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BackgroundThe 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.MethodsPREMIER (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.ResultsAs 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.ConclusionsThe 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 registrationNCT02186561.

BackgroundEndovascular thrombectomy (EVT) has become the mainstay treatment for large vessel occlusion, with favorable safety and efficacy profile. However, the safety and efficacy of EVT in concurrent multi-territory occlusions (MTVOs) remains unclear.ObjectiveTo investigate the prevalence, clinical and technical outcomes of concurrent EVT for MTVOs.MethodsData were included from the Stroke Thrombectomy and Aneurysm Registry (STAR) with 32 stroke centers for EVT performed to treat bilateral anterior or concurrent anterior and posterior circulation occlusions between 2017 and 2021. Patients with MTVO were identified, and propensity score matching was used to compare this group with patients with occlusion in a single arterial territory.ResultsOf a total of 7723 patients who underwent EVT for acute ischemic stroke, 54 (0.7%) underwent EVT for MTVOs (mean age 69±12.5; female 50%). 28% had bilateral and 72% had anterior and posterior circulations occlusions. The rate of successful recanalization (Thrombolysis in Cerebral Infarction 2b/3), complications, modified Rankin score at 90 days, and mortality was not significantly different between the matched cohorts. Multivariate analysis confirmed that MTVOs were not associated with poor functional outcome, symptomatic intracranial hemorrhage, or longer procedure time.ConclusionCompared with EVT for single vessel occlusions, EVT in appropriately selected patients with MTVOs has a similar efficacy and safety profile.

BackgroundEndovascular thrombectomy (EVT) is the standard-of-care for proximal large vessel occlusion (LVO) stroke. Data on technical and clinical outcomes in distal vessel occlusions (DVOs) remain limited.MethodsThis was a retrospective study of patients undergoing EVT for stroke at 32 international centers. Patients were divided into LVOs (internal carotid artery/M1/vertebrobasilar), medium vessel occlusions (M2/A1/P1) and isolated DVOs (M3/M4/A2/A3/P2/P3) and categorized by thrombectomy technique. Primary outcome was a good functional outcome (modified Rankin Scale ≤2) at 90 days. Secondary outcomes included recanalization, procedure-time, thrombectomy attempts, hemorrhage, and mortality. Multivariate logistic regressions were used to evaluate the impact of technical variables. Propensity score matching was used to compare outcome in patients with DVO treated with aspiration versus stent retrieverResultsWe included 7477 patients including 213 DVOs. Distal location did not independently predict good functional outcome at 90 days compared with proximal (p=0.467). In distal occlusions, successful recanalization was an independent predictor of good outcome (adjusted odds ratio (aOR) 5.11, pConclusionsOutcomes following EVT for DVO are comparable to LVO with similar results between techniques. Techniques may exhibit different futility metrics; stent retriever thrombectomy was influenced by attempts whereas aspiration was more dependent on procedure time.

BackgroundAtrial fibrillation (AF) associated ischemic stroke is associated with worse functional outcomes, less effective recanalization, and increased rates of hemorrhagic complications after intravenous thrombolysis (IVT). Conversely, AF is not associated with hemorrhagic complications or functional outcomes in patients undergoing mechanical thrombectomy (MT). This differential effect of MT and IVT in AF associated stroke raises the question of whether bridging thrombolysis increases hemorrhagic complications in AF patients undergoing MT.MethodsThis international cohort study of 22 comprehensive stroke centers analyzed patients with large vessel occlusion (LVO) undergoing MT between June 1, 2015 and December 31, 2020. Patients were divided into four groups based on comorbid AF and IVT exposure. Baseline patient characteristics, complications, and outcomes were reported and compared.Results6461 patients underwent MT for LVO. 2311 (35.8%) patients had comorbid AF. In non-AF patients, bridging therapy improved the odds of good 90 day functional outcomes (adjusted OR (aOR) 1.29, 95% CI 1.03 to 1.60, p=0.025) and did not increase hemorrhagic complications. In AF patients, bridging therapy led to significant increases in symptomatic intracranial hemorrhage and parenchymal hematoma type 2 (aOR 1.66, 1.07 to 2.57, p=0.024) without any benefit in 90 day functional outcomes. Similar findings were noted in a separate propensity score analysis.ConclusionIn this large thrombectomy registry, AF patients exposed to IVT before MT had increased hemorrhagic complications without improved functional outcomes, in contrast with non-AF patients. Prospective trials are warranted to assess whether AF patients represent a subgroup of LVO patients who may benefit from a direct to thrombectomy approach at thrombectomy capable centers.

