Background The use of flow diversion to treat intracranial aneurysms has increased in recent years. Objective To assess the safety and angiographic efficacy of the p64 flow modulation device. Methods Diversion-p64 is an international, prospective, multicenter, single-arm, study conducted at 26 centers. The p64 flow modulation device was used to treat anterior circulation aneurysms between December 2015 and January 2019. The primary safety endpoint was the incidence of major stroke or neurologic death at 3–6 months, with the primary efficacy endpoint being complete aneurysm occlusion (Raymond-Roy Occlusion Classification 1) on follow-up angiography. Results A total of 420 patients met the eligibility criteria and underwent treatment with the p64 flow modulation device (mean age 55±12.0 years, 86.2% female). Mean aneurysm dome width was 6.99±5.28 mm and neck width 4.47±2.28 mm. Mean number of devices implanted per patient was 1.06±0.47, with adjunctive coiling performed in 14.0% of the cases. At the second angiographic follow-up (mean 375±73 days), available for 343 patients (81.7%), complete aneurysm occlusion was seen in 287 (83.7%) patients. Safety data were available for 413 patients (98.3%) at the first follow-up (mean 145±43 days) with a composite morbidity/mortality rate of 2.42% (n=10). Conclusions Diversion-p64 is the largest prospective study using the p64 flow modulation device. The results of this study demonstrate that the device has a high efficacy and carries a low rate of mortality and permanent morbidity.
Background: Wide-necked cerebral aneurysms in the setting of acute subarachnoid hemorrhage (SAH) remain difficult to treat with endovascular methods despite recent progress in the neuroendovascular field. Objective: To evaluate the effectiveness and safety of the Comaneci device (Rapid Medical, Israel) in endovascular coil embolization of acutely ruptured, wide-necked sidewall, or bifurcation cerebral aneurysms. Methods: We retrospectively reviewed 45 anterior communicating artery, 24 internal carotid artery, 21 middle cerebral artery bifurcation, 15 anterior cerebral artery, and 13 posterior circulation aneurysms, which were treated using Comaneci-assisted coil embolization from August 2017 to January 2019. We evaluated procedural complications, clinical outcomes, and mid-term angiographic follow-up. Immediate and 90 d-clinical outcome and radiological follow-up were obtained in all patients. Results: Comaneci-assisted coil embolization was performed in 118 acutely ruptured aneurysms. The technique was carried out successfully in all cases. Simultaneous application of 2 separated Comaneci devices was performed in 8/118 cases (6.77%). Periprocedural thromboembolic complications related to the device were seen in 7/118 cases (5.93%) and severe vasospasm of the parent artery after manipulation of the Comaneci device occurred in 5/118 cases (4.2%). The procedural-related morbidity rate was 2.54%, and there was no procedural related mortality. Among the available survivors, angiographic follow-ups were obtained at 3 and 6 mo, and complete aneurysmal obliteration was confirmed in 81/112 (72.3%) and 75/112 (66.9%) cases, respectively. Mid-term follow-up reviewed total recanalization rate of 14.28%. Conclusion: Comaneci-assisted embolization of wide-necked intracranial aneurysms in patients presenting with acute SAH is associated with high procedural safety and adequate occlusion rates. Furthermore, dual antiplatelet therapy can be safely avoided in this patient group.
BACKGROUND AND PURPOSE: Stent-assisted treatment techniques can be an effective treatment option for intracranial aneurysms. The aim of this study was to evaluate the periprocedural feasibility and safety of the new LVIS EVO stent for the treatment of intracranial aneurysms. MATERIALS AND METHODS: Patients with intracranial aneurysms treated with the LVIS EVO in 11 European neurovascular centers were retrospectively reviewed. Patient and aneurysm characteristics, procedural parameters, immediate grade of occlusion, and technical and clinical complications were assessed. RESULTS: Fifty-seven patients with 59 aneurysms were treated with the LVIS EVO device; 57.6% of the aneurysms were incidental; 15.3% were acutely ruptured; 15.3% were recanalized or residual aneurysms; and 11.9% were treated for symptoms other than acute hemorrhage. The most frequent aneurysm locations were the middle cerebral artery (25.4%) and the anterior communicating artery (22.0%). The rate of immediate successful deployment was 93.2%. In 6.8% (n = 4) of cases, additional in-stent angioplasty was needed. The immediate complete occlusion rate was 54.2%, while there was a residual aneurysm in 35.6% and a residual neck in 10.2%. Periprocedural technical complications occurred in 7/59 treatments (11.9%; the most frequent technical complication [n = 3] was thrombus formation), which all resolved completely without clinical sequelae. Postprocedural neurologic complications occurred after 4/59 treatments (6.8%; 2 transient ischemic attacks, 1 minor stroke, 1 major stroke), of which only 1 persistent complication was directly related to the procedure (minor stroke in the vascular territory distal to the stent). CONCLUSIONS: The LVIS EVO stent is a safe, feasible device for the treatment of intracranial aneurysms.
Background: The primary goal of conventional endovascular and microvascular approaches is the clinical and radiological resolution of the symptomatic aneurysm-induced mass effect. This study assessed the volume changes and mass effect reduction due to sac shrinkage after treatment with flow diverter stents (FD) for unruptured cerebral aneurysms.Methods: We analyzed retrospectively 36 symptomatic aneurysms that were larger or equal to 25 mm in diameter in patients treated at our center from January 2016 to April 2022. Radiological and clinical outcomes were analyzed, including aneurysmal volume changes and resolution of aneurysm-related symptoms.Results: At 6 months, 25 aneurysms decreased in size, 2 remained unchanged, and 9 aneurysms demonstrated a post-treatment dimensional increase. At 12 months, 30 aneurysms showed a progressive radiological volume reduction. Either no change or negligible shrinkage was observed in the remaining six aneurysms. At 24 months, 32 aneurysms showed aneurysmal shrinkage by a mean 47% volume loss with respect to baseline. At the last follow-up, all 13 patients who had presented with third cranial nerve palsy showed improvements. Complete reversal of the pretreatment edematous changes was confirmed in all cases. The overall post-treatment complication rate was 8.3%, as 3 patients experienced non-fatal delayed rupture of their aneurysm. There was no mortality in this study.Conclusion: Flow diversion could effectively induce progressive aneurysmal shrinkage and resolution of the mass effect associated with giant symptomatic cerebral aneurysms.