Abstract
The recently reported superiority of mechanical thrombectomy to intravenous thrombolytics has jettisoned endovascular intervention into the forefront of acute ischemic stroke (AIS) ...management. These successes have allowed a chance for recanalization for patients not meeting the strict eligibility criteria for intravenous thrombolytics. Stent retrieval and aspiration have emerged as two of the most popular and effective approaches for AIS thrombectomy. Since the beginning of mechanical thrombectomy with the Merci device (Stryker) and first-generation Penumbra aspiration system (Penumbra Inc), contemporary techniques have demonstrated reliable recanalization and improved clinical outcomes. Here, we review the use of stent retrieval and aspiration, as well as their synergy, in the management of AIS.
Summary Background The Solitaire Flow Restoration Device is a novel, self-expanding stent retriever designed to yield rapid flow restoration in acute cerebral ischaemia. We compared the efficacy and ...safety of Solitaire with the standard, predicate mechanical thrombectomy device, the Merci Retrieval System. Methods In this randomised, parallel-group, non-inferiority trial, we enrolled patients from 18 sites (17 in the USA and one in France). Patients were eligible for inclusion if they had acute ischaemic stroke with moderate to severe neurological deficits and were treatable by thrombectomy within 8 h of stroke symptom onset. We used a computer-generated randomisation sequence to randomly allocate patients to receive thrombectomy treatment with either Solitaire or Merci (1:1; block sizes of four and stratified by centre and stroke severity). The primary endpoint was Thrombolysis In Myocardial Ischemia (TIMI) scale 2 or 3 flow in all treatable vessels without symptomatic intracranial haemorrhage, after up to three passes of the assigned device, as assessed by an independent core laboratory, which was masked to study assignment. Primary analysis was done by intention to treat. A prespecified efficacy stopping rule triggered an early halt to the trial. The study is registered with ClinicalTrials.gov , number NCT 01054560. Results Between February, 2010, and February, 2011, we randomly allocated 58 patients to the Solitaire group and 55 patients to the Merci group. The primary efficacy outcome was achieved more often in the Solitaire group than it was in the Merci group (61% vs 24%; difference 37% 95% CI 19–53, odds ratio OR 4·87 95% CI 2·14–11·10; pnon-inferiority <0·0001, psuperiority =0·0001). More patients had good 3-month neurological outcome with Solitaire than with Merci (58% vs 33%; difference 25% 6–43, OR 2·78 1·25–6·22; pnon-inferiority =0·0001, psuperiority =0·02). 90-day mortality was lower in the Solitaire group than it was in the Merci group (17 vs 38; difference −21% –39 to −3, OR 0·34 0·14–0·81; pnon-inferiority =0·0001, psuperiority =0·02). Interpretation The Solitaire Flow Restoration Device achieved substantially better angiographic, safety, and clinical outcomes than did the Merci Retrieval System. The Solitaire device might be a future treatment of choice for endovascular recanalisation in acute ischaemic stroke. Funding Covidien/ev3.
the purpose of this study was to identify significant morphological and hemodynamic parameters that discriminate intracranial aneurysm rupture status using 3-dimensional angiography and computational ...fluid dynamics.
one hundred nineteen intracranial aneurysms (38 ruptured, 81 unruptured) were analyzed from 3-dimensional angiographic images and computational fluid dynamics. Six morphological and 7 hemodynamic parameters were evaluated for significance with respect to rupture. Receiver operating characteristic analysis identified area under the curve (AUC) and optimal thresholds separating ruptured from unruptured aneurysms for each parameter. Significant parameters were examined by multivariate logistic regression analysis in 3 predictive models-morphology only, hemodynamics only, and combined-to identify independent discriminants, and the AUC receiver operating characteristic of the predicted probability of rupture status was compared among these models.
morphological parameters (size ratio, undulation index, ellipticity index, and nonsphericity index) and hemodynamic parameters (average wall shear stress WSS, maximum intra-aneurysmal WSS, low WSS area, average oscillatory shear index, number of vortices, and relative resident time) achieved statistical significance (P<0.01). Multivariate logistic regression analysis demonstrated size ratio to be the only independently significant factor in the morphology model (AUC, 0.83; 95% CI, 0.75 to 0.91), whereas WSS and oscillatory shear index were the only independently significant variables in the hemodynamics model (AUC, 0.85; 95% CI, 0.78 to 0.93). The combined model retained all 3 variables, size ratio, WSS, and oscillatory shear index (AUC, 0.89; 95% CI, 0.82 to 0.96).
all 3 models-morphological (based on size ratio), hemodynamic (based on WSS and oscillatory shear index), and combined-discriminate intracranial aneurysm rupture status with high AUC values. Hemodynamics is as important as morphology in discriminating aneurysm rupture status.
