Initial multicentre experience using the neuroform atlas stent for the treatment of un-ruptured saccular cerebral aneurysms.

Purpose: The Neuroform Atlas is a self-expandable and low-profiled stent that is used for aneurysm neck scaffolding and has been recently approved for clinical practice in Korea. We present our initial experiences of endovascular coiling using the Neuroform Atlas stent.Materials and methods: All cerebral aneurysms treated by stent-assisted coiling with a Neuroform atlas stent in two institutions between February and May 2018 were retrospectively evaluated. Fifty-one patients with 55 un-ruptured saccular cerebral aneurysms (mean size: 4.72 ± 1.81 mm, mean neck diameter: 3.82 ± 1.23 mm, mean dome-to-neck ratio: 1.21) were included in our study (40 females, mean age: 59.29 ± 11.96 years). Patient demographics, aneurysm characteristics, initial angiographic post procedural outcomes, and clinical and angiographic follow-up data were analysed.Results: There was one case of procedural failure due to a downward slip during stent deployment. The technical success rate was 98.2% (54/55). A post-procedure control angiogram showed complete occlusion in 27 (50%), residual neck in 16 (29.6%) and residual sac in 11 (20.4%) aneurysms. There were no procedure-related complications. In one case, a symptomatic thromboembolism with left hand grip weakness (grade IV) was observed two days after the procedure and resolved at discharge. The modified Rankin scale score at discharge was 0 in all patients. Angiographic follow-up data at a mean of 4.8 months were available for 51/54 (94.4%) aneurysms. Among them, 27 aneurysms (52.9%) were stable, 20 aneurysms (39.2%) showed progressive occlusion and 4 aneurysms showed an increased modified Raymond Roy occlusion classification score (only one of these patients was included in the recanalization criteria).Conclusion: Our findings suggest the Neuroform Atlas stent can be useful for the coiling of cerebral aneurysms without significant complications regardless of aneurysm location.

Stent-assisted embolization of wide-neck anterior communicating artery aneurysms: Review of consecutive 34 cases.

OBJECTIVE: We report our experience with stent-assisted coiling of anterior communicating artery aneurysms with special consideration of angiographic and clinical outcomes, retreatment rate and periprocedural complications. MATERIALS AND METHODS: The analysis included 34 consecutive ruptured and unruptured wide-neck aneurysms. The aneurysm size ranged from 2 to 18mm (mean 5.47). Clinical examinations with the use of modified Rankin Score and angiographic outcomes were evaluated initially post-embolization and at a minimum follow-up of 6 months. RESULTS: Initial post-treatment complete and near-complete aneurysm occlusion was achieved in 32 (94%) and 2 (6%) cases, respectively. Imaging follow-up, performed in 28 (82%) patients, showed no change in the degree of occlusion in 25 (89%) cases and coil compaction in 3 (11%) patients. Of these, one (3.6%) patient underwent a second coil embolization. The periprocedural severe complication rate was 2.9% (1/35) and was associated with prolonged attempt of retrieval of migrated coil resulting in anterior cerebral artery infarct with serious clinical consequences. In another 3 patients periprocedural adverse events without delayed clinical consequences were noticed. The clinical follow-up evaluation achieved in 33 (97%) patients showed no change in 30 (91%) cases, one patient (3%) with clinical improvement and two (6%) cases of neurological deterioration. CONCLUSIONS: The use of stent is feasible and effective for coil embolization of wide-necked anterior communicating artery aneurysms. Although periprocedural complications resulting in severe morbidity are rare, they should be noted, since in terms of thromboembolic events some of them presumably have a potential to be avoidable.

Y Stent-Assisted Coiling Technique for Bifurcation Aneurysms Using Double Neuroform® Stent: a Large Restrospective Series.

