The Pipeline Embolization Device for the Intracranial Treatment of Aneurysms Trial

Neurointerventional Service, Department of Radiology, NYU Langone Medical Center, New York, New York, USA.
American Journal of Neuroradiology (Impact Factor: 3.59). 01/2011; 32(1):34-40. DOI: 10.3174/ajnr.A2421
Source: PubMed


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.
Patients with unruptured aneurysms that were wide-necked (> 4 mm), had unfavorable dome/neck ratios (<1.5), 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.
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 = 18) or 2 (n = 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 (≥ 50%) was identified at follow-up angiography.
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.

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Available from: Stephan Wetzel, Mar 19, 2014
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    • "In addition, endovascular coiling of giant aneurysms without concomitant stenting is associated with relatively high rates of recurrence.13) The recent addition of flow-diverting stents (FDS) to the endovascular armamentarium has resulted in drastic improvement of the ability to administer safe and effective treatment of giant aneurysms.1)14) Successful deployment of a FDS across an aneurysm neck is predicated upon microcatheter access to the distal segment of the parent artery past the aneurysm neck. "
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    ABSTRACT: Treatment of giant intracranial aneurysms, via either surgical or endovascular approaches, is associated with a high level of technical difficulty as well as a high rate of treatment-related morbidity and mortality. Flow-diverting stents, such as the Pipeline embolization device (PED), have drastically altered the therapeutic strategies for the treatment of giant aneurysms. Gaining endovascular access using a microcatheter to the portion of the parent artery distal to the aneurysm neck is requisite for safe and effective stent deployment. Giant aneurysms are often associated with vascular tortuosity, which necessitates significant catheter support systems to enable maneuvering of PEDs across the aneurysm neck. This is also required in order to reduce the probability of stent herniation within giant aneurysms. We report on a case of a giant supraclinoid internal carotid artery (ICA) aneurysm which was treated successfully with a PED utilizing a balloon anchor technique to facilitate direct microcatheter access across the aneurysm neck.
    06/2014; 16(2):125-30. DOI:10.7461/jcen.2014.16.2.125
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    • "In addition, McAuliffe et al.17) experienced two cases of PED migration through the initial learning curve. After treatment with PED, intracranial hemorrhage of 0~6% was reported and possible causes were aneurysm rupture during the procedure, hemorrhagic transformation from ischemic tissue, inflammation of aneurysm wall, and foreign body's reaction.5)10)20)22)26) "
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    ABSTRACT: The pipeline™ embolization device (PED) is a braided, tubular, bimetallic endoluminal implant used for occlusion of intracranial aneurysms through flow disruption along the aneurysm neck. The authors report on two cases of giant internal carotid artery aneurysm treated with the PED. In the first case, an aneurysm measuring 26.4 mm was observed at the C3-C4 portion of the left internal carotid artery in a 64-year-old woman who underwent magnetic resonance imaging (MRI) for dizziness and diplopia. In the second case, MRI showed an aneurysm measuring 25 mm at the C4-C5 portion of the right internal carotid artery in a 39-year-old woman with right ptosis and diplopia. Each giant aneurysm was treated with deployment of a PED (3.75 mm diameter/20 mm length and 4.5 mm diameter/25 mm length, respectively). Nine months later, both cases showed complete radiological occlusion of the giant intracranial aneurysm and sac shrinkage. We suggest that use of the PED can be a therapeutic option for giant intracranial aneurysms.
    06/2014; 16(2):112-8. DOI:10.7461/jcen.2014.16.2.112
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    • "As opposed to coil embolization techniques, flow diverter techniques cause aneurysms to occlude over time rather than immediately at the end of the procedure. This explains why aneurysm occlusion rates continue to increase between 6 and 12 months with flow diverters [3] [7]. Side branches, such as the ophthalmic artery with internal carotid flow diverters, may remain patent or be occluded after flow diverter implantation (Figure 3) [8]. "
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    ABSTRACT: Flow diverters (pipeline embolization device, Silk flow diverter, and Surpass flow diverter) have been developed to treat intracranial aneurysms. These endovascular devices are placed within the parent artery rather than the aneurysm sac. They take advantage of altering hemodynamics at the aneurysm/parent vessel interface, resulting in gradual thrombosis of the aneurysm occurring over time. Subsequent inflammatory response, healing, and endothelial growth shrink the aneurysm and reconstruct the parent artery lumen while preserving perforators and side branches in most cases. Flow diverters have already allowed treatment of previously untreatable wide neck and giant aneurysms. There are risks with flow diverters including in-stent thrombosis, perianeurysmal edema, distant and delayed hemorrhages, and perforator occlusions. Comparative efficacy and safety against other therapies are being studied in ongoing trials. Antiplatelet therapy is mandatory with flow diverters, which has highlighted the need for better evidence for monitoring and tailoring antiplatelet therapy. In this paper we review the devices, their uses, associated complications, evidence base, and ongoing studies.
    Stroke Research and Treatment 05/2014; 2014(6):415653. DOI:10.1155/2014/415653
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