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.
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.
Trials examining the benefit of thrombectomy in anterior circulation proximal large vessel occlusion stroke have enrolled patients considered to have salvageable brain tissue, who were randomly ...assigned beyond 6 h and (depending on study protocol) up to 24 h from time last seen well. We aimed to estimate the benefit of thrombectomy overall and in prespecified subgroups through individual patient data meta-analysis.
We did a systematic review and individual patient data meta-analysis between Jan 1, 2010, and March 1, 2021, of randomised controlled trials of endovascular stroke therapy. In the Analysis Of Pooled Data From Randomized Studies Of Thrombectomy More Than 6 Hours After Last Known Well (AURORA) collaboration, the primary outcome was disability on the modified Rankin Scale (mRS) at 90 days, analysed by ordinal logistic regression. Key safety outcomes were symptomatic intracerebral haemorrhage and mortality within 90 days.
Patient level data from 505 individuals (n=266 intervention, n=239 control; mean age 68·6 years SD 13·7, 259 51·3% women) were included from six trials that met inclusion criteria of 17 screened published randomised trials. Primary outcome analysis showed a benefit of thrombectomy with an unadjusted common odds ratio (OR) of 2·42 (95% CI 1·76–3·33; p<0·0001) and an adjusted common OR (for age, gender, baseline stroke severity, extent of infarction on baseline head CT, and time from onset to random assignment) of 2·54 (1·83–3·54; p<0·0001). Thrombectomy was associated with higher rates of independence in activities of daily living (mRS 0–2) than best medical therapy alone (122 45·9% of 266 vs 46 19·3% of 238; p<0·0001). No significant difference between intervention and control groups was found when analysing either 90-day mortality (44 16·5% of 266 vs 46 19·3% of 238) or symptomatic intracerebral haemorrhage (14 5·3% of 266 vs eight 3·3% of 239). No heterogeneity of treatment effect was noted across subgroups defined by age, gender, baseline stroke severity, vessel occlusion site, baseline Alberta Stroke Program Early CT Score, and mode of presentation; treatment effect was stronger in patients randomly assigned within 12–24 h (common OR 5·86 95% CI 3·14–10·94) than those randomly assigned within 6–12 h (1·76 1·18–2·62; pinteraction=0·0087).
These findings strengthen the evidence for benefit of endovascular thrombectomy in patients with evidence of reversible cerebral ischaemia across the 6–24 h time window and are relevant to clinical practice. Our findings suggest that in these patients, thrombectomy should not be withheld on the basis of mode of presentation or of the point in time of presentation within the 6–24 h time window.
Stryker Neurovascular.
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.
OBJECTIVE The long-term effectiveness of endovascular treatment of large and giant wide-neck aneurysms using traditional endovascular techniques has been disappointing, with high recanalization and ...re-treatment rates. Flow diversion with the Pipeline Embolization Device (PED) has been recently used as a stand-alone therapy for complex aneurysms, showing significant improvement in effectiveness while demonstrating a similar safety profile to stent-supported coil treatment. However, relatively little is known about its long-term safety and effectiveness. Here the authors report on the 3-year safety and effectiveness of flow diversion with the PED in a prospective cohort of patients with large and giant internal carotid artery aneurysms enrolled in the Pipeline for Uncoilable or Failed Aneurysms (PUFS) trial. METHODS The PUFS trial is a prospective study of 107 patients with 109 aneurysms treated with the PED. Primary effectiveness and safety end points were demonstrated based on independently monitored 180-day clinical and angiographic data. Patients were enrolled in a long-term follow-up protocol including 1-, 3-, and 5-year clinical and imaging follow-up. In this paper, the authors report the midstudy (3-year) effectiveness and safety data. RESULTS At 3 years posttreatment, 74 subjects with 76 aneurysms underwent catheter angiography as required per protocol. Overall, complete angiographic aneurysm occlusion was observed in 71 of these 76 aneurysms (93.4% cure rate). Five aneurysms were re-treated, using either coils or additional PEDs, for failure to occlude, and 3 of these 5 were cured by the 3-year follow-up. Angiographic cure with one or two treatments of Pipeline embolization alone was therefore achieved in 92.1%. No recanalization of a previously completely occluded aneurysm was noted on the 3-year angiograms. There were 3 (2.6%) delayed device- or aneurysm-related serious adverse events, none of which led to permanent neurological sequelae. No major or minor late-onset hemorrhagic or ischemic cerebrovascular events or neurological deaths were observed in the 6-month through 3-year posttreatment period. Among 103 surviving patients, 85 underwent functional outcome assessment in which modified Rankin Scale scores of 0-1 were demonstrated in 80 subjects. CONCLUSIONS Pipeline embolization is safe and effective in the treatment of complex large and giant aneurysms of the intracranial internal carotid artery. Unlike more traditional endovascular treatments, flow diversion results in progressive vascular remodeling that leads to complete aneurysm obliteration over longer-term follow-up without delayed aneurysm recanalization and/or growth. Clinical trial registration no.: NCT00777088 (clinicaltrials.gov).
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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