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 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).
Modern interventional neuroradiology has a leading role in the treatment of ischemic and hemorrhagic stroke, and it provides more and more important treatment options for degenerative diseases of the ...vertebral column and the management of correlated pain. During the last decades interventional neuroradiology has played a primary role in the treatment of intracranial berry aneurysms due to the continuous technical improvements. Ongoing studies proved superiority of mechanical stent-thrombectomy in acute proximal occlusion of cerebral arteries. Less invasive neurointerventional methods, such as vertebroplasty, are widely used in osteoporotic and neoplastic pathologic fractures of the vertebral bodies. These treatments should be performed in a specialized center by well trained physicians.
Introduction
This study was performed to assess the effect of aneurysm geometry on parameters that may have an impact on the natural history of intracranial aneurysms, such as intraaneurysmal flow ...pressure and shear stress.
Methods
Flow was simulated in 21 randomly selected aneurysms using finite volume modeling. Ten aneurysms were classified as side-wall aneurysms, with either single-sided or circumferential involvement of the parent artery wall, and 11 as bifurcation aneurysms (symmetric or asymmetric), with an axis either perpendicular or parallel to the parent artery. The flow patterns were classified as either jet or vortex types (with regular or irregular vortex flow). Pressures and shear stresses were characterized as evenly or unevenly distributed over the aneurysm wall and neck.
Results
All side-wall and four of the bifurcation aneurysms with a perpendicular axis had a vortex type flow pattern and seven bifurcation aneurysms with a parallel axis (four symmetric and two asymmetric) had a jet flow pattern. Jet type flow was associated with an uneven pressure distribution in seven out of seven aneurysms. Vortex type flow resulted in an even pressure distribution in five out of six aneurysms with an irregular flow pattern and six out of eight with a regular flow pattern. No firm relationship could be established between any geometrical type and shear stress distribution. Only 1 of 14 aneurysms with a perpendicular axis, but 4 of 7 aneurysms with a parallel axis, had ruptured.
Conclusion
Aneurysm geometry does have an impact on flow conditions. Aneurysms with a main axis parallel to the parent artery have a tendency to have a jet flow pattern and uneven distribution of unsteady pressure. These aneurysms may have a higher rate of rupture as than those with a main axis perpendicular to the parent artery.
Former studies reported internal jugular vein stenosis in patients with multiple sclerosis. We aimed to evaluate if these venous stenoses were real and cerebral venous outflow of patients with ...multiple sclerosis differed from that of normal controls.
20 controls were prospectively investigated by angiography and duplex ultrasound. Seven patients with multiple sclerosis underwent angiography at other centers; we reviewed these registrations and performed venous ultrasound examinations.
Angiography displayed > 50% stenosis of internal jugular vein in 19 controls (69 ± 17% on the right and 73 ± 13% on the left side) and < 50% stenosis in 1 control (43.5% and 44.6%). All 7 patients had at least one-sided stenosis. The mean degree of stenosis was 63 ± 16% on the right and 67 ± 13% on the left side. There was no significant difference in the degree of stenosis between patients and controls. However, these "stenoses" disappeared if the contrast agent was injected at a catheter position below the orifice of the subclavian vein during venography. The venous flow volume was also similar between groups: 479.7 ± 214.1 and 509.8 ± 212.0 ml/min (right and left side) in the patients and 461.3 ± 224.3 and 513.6 ± 352.2 ml/min in the control group; p = 0.85 and 0.98 (right and left). Color and power duplex imaging also revealed normal blood flow of the internal jugular vein in all patients and controls.
The cerebral venous status of patients with multiple sclerosis and controls were similar. The angiographic "stenoses" were virtual, caused by the contrast dilution effect of the non-contrast blood stream of the subclavian vein.
Our aim was to study the effectiveness of coronary stent implantation during the endovascular treatment (EVT) of acute basilar artery occlusion (BAO) with occlusion-underlying intracranial ...atherosclerotic stenosis (ICAS).
We retrospectively analysed 91 consecutive BAO patients who underwent EVT between February 2014 and January 2019 in a single, high-volume neurointerventional centre. We studied the effect of immediate coronary stent implantation on the clinical outcome of BAO with occlusion-underlying stenosis. BAO patients with underlying ICAS (n=41) were characterised by longer symptom-onset-to-reperfusion times (231 min vs 173 min, p=0.0020), lower TICI 2b-3 reperfusion rates (65.85% vs 90.00%, p=0.0084), and higher overall mortality (HR 2.021, p=0.0417) compared to the BAO cases without ICAS (n=50). The patients undergoing stenting (n=18) had lower residual basilar artery (BA) stenosis (14.7% vs 81.0%, p<0.0001), higher chance for functional recovery (OR 7.6, p=0.0250) and higher chance of survival (HR 4.163, p=0.0026) compared to the BAO-ICAS cases treated without coronary stents (n=21).
The immediate treatment of the occlusion-underlying stenosis with coronary stents and dual antiplatelet therapy (DAPT) in BAO was associated with improved overall survival and better functional outcomes.
Summary
Cerebral venous sinus thrombosis (CVST) is an uncommon but potentially lethal event. When showing a malignant clinical course despite anticoagulant therapy, new endovascular techniques and ...technology allow the possibility of more aggressive thrombolysis and thrombectomy. The authors present a case of recanalization of an extensive cerebral thrombosis using a new endovascular thromboaspiration device, the Penumbra System™.
Background and purpose
CVST in children is a rare but potentially lethal disorder. When showing a malignant progression despite anticoagulant therapy, the use of local thrombolytics and thrombectomy procedures might provide therapeutic solution.
Methods
A 16-year-old girl presented with signs and symptoms of a hemorrhagic cerebral sinus thrombosis and showed progression despite full dose anticoagulant therapy. The evolution being attributed to increasing mass effect, decompressive surgery was performed without clinical improvement. Further brain imaging demonstrated progression of the sinus thrombosis. Repeated local thrombectomy with the Penumbra thrombectomy system and continuous, relatively low dose local thrombolysis was performed during a period of 60 h, resulting in recanalization and clinical improvement. The methodology of combined thromboaspiration and thrombolysis is described.
Conclusions
We present a novel method for revascularization using the Penumbra System™ in combination with long-term, relatively low dose thrombolysis, in the setting of both clinically and morphologically progressive, hemorrhagic sinus thrombosis. The procedure proved to be both safe and effective and may be considered in the future for patients with progressive sinovenous thrombosis despite adequate medical therapy.
The overall safety of the HydroCoil, an expansile hybrid hydrogel-platinum coil, is unknown. We report a prospective observational study of our first 100 cerebral aneurysms treated with HydroCoils, ...focusing on safety and initial efficacy.
Indications, procedural complications, clinical and angiographic outcomes were recorded. Packing density, number of coils deployed and angiographic results were compared with those in a matched control group of 100 aneurysms treated solely with bare platinum coils. HydroCoil complication rates were compared to bare platinum coil rates at our institution and in published series.
Adjuvant HydroCoil treatment led to increased mean percentage aneurysm filling compared to controls (50 +/- 21% versus 27 +/- 13%, P < 0.001). Immediate posttreatment angiographic results showed significantly (P < 0.001) more complete occlusions and fewer incomplete (<95%) occlusions compared to controls. Intermediate follow-up angiograms (median 7.5 months) in 63 aneurysms showed a trend towards fewer incomplete occlusions with HydroCoil treatment. There were significantly fewer major recurrences with HydroCoil treatment compared to the control treatment (9.5% versus 22.6%, P = 0.046). In the adjuvant HydroCoil group, major recurrent aneurysms had significantly less percentage volume packing with HydroCoils than non-recurrent aneurysms (50.3 +/- 5.0% versus 65.3 +/- 18.0%, P = 0.04). There was a 12% procedural complication rate, 6% procedural morbidity and 1% mortality rate, similar to institutional and reported bare platinum coil complication rates.
HydroCoils can be safely deployed with a similar complication rate to bare platinum coils. They result in improved aneurysm filling. Intermediate follow-up angiography showed significantly fewer major recurrences. Long-term follow-up is required to confirm initial improved stability.
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