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.

Aneurysm treatment with the Woven EndoBridge (WEB) device in the combined population of two prospective, multicenter series: 5-year follow-up.

BACKGROUND: Evaluating a new endovascular treatment for intracranial aneurysms must not only demonstrate short-term safety and efficacy, but also evaluate longer-term outcomes (eg, delayed complications, anatomical results, retreatment). The current analysis reports the 5-year clinical and anatomical results of Woven EndoBridge (WEB) treatment in two European combined trial populations (WEBCAST (WEB Clinical Assessment of Intrasaccular Aneurysm Therapy) and WEBCAST-2). METHODS: All adverse events occurring between the procedure and 5-year follow-up were independently evaluated by an expert. Aneurysm occlusion was evaluated by an independent core laboratory using a three-grade scale: complete occlusion, neck remnant, and aneurysm remnant. In cases where data were not available at 5-year follow-up, the last observation carry forward (LOCF) method was used. RESULTS: The safety and efficacy populations comprised 100 patients and 95 aneurysms, respectively. No adverse event related to the device occurred after the procedure during the 5-year follow-up period. Mortality at 5 years was 7.0% (7/100 patients) including mortality related to the WEB (0/100, 0.0%), the procedure (1/100, 1.0%), and another condition (6/100, 6.0%). At 5 years, complete aneurysm occlusion was observed in 49/95 (51.6%) aneurysms, neck remnant in 25/95 (26.3%), and aneurysm remnant in 21/95 (22.1%). Retreatment rate at 5 years was 11.6% (11/95 aneurysms). CONCLUSIONS: This analysis conducted in a population of patients with wide-neck bifurcation aneurysms confirms WEB's safety profile. Additional evidence demonstrates good stability of aneurysm occlusion with adequate occlusion (complete occlusion or neck remnant) at 5 years in 77.9% of aneurysms with a low retreatment rate (11.6%). CLINICAL TRIAL REGISTRATION: WEBCAST and WEBCAST-2: Unique identifier: NCT01778322.

eCLIPs bifurcation remodeling system for treatment of wide neck bifurcation aneurysms with extremely low dome-to-neck and aspect ratios: a multicenter experience.

BACKGROUND: Wide necked bifurcation aneurysms (WNBA) are among the most difficult aneurysms to treat. Very low dome-to-neck (DTN) and aspect ratios provide an even greater challenge in the management of WNBAs. We present the safety and efficacy profile for endovascular clip system (eCLIPs) device in the treatment of this subset of WNBAs with very unfavorable morphologies. METHODS: In our case series, 24 patients treated at 12 international centers were taken from a larger prospective voluntary post-marketing registry of 65 patients treated with the eCLIPs device and coiling. Those who had WNBAs at either the carotid or basilar terminus with a DTN ratio <1.6 and aspect ratio <1.2 were included. Radiologic and clinical outcomes were assessed immediately after the procedure and at the latest follow-up. RESULTS: The eCLIPs device was successfully deployed in 23 cases (96%). One patient (4.2%) died due to guidewire perforation distal to the implant site. No other complications were documented. After a mean follow-up of 15.8 months (range 3-40 months), good radiologic outcomes (modified Raymond-Roy classification (MRRC) scores of 1 or 2) were documented in 20 of 21 patients (95%) with follow-up data. The lone patient with an MRRC score of 3 showed coiled compaction after incomplete neck coverage with the device. CONCLUSION: Our series of patients with aneurysms having adverse DTN and aspect ratios demonstrated that the eCLIPs device has a safety and efficacy profile comparable with currently available devices in the treatment of WNBAs.

Aneurysm treatment with WEB in the cumulative population of two prospective, multicenter series: 3-year follow-up.

BACKGROUND: WEB treatment is an endovascular approach for wide-neck bifurcation aneurysms that has demonstrated high safety and good efficacy in mid-term follow-up. While evaluating safety in the long term is important to determine if delayed adverse events occur affecting late morbidity and mortality, the most important point to evaluate is the long-term stability of aneurysm occlusion. The current analysis reports the 3-year clinical and anatomical results of WEB treatment in the combined population of two European trials (WEBCAST (WEB Clinical Assessment of Intrasaccular Aneurysm Therapy) and WEBCAST-2). METHODS: Aneurysm occlusion was evaluated using a 3-grade scale: complete occlusion, neck remnant, and aneurysm remnant. RESULTS: The safety population comprised 79 patients. The efficacy population comprised 61 aneurysms. Aneurysm locations were middle cerebral artery in 32/61 aneurysms (52.5%), anterior communicating artery in 13/61 (21.3%), basilar artery in 9/61 (14.8%), and internal carotid artery terminus in 7/61 (11.5%). No adverse events related to the device or procedure occurred between 2 and 3 years. At 3 years, complete occlusion was observed in 31/61 (50.8%) aneurysms, neck remnant in 20/61 (32.8%), and aneurysm remnant in 10/61 (16.4%). Between 1 year and 3 years, aneurysm occlusion was improved or stable in 53/61 (86.9%) aneurysms and worsened in 8/61 (13.1%). Worsening was mostly from complete occlusion to neck remnant in 6/61 (9.8%) aneurysms. The retreatment rate at 3 years was 11.4%. CONCLUSIONS: This analysis confirms the high safety profile of WEB. Moreover, evidence demonstrates the great stability of aneurysm occlusion with adequate occlusion (complete occlusion or neck remnant) in 83.6% of aneurysms. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. WEBCAST and WEBCAST-2: Unique identifier: NCT01778322.