BACKGROUND: Stent assisted coiling technique have shown to be an effective and safe endovascular strategy for wide neck bifurcation aneurysms in achieving greater packing, allowing the closure of the aneurysm and preserving the parent arteries, compared to simple coiling. MATERIAL AND METHODS: We conducted a retrospective analysis of 79 patients with cerebral aneurysms treated using 'Y'-configuration double Neuroform® stent-assisted coiling at our center from July 2009 to July 2022. RESULTS: Of the 79 patients, 76% (60/79) were incidental unruptured cerebral aneurysm and 24% were patients treated for aneurysm recanalization of a previous ruptured aneurysm (19/79). The most frequent locations were anterior communicating artery (AComA) 44.3% (35/79) and middle cerebral artery (MCA) 32.9% (26/79). We found a complete and almost complete aneurysm occlusion (Raymond-Roy occlusion classification (RROC) 1 and 2): in 100% (79/79) in the angiography after procedure, in 97.6% (42/43) at the first follow-up at 6-8 months and 100% (57/57) at the first 1-2 years of follow-up. No mortality related to treatment was detected. We registered 2.5% (2/79) major ipsilateral strokes, one due to acute in stent thrombosis (patient had a mRS: 0 in follow up at 90 days) and a spinal anterior artery occlusion (patient had a mRS: 3 in follow up at 90 days). CONCLUSION: The 'Y' stent-assisted coiling technique with double Neuroform® is a safe and effective technique for the treatment of wide-neck bifurcation aneurysms, with high rates of complete occlusion, preserving the permeability of the afferent and efferent arteries and low rate of complications.

The Safety and Efficacy of eCLIPs for Treatment of Wide-Necked Bifurcation Aneurysms: A Systematic Review and Meta-Analysis.

BACKGROUND: Wide-necked bifurcation aneurysms (WNBAs) are challenging intracranial aneurysms. Several device and treatment approaches have been proposed for the treatment of WNBAs. The endovascular clip system (eCLIPs) is a newly developed endovascular device with flow diverter and flow disruptor features. This study aims to investigate the safety and efficacy of the eCLIPs for treatment of patients with WNBAs. METHODS: This is a systematic review and meta-analysis study conducted in accordance with the PRISMA (preferred reporting items for systematic reviews and meta-analyses) guidelines. The electronic databases of PubMed, Embase, Scopus, and Web of Science were systematically reviewed from inception to June 19, 2023. The rate of complete and near-complete occlusion, successful device implantation, and serious adverse events were pooled using STATA, version 17. RESULTS: A total of 5 studies with 110 patients with WNBAs were systematically investigated. Our findings show that the immediate successful implantation rate of eCLIPs was 0.93 (95% confidence interval [CI], 0.88-0.97). Moreover, the immediate postoperative complete occlusion rate was 0.34 (95% CI, 0.10-0.58), and the immediate postoperative near-complete occlusion rate was 0.35 (95% CI, 0.24-0.45). Also, the near-complete occlusion rate at the latest follow-up was 0.3 (95% CI, 0.16-0.44). The serious adverse event rate was 0.14 (95% CI, 0.05-0.22). Stroke was also reported in 2 studies, with 1 study reporting 1 patient who experienced stroke within the first 24 hours and 1 study reporting no patients with stroke. CONCLUSIONS: Our findings document that the eCLIPs is a safe and effective device for treating patients with WNBAs and associated with favorable outcomes.

A case report: Ruptured aneurysm with a wide neck treated by flow diverter stent and coil embolization.