Abstract
BACKGROUND: Early and mid-term safety and efficacy of aneurysm treatment with the Pipeline Embolization Device (PED) has been well demonstrated in prior studies.
OBJECTIVE: To present 5-yr ...follow-up for patients treated in the Pipeline for Uncoilable or Failed Aneurysms clinical trial.
METHODS: In our prospective, multicenter trial, 109 complex internal carotid artery (ICA) aneurysms in 107 subjects were treated with the PED. Patients were followed per a standardized protocol at 180 d and 1, 3, and 5 yr. Aneurysm occlusion, in-stent stenosis, modified Rankin Scale scores, and complications were recorded.
RESULTS: The primary endpoint of complete aneurysm occlusion at 180 d (73.6%) was previously reported. Aneurysm occlusion for those patients with angiographic follow-up progressively increased over time to 86.8% (79/91), 93.4% (71/76), and 95.2% (60/63) at 1, 3, and 5 yr, respectively. Six aneurysms (5.7%) were retreated. New serious device-related events at 1, 3, and 5 yr were noted in 1% (1/96), 3.5% (3/85), and 0% (0/81) of subjects. There were 4 (3.7%) reported deaths in our trial. Seventy-eight (96.3%) of 81 patients with 5-yr clinical follow-up had modified Rankin Scale scores ≤2. No delayed neurological deaths or hemorrhagic or ischemic cerebrovascular events were reported beyond 6 mo. No recanalization of a previously occluded aneurysm was observed.
CONCLUSION: Our 5-yr findings demonstrate that PED is a safe and effective treatment for large and giant wide-necked aneurysms of the intracranial ICA, with high rates of complete occlusion and low rates of delayed adverse events.
To evaluate the safety and effectiveness of the Pipeline Embolization Device (PED; ev3/Covidien, Irvine, Calif) in the treatment of complex intracranial aneurysms.
The Pipeline for Uncoilable or ...Failed Aneurysms is a multicenter, prospective, interventional, single-arm trial of PED for the treatment of uncoilable or failed aneurysms of the internal carotid artery. Institutional review board approval of the HIPAA-compliant study protocol was obtained from each center. After providing informed consent, 108 patients with recently unruptured large and giant wide-necked aneurysms were enrolled in the study. The primary effectiveness endpoint was angiographic evaluation that demonstrated complete aneurysm occlusion and absence of major stenosis at 180 days. The primary safety endpoint was occurrence of major ipsilateral stroke or neurologic death at 180 days.
PED placement was technically successful in 107 of 108 patients (99.1%). Mean aneurysm size was 18.2 mm; 22 aneurysms (20.4%) were giant (>25 mm). Of the 106 aneurysms, 78 met the study's primary effectiveness endpoint (73.6%; 95% posterior probability interval: 64.4%-81.0%). Six of the 107 patients in the safety cohort experienced a major ipsilateral stroke or neurologic death (5.6%; 95% posterior probability interval: 2.6%-11.7%).
PED offers a reasonably safe and effective treatment of large or giant intracranial internal carotid artery aneurysms, demonstrated by high rates of complete aneurysm occlusion and low rates of adverse neurologic events; even in aneurysms failing previous alternative treatments.
Objective
Faster time from onset to recanalization (OTR) in acute ischemic stroke using endovascular therapy (ET) has been associated with better outcome. However, previous studies were based on ...less‐effective first‐generation devices, and analyzed only dichotomized disability outcomes, which may underestimate the full effect of treatment.