Validation studies of virtual reality simulation performance metrics for mechanical thrombectomy in ischemic stroke.

INTRODUCTION: Mechanical thrombectomy (MT) has transformed the treatment of ischemic stroke. However, patient access to MT may be limited due to a shortage of doctors specifically trained to perform MT. The studies reported here were done to (1) develop, operationally define, and seek consensus from procedure experts on the metrics which best characterize a reference procedure for the performance of an MT for ischemic stroke and (2) evaluate their construct validity when implemented in a virtual reality (VR) simulation. METHODS: In study 1, the metrics for a reference approach to an MT procedure for ischemic stroke of 10 phases, 46 steps, and 56 errors and critical errors, were presented to an international Delphi panel of 21 consultant level interventional neuroradiologists (INRs). In study 2, the metrics were used to assess 8 expert and 10 novice INRs performing a VR simulated routine MT procedure. RESULTS: In study 1, the Delphi panel reached consensus on the appropriateness of the procedure metrics for a reference approach to MT in ischemic stroke. Group differences in median scores in study 2 demonstrated that experienced INRs performed the case 19% faster (P=0.029), completed 40% more procedure phases (P=0.009), 20% more steps (P=0.012), and made 42% fewer errors (P=0.016) than the novice group. CONCLUSIONS: The international Delphi panel agreed metrics implemented in a VR simulation of MT distinguished between the computer scored procedure performance of INR experts and novices. The studies reported here support the demonstration of face, content, and construct validity of the MT metrics.

Mechanical thrombectomy in basilar artery thrombosis: technical advances and safety in a 10-year experience.

PURPOSE: Multiple endovascular devices have been used for mechanical thrombectomy (MT) in basilar artery occlusion (BAO) for >10 years. Based on a single-center experience during the course of one decade, we present data on safety and efficacy of previous MT devices compared with modern stent retriever and suction thrombectomy. MATERIALS AND METHODS: Eighty-one patients (29 women, 52 men, mean age 61.5 years, range 17-90) with angiographically confirmed BAO that had been treated by MT between 2001 and 2011 were retrospectively evaluated. Patients in group 1 (n = 60) had been treated between 2001 and 2008 with different devices available at that time. Patients in group 2 (n = 21) had been treated by modern stent retriever or local suction devices between 2008 and 2011. Recanalization rate, needle to recanalization time, procedure-related complications, and distal embolization of thrombotic material were recorded and compared. RESULTS: Recanalization rates of 95% were high in both groups. Procedure-related dissection (n = 5) and subarachnoid hemorrhage (n = 9) occurred in group 1 but not in group 2 (p < 0.016). Needle-to-recanalization time was less than half in group 2 compared with group 1 (54.6 vs. 132.3 min, p < 0.01). Frequency of distal embolization was comparable in both groups (47%). CONCLUSION: High recanalization rates have been achieved since the introduction of MT in BAO. However, modern stent retriever and suction devices allow for safer and more rapid recanalization compared with previous MT devices.

Giant multilevel thoracic hemangioma with spinal cord compression in a patient with Klippel-Weber-Trenaunay syndrome: case report.

STUDY DESIGN: Case report and clinical discussion. OBJECTIVE: We intend to report a very rare case of a giant spinal hemangioma causing myelopathy. SUMMARY OF BACKGROUND DATA: Multilevel symptomatic spinal hemangiomas causing acute neurologic symptoms are rare disorders. We found only sporadic reports in English literature. METHODS: We describe a very rare case in which Klippel-Trenaunay-Weber syndrome is associated with a multisegmental vertebral hemangioma causing a rapidly progressing thoracic myelopathy. RESULTS: Because of the extension of the disease, surgical intervention was not feasible, the patient was treated by radiotherapy. The patient showed a complete regression of symptoms with stable condition after 3 months. CONCLUSIONS: In extensive spinal hemangiomas, radiotherapy may represent a safe treatment modality with rapid clinical improvement even in cases with spinal cord compression. This report contributes to a wide range of known vascular abnormalities in Klippel-Trenaunay-Weber syndrome and supports the need for a careful multisystemic evaluation of these patients.