Diagnosis and endovascular treatment for ruptured wide neck aneurysms are challenges in clinics, particularly in developing countries. In the present study, we described a clinical case with a ruptured wide neck aneurysm in Vietnam treated by flow diverter stent and coil embolization. A 77-year-old- female patient had a right droopy eyelid for 2 months. The patient was admitted to hospital on the second day after being presented with a sudden-severe headache. Cerebral computed tomography (CT) and magnetic resonance imaging (MRI) were taken on the second day and fifth day after the onset of the headache. The results showed an aneurysm in the right internal carotid artery but no potential subarachnoid hemorrhage (SAH) was displayed. An uncoagulated blood was found in cerebrospinal fluid indicated by a lumbar puncture test. Digital subtraction angiography provided images with one wide-neck right internal carotid aneurysm. The patient was treated by flow diverter stent and coil embolization and the dual antiplatelet therapy with ticagrelor and aspirin at home. After 45 days, the patient did not face with any complication, no neurological symptoms, and the aneurysm was partially thrombosed indicated by MRI images. These results suggested that a lumbar puncture should be analyzed on the patient with brain aneurysm appeared a sudden severe headache and even no potential SAH on brain MRI or CT was found. The combination of flow diverter stent and coil embolization to treat cases with ruptured wide necked aneurysms should be considered in the future.

Stent-assisted Coil Embolization Using a Transcirculation Technique for Superior Cerebellar Artery Aneurysm: A Report of Two Cases.

Stent-assisted coil embolization (SACE) is useful for treating wide-necked aneurysms. Most superior cerebellar artery (SCA) aneurysms have a wide neck, but there are few reports of SCA aneurysms treated with SACE. One reason is that the anatomical characteristic of SCA aneurysm is not suitable for standard SACE. It is often challenging to deliver a stent to SCA via the basilar artery in an anterograde manner. In contrast, it is not difficult to deliver a stent to SCA from the anterior circulation via the posterior communicating artery. This method, in which a catheter is navigated from the anterior to the posterior circulation, is called a transcirculation technique. We report two cases of SCA aneurysm successfully treated with SACE using transcirculation technique. This approach is helpful for wide-necked SCA aneurysms.

Primary coiling of a wide-neck unruptured aneurysm in the trifurcation of the P2 segment of the posterior cerebral artery: A case report.

Intracranial aneurysms are now treatable with coils, stents, and flow diverters in recent years. For saccular aneurysms with broad necks and short domes, stent-assisted coiling has become a common technique, but over time, the complications-both intraprocedural and in a delayed fashion-occur more frequently than coiling alone. Nonstent or balloon-assisted coiling results in lower aneurysm recanalization, lower aneurysm rupture or re-rupture, or lower aneurysm retreatment. This paper illustrates a successful coiling of wide-neck unruptured aneurysm in the trifurcation of the left P2 posterior cerebral artery done without the assistance of stents or balloons.

Endovascular Treatment of Complex Intracranial Aneurysms With LEO+ Stents: The LEO II Cohort Study.

Introduction: Stent-assisted coiling is an established treatment option for intracranial aneurysms, particularly, wide neck aneurysms with complex anatomy. The purpose of the present study was to assess the safety and efficacy of LEO+ stents in the treatment of intracranial aneurysms. Materials and Methods: A prospective, observational, multicenter study including 12 centers was performed on patients with ruptured, unruptured, and recanalized intracranial aneurysms treated with LEO+ stents. The primary efficacy endpoint was the rate of complete aneurysmal occlusion at 18 months post-procedure, and the primary safety endpoint was the morbidity and mortality at 18 months post-procedure. Results: From March 2015 to June 2017, 176 patients were enrolled (mean age of 54.8 ± 11.5 years; 65.9% women). The aneurysms were located mainly in the anterior communicating artery (29.2%) and the middle cerebral artery (28.6%). They were mostly saccular (94%), with a mean dome size of 5.3 ± 2.6 mm and a mean aspect ratio of 1.2 ± 1.0. In total, 3% of the aneurysms were treated in the acute phase of rupture. Complete/nearly complete aneurysmal occlusion and major recanalization were observed in 89% (n = 146/164) and 1.8% (n = 3/164) of patients at 18-month follow-up, respectively. The LEO+ related mortality rate was 0.6% (n = 1/170), the morbidity rate was 4.1% (n = 7/170), and these patients were mRS 0-2 at 18 months. Conclusion: Our results reflecting the use of LEO+ stents in real-world conditions confirm the efficacy and safety of LEO+ stents in the management of complex intracranial aneurysms.