BackgroundPreliminary clinical studies on the safety and efficacy of the pipeline embolization device (PED) for the treatment of small/medium aneurysms have demonstrated high occlusion rates with low complications.ObjectiveTo evaluate the safety and effectiveness of the PED for treatment of wide necked small and medium intracranial aneurysms.MethodsPREMIER is a prospective, multicenter, single arm trial. Patients were treated with the PED for unruptured wide necked aneurysms, measuring ≤12 mm along the internal carotid artery or vertebral artery, between July 2014 and November 2015. At 1 year post-procedure, the primary effectiveness endpoint was complete occlusion (Raymond grade 1) without major parent vessel stenosis (≤50%) or retreatment, and the primary safety endpoint was major stroke in the territory supplied by the treated artery or neurologic death.ResultsA total of 141 patients were treated with PEDs (mean age 54.6±11.3 years, 87.9% (124/141) women). Mean aneurysm size was 5.0±1.92 mm, and 84.4% (119/141) measured ConclusionsTreatment of wide necked small/medium aneurysms with the PED results in high rates of complete occlusion without significant parent vessel stenosis and low rates of permanent neurologic complications.Trial registrationNCT02186561.

BackgroundRuptured aneurysms of the intracranial vertebral artery (VA) or posterior inferior cerebellar artery (PICA) are challenging to treat as they are often dissecting aneurysms necessitating direct sacrifice of the diseased segment, which is thought to carry high morbidity due to brainstem and cerebellar stroke. However, relatively few studies evaluating outcomes following VA or proximal PICA sacrifice exist. We sought to determine the efficacy and outcomes of endovascular VA/PICA sacrifice.MethodsA retrospective series of ruptured VA/PICA aneurysms treated by endovascular sacrifice of the VA (including the PICA origin) or proximal PICA is reviewed. Collected data included demographic, radiologic, clinical, and disability information.ResultsTwenty-one patients were identified. Median age was 57 years (IQR 11); 15 were female. The Hunt and Hess grade was mostly 3 and 4 (18/21). Seven cases (33%) involved VA-V4 at the PICA take-off, and 14 cases (67%) involved the PICA exclusively. For VA pathology, V4 was sacrificed in all cases, while for PICA pathology, sacrificed segments included anterior medullary (4/14), lateral medullary (7/14), and tonsillomedullary (3/14) segments. Four patients went to hospice (19%). Twelve patients (57%) had evidence of stroke on follow-up imaging: cerebellar (8), medullary (1), and both (3). One patient required suboccipital decompression for brainstem compression. No aneurysm re-rupture occurred. Median discharge modified Rankin Scale score was 2.0 (IQR 2), which decreased to 1.0 (IQR 1) at median follow-up of 6.5 months (IQR 23).ConclusionsEndovascular sacrifice of V4 or PICA aneurysms may carry less morbidity than previously thought, and is a viable alternative for poor surgical candidates or those with good collateral perfusion.

BackgroundThe pipeline embolization device (PED) is approved for the treatment of large aneurysms of the proximal internal carotid artery (ICA). Its off-label application in treating aneurysms located specifically at the ICA terminus (ICA-T) has not been studied.MethodsWe conducted a retrospective chart review of patients from 2011 to 7 treated with PEDs. Out of 365 patients, 10 patients with ICA-T aneurysms were included. Patient demographics, procedural information, follow-up imaging, and clinical assessments were recorded.ResultsMean age was 46.9 years (± 8.8), and 6 (60%) patients were women. The mean maximum diameter of the aneurysms treated was 14.7 mm (± 10.7) and the mean neck diameter was 9.3 mm (± 6.6). Reasons for presentation included six incidental findings, one acute subarachnoid hemorrhage (SAH), and three patients with prior SAH. Kamran–Byrne Occlusion Scale scores for the treated aneurysms were as follows: three class IV (complete obliteration), four class III (ConclusionThe PED has potential for treating ICA-T aneurysms not amenable to conventional treatment strategies. Further studies are warranted to confirm the long term outcomes.

