The Comaneci device offers a new promising and reliable technique that can safely support aneurysm coiling occlusion even in a rupture environment. However, long term monitoring of patients treated by this device is mandatory.
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.
BackgroundThe use of flow diversion to treat intracranial aneurysms has increased in recent years.ObjectiveTo assess the safety and angiographic efficacy of the p64 flow modulation device.MethodsDiversion-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.ResultsA 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).ConclusionsDiversion-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.
BackgroundTemporary placement of a retrievable neck bridging device, allowing parent vessel flow, is an attractive alternative to balloon remodeling for treatment of ruptured intracranial aneurysms.ObjectiveTo present, in a single-center study, our initial experience with Cascade (Perflow, Israel) in the treatment of ruptured intracranial aneurysms.MethodsDuring a period of 1.5 months, 12 patients with aneurysmal subarachnoid hemorrhage underwent coil embolization in conjunction with Cascade in our center. Retrospective analysis of prospectively collected angiographic and clinical data was conducted to assess the safety and efficacy of the device.ResultsAmong all treated patients, 41.7% (5/12) were female, the median age was 55 (47–77) years, the median aneurysm dome size was 5.75 mm (3–9.1), and the median neck size was 3.55 mm (2.3–7.9). Complete obliteration (Raymond 1) was achieved in 75% (9/12) of cases, and intentional residual neck (Raymond 2) was left in three cases (25%). None of the patients received any oral or intravenous antiplatelet therapy perioperatively. No thromboembolic complications, device-related spasm, vessel perforation, or coil entanglement were detected in any of the treated patients.ConclusionsIn our initial experience, treatment of wide-neck ruptured intracranial aneurysms with Cascade is safe and effective, without the need for adjuvant antiplatelet therapy. Long-term follow-up data in larger cohorts are needed to confirm these preliminary findings.
Background and purpose Low-profile self-expandable stents have increased the number of intracranial aneurysms treated by endovascular means. The new low-profile visible intraluminal support device LVIS EVO (Microvention), the successor of LVIS Jr, is a self-expandable and retrievable microstent system, designed for implantation into intracranial arteries with a diameter up to 2.0 mm. In this retrospective study we aimed to elucidate the technical feasibility and clinical safety of the novel LVIS EVO stent for stent-assisted coil embolisation of intracranial aneurysms. Materials and methods A single centre technical report of the first six consecutive cases of stent-assisted coil embolisation with the novel LVIS EVO stent for the treatment of unruptured or recanalised intracranial aneurysms. Records were made of basic demographics, aneurysmal characteristics, device properties and related technical details, adverse events, clinical outcomes and occlusion rates on available radiological follow-up. Results Six LVIS EVO devices were successfully implanted in all subjects to treat a total number of six intracranial aneurysms. No device-related intraprocedural complications were seen. At early clinical follow-up six out of six (100%) patients had a modified Ranking score of 0–1. Early angiographic and cross-sectional radiological follow-up, available in five out of six (83.3%) of the patients confirmed unchanged aneurysmal occlusion rates. A minor, transitory neurological deficit was recorded in one of the six (16.6%) patients. Mortality was 0%. Conclusions Preliminary experience in this subset of our patients confirms a notably improved technical behaviour of the novel LVIS EVO stent system when compared to its ancestor LVIS Jr. The enhanced visibility of the stent and the refined delivery/retrieval capabilities of the stent further increase the safety margins of the devices profile, especially in cases of tortuous anatomy.
Background: Despite the well-established potent benefit of mechanical thrombectomy (MT) for large vessel occlusion (LVO) stroke, access to MT has not been studied globally. We conducted a worldwide survey of countries on 6 continents to define MT access (MTA), the disparities in MTA, and its determinants on a global scale. Methods: Our survey was conducted in 75 countries through the Mission Thrombectomy 2020+ global network between November 22, 2020, and February 28, 2021. The primary end points were the current annual MTA, MT operator availability, and MT center availability. MTA was defined as the estimated proportion of patients with LVO receiving MT in a given region annually. The availability metrics were defined as ([current MT operators×50/current annual number of estimated thrombectomy-eligible LVOs]×100 = MT operator availability) and ([current MT centers×150/current annual number of estimated thrombectomy-eligible LVOs]×100= MT center availability). The metrics used optimal MT volume per operator as 50 and an optimal MT volume per center as 150. Multivariable-adjusted generalized linear models were used to evaluate factors associated with MTA. Results: We received 887 responses from 67 countries. The median global MTA was 2.79% (interquartile range, 0.70–11.74). MTA was <1.0% for 18 (27%) countries and 0 for 7 (10%) countries. There was a 460-fold disparity between the highest and lowest nonzero MTA regions and low-income countries had 88% lower MTA compared with high-income countries. The global MT operator availability was 16.5% of optimal and the MT center availability was 20.8% of optimal. On multivariable regression, country income level (low or lower–middle versus high: odds ratio, 0.08 [95% CI, 0.04–0.12]), MT operator availability (odds ratio, 3.35 [95% CI, 2.07–5.42]), MT center availability (odds ratio, 2.86 [95% CI, 1.84–4.48]), and presence of prehospital acute stroke bypass protocol (odds ratio, 4.00 [95% CI, 1.70–9.42]) were significantly associated with increased odds of MTA. Conclusions: Access to MT on a global level is extremely low, with enormous disparities between countries by income level. The significant determinants of MT access are the country’s per capita gross national income, prehospital LVO triage policy, and MT operator and center availability.
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