOs. METHODS: The PubMed database was searched for studies examining the utility of MT in DMVOs (middle cerebral artery M2-3-4, anterior cerebral artery, and posterior cerebral artery). Studies providing data for aspiration thrombectomy (ASP), stent retriever thrombectomy (SR), and combined SR+ASP technique were included. Non-comparative studies were excluded. Safety and efficacy data were collected for each technique. The Nested Knowledge AutoLit platform was utilized for literature search, screening, and data extraction. Pooled data were presented as descriptive statistics. RESULTS: 13 studies comprising 2422 MT procedures were identified. The overall successful recanalization rate was 77.0% (1513/1964) for DMVOs. SR+ASP had a successful recanalization rate of 83.7% (297/355), SR had a 75.6% rate (638/844), while ASP alone had a 74.2% rate (386/520). The overall functional independence rate was 51.3% (851/1659) among DMVOs. The ASP alone group had a functional independence rate of 46.9% (219/467), while functional independence rates of the SR and SR+ASP groups were 51.5% (372/723) and 61.7% (174/282), respectively. Finally, the subarachnoid hemorrhage rates were 1.8% (4/217) for the ASP group, 9.3% (26/281) for the SR group, and 11.9% (41/344) for the SR+ASP group. CONCLUSIONS: Our systematic review supports the proposition that MT is a safe and effective treatment option for DMVOs. Additionally, while the SR+ASP group had consistently high rates of clot clearance and good neurological outcomes, the SR and SR+ASP groups also had higher rates of subarachnoid hemorrhage, highlighting the need for improved DMVO treatment devices.

Prospective study on embolization of intracranial aneurysms with the pipeline device (PREMIER study): 3-year results with the application of a flow diverter specific occlusion classification.

BACKGROUND: The pipeline embolization device (PED; Medtronic) has presented as a safe and efficacious treatment for small- and medium-sized intracranial aneurysms. Independently adjudicated long-term results of the device in treating these lesions are still indeterminate. We present 3-year results, with additional application of a flow diverter specific occlusion scale. METHODS: PREMIER (prospective study on embolization of intracranial aneurysms with pipeline embolization device) is a prospective, single-arm trial. Inclusion criteria were patients with unruptured wide-necked intracranial aneurysms ≤12 mm. Primary effectiveness (complete aneurysm occlusion) and safety (major neurologic event) endpoints were independently monitored and adjudicated. RESULTS: As per the protocol, of 141 patients treated with a PED, 25 (17.7%) required angiographic follow-up after the first year due to incomplete aneurysm occlusion. According to the Core Radiology Laboratory review, three (12%) of these patients progressed to complete occlusion, with an overall rate of complete aneurysm occlusion at 3 years of 83.3% (115/138). Further angiographic evaluation using the modified Cekirge-Saatci classification demonstrated that complete occlusion, neck residual, or aneurysm size reduction occurred in 97.1%. The overall combined safety endpoint at 3 years was 2.8% (4/141), with only one non-debilitating major event occurring after the first year. There was one case of aneurysm recurrence but no cases of delayed rupture in this series. CONCLUSIONS: The PED device presents as a safe and effective modality in treating small- and medium-sized intracranial aneurysms. The application of a flow diverter specific occlusion classification attested the long-term durability with higher rate of successful aneurysm occlusion and no documented aneurysm rupture. TRIAL REGISTRATION: NCT02186561.

Aristotle 24 microwire early experience.

Larger microcatheters are being used with increasing frequency in routine neurovascular procedures. Navigating catheters safely and effectively to the target intracranial vessels can be a challenge when using conventional 0.014″ microwires. A new family of 0.024″ Aristotle 24 microwires (Scientia Vascular, West Valley City, UT) specifically designed for intracranial navigation were recently introduced. These microwires offer significant technical advantages over the standard 0.014″ microwires, including a reduced ledge gap, improved torquability and support, and overall safety. This video case series contains several illustrative cases to demonstrate the features of the novel Aristotle 24 microwire for use in endovascular neurointervention.

A novel angiographic method to estimate arterial blood flow rates using contrast reflux: Effect of injection parameters.

BACKGROUND: Contrast reflux, which is the retrograde movement of contrast against flow direction, is commonly observed during angiography. Despite a vast body of literature on angiography, the hemodynamic factors affecting contrast reflux have not been studied. Numerous methods have been developed to extract flow from angiography, but the reliability of these methods is not yet sufficient to be of routine clinical use. PURPOSE: To evaluate the effect of baseline blood flow rates and injection conditions on the extent of contrast reflux. To estimate arterial flow rates based on measurement of contrast reflux length. MATERIALS AND METHODS: Iodinated contrast was injected into an idealized tube as well as a physiologically accurate model of the cervico-cerebral vasculature. A total of 194 high-speed angiograms were acquired under varying "blood" flow rates and injection conditions (catheter size, injection rate, and injection time). The length of contrast reflux was compared to the input variables and to dimensionless fluid dynamics parameters at the catheter-tip. Arterial blood flow rates were estimated using contrast reflux length as well as a traditional transit-time method and compared to measured flow rates. RESULTS: Contrast reflux lengths were significantly affected by contrast injection rate (p < 0.0001), baseline blood flow rate (p = 0.0004), and catheter size (p = 0.04), but not by contrast injection time (p = 0.4). Reflux lengths were found to be correlated to dimensionless fluid dynamics parameters by an exponential function (R2  = 0.6-0.99). When considering the entire dataset in unison, flow estimation errors with the reflux-length method (39% ± 33%) were significantly higher (p = 0.003) than the transit-time method (33% ± 36%). However, when subgrouped by catheter, the error with the reflux-length method was substantially reduced and was significantly lower (14% ± 14%, p < 0.0001) than the transit-time method. CONCLUSION: Results show correlations between contrast reflux length and baseline hemodynamic parameters that have not been reported previously. Clinically relevant blood flow rate estimation is feasible by simple measurement of reflux length. In vivo and clinical studies are required to confirm these correlations and to refine the methodology of estimating blood flow by reflux.

Immediate flow-diversion characteristics of a novel primarily bioresorbable flow-diverting stent.

OBJECTIVE: Flow-diverting stents with a resorbable component have significant theoretical benefits over full metal stents, although currently there are none in clinical use. In this study, the authors sought to determine the immediate flow-diversion characteristics of a novel primarily bioresorbable flow-diverting stent. METHODS: Bioresorbable stents were deployed into glass tube models to determine porosity and pore density. In vitro flow diversion behavior was evaluated using high frame rate angiography under pulsatile flow conditions in a patient-specific silicone aneurysm model treated with the resorbable stent as well as the Surpass Evolve stent. In vivo flow diversion was characterized by deployment into 20 rabbit saccular aneurysm models, and grading was based on the O'Kelly-Marotta scale and the 4F-flow diversion predictive score. RESULTS: Porosities and pore densities of the bioresorbable stent were in the flow-diverting range for all target vessel diameters. Quantified results of immediate angiography after placement of the bioresorbable stent into a silicone aneurysm model demonstrated greater flow diversion compared to the Evolve stent. Bioresorbable stent placement in saccular aneurysm models resulted in an immediate O'Kelly-Marotta grade of A3 or better and a 4F-flow diversion predictive score of 4 or better in all cases. CONCLUSIONS: The bioresorbable stent has immediate flow-diversion characteristics that are comparable to commercially available metal stents. Longer-term studies are underway to determine the ability of the resorbable fibers to act as a neointimal scaffold and result in long-term aneurysm occlusion.