BackgroundThe off-label use of flow diverters in the treatment of distal aneurysms continues to be debated.ObjectiveTo report our multicenter experience in the treatment of complex anterior cerebral artery aneurysms with the Pipeline embolization device (PED).MethodsThe neurointerventional databases of the four participating institutions were retrospectively reviewed for aneurysms treated with PED between October 2011 and January of 2016. All patients treated for anterior cerebral artery aneurysms were included in the analysis. Clinical presentation, location, type, vessel size, procedural complications, clinical and imaging follow-up were included in the analysis.ResultsTwenty patients (13 female) with 20 aneurysms met the inclusion criteria in our study. Fifteen aneurysms were classified as saccular and five as fusiform (mean size 7.3 mm). Thirteen aneurysms were located in the anterior communicating region (ACOM or A1/2 junction), six were A2-pericallosal, and one was located in the A1 segment. Six patients had presented previously with subarachnoid hemorrhage and had their aneurysms initially clipped or coiled. There was one minor event (a small caudate infarct) and one major event (intraparenchymal hemorrhage). Sixteen of the 20 patients had angiographic follow-up (mean 10 months). Eleven aneurysms were completely occluded, one had residual neck, and four had residual aneurysm filling.ConclusionsThe treatment of complex anterior cerebral artery aneurysms with the PED as an alternative for patients who are not good candidates for conventional methods is technically feasible and safe. Mid-term results are promising but larger series with long-term follow-up are required to assess its effectiveness.

BackgroundAneurysmal subarachnoid hemorrhage is a potentially devastating condition, and among the first priorities of treatment is aneurysm occlusion to prevent re-hemorrhage. An emerging strategy to treat patients whose aneurysms are not ideal for surgical or endovascular treatment is subtotal coiling followed by flow diversion in the recovery phase or ‘plug and pipe’. However, data regarding the safety and efficacy of this strategy are lacking.MethodsA retrospective cohort study was performed to evaluate the efficacy and safety of ‘plug and pipe’. All patients with a ruptured intracranial aneurysm intentionally, subtotally treated by coiling in the acute stage followed by flow diversion after recovery, were included. The primary outcome was re-hemorrhage. Secondary outcomes included aneurysm occlusion and functional status. Complications were reviewed.Results22 patients were included. No patient suffered a re-hemorrhage, either in the interval between coiling and flow diversion or in follow-up. The median interval between aneurysm rupture and flow diversion was 3.5 months. Roy–Raymond (R-R) class I or II occlusion was achieved in 91% of target aneurysms at the last imaging follow-up (15/22(68%) R-R 1 and 5/22(23%) R-R 2). Complications occurred in 2 (9%) patients, 1 of which was neurological.ConclusionsOverall, these data suggest that subtotal coiling of ruptured intracranial aneurysms followed by planned flow diversion is both safe and effective. Patients who may most benefit from ‘plug and pipe’ are those with aneurysms that confer high operative risk and those whose severity of medical illness increases the risk of microsurgical clip ligation.

BackgroundAdministration of ε-aminocaproic acid (εACA), as adjuvant therapy following incompletely embolized cranial dural arteriovenous (dAVFs) and direct carotid artery to cavernous sinus fistulae (CCFs), is a strategy to promote post-procedural thrombosis. However, the efficacy of εACA to treat incompletely obliterated dAVFs and CCFs has not been published. The purpose of this study was to determine if administration of εACA following incomplete embolization of cranial dAVFs or CCFs was associated with an increased likelihood of cure on follow-up imaging compared with patients not given adjuvant εACA.MethodsA retrospective cohort study was performed. All patients who underwent treatment of a dAVF or CCF at our institution between 1998 and 2016 were reviewed (n=262). Patients with residual shunting following the first attempted endovascular embolization were included in the analysis (n=52). The study groups were those treated with εACA following incomplete obliteration of the fistula and those who were not. The primary outcome was obliteration of the fistula on initial follow-up imaging. Complication rates between cohorts were compared.Results20 (38%) patients with incompletely obliterated fistulae were treated with adjuvant εACA. A trend towards an improved rate of complete obliteration on initial follow-up imaging was observed in the group treated with εACA (55% vs 34% in the group not treated with εACA, p=0.14). No difference in clinical outcomes or thromboembolic complications was observed between the groups.ConclusionsIn summary, these data suggest that administration of εACA is a safe adjuvant therapy in the management of cranial dAVFs and CCFs that are incompletely treated endovascularly.

Background Pericallosal, or A2 bifurcation, aneurysms are an infrequently encountered cause of subarachnoid hemorrhage (SAH). While the International Subarachnoid Aneurysm Trial showed improved outcomes for patients with any ruptured anterior circulation aneurysm treated with embolization, there was also a higher recurrence rate for embolized aneurysms. Notably, there were relatively few pericallosal aneurysms. Objective Specific analysis of pericallosal aneurysms may help guide therapeutic decisions. Methods Retrospective analysis of patients who presented with proven saccular pericallosal aneurysms was performed at two institutions from 1999 to 2009. Patients were stratified according to presentation Hunt and Hess grades and modified Fisher scores, treatment modality and outcomes as well as development of vasospasm, hydrocephalus and required treatment. Results Eighty-eight patients with pericallosal aneurysms were identified. Sixty-two presented with SAH and 26 in elective fashion, 2 of whom had a prior history of SAH. Fifty-four patients underwent microsurgical repair and 32 endovascular repair. Patients presenting with SAH due to pericallosal aneurysm treated with an endovascular approach were more likely to have a good modified Rankin scale (mRS) (mRS 0–2 vs 3–6) (p=0.028), to make a complete recovery (mRS=0) (p=0.017) and were less likely to die (mRS=6) (p=0.026). Patients with electively treated pericallosal aneurysms did not have statistically significant differences in outcome between surgical and endovascular cohorts. Differences in secondary endpoints did not reach significance. Conclusion Patients with ruptured pericallosal aneurysms fare better with endovascular therapy, with better chance of complete recovery. Surgical and endovascular treatments of unruptured pericallosal aneurysms have similar results and outcome.

PurposeThe pipeline embolization device (PED) necessitates dual antiplatelet therapy (APT) to decrease thrombotic complications while possibly increasing bleeding risks. The role of APT dose, duration, and response in patients with hemorrhagic and thromboembolic events warrants further analysis.MethodsA PubMed and Google Scholar search from 2009 to 2014 was performed using the following search terms individually or in combination: pipeline embolization device, aneurysm(s), and flow diversion, excluding other flow diverters. Review of the bibliographies of the retrieved articles yielded 19 single and multicenter studies. A statistical meta-analysis between aspirin (ASA) dose (low dose ≤160 mg, high dose ≥300 mg), loading doses of APT agents, post-PED APT regimens, and platelet function testing (PFT) with hemorrhagic or thrombotic complications was performed.ResultsASA therapy for ≤6 months post-PED was associated with increased hemorrhagic events. High dose ASA ≤6 months post-PED was associated with fewer thrombotic events compared with low dose ASA. Post-PED clopidogrel for ≤6 months demonstrated an increased incidence of symptomatic thrombotic events. Loading doses of ASA plus clopidogrel demonstrated a decreased incidence of permanent symptomatic hemorrhagic events. PFT did not show a statistically significant relationship with symptomatic hemorrhagic or thrombotic complications.ConclusionsHigh dose ASA >6 months is associated with fewer permanent thrombotic and hemorrhagic events. Clopidogrel therapy ≤6 months is associated with higher rates of thrombotic events. Loading doses of ASA and clopidogrel were associated with a decreased incidence of hemorrhagic events. PFT did not have any significant association with symptomatic events.

Background Stable access to target lesions is foundational to endovascular therapy, be it in hemorrhagic or ischemic disease. Continued evolution in access technology has resulted in next generation catheters that afford improved trackability and proximal support. Objective Assess safety and patterns of use at two high volume centers, and conceptualize usage patterns. Materials and methods A retrospective review of 608 cases in which a ‘next generation’ catheter was used during 2008–2010 at Cleveland Clinic (Cleveland, Ohio, USA) and throughout 2009–2010 at Emory University Hospital (Atlanta, Georgia, USA) was conducted, and the cases classified by indication. Catheter placement, distal most location, and related complications were recorded and experience summarized. We also reviewed the differences in the catheters and the rationale for catheter selection, as well as relative costs for each approach. Results 311 Neuron 053, 166 Neuron 070, 36 distal access catheter (DAC) 3.9 F, 61 DAC 4.3 F, and 34 DAC 5.2 F catheters were deployed. Of these, 459 placements were in the anterior circulation, 130 in the posterior circulation, 11 in the external carotid artery, and eight were used intravenously. Complication rates were 9/131 (6.9%) for the DAC catheter group, 16/311 (5.1%) for the Neuron 053 group, and 14/166 (8.4%) for the Neuron 070 group (p=0.37, χ2 test). Conclusions Next generation access catheters possess characteristics that blend qualities of traditional microcatheters and stiff guide catheters. There was no statistically significant difference in complication rates between the various catheter families in this small retrospective review, and the complication rates were similar to historical complication rates.