BACKGROUND AND PURPOSE:The safety and efficacy of the PulseRider for the treatment of wide-neck, bifurcation aneurysms at the basilar and carotid terminus locations were studied in a prospective trial, the Adjunctive Neurovascular Support of Wide-Neck Aneurysm Embolization and Reconstruction (ANSWER) trial, reporting on initial 6-month angiographic and clinical results. This report provides insight into the longer term durability and safety with 12-month data. MATERIALS AND METHODS:Aneurysms treated with the PulseRider among enrolled sites were prospectively studied. Updated 12-month data on clinical and imaging end points are included. RESULTS:Thirty-four patients were enrolled (29 women, 5 men) with a mean age of 60.9 years. The mean aneurysm height ranged from 2.4 to 15.9 mm with a mean neck size of 5.2 mm (range, 2.3-11.6 mm). At 1 year, there were no device migrations or symptomatic in-stent stenoses. Raymond-Roy I occlusion was achieved in 53% of cases at the time of treatment and progressed to 61% and 67% at 6 and 12 months, respectively. Adequate occlusion (Raymond-Roy I/II) progressed from 88% at 6 months to 90% at 12 months. No recanalizations were observed. There was 1 delayed ischemic event. Good outcome (mRS 0-2) was achieved in 90% of patients. CONCLUSIONS:The updated 1-year results from the ANSWER trial demonstrate aneurysm stability and an acceptable safety profile for aneurysms treated at the basilar apex and carotid terminus. Prospective data from a larger set of aneurysms treated at other locations are required to assess how treatment with PulseRider compares with alternatives for treating wide-neck bifurcation aneurysms.

© 2015 American Academy of Neurology.Objective: We endeavored to develop an unruptured intracranial aneurysm (UIA) treatment score (UIATS) model that includes and quantifies key factors involved in clinical decision-making in the management of UIAs and to

Background and purpose

Differential Subsampling with Cartesian Ordering (DISCO), an ultrafast high-spatial-resolution head MRA, has been introduced. We aimed to determine the diagnostic performance of DISCO-MRA in grading residual aneurysm in comparison with TOF-MRA in patients with treated intracranial aneurysms.

Materials and methods

Patients with endovascular treatment and having undergone DISCO-MRA, TOF-MRA, and DSA were included for review. The voxel size and acquisition time were 0.75 × 0.75 × 1 mm³/6 seconds for DISCO-MRA and 0.6 × 0.6 × 1 mm³/6 minutes for TOF-MRA. Residual aneurysms were determined using the Modified Raymond-Roy Classification on TOF-MRA and DISCO-MRA by 2 neuroradiologists independently and were compared against DSA as the reference standard. Statistical analysis was performed using the κ statistic and the χ² test.

Results

Sixty-eight treated intracranial aneurysms were included. The intermodality agreement was κ = 0.82 (95% CI, 0.67-0.97) between DISCO and DSA and 0.44 (95% CI, 0.28-0.61) between TOF and DSA. Modified Raymond-Roy Classification scores matched DSA scores in 60/68 cases (88%; χ² = 144.4, P < .001 for DISCO and 46/68 cases (68%; χ² = 65.0, P < .001) for TOF. The diagnostic accuracy for the detection of aneurysm remnants was higher for DISCO (0.96; 95% CI, 0.88-0.99) than for TOF (0.79; 95% CI, 0.68-0.88).

Conclusions

In patients with endovascularly treated intracranial aneurysms, DISCO-MRA provides superior diagnostic performance in comparison with TOF-MRA in delineating residual aneurysms in a fraction of the time.

BACKGROUND AND PURPOSE: Patients with acute stroke with robust collateral flow have better clinical outcomes and may benefit from endovascular treatment throughout an extended time window. Using a multiparametric approach, we aimed to identify MR perfusion parameters that can represent the extent of collaterals, approximating DSA. MATERIALS AND METHODS: Patients with anterior circulation proximal arterial occlusion who had baseline MR perfusion and DSA were evaluated. The volume of arterial tissue delay (ATD) at thresholds of 2-6 seconds (ATD2-6 seconds) and >6 seconds (ATD>6 seconds) in addition to corresponding values of normalized CBV and CBF was calculated using VOI analysis. The association of MR perfusion parameters and the status of collaterals on DSA were assessed by multivariate analyses. Receiver operating characteristic analysis was performed. RESULTS: Of 108 patients reviewed, 39 met our inclusion criteria. On DSA, 22/39 (56%) patients had good collaterals. Patients with good collaterals had significantly smaller baseline and final infarct volumes, smaller volumes of severe hypoperfusion (ATD>6 seconds), larger volumes of moderate hypoperfusion (ATD2-6 seconds), and higher relative CBF and relative CBV values than patients with insufficient collaterals. Combining the 2 parameters into a Perfusion Collateral Index (volume of ATD2-6 seconds × relative CBV2-6 seconds) yielded the highest accuracy for predicting collateral status: At a threshold of 61.7, this index identified 15/17 (88%) patients with insufficient collaterals and 22/22 (100%) patients with good collaterals, for an overall accuracy of 94.1%. CONCLUSIONS: The Perfusion Collateral Index can predict the baseline collateral status with 94% diagnostic accuracy compared with DSA.

