Evaluation of Pipeline Flex delivery system for the treatment of unruptured aneurysms

Aguilar‐Salinas, Pedro; Brasiliense, Leonardo B.C.; Gonsales, Douglas; Mitchell, Bartley D.; Lima, Andrey; Sauvageau, Eric; Hanel, Ricardó A.

doi:10.1080/17434440.2016.1231573

Cited by 13 publications

(10 citation statements)

References 102 publications

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“…Mortality rates ranged from 0% to 2.3%,1 2 8 27 28 and occlusion rates ranged from 70.0% to 91.7% 1 2 5 6 8 27 28. One major international retrospective study, IntrePED, analyzed the results of 793 patients with 906 aneurysms treated with PEDs in 17 centers 15. There were 473 (52.2%) small aneurysms (<10 mm), 349 (38.5%) of which were located in the ICA.…”

Section: Discussionmentioning

confidence: 99%

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Prospective study on embolization of intracranial aneurysms with the pipeline device: the PREMIER study 1 year results

Hanel

Kallmes

Lopes³

et al. 2019

J NeuroIntervent Surg

187

138

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BackgroundPreliminary clinical studies on the safety and efficacy of the pipeline embolization device (PED) for the treatment of small/medium aneurysms have demonstrated high occlusion rates with low complications.ObjectiveTo evaluate the safety and effectiveness of the PED for treatment of wide necked small and medium intracranial aneurysms.MethodsPREMIER is a prospective, multicenter, single arm trial. Patients were treated with the PED for unruptured wide necked aneurysms, measuring ≤12 mm along the internal carotid artery or vertebral artery, between July 2014 and November 2015. At 1 year post-procedure, the primary effectiveness endpoint was complete occlusion (Raymond grade 1) without major parent vessel stenosis (≤50%) or retreatment, and the primary safety endpoint was major stroke in the territory supplied by the treated artery or neurologic death.ResultsA total of 141 patients were treated with PEDs (mean age 54.6±11.3 years, 87.9% (124/141) women). Mean aneurysm size was 5.0±1.92 mm, and 84.4% (119/141) measured <7 mm. PED placement was successful in 99.3% (140/141) of patients. Mean number of PEDs implanted per patient was 1.1±0.26; a single PED was used in 92.9% (131/141) of patients. At 1 year, 97.9% (138/141) of patients underwent follow-up angiography with 76.8% (106/138) of patients having met the study’s primary effectiveness endpoint. The combined major morbidity and mortality rate was 2.1% (3/140).ConclusionsTreatment of wide necked small/medium aneurysms with the PED results in high rates of complete occlusion without significant parent vessel stenosis and low rates of permanent neurologic complications.Trial registrationNCT02186561.

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Section: Discussionmentioning

confidence: 99%

“…The features of PED Classic and PED Flex have been previously described 15 16. PED Flex was introduced during the second half of the study, with no change in implant procedures.…”

Section: Methodsmentioning

confidence: 99%

Prospective study on embolization of intracranial aneurysms with the pipeline device: the PREMIER study 1 year results

Hanel

Kallmes

Lopes³

et al. 2019

J NeuroIntervent Surg

187

138

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“…Even with a high rate of complex cavernous geometry, balloon angioplasty was used to improve PED vessel wall apposition in only 8 cases (7%). This low rate of balloon angioplasty for postprocessing the PED is a function of the deployment characteristics of PED Flex [8,10,11], microcatheter selection, and the stability plus trackability of Cat5.…”

Section: Discussionmentioning

confidence: 99%

Utilization of a Novel, Multi-Durometer Intracranial Distal Access Catheter: Nuances and Experience in 110 Consecutive Cases of Aneurysm Flow Diversion

Colby

Lin

et al. 2017

Intervent Neurol

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Background: Coaxial catheter support systems provide a safe and stable foundation in endovascular treatment of intracranial aneurysms. Increasingly, robust distal intracranial support is sought during complex neurointerventions. The AXS Catalyst 5 distal access catheter (Cat5) is a new intracranial catheter designed for improved trackability and stability. We report the first experience using Cat5 for aneurysm treatment by flow diversion. Methods: A single-center aneurysm database was reviewed for cases of aneurysm treatment with the Pipeline embolization device (PED) that utilized Cat5. Data were collected for patient demographics, aneurysm characