Aspiration thrombectomy versus stent retriever thrombectomy as first-line approach for large vessel occlusion (COMPASS): a multicentre, randomised, open label, blinded outcome, non-inferiority trial.

BACKGROUND: Stent retriever thrombectomy of large-vessel occlusion results in better outcomes than medical therapy alone. Alternative thrombectomy strategies, particularly a direct aspiration as first pass technique, while promising, have not been rigorously assessed for clinical efficacy in randomised trials. We designed COMPASS to assess whether patients treated with aspiration as first pass have non-inferior functional outcomes to those treated with a stent retriever as first line. METHODS: We did a multicentre, randomised, open label, blinded outcome, core lab adjudicated non-inferiority trial at 15 sites (ten hospitals and four specialty clinics in the USA and one hospital in Canada). Eligible participants were patients presenting with acute ischaemic stroke from anterior circulation large-vessel occlusion within 6 h of onset and an Alberta Stroke Program Early CT Score of greater than 6. We randomly assigned participants (1:1) via a central web-based system without stratification to either direct aspiration first pass or stent retriever first line thrombectomy. Those assessing primary outcomes via clinical examinations were masked to group assignment as they were not involved in the procedures. Physicians were allowed to use adjunctive technology as was consistent with their standard of care. The null hypothesis for this study was that patients treated with aspiration as first pass achieve inferior outcomes compared with those treated with a stent retriever first line approach. The primary outcome was non-inferiority of clinical functional outcome at 90 days as measured by the percentage of patients achieving a modified Rankin Scale score of 0-2, analysed by intent to treat; non-inferiority was established with a margin of 0·15. All randomly assigned patients were included in the safety analyses. This trial is registered at ClinicalTrials.gov, number: NCT02466893. FINDINGS: Between June 1, 2015, and July 5, 2017, we assigned 270 patients to treatment: 134 to aspiration first pass and 136 to stent retriever first line. A modified Rankin score of 0-2 at 90 days was achieved by 69 patients (52%; 95% CI 43·8-60·3) in the aspiration group and 67 patients (50%; 41·6-57·4) in the stent retriever group, showing that aspiration as first pass was non-inferior to stent retriever first line (pnon-inferiority=0·0014). Intracranial haemorrhage occurred in 48 (36%) of 134 in the aspiration first pass group, and 46 (34%) of 135 in the stent retriever first line group. All-cause mortality at 3 months occurred in 30 patients (22%) in both groups. INTERPRETATION: A direct aspiration as first pass thrombectomy conferred non-inferior functional outcome at 90 days compared with stent retriever first line thrombectomy. This study supports the use of direct aspiration as an alternative to stent retriever as first-line therapy for stroke thrombectomy. FUNDING: Penumbra.

Pipeline embolization of MCA aneurysms in the M2-M4 segment: Dual center study and meta-analysis.

OBJECTIVE: Flow diversion of distal MCA aneurysms in the M2-M4 segments with Pipeline embolization device is promising, but further study is needed. Here, we seek to quantify the safety and efficacy of Pipeline embolization in the M2-M4 region in a dual-center cohort and comprehensive meta-analysis. METHODS: Clinical and angiographic data of eligible patients was obtained from participating centers. A systematic review was performed with searches of Pubmed, Scopus, Embase, and the Cochrane Library for articles from inception to May 2021. 86 studies were identified in systematic review. Of these, 7 studies with 46 aneurysms met the inclusion criteria and were aggregated with 8 aneurysms from our dual-center cohort for analysis. RESULTS: In our dual-center cohort, complete occlusion was observed in 88% (7/8) of aneurysms, and no patients experienced hemorrhagic or thromboembolic complications. Clinical outcomes were reported for 100% (54/54) of aneurysms included in meta-analysis and angiographic follow-up was available for 91% (49/54). The overall rate of complete aneurysm occlusion was 80% (95% CI, 69-91%), and the overall rate of clinical complication was 9% (95% CI, 2-16%). CONCLUSION: Pipeline embolization of cerebral aneurysms of the M2-M4 segments of the MCA was reasonably effective and safe in a small group of selected patients, but further study is needed to validate these preliminary results.

Pipeline embolization of proximal middle cerebral artery aneurysms: A multicenter cohort study.

BACKGROUND AND PURPOSE: Flow diversion of aneurysms located in the M1 segment and middle cerebral artery bifurcation with Pipeline embolization device is sometimes performed, but further study is needed to support its regular use in aneurysm treatment. Here, we report measures of safety and efficacy for Pipeline embolization in the proximal middle cerebral artery in a multi-center cohort. MATERIALS AND METHODS: Clinical and angiographic data of eligible patients were retrospectively obtained from participating centers and assessed for key clinical and angiographic outcomes. Additional details were extracted for patients with complications. RESULTS: In our multi-center cohort, complete aneurysm occlusion was achieved in 71% (17/24) of treated aneurysms. There were no deaths or disabling strokes, but non-disabling ischemic strokes occurred in 8% (2/24) of patients. For aneurysms in the M1 segment, complete aneurysm occlusion was observed in 75% (12/16) of aneurysms, aneurysm volume reduction was observed in 100% (16/16) of aneurysms, and non-disabling ischemic strokes occurred in 13% (2/16) of patients. For aneurysms at the middle cerebral artery bifurcation, complete aneurysm occlusion was observed in 63% (5/8) of aneurysms, aneurysm volume reduction occurred in 88% (7/8) of aneurysms, and ischemic or hemorrhagic complications occurred in 0% (0/8) of patients. CONCLUSION: Pipeline embolization of cerebral aneurysms in the M1 segment and middle cerebral artery bifurcation demonstrated a 71% rate of complete aneurysm occlusion. There were no deaths or disabling strokes, but there was an 8% rate of non-disabling ischemic strokes.

Pipeline embolization of distal posterior inferior cerebellar artery aneurysms.

BACKGROUND AND PURPOSE: Flow diversion is commonly used to treat intracranial aneurysms in various regions of the cerebral vasculature, but is only approved for use in the internal carotid arteries. Treatment of distal PICA aneurysms with PED is sometimes performed but has not been well studied. Here, we report our experience with flow diversion of distal PICA aneurysms with PED. MATERIALS AND METHODS: Clinical and angiographic data of eligible patients was retrospectively obtained and assessed for key demographic characteristics and clinical and angiographic outcomes. Principal outcomes included rates of aneurysm occlusion, ischemic or hemorrhagic complication, technical complication, and in-stent stenosis. RESULTS: Three female and 2 male patients underwent placement of PED in the PICA for treatment of 5 distal PICA aneurysms. Clinical and angiographic follow-up was obtained for all patients. Complete aneurysm occlusion was observed in 100% (5/5) of treated aneurysms at 6 month and longest angiographic follow-up. While there were no ischemic or device-related complications, delayed hemorrhagic complications occurred in 20% (1/5) of patients. CONCLUSION: Pipeline embolization of distal PICA aneurysms can be performed in select patients. Further study is necessary in larger cohorts to better define clinical scenarios in which flow diversion in the distal PICA should be considered.

Dual antiplatelet therapy does not improve outcomes after aneurysmal subarachnoid hemorrhage compared with aspirin monotherapy.

BACKGROUND: The pathophysiology of delayed cerebral ischemia (DCI) after aneurysmal subarachnoid hemorrhage (aSAH) may include platelet activation and microthrombi formation. Antiplatelet therapy may reduce the incidence of DCI and improve clinical outcomes after aSAH. This study compared outcomes among aSAH patients receiving aspirin monotherapy versus dual antiplatelet therapy (DAPT). METHODS: Aneurysmal subarachnoid hemorrhage patients treated at a single institution between November 2011 and December 2017 were divided according to whether they received aspirin monotherapy or DAPT after endovascular treatment. Baseline characteristics and outcomes of the groups were compared, including incidences of delayed cerebral ischemia, bleeding complications, symptomatic vasospasm, in-hospital mortality, and functional status 6 months after discharge. RESULTS: During the study period, 142 patients met study inclusion criteria, of which 123 were treated with aspirin monotherapy (87 %) and 19 were treated with DAPT (13 %). There was no statistically significant difference between the aspirin monotherapy and DAPT groups with respect to incidences of delayed cerebral ischemia (4.9 vs 10.5 %; p = 0.32), symptomatic vasospasm (13.0 vs 15.8 %; p = 0.74), or good clinical outcome at 6-month follow up (73.3 vs 66.7 %; p = 0.56). The DAPT group experienced a higher incidence of in-hospital mortality (21 vs 5.7 %; p = 0.02), but DAPT did not remain independently predictive of this outcome on regression analysis. There was a trend toward a higher bleeding complication rate in the DAPT group (0.8 vs 5.3 %; p = 0.13). CONCLUSIONS: DAPT does not reduce the incidence of DCI or improve outcomes in aSAH patients, and may increase the risk of clinically significant bleeding complications.

Endovascular Treatment of Posterior Inferior Cerebellar Artery Aneurysms with Flow Diversion.

BACKGROUND: Flow diversion is a viable alternative for treatment of wide-neck and fusiform aneurysms originating from the posterior inferior cerebellar artery (PICA), but coverage of the PICA and vertebral perforating arteries may be a concern. The aim of this study was to examine procedural, clinical, and angiographic outcomes of patients with PICA aneurysms treated with the Pipeline Embolization Device. METHODS: Retrospective review was performed of PICA aneurysms treated with the Pipeline device at 3 neurovascular centers, including periprocedural complications and clinical and angiographic outcomes. RESULTS: In 16 procedures, 14 PICA aneurysms were treated with the Pipeline device. These included 11 saccular aneurysms with a mean size of 7.4 mm (range, 2.0-11.1 mm) and 3 fusiform aneurysms with a mean diameter of 6.1 mm (range, 5.0-8.0 mm) and mean length of 10.3 mm (range, 6.0-15.0 mm). One patient developed a PICA territory infarct with mild leg weakness that resolved in <7 days. Overall complication rate was 7% (1/14) per patient and 6% (1/16) per procedure. Mean duration of clinical follow-up was 13.5 months (range, 3 weeks to 61.7 months), with all patients returning to baseline functional status. Complete or near-complete aneurysm occlusion was achieved in 58% (7/12) of cases with angiographic follow-up (mean, 15 months; range, 4-61 months). All covered PICAs remained patent. CONCLUSIONS: Flow diversion of PICA aneurysms is a safe and viable treatment option when traditional endovascular options are unlikely to preserve parent vessel patency.

Endovascular Treatment of Posterior Cerebral Artery Aneurysms With Flow Diversion: Case Series and Systematic Review.

BACKGROUND: Flow diversion of posterior cerebral artery (PCA) aneurysms has not been widely reported, possibly owing to concerns regarding parent vessel size and branch vessel coverage. OBJECTIVE: To examine the safety and effectiveness of PCA aneurysm flow diverter treatment. METHODS: Retrospective review of PCA aneurysms treated with the Pipeline Embolization Device (PED; Medtronic Inc, Dublin, Ireland) at 3 neurovascular centers, including periprocedural complications and clinical and angiographic outcomes. Systematic review of the literature identified published reports of PCA aneurysms treated with flow diversion. Rates of aneurysm occlusion and complications were calculated, and outcomes of saccular and fusiform aneurysm treatments were compared. RESULTS: Ten PCA aneurysms in 9 patients were treated with the PED. There were 2 intraprocedural thromboembolic events (20%), including 1 symptomatic infarction and 1 delayed PED thrombosis. Eight of 10 patients returned to or improved from their baseline functional status. Complete aneurysm occlusion with parent vessel preservation was achieved in 75% (6/8) of cases at mean follow-up of 16.7 mo. Eleven of 12 (92%) major branch vessels covered by a PED remained patent. Including the present study, systematic review of 15 studies found a complete aneurysm occlusion rate of 88% (30/34) and complication rate of 26% (10/38), including 5 symptomatic ischemic strokes (13%; 5/38). Fusiform aneurysms more frequently completely occluded compared with saccular aneurysms (100% vs 70%; P = .03) but were associated with a higher complication rate (43% vs 9%; P = .06). CONCLUSION: The safety and effectiveness profile of flow diverter treatment of PCA aneurysms may be acceptable in select cases.

Initial hospital management of patients with emergent large vessel occlusion (ELVO): report of the standards and guidelines committee of the Society of NeuroInterventional Surgery.

OBJECTIVE: To summarize the current literature regarding the initial hospital management of patients with acute ischemic stroke (AIS) secondary to emergent large vessel occlusion (ELVO), and to offer recommendations designed to decrease the time to endovascular treatment (EVT) for appropriately selected patients with stroke. METHODS: Using guidelines for evidenced-based medicine proposed by the Stroke Council of the American Heart Association, a critical review of all available medical literature supporting best initial medical management of patients with AIS secondary to ELVO was performed. The purpose was to identify processes of care that most expeditiously determine the eligibility of a patient with an acute stroke for interventions including intravenous fibrinolysis with recombinant tissue plasminogen activator (IV tPA) and EVT using mechanical embolectomy. RESULTS: This review identifies four elements that are required to achieve timely revascularization in ELVO. (1) In addition to non-contrast CT (NCCT) brain scan, CT angiography should be performed in all patients who meet an institutional threshold for clinical stroke severity. The use of any advanced imaging beyond NCCT should not delay the administration of IV tPA in eligible patients. (2) Activation of the neurointerventional team should occur as soon as possible, based on either confirmation of large vessel occlusion or a prespecified clinical severity threshold. (3) Additional imaging techniques, particularly those intended to physiologically select patients for EVT (CT perfusion and diffusion-perfusion mismatch imaging), may provide additional value, but should not delay EVT. (4) Routine use of general anesthesia during EVT procedures, should be avoided if possible. These workflow recommendations apply to both primary and comprehensive stroke centers and should be tailored to meet the needs of individual institutions. CONCLUSIONS: Patients with ELVO are at risk for severe neurologic morbidity and mortality. To achieve the best possible clinical outcomes stroke centers must optimize their triage strategies. Strategies that provide patients with ELVO with the fastest access to reperfusion depend upon detail-oriented process improvement.