BACKGROUND AND PURPOSE: Automated ASPECTS has the potential of reducing interobserver variability in the determination of early ischemic changes. We aimed to assess the performance of an automated ASPECTS software against the assessment of a neuroradiologist in a comparative analysis with concurrent CTP-based CBV ASPECTS. MATERIALS AND METHODS: Patients with anterior circulation stroke who had baseline NCCT and CTP and underwent successful mechanical thrombectomy were included. NCCT-ASPECTS was assessed by 2 neuroradiologists, and discrepancies were resolved by consensus. CTP-CBV ASPECTS was assessed by a different neuroradiologist. Automated ASPECTS was provided by Brainomix software. ASPECTS was dichotomized (ASPECTS ≥6 or <6) and was also based on the time from onset (>6 or ≤6 hours). RESULTS: A total of 58 patients were included. The interobserver agreement for NCCT ASPECTS was moderate (κ = 0.48) and marginally improved (κ = 0.64) for dichotomized data. Automated ASPECTS showed excellent agreement with consensus reads (κ = 0.84) and CTP-CBV ASPECTS (κ = 0.84). Intraclass correlation coefficients for ASPECTS across all 3 groups were 0.84 (95% CI, 0.76-0.90, raw scores) and 0.94 (95% CI, 0.91-0.96, dichotomized scores). Automated scores were comparable with consensus reads and CTP-CBV ASPECTS in patients when grouped on the basis of time from symptom onset (>6 or ≤6 hours). There was significant (P < .001) negative correlation with final infarction volume and the 3 ASPECTS groups (r = -0.52, consensus reads; -0.58, CTP-CBV; and -0.66, automated). CONCLUSIONS: ASPECTS derived from an automated software performs equally as well as consensus reads of expert neuroradiologists and concurrent CTP-CBV ASPECTS and can be used to standardize ASPECTS reporting and minimize interpretation variability.

BACKGROUND AND PURPOSE: The Bayesian probabilistic method has shown promising results to offset noise-related variability in perfusion analysis. Using CTP, we aimed to find optimal Bayesian-estimated thresholds based on multiparametric voxel-level models to estimate the ischemic core in patients with acute ischemic stroke. MATERIALS AND METHODS: Patients with anterior circulation acute ischemic stroke who had baseline CTP and achieved successful recanalization were included. In a subset of patients, multiparametric voxel-based models were constructed between Bayesian-processed CTP maps and follow-up MRIs to identify pretreatment CTP parameters that were predictive of infarction using robust logistic regression. Subsequently CTP-estimated ischemic core volumes from our Bayesian model were compared against routine clinical practice oscillation singular value decomposition-relative cerebral blood flow <30%, and the volumetric accuracy was assessed against final infarct volume. RESULTS: In the constructed multivariate voxel-based model, 4 variables were identified as independent predictors of infarction: TTP, relative CBF, differential arterial tissue delay, and differential mean transit time. At an optimal cutoff point of 0.109, this model identified infarcted voxels with nearly 80% accuracy. The limits of agreement between CTP-estimated ischemic core and final infarct volume ranged from -25 to 27 mL for the Bayesian model, compared with -61 to 52 mL for oscillation singular value decomposition-relative CBF. CONCLUSIONS: We established thresholds for the Bayesian model to estimate the ischemic core. The described multiparametric Bayesian-based model improved consistency in CTP estimation of the ischemic core compared with the methodology used in current clinical routine.

Background and purpose

Comparing outcomes between endovascular aneurysm coiling trials can be difficult because of heterogeneity in patients and end points. We sought to understand the impact of geography on aneurysm retreatment in patients enrolled in the Matrix and Platinum Science Trial.

Materials and methods

Post hoc analysis was performed on data from the Matrix and Platinum Science trial. Patients were stratified as either North American or international. Baseline patient demographics, comorbidities, aneurysm characteristics, procedural complications, and clinical and angiographic outcomes were compared.

Results

We evaluated 407 patients from 28 North American sites and 219 patients from 15 international sites. Patient demographics differed significantly between North American and international sites. Aneurysms were well occluded postprocedure more often at international than North American sites (P < .001). Stents were used significantly more often at North American sites (32.7% [133 of 407]) compared with international sites (10.0% [22 of 219]; P < .001). At 455 days, there was no difference in the proportion of patients alive and free of disability (P = .56) or with residual aneurysm filling (P = .10). Ruptured aneurysms were significantly more likely to have been retreated at North American sites within the first year (P < .001) and at 2 years (P < .001). Among all patients for whom the treating physician believed there to be Raymond 3 aneurysm filling at follow-up, absolute rates of retreatment at international and North American sites were similar by 2-year follow-up.

