Definitive Reconstruction of Circumferential, Fusiform Intracranial Aneurysms with the Pipeline Embolization Device (original) (raw)
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Curative Endovascular Reconstruction of Cerebral Aneurysms with the Pipeline Embolization Device
Neurosurgery, 2009
OBJECTIVES The Pipeline embolization device (PED) (Chestnut Medical Technologies, Inc., Menlo Park, CA) is a new microcatheter-delivered endovascular construct designed to achieve the curative reconstruction of the parent arteries giving rise to wide-necked and fusiform intracranial aneurysms. We present our initial periprocedural experience with the PED and midterm follow-up results for a series of 53 patients. METHODS Patients harboring large and giant wide-necked, nonsaccular, and recurrent intracranial aneurysms were selected for treatment. All patients were pretreated with dual antiplatelet medications for at least 72 hours before surgery and continued taking both agents for at least 6 months after treatment. A control digital subtraction angiogram was typically performed at 3, 6, and 12 months. RESULTS Fifty-three patients (age range, 11–77 years; average age, 55.2 years; 48 female) with 63 intracranial aneurysms were treated with the PED. Small (n = 33), large (n = 22), and g...
American Journal of Neuroradiology, 2010
BACKGROUND AND PURPOSE: Aneurysm treatment by intrasaccular packing has been associated with a relatively high rate of recurrence. The use of mesh tubes has recently gained traction as an alternative therapy. This article summarizes the midterm results of using an endoluminal sleeve, the PED, in the treatment of aneurysms. MATERIALS AND METHODS: A total of 19 wide-neck aneurysms were treated in 18 patients: 10 by implantation of PEDs alone and 9 by a combination of PED and coils. Angiographic and clinical results were recorded immediately and at 6 months following treatment. RESULTS: Immediate angiographic occlusion was achieved in 4 and flow reduction, in another 15 aneurysms. Angiography at 6 months demonstrated complete occlusion in 17 and partial filling in 1 of 18 patients. There was no difference between coil-packed and unpacked aneurysms. Of 28 side branches covered by Ն1 device, the ophthalmic artery was absent immediately in 1 and at 6 months in another 2 cases. One patient experienced abrupt in-stent thrombosis resulting in a transient neurologic deficit, and 1 patient died due to rupture of a coexisting aneurysm. All giant aneurysms treated with PED alone were demonstrated by follow-up cross-sectional imaging to have involuted by 6 months. CONCLUSIONS: Treatment of large, wide-neck, or otherwise untreatable aneurysms with functional reconstruction of the parent artery may be achieved with relative safety using dedicated flowmodifying devices with or without adjunctive use of intrasaccular coil packing. ABBREVIATIONS: AICA ϭ anterior inferior cerebellar artery; BA ϭ basilar artery; Immed ϭ Immediate; DSA ϭ digital subtraction angiography; ICA ϭ internal carotid artery; ID ϭ internal diameter; MRA ϭ MR angiography; N/A ϭ not applicable; PcomA ϭ posterior communicating artery; PED ϭ Pipeline Embolization Device; PITA ϭ Pipeline Embolization Device for Intracranial Treatment of Aneurysms; Recan ϭ recanalization; SAH ϭ subarachnoid hemorrhage; SCA ϭ superior cerebellar artery; Sup ϭ superior
The Pipeline Embolization Device for the Intracranial Treatment of Aneurysms Trial
American Journal of Neuroradiology, 2010
BACKGROUND AND PURPOSE: Endoluminal reconstruction with flow diverting devices represents a novel constructive technique for the treatment of cerebral aneurysms. We present the results of the first prospective multicenter trial of a flow-diverting construct for the treatment of intracranial aneurysms. MATERIALS AND METHODS: Patients with unruptured aneurysms that were wide-necked (Ͼ4 mm), had unfavorable dome/neck ratios (Ͻ1.5), or had failed previous therapy were enrolled in the PITA trial between January and May 2007 at 4 (3 European and 1 South American) centers. Aneurysms were treated with the PED with or without adjunctive coil embolization. All patients underwent clinical evaluation at 30 and 180 days and conventional angiography 180 days after treatment. Angiographic results were adjudicated by an experienced neuroradiologist at a nonparticipating site. RESULTS: Thirty-one patients with 31 intracranial aneurysms (6 men; 42-76 years of age; average age, 54.6 years) were treated during the study period. Twenty-eight aneurysms arose from the ICA (5 cavernous, 15 parophthalmic, 4 superior hypophyseal, and 4 posterior communicating segments), 1 from the MCA, 1 from the vertebral artery, and 1 from the vertebrobasilar junction. Mean aneurysm size was 11.5 mm, and mean neck size was 5.8 mm. Twelve (38.7%) aneurysms had failed (or recurred after) a previous endovascular treatment. PED placement was technically successful in 30 of 31 patients (96.8%). Most aneurysms were treated with either 1 (n ϭ 18) or 2 (n ϭ 11) PEDs. Fifteen aneurysms (48.4%) were treated with a PED alone, while 16 were treated with both PED and embolization coils. Two patients experienced major periprocedural stroke. Follow-up angiography demonstrated complete aneurysm occlusion in 28 (93.3%) of the 30 patients who underwent angiographic follow-up. No significant in-construct stenosis (Ն50%) was identified at follow-up angiography. CONCLUSIONS: Intracranial aneurysm treatment with the PED is technically feasible and can be achieved with a safety profile analogous to that reported for stent-supported coil embolization. PED treatment elicited a very high rate (93%) of complete angiographic occlusion at 6 months in a population of the most challenging anatomic subtypes of cerebral aneurysms.
Treatment of unruptured intracranial aneurysms with the pipeline embolization device
Journal of Clinical Neuroscience, 2014
The pipeline embolization device (PED; ev3 Endovascular, Plymouth, MN, USA) is a flow-diverter used in the endovascular treatment of intracranial aneurysms, particularly those with unfavorable configurations. It causes progressive flow redirection leading to aneurysm thrombosis. This study aimed to present a systematic review of the published literature on the clinical outcomes of PED. A Medline search of the English language literature was performed using the keywords ''intracranial aneurysms'' and ''pipeline embolization device'' or ''flow diverters''. The inclusion criteria were: n > 10 patients; unruptured aneurysms; documentation of complications; and at least 3 months of follow-up. A total of 13 studies, with 905 patients and 1043 aneurysms, were included. The mean age was 53.8 years, with women comprising 76.3% of patients. The mean aneurysm diameter was 11.1 mm with 37% classed as large aneurysms and 10% classed as giant. The cumulative mortality rate was 2.3%. Seventeen patients had a stroke (1.9%), while 19 (2.0%) had a transient ischemic attack and 21 patients (2.3%) had an intracranial hemorrhage. The two outcome measures were the cumulative event rate (16.7%) and the 6 month aneurysm occlusion rate (79.7%). A funnel plot with study size plotted against the two outcome measures revealed publication bias. Data from recent studies suggest that complication and mortality rates associated with PED may be similar to other contemporary endovascular techniques, with a better 6 month aneurysm occlusion rate. More prospective clinical trials are warranted to further validate these results.
World Journal of Neuroscience, 2014
Background: The introduction of pipeline embolisation device (PED) has improved the feasibility of endovascular treatment of intracranial aneurysms. The device allows for endoluminal reconstruction across the aneurysm neck but is permeable enough that flow is preserved across the pressure gradients into sidebranch arteries. In spite of higher rates of aneurysm occlusion, there is lack of data concerning medium to long-term clinical and imaging results. Methods: This study was a prospective single center analysis of complications, imaging results, and medium term clinical outcomes after PED treatment of intracranial aneurysms. We included cases over a 17-month period in a tertiary interventional neuroradiology center. We collected data on demographics, vascular risk factors, clinical presentation, angiographic results post treatment, angiographic follow-up and clinical follow-up. Results: Thirty-three patients were included, 25 females and 8 males, with mean age of 55 years; 3 presented with acute subarachnoid hemorrhage and 30 for elective treatment. Thirty-seven aneurysms were treated: 35 Internal Carotid Artery (ICA), 1 basilar trunk fusiform, and 1 vertebral artery intradural dissecting aneurysms. No deaths have occurred. Five patients suffered transient neurological complications (15%). Overall aneurysm occlusion was demonstrated in 85% of patients at the end of one year. Discussion: Overall, the technique of flow diversion and endoluminal reconstruction differs greatly from the established endosaccular packing techniques of standard coiling, balloon remodeling, or stent assisted coiling. Our midterm follow-up confirms that, the rates of clinically significant complications compare favorably with published data on stent assisted coiling, potentially making these devices a truly revolutionizing technique.
The Role of the Pipeline Embolization Device for the Treatment of Dissecting Intracranial Aneurysms
American Journal of Neuroradiology, 2011
Intracranial dissecting aneurysms constitute rare lesions with complex management and elevated morbidity and mortality. Results of 23 patients harboring such lesions treated with the PED are reported. Standard dual antiplatelet therapy was instituted. Neurologic and angiographic assessments were obtained at 3, 6, and 12 months. Clinical presentation included SAH (52%), symptoms of mass effect (22%), ischemia (4%), and incidental finding (22%). The posterior circulation was affected in 91% of cases. Total occlusion was demonstrated in 69.5% of patients, with an increment to 87.5% considering only patients with at least 3 months of follow-up. Small aneurysms demonstrated higher rates of total occlusion (6/7) compared with large (5/7) and giant (5/9) ones. Good clinical outcome was achieved in 74% of patients. Reconstructive endovascular treatment of intracranial dissecting aneurysms with the PED provided good clinical and angiographic results with acceptable risks, representing an attractive therapeutic option for this complex disease, especially when parent vessel preservation is mandatory.
Off-Label Application of Pipeline Embolization Device for Intracranial Aneurysms
Neurointervention, 2019
The Pipeline embolization device (PED) is approved in the USA for treating giant and large aneurysms arising from the petrous to superior hypophyseal segments of the internal carotid artery in patients older than 21 years of age. This study investigates off-label PED results in a large cohort. Materials and Methods: Retrospective, single-center review of all patients who had off-label PED surgery. Results: Sixty-two aneurysms (48 patients) underwent off-label PED treatment from 2012-2017. There were 44 females and four males (age 21 to 75 years; mean/median, 54.3/55.0 years). The most common presenting symptom was headache (47/62, 75.8%). All aneurysms were in the anterior circulation. Aneurysm size ranged from 1.4 to 25.0 mm (mean/median, 7.6/6.9 mm). Fifty-two aneurysms had post-operative imaging with total/near-complete occlusion of 84.6% (44/52). Aneurysm-based operative near-term complication rate was 9.7% while there were no permanent complications. For aneurysms and headache, 86.7% improved/resolved after embo-surgery, and were four times more likely to have a better clinical outcome (resolved or improved symptoms) after surgery (odds ratio [OR], 4.333; P=0.0325). Left-sided aneurysms had a higher occlusion rate (OR, 20; P=0.0073). Hypertension (OR, 4.2; P=0.0332) and smoking (OR, 7; P=0.0155) were more prone towards aneurysm occlusion. Patients without a family history were 14 times more likely to have favorable imaging outcome (P=0.0405). There is no difference of occlusion rates between untreated and previously treated aneurysms (P=0.6894). Overall, occlusion rate decreased by 14% with an increase of aneurysm size by 1 mm (P=0.0283). Conclusion: For anterior circulation aneurysms, the off-label application of PED is as effective and safe as reported for on-label intracranial aneurysms.