Safety and Long-Term Efficacy Outcomes for Endovascular Treatment of Wide-Neck Bifurcation Aneurysms of the Middle Cerebral Artery: Insights From the SMART Registry.

INTRODUCTION: Wide-necked middle cerebral artery bifurcation aneurysms pose specific challenges to endovascular management. Surgical clipping remains the standard treatment approach for these aneurysms in many centers. While recent data suggests the endovascular treatment may be comparable, a prospective datapoint has been lacking. MATERIALS AND METHODS: The Penumbra SMART registry, a prospective, multi-center, single-arm outcomes registry of Penumbra coil-treated aneurysms, was queried for endovascularly treated MCA bifurcation aneurysms with wide necks (dome:neck ratio <2 or neck >4 mm). Safety and efficacy outcomes were summarized for ruptured and unruptured aneurysms, including rupture, complication rate, and 1-year occlusion outcomes. RESULTS: Seventy-two aneurysms across 31 sites were enrolled. Of these, a total of 15 presented as ruptured aneurysms. Serious adverse events were reported in 21 (29.2%) of patients, with 8 (11.1%) attributed to the device/procedure. Immediately postoperatively, 75.0% of cases achieved "adequate" Raymond Roy Class I (40.3%) or II (34.7%) occlusion outcomes. Of the 72 patients treated, 60 (83.3%) underwent follow-up angiography at 1 year, and among these, 95.0% had 1-year occlusion outcomes of Raymond Roy Class I (71.7%) or II (23.3%). A total of 6 aneurysms (10.0%) were required or were planned for retreatment at the last follow-up. CONCLUSION: This study represents the most significant prospective sample of endovascularly treated wide-neck MCA bifurcation aneurysms conducted to date. It supports the safety and efficacy of endovascular treatment of these aneurysms.

Wide-Neck and Bifurcation Aneurysms: Balancing Open and Endovascular Therapies.

Wide-neck aneurysms (WNA) often require advanced open surgical and endovascular techniques to achieve adequate aneurysm occlusion. Microsurgical treatment often requires advanced clip configurations. Occasionally, more complex open surgical techniques are required. Advancements in endovascular therapies (EVT) and devices have expanded endovascular treatment options for WNAs and have improved aneurysm occlusion rates compared with primary coiling. Certain EVT require dual antiplatelet therapy, limiting their use in the ruptured setting. Evidence suggests that microsurgical treatment should remain a consideration for treatment of ruptured WNAs, but perhaps with novel endovascular techniques and devices, EVT should be first-line treatment in the unruptured setting.

Endovascular Therapy Versus Microsurgical Clipping of Ruptured Wide Neck Aneurysms (EVERRUN Registry): a multicenter, prospective propensity score analysis.

OBJECTIVE: Randomized controlled trials have demonstrated the superiority of endovascular therapy (EVT) compared to microsurgery (MS) for ruptured aneurysms suitable for treatment or when therapy is broadly offered to all presenting aneurysms; however, wide neck aneurysms (WNAs) are a challenging subset that require more advanced techniques and warrant further investigation. Herein, the authors sought to investigate a prospective, multicenter WNA registry using rigorous outcome assessments and compare EVT and MS using propensity score analysis (PSA). METHODS: Untreated, ruptured, saccular WNAs were included in the analysis. A WNA was defined as having a neck ≥ 4 mm or a dome/neck ratio (DNR) < 2. The primary outcome was the modified Rankin Scale (mRS) score at 1 year posttreatment, as assessed by blinded research nurses (good outcome: mRS scores 0-2) and compared using PSA. RESULTS: The analysis included 87 ruptured aneurysms: 55 in the EVT cohort and 32 in the MS cohort. Demographics were similar in the two cohorts, including Hunt and Hess grade (p = 0.144) and modified Fisher grade (p = 0.475). WNA type inclusion criteria were similar in the two cohorts, with the most common type having a DNR < 2 (EVT 60.0% vs MS 62.5%). More anterior communicating artery aneurysms (27.3% vs 18.8%) and posterior circulation aneurysms (18.2% vs 0.0%) were treated with EVT, whereas more middle cerebral artery aneurysms were treated with MS (34.4% vs 18.2%, p = 0.025). Within the EVT cohort, 43.6% underwent stand-alone coiling, 50.9% balloon-assisted coiling, 3.6% stent-assisted coiling, and 1.8% flow diversion. The 1-year mRS score was assessed in 81 patients (93.1%), and the primary outcome demonstrated no increased risk for a poor outcome with MS compared to EVT (OR 0.43, 95% CI 0.13-1.45, p = 0.177). The durability of MS was higher, as evidenced by retreatment rates of 12.7% and 0% for EVT and MS, respectively (p = 0.04). CONCLUSIONS: EVT and MS had similar clinical outcomes at 1 year following ruptured WNA treatment. Because of their challenging anatomy, WNAs may represent a population in which EVT's previously demonstrated superiority for ruptured aneurysm treatment is less relevant. Further investigation into the treatment of ruptured WNAs is warranted.

Endovascular therapy versus microsurgical clipping of unruptured wide-neck aneurysms: a prospective multicenter study with propensity score analysis.

OBJECTIVE: Numerous techniques have been developed to treat wide-neck aneurysms (WNAs), each with different safety and efficacy profiles. Few studies have compared endovascular therapy (EVT) with microsurgery (MS). The authors' objective was to perform a prospective multicenter study of a WNA registry using rigorous outcome assessments and to compare EVT and MS using propensity score analysis (PSA). METHODS: Unruptured, saccular, not previously treated WNAs were included. WNA was defined as an aneurysm with a neck width ≥ 4 mm or a dome-to-neck ratio (DTNR) < 2. The primary outcome was modified Rankin Scale (mRS) score at 1 year after treatment (good outcome was defined as mRS score 0-2), as assessed by blinded research nurses and compared with PSA. Angiographic outcome was assessed using the Raymond scale with core laboratory review (adequate occlusion was defined as Raymond scale score 1-2). RESULTS: The analysis included 224 unruptured aneurysms in the EVT cohort (n = 140) and MS cohort (n = 84). There were no differences in baseline demographic characteristics, such as proportion of patients with good baseline mRS score (94.3% of the EVT cohort vs 94.0% of the MS cohort, p = 0.941). WNA inclusion criteria were similar between cohorts, with the most common being both neck width ≥ 4 mm and DTNR < 2 (50.7% of the EVT cohort vs 50.0% of the MS cohort, p = 0.228). More paraclinoid (32.1% vs 9.5%) and basilar tip (7.1% vs 3.6%) aneurysms were treated with EVT, whereas more middle cerebral artery (13.6% vs 42.9%) and pericallosal (1.4% vs 4.8%) aneurysms were treated with MS (p < 0.001). EVT aneurysms were slightly larger (p = 0.040), and MS aneurysms had a slightly lower mean DTNR (1.4 for the EVT cohort vs 1.3 for the MS cohort, p = 0.010). Within the EVT cohort, 9.3% of patients underwent stand-alone coiling, 17.1% balloon-assisted coiling, 34.3% stent-assisted coiling, 37.1% flow diversion, and 2.1% PulseRider-assisted coiling. Neurological morbidity secondary to a procedural complication was more common in the MS cohort (10.3% vs 1.4%, p = 0.003). One-year mRS scores were assessed for 218 patients (97.3%), and no significantly increased risk of poor clinical outcome was found for the MS cohort (OR 2.17, 95% CI 0.84-5.60, p = 0.110). In an unadjusted direct comparison, more patients in the EVT cohort achieved a good clinical outcome at 1 year (93.4% vs 84.1%, p = 0.048). Final adequate angiographic outcome was superior in the MS cohort (97.6% of the MS cohort vs 86.5% of the EVT cohort, p = 0.007). CONCLUSIONS: Although the treatments for unruptured WNA had similar clinical outcomes according to PSA, there were fewer complications and superior clinical outcome in the EVT cohort and superior angiographic outcomes in the MS cohort according to the unadjusted analysis. These results may be considered when selecting treatment modalities for patients with unruptured WNAs.