Conclusions

Data from the Matrix and Platinum Science Trial demonstrate that aneurysm retreatment occurs with different frequency and at different times in different regions of the world. This trend has critical value when interpreting trials reporting short-term outcomes, especially when judgment-based metrics such as retreatment are primary end points that may or may not take place within the defined study follow-up period. Though these variations can be controlled for and balanced within a given randomized trial, such differences in practice patterns must be accounted for in any attempt to compare outcomes between different trials. Despite these differences, endovascular-treated intracranial aneurysms around the world have similar clinical outcomes.

Background and purpose

Stent-assisted coiling may result in less aneurysm recanalization but more complications than coiling alone. We evaluated outcomes of coiling with and without stents in the multicenter Matrix and Platinum Science Trial.

Materials and methods

All patients in the Matrix and Platinum Science Trial with unruptured intracranial aneurysms treated per protocol were included. Baseline patient and aneurysm characteristics, procedural details, neurologic outcomes, angiographic outcomes, and safety data were analyzed.

Results

Overall, 137 of 361 (38%) patients were treated with a stent. Stent-coiled aneurysms had wider necks (≥4 mm in 62% with stents versus 33% without, P < .0001) and lower dome-to-neck ratios (1.3 versus 1.8, P < .0001). Periprocedural serious adverse events occurred infrequently in those treated with and without stents (6.6% versus 4.5%, P = .39). At 1 year, total significant adverse events, mortality, and worsening of mRS were similar in treatment groups, but ischemic strokes were more common in stent-coiled patients than in coiled patients (8.8% versus 2.2%, P = .005). However, multivariate analysis confirmed that at 2 years after treatment, prior cerebrovascular accident (OR, 4.7; P = .0089) and aneurysm neck width ≥4 mm (OR, 4.5; P = .02) were the only independent predictors of ischemic stroke. Stent use was not an independent predictor of ischemic stroke at 2 years (OR, 1.1; P = .94). Stent use did not predict target aneurysm recurrence at 2 years, but aneurysm dome size ≥10 mm (OR, 9.94; P < .0001) did predict target aneurysm recurrence.

Conclusions

Stent-coiling had similar outcomes as coiling despite stented aneurysms having more difficult morphology than coiled aneurysms. Increased ischemic events in stent-coiled aneurysms were attributable to baseline risk factors and aneurysm morphology.

Background and purpose

The goal of the Stroke Treatment Academic Industry Roundtable (STAIR) meetings is to advance the development of stroke therapies. At STAIR VIII, consensus recommendations were developed for clinical trial strategies to demonstrate the benefit of endovascular reperfusion therapies for acute ischemic stroke.

Summary of review

Prospects for success with forthcoming endovascular trials are robust, because new neurothrombectomy devices have superior reperfusion efficacy compared with earlier-generation interventions. Specific recommendations are provided for trial designs in 3 populations: (1) patients undergoing intravenous fibrinolysis, (2) early patients ineligible for or having failed intravenous fibrinolysis, and (3) wake-up and other late-presenting patients. Among intravenous fibrinolysis-eligible patients, key principles are that CT or MRI confirmation of target arterial occlusions should precede randomization; endovascular intervention should be pursued with the greatest rapidity possible; and combined intravenous and neurothrombectomy therapy is more promising than neurothrombectomy alone. Among patients ineligible for or having failed intravenous fibrinolysis, scientific equipoise was affirmed and the need to randomize all eligible patients emphasized. Vessel imaging to confirm occlusion is mandatory, and infarct core and penumbral imaging is desirable in later time windows. Additional STAIR VIII recommendations include approaches to test multiple devices in a single trial, utility weighting of disability end points, and adaptive designs to delineate time and tissue injury thresholds at which benefits from intervention no longer accrue.

Conclusions

Endovascular research priorities in acute ischemic stroke are to perform trials testing new, highly effective neuro thrombectomy devices rapidly deployed in patients confirmed to have target vessel occlusions.

Background and purpose

The Stroke Treatment Academic Industry Roundtable (STAIR) sponsored an imaging session and workshop during the Stroke Treatment Academic Industry Roundtable XI via webinar on October 1 to 2, 2020, to develop consensus recommendations, particularly regarding optimal imaging at primary stroke centers.

Methods

This forum brought together stroke neurologists, neuroradiologists, neuroimaging research scientists, members of the National Institute of Neurological Disorders and Stroke, industry representatives, and members of the US Food and Drug Administration to discuss imaging priorities in the light of developments in reperfusion therapies, particularly in an extended time window, and reinvigorated interest in brain cytoprotection trials.

Results

The imaging session summarized and compared the imaging components of recent acute stroke trials and debated the optimal imaging strategy at primary stroke centers. The imaging workshop developed consensus recommendations for optimizing the acquisition, analysis, and interpretation of computed tomography and magnetic resonance acute stroke imaging, and also recommendations on imaging strategies for primary stroke centers.

Conclusions

Recent positive acute stroke clinical trials have extended the treatment window for reperfusion therapies using imaging selection. Achieving rapid and high-quality stroke imaging is therefore critical at both primary and comprehensive stroke centers. Recommendations for enhancing stroke imaging research are provided.