Methods
In the combined databases of the SWIFT and STAR trials, we identified patients treated with the Solitaire stent retriever with achievement of substantial reperfusion (Thrombolysis in Cerebral Infarction TICI 2b–3). Ordinal numbers needed to treat values were derived by populating joint outcome tables.
Results
Among 202 patients treated with ET with TICI 2b to 3 reperfusion, mean age was 68 (±13), 62% were female, and median National Institutes of Health Stroke Scale (NIHSS) score was 17 (interquartile range IQR: 14–20). Day 90 modified Rankin Scale (mRS) outcomes for OTR time intervals ranging from 180 to 480 minutes showed substantial time‐related reductions in disability across the entire outcome range. Shorter OTR was associated with improved mean 90‐day mRS (1.4 vs. 2.4 vs. 3.3, for OTR groups of 124‐240 vs. 241‐360 vs. 361‐660 minutes; p < 0.001). The number of patients identified as benefitting from therapy with shorter OTR were 3‐fold (range, 1.5–4.7) higher on ordinal, compared with dichotomized analysis. For every 15‐minute acceleration of OTR, 34 per 1,000 treated patients had improved disability outcome.
Interpretation
Analysis of disability over the entire outcome range demonstrates a marked effect of shorter time to reperfusion upon improved clinical outcome, substantially higher than binary metrics. For every 5‐minute delay in endovascular reperfusion, 1 of 100 patients has a worse disability outcome. Ann Neurol 2015;78:584–593
Among patients with acute ischemic stroke due to occlusions in the proximal anterior intracranial circulation, less than 40% regain functional independence when treated with intravenous tissue ...plasminogen activator (t-PA) alone. Thrombectomy with the use of a stent retriever, in addition to intravenous t-PA, increases reperfusion rates and may improve long-term functional outcome.
We randomly assigned eligible patients with stroke who were receiving or had received intravenous t-PA to continue with t-PA alone (control group) or to undergo endovascular thrombectomy with the use of a stent retriever within 6 hours after symptom onset (intervention group). Patients had confirmed occlusions in the proximal anterior intracranial circulation and an absence of large ischemic-core lesions. The primary outcome was the severity of global disability at 90 days, as assessed by means of the modified Rankin scale (with scores ranging from 0 no symptoms to 6 death).
The study was stopped early because of efficacy. At 39 centers, 196 patients underwent randomization (98 patients in each group). In the intervention group, the median time from qualifying imaging to groin puncture was 57 minutes, and the rate of substantial reperfusion at the end of the procedure was 88%. Thrombectomy with the stent retriever plus intravenous t-PA reduced disability at 90 days over the entire range of scores on the modified Rankin scale (P<0.001). The rate of functional independence (modified Rankin scale score, 0 to 2) was higher in the intervention group than in the control group (60% vs. 35%, P<0.001). There were no significant between-group differences in 90-day mortality (9% vs. 12%, P=0.50) or symptomatic intracranial hemorrhage (0% vs. 3%, P=0.12).
In patients receiving intravenous t-PA for acute ischemic stroke due to occlusions in the proximal anterior intracranial circulation, thrombectomy with a stent retriever within 6 hours after onset improved functional outcomes at 90 days. (Funded by Covidien; SWIFT PRIME ClinicalTrials.gov number, NCT01657461.).
Computed tomography perfusion imaging can estimate the size of the ischemic core, which can be used for the selection of patients for endovascular therapy. The relative cerebral blood volume (rCBV) ...and relative cerebral blood flow (rCBF) thresholds chosen to identify ischemic core influence the accuracy of prediction. We aimed to analyze the accuracy of various rCBV and rCBF thresholds for predicting the 27-hour infarct volume using RAPID automated analysis software from the SWIFT PRIME trial (Solitaire With the Intention for Thrombectomy as Primary Endovascular Treatment) data.
Patients from the SWIFT PRIME study who achieved complete reperfusion based on time until the residue function reached its peak >6 s perfusion maps obtained at 27 hours were included. Patients from both the intravenous tissue-type plasminogen activator only and endovascular groups were included in analysis. Final infarct volume was determined on magnetic resonance imaging (fluid-attenuated inversion recovery images) or computed tomography scans obtained 27 hours after symptom onset. The predicted ischemic core volumes on rCBV and rCBF maps using thresholds ranging between 0.2 and 0.8 were compared with the actual infarct volume to determine the most accurate thresholds.
Among the 47 subjects, the following baseline computed tomography perfusion thresholds most accurately predicted the actual 27-hour infarct volume: rCBV=0.32, median absolute error (MAE)=9 mL; rCBV=0.34, MAE=9 mL; rCBF=0.30, MAE=8.8 mL; rCBF=0.32, MAE=7 mL; and rCBF=0.34, MAE=7.3.
Brain regions with rCBF 0.30 to 0.34 or rCBV 0.32 to 0.34 thresholds provided the most accurate prediction of infarct volume in patients who achieved complete reperfusion with MAEs of ≤9 mL.
URL: http://www.clinicaltrials.gov. Unique identifier: NCT01657461.
OBJECTIVE The Pipeline Embolization Device (PED) has become increasingly used for the treatment of intracranial aneurysms. Given its high metal surface area coverage, there is concern for the patency ...of branch vessels that become covered by the device. Limited data exist regarding the patency of branch vessels adjacent to aneurysms that are covered by PEDs. The authors assessed the rate of intracranial internal carotid artery, anterior circulation branch vessel patency following PED placement at their institution. METHODS The authors retrospectively reviewed the records of 82 patients who underwent PED treatment between 2009 and 2014 and in whom the PED was identified to cover branch vessels. Patency of the anterior cerebral, posterior communicating, anterior choroidal, and ophthalmic arteries was evaluated using digital subtraction angiography preoperatively and postoperatively after PED deployment and at longer-term follow-up. RESULTS Of the 127 arterial branches covered by PEDs, there were no immediate postoperative occlusions. At angiographic follow-up (mean 10 months, range 3-34.7 months), arterial side branches were occluded in 13 (15.8%) of 82 aneurysm cases and included 2 anterior cerebral arteries, 8 ophthalmic arteries, and 3 posterior communicating arteries. No cases of anterior choroidal artery occlusion were observed. Patients with branch occlusion did not experience any neurological symptoms. CONCLUSIONS In this large series, the longer-term rate of radiographic side branch arterial occlusion after coverage by a flow diverter was 15.8%. Terminal branch vessels, such as the anterior choroidal artery, remained patent in this series. The authors' series suggests that branch vessel occlusions are clinically silent and should not deter aneurysm treatment with flow diversion.
The use of flow-diverting stents has gained momentum as a curative approach in the treatment of complex proximal anterior circulation intracranial aneurysms. There have been some reported attempts of ...treating formidable lesions in the posterior circulation. Posterior circulation giant fusiform aneurysms have a particularly aggressive natural history. To date, no one approach has been shown to be comprehensively effective or low risk. The authors report the initial results, including the significant morbidity and mortality encountered, with flow diversion in the treatment of large or giant fusiform vertebrobasilar aneurysms at Millard Fillmore Gates Circle Hospital.
The authors retrospectively reviewed their prospectively collected endovascular database to identify patients with intracranial aneurysms who underwent treatment with flow-diverting devices and determined that 7 patients had presented with symptomatic large or giant fusiform vertebrobasilar aneurysms. The outcomes of these patients, based on the modified Rankin Scale (mRS), were tabulated, as were the complications experienced.
Among the 7 patients, Pipeline devices were placed in 6 patients and Silk devices in 1 patient. At the last follow-up evaluation, 4 patients had died (mRS score of 6), all of whom were treated with the Pipeline device. The other 3 patients had mRS scores of 5 (severe disability), 1, and 0. The deaths included posttreatment aneurysm ruptures in 2 patients and lack of improvement in neurological status related to presenting brainstem infarcts and subsequent withdrawal of care in the other 2 patients.
Whether flow diversion will be an effective strategy for treatment of large or giant fusiform vertebrobasilar aneurysms remains to be seen. The authors' initial experience suggests substantial morbidity and mortality associated with the treatment and with the natural history. As outcomes data slowly become available for patients receiving these devices for fusiform posterior circulation aneurysms, practitioners should use these devices judiciously.
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