Passability and Impassability of Microcatheters Through the Neuroform Atlas Stent During the Trans-cell Approach: An Experimental Evaluation.

BACKGROUND: Trans-cell approach for the Neuroform Atlas stent (Stryker Neurovascular, Fremont, CA) is occasionally unsuccessful as a microcatheter can become stuck in the struts. This study aimed to evaluate the passability and impassability of 0.0165-inch microcatheters through the Neuroform Atlas stent using a simplified benchtop model. METHODS: The distal struts of the target cell, referred to as the concave or convex crown, were found to interfere with microcatheter advancement during the trans-cell approach. The procedure was performed across each crown using the 1.7-Fr SL-10 and 1.6-Fr Headway Duo microcatheters (MicroVention-Terumo, Aliso Viejo, CA), and it was repeated 20 times. We evaluated the procedural success rate, passability of each microcatheter using the maximum moving distance of the target crown in successful procedures, and device behaviors. RESULTS: The procedural success rate across the concave crown was significantly higher than that across the convex crown in both microcatheters. The maximum moving distance of the concave crown was significantly shorter in the Headway Duo microcatheter than in the SL-10 microcatheter. All procedures across the convex crown were not successful because the sharp end of the crown fell into the interspace inside the microcatheter tip, which is referred to as the crown jackpot phenomenon. The trapped microcatheter was never released from the crown unless it was pulled back proximally. CONCLUSIONS: Target crowns and microcatheters affected the use of the trans-cell approach through the Neuroform Atlas stent. The passability was excellent in a lower profile 0.0165-inch microcatheter. Moreover, neurointerventionalists must be knowledgeable of the crown jackpot phenomenon, which might cause fatal stent migration.

The pCONUS HPC: 30-Day and 180-Day In Vivo Biocompatibility Results.

BACKGROUND: Endovascular stents are commonly used during neurointerventional procedures; however, the concomitant use of dual anti-platelet treatment (DAPT) can limit their use. There is a need to develop stent coatings that mitigate requirement for DAPT. METHODS: The hydrophilic polymer coating is a novel glycan-based multilayer polymer that inhibits platelet adhesion. After Institutional Animal Care and Use Committee approval, 18 New Zealand white rabbits (mean weight 4.02 ± 0.51 kg) were commenced on DAPT (ASA 10 mg/kg/day and clopidogrel 10 mg/kg/day). A bare nitinol pCONUS and coated pCONUS HPC were implanted into the common carotid arteries of each rabbit. Histological examinations were performed at 30 days (n = 9) and 180 days (n = 8) to assess the acute and chronic inflammatory reactions to the pCONUS HPC. Wilcoxon/Kruskal-Wallis and ANOVA were used with p value < 0.05 considered as significant. RESULTS: There is no statistically significant difference in inflammation within the intima/media or adventitia at 30 days (p = 0.3901 and p = 1, respectively) or at 180 days (p = 0.144 and p = 1, respectively) between pCONUS and pCONUS HPC cohorts. There is no significant difference in the presence of granulomas or giant cells between the cohorts at either 30 days (p = 1 and p = 0.8363) or 180 days (p = 1.00 and p = 0.149). At 30 days and 180 days, there was near-complete endothelialisation of the stent struts and no significant difference between the pCONUS or pCONUS HPC (p = 0.7832 and p = 0.334, respectively). CONCLUSION: pCONUS HPC stents do not elicit an acute or chronic inflammatory response in vivo with no significant difference in the tissue response to bare nitinol pCONUS stents or pCONUS HPC stents.

