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      Pipeline embolization device (PED) for neurovascular reconstruction: initial experience in the treatment of 101 intracranial aneurysms and dissections

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          Abstract

          Introduction

          The purpose of this study was to evaluate the safety and efficacy of the recently available flow diverter “pipeline embolization device” (PED) for the treatment of intracranial aneurysms and dissections.

          Methods

          Eighty-eight consecutive patients underwent an endovascular treatment of 101 intracranial aneurysms or dissections using the PED between September 2009 and January 2011. The targeted vessels include 79 (78%) in the anterior circulation and 22 (22%) in the posterior circulation. We treated 96 aneurysms and 5 vessel dissections. Multiple devices were implanted in 67 lesions (66%).

          Results

          One technical failure of the procedure was encountered. Immediate exclusion of the target lesion was not observed. Angiographic follow-up examinations were carried out in 80 patients (91%) with 90 lesions and revealed complete cure of the target lesion(s) in 47 (52%), morphological improvement in 32 lesions (36%), and no improvement in 11 lesions (12%). Six major complications were encountered: one fatal aneurysm rupture, one acute and one delayed PED thrombosis, and three hemorrhages in the dependent brain parenchyma.

          Conclusion

          Our experience reveals that the PED procedure is technically straightforward for the treatment of selected wide-necked saccular aneurysms, fusiform aneurysms, remnants of aneurysms, aneurysms with a high likelihood of failure with conventional endovascular techniques, and dissected vessels. While vessel reconstruction, performed after dissection, is achieved within days, remodeling of aneurysmal dilatations may take several months. Dual platelet inhibition is obligatory. Parenchymal bleeding into brain areas dependent on the target vessel is uncommon.

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          Most cited references 27

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          Curative endovascular reconstruction of cerebral aneurysms with the pipeline embolization device: the Buenos Aires experience.

          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. 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. 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 giant (n = 8) wide-necked aneurysms were included. A total of 72 PEDs were used. Treatment was achieved with a single PED in 44 aneurysms, with 2 overlapping PEDs in 17 aneurysms, and with 3 overlapping PEDs in 2 aneurysms. The mean time between the treatment and last follow-up digital subtraction angiogram was 5.9 months (range, 1-22 months). Complete angiographic occlusion was achieved in 56%, 93%, and 95% of aneurysms at 3 (n = 42), 6 (n = 28), and 12 (n = 18) months, respectively. The only aneurysm that remained patent at the time of the 12-month follow-up examination had been treated previously with stent-supported coiling. The presence of a preexisting endoluminal stent may have limited the efficacy of the PED reconstruction in this aneurysm. No aneurysms demonstrated a deterioration of angiographic occlusion during the follow-up period (i.e., no recanalizations). No major complications (stroke or death) were encountered during the study period. Three patients (5%), all with giant aneurysms, experienced transient exacerbations of preexisting cranial neuropathies and headache after the PED treatment. All 3 were treated with corticosteroids, and these symptoms resolved within 1 month. Endovascular reconstruction with the PED represents a safe, durable, and curative treatment of selected wide-necked, large and giant cerebral aneurysms. The rate of complete occlusion at the time of the 12-month follow-up examination approached 100% in the present study. To date, no angiographic recurrences have been observed during serial angiographic follow-up.
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            Treatment of intracranial aneurysms by functional reconstruction of the parent artery: the Budapest experience with the pipeline embolization device.

            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. 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. 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 > or =1 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. Treatment of large, wide-neck, or otherwise untreatable aneurysms with functional reconstruction of the parent artery may be achieved with relative safety using dedicated flow-modifying devices with or without adjunctive use of intrasaccular coil packing.
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              Flow-diverter stent for the endovascular treatment of intracranial aneurysms: a prospective study in 29 patients with 34 aneurysms.

              The purpose of this study is to report our preliminary experience with the flow-diverter Silk stent for the endovascular treatment of intracranial aneurysms. This prospective study was approved by the authors' ethical committees. Twenty-nine patients with 34 fusiform or wide-necked unruptured aneurysms were included and treated by Silk stent placement alone by 2 physicians in 3 different centers. Technical issues, immediate findings, delayed complications, clinical follow-up, and imaging follow-up at 3 and 6 months were assessed. Endovascular treatment was successfully performed in 26 patients (90%). In 3 patients, the stent could not be delivered. Mortality and morbidity rates were of 4% (1 of 26) and 15% (4 of 26), respectively; 1 patient died from a delayed aneurysm rupture related to stent migration, 3 experienced a thromboembolic event, and 1 patient developed progressive visual disturbances related to an increased mass effect. Clinical outcome in 25 patients was unchanged (n=19), improved (n=2), or worsened (=4). Angiographic follow-up in 24 patients (29 aneurysms) showed 20 complete occlusions (69%), 1 neck remnant (3.5%), and 8 incomplete occlusions (27.5%). Significant parent artery stenosis at 6 months occurred in 8 cases (33%). Despite the potential interest of the Silk flow-diverter stent to treat complex intracranial aneurysms without coils, the delayed complication rate is quite high and leads to use this technique only in selective cases.
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                Author and article information

                Contributors
                +49-711-27834500 , +49-711-27834509 , hhhenkes@aol.com
                Journal
                Neuroradiology
                Neuroradiology
                Springer-Verlag (Berlin/Heidelberg )
                0028-3940
                1432-1920
                1 September 2011
                1 September 2011
                April 2012
                : 54
                : 4
                : 369-382
                Affiliations
                [1 ]Neuroradiologische Klinik, Neurozentrum, Klinikum Stuttgart, Stuttgart, Germany
                [2 ]Neurologische Klinik, Neurozentrum, Klinikum Stuttgart, Stuttgart, Germany
                [3 ]Neurochirurgische Klinik, Neurozentrum, Klinikum Stuttgart, Stuttgart, Germany
                Article
                948
                10.1007/s00234-011-0948-x
                3304061
                21881914
                © The Author(s) 2011
                Categories
                Interventional Neuroradiology
                Custom metadata
                © Springer-Verlag 2012

                Radiology & Imaging

                flow diverter, dissection, pipeline embolization device, aneurysm

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