Surpass Flow-Diverter in the Treatment of Two Wide-Neck Aneurysms in the Scheme of an Arteriovenous Malformation Patient: A Case Study.

BACKGROUND: The cerebral arterial aneurysm, especially in the circumstances of ateriovenous malformation (AVM), has higher risk of rupture than normal isolated aneursym. Therefore, the treatment strategy needs to be plan very carefully in such case. CASE PRESENTATION: We report a patient with 2 wide-neck aneurysms located in the feeding artery of the arteriovenous malformation and he, then, was treated by using Surpass stent (flow-diverter) to eliminate the aneurysms. CONCLUSION: In our case, multiple wide-neck aneurysms in combination with low risk unruptured AVM, using long Surpass stent-diversion is an effective way to eliminate all the aneurysms in the main feeding artery while still preserving the AVM anatomy.

Treatment of Recurrent Wide Neck Bifurcation Aneurysm With the Barrel Vascular Reconstruction Device.

We present a case of successful embolization of a recurrent wide neck bifurcation aneurysm with a Barrel vascular reconstruction device (VRD). The unique properties of this novel device allowed optimal aneurysm neck coverage during third consecutive re-treatment, ultimately resulting in complete aneurysm obliteration. The parent vessel anatomy and the neck morphology of the aneurysm, in combination with a presence of a large pre-existing coil mass, were ideal for Barrel stent placement. The expanded portion of the device conformed perfectly to the recanalized aneurysm neck, providing optimal support for additional coil embolization. This case illustrates the advantages of Barrel VRD for definitive embolization of large, recurrent, and previously coiled wide-neck bifurcation aneurysm as a reasonable alternative to other traditional treatment modalities, such as flow diversion or Y and X stenting.

Neuroform Atlas Stent System for the treatment of intracranial aneurysm: primary results of the Atlas Humanitarian Device Exemption cohort.

BACKGROUND AND OBJECTIVE: Stent-assisted coil embolization is a well-established treatment of intracranial wide-necked aneurysms. The Neuroform Atlas Stent System is a new generation microstent designed to enhance coil support, conformability, deliverability, and improve deployment accuracy. We present the 1-year efficacy and angiographic results of the Humanitarian Device Exemption (HDE) cohort from the Atlas Investigational Device Exemption (IDE) clinical trial. METHOD: The Atlas IDE trial is a prospective, multicenter, single-arm, open-label study of unruptured wide-necked intracranial aneurysms treated with the Neuroform Atlas stent and approved coils. The primary efficacy endpoint was the rate of 12-month complete aneurysm angiographic occlusion (Raymond class I) without target aneurysm retreatment or significant parent artery stenosis (>50%) at the target location. The primary safety endpoint was the rate of major ipsilateral stroke or neurological death within 12 months. Imaging core laboratory and Clinical EventsCommittee adjudicated the primary endpoints. RESULTS: 30 patients were enrolled at eight US centers, with 27 patients completing the 12-month angiographic follow-up. The mean age was 59.4±11.8 years and 24/30 patients (80%) were women. The mean aneurysm size was 5.3±1.7 mm and the dome:neck ratio was 1.1±0.2. Procedural technical success of Neuroform Atlas Stent deployment was 100%. 27 patients completed 12-month angiographic follow-up and 30 patients completed their 6-month follow-up. When applying the last observation carried forward method, the primary efficacy endpoint was observed in 26/30 patients (86.7%, 95% CI 69.3% to 96.2%) compared with 25/27 patients (92.6%, 95% CI 75.7% to 99.1%) who completed the 12-month angiographic follow-up. The primary safety endpoint of stroke occurred in one patient (3.3%), who made a complete clinical recovery at discharge. There were no neurological deaths. CONCLUSION: The Neuroform Atlas stent in conjunction with coils demonstrated a high rate of complete aneurysm occlusion at 12-month angiographic follow-up, with an improved safety profile in the HDE cohort. CLINICAL TRIALGOV REGISTRATION NUMBER: NCT0234058;Results.

Stents and Stent Mimickers in Endovascular Management of Wide-neck Intracranial Aneurysms.

Subarachnoid hemorrhage due to a ruptured cerebral aneurysm is a disastrous event accounting for approximately 5%-15% of all stroke cases and has a high mortality rate. One of the major goals in the management of these patients is to prevent rebleeding by securing the aneurysm either surgically or by endovascular means. Endovascular treatment is considered the first line of treatment for intracranial aneurysms; however, wide-neck aneurysms (WNAs) are specifically difficult to treat by endovascular means due to the difficulty in achieving a stable coil mass inside the aneurysm sac. To overcome this problem, assisted endovascular treatment techniques and devices have evolved over the years. Amongst these, stent-assisted coiling (SAC) techniques provide a scaffold for coil embolization. The concept of the stent-assisted technique inspired creative pioneers to invent new tools like the PulseRider (Pulsar Vascular, Inc. CA, USA) and the pCONUS (Phenox GmbH, Germany), which are a great help in managing wide-neck and bifurcation aneurysms. The concept of stent within stents and its related hemodynamic effect has led to the novel development of flow diverters for reconstructing the arterial wall and correcting the hemodynamic disturbances. In this article, we review the stents and stent-like devices currently in practice for the endovascular management of wide-neck and branch intracranial aneurysms.

Using the Barrel Technique with the LVIS Jr (Low-profile Visualized Intraluminal Support) Stent to Treat a Wide Neck MCA Bifurcation Aneurysm.

The treatment of wide-neck bifurcation cerebral aneurysms is challenging especially if at least one of the arteries arise from an obtuse angle. These wide-neck bifurcation aneurysms are difficult to treat with the usual balloon and stent assisted coiling, including Y stenting or double-barrel stent techniques [1, 2]. Other available options include using current devices with the waffle cone or double waffle cone techniques [3, 4]. Novel devices that are in development include intrasaccular devices and the barrel bifurcation vascular reconstruction device (Covidien) [5, 6, 7]. We report the use of a novel barrel technique using the LVIS (low-profile visualized intraluminal support) Jr stent for the treatment of a wide-neck bifurcation aneurysm.

Use of stent-assisted coil embolization for the treatment of wide-necked aneurysms: A systematic review.

BACKGROUND: The use of stent-assisted coiling (SAC) has been shown to be a treatment option for complex aneurysms. We reviewed systematically the immediate and mid-term angiographic results following treatment of wide-necked aneurysms with self-expanding stents and coils, as well as the peri- and postprocedural rate of complications. METHODS: A computerized database search was conducted from 01/2000 to 04/2011 using appropriate indexed terms on Pubmed. Inclusion criteria were: (1) homogeneous populations of ≥10 patients with wide-necked aneurysms; (2) use of a self-expandable neurovascular stent and coils for aneurysm treatment; (3) immediate and follow-up angiographic results; and (4) periprocedural and delayed thrombotic complications. RESULTS: Seventeen studies were included, containing retrospectively collected data on 656 patients/702 aneurysms. The target aneurysm was located on the anterior circulation in 78.4% of patients. The immediate rate of complete occlusion was 46.3%, (19.3-98.1%). The intra- and postprocedural rate of intrastent thrombosis or thromboembolic event was 4.6% and 4.3%, respectively. Complete occlusion was documented in 71.9% at last angiographic follow-up. The rate of recanalization was 13.2% of aneurysms (0-28.8%). Delayed in-stent stenosis occurred in 5.3% cases (0-20.6%). CONCLUSION: SAC has been considered a treatment option for selected wide-necked aneurysms in some institutions. The use of intracranial stents should take into consideration the risk of ischemic complications, recanalization, delayed in-stent stenosis; and the currently unknown lifetime risks for stenosis, vascular injury, device failure, and aneurysm recurrence related to intracranial stenting. There is an evident need for a prospective multicenter registry for all treated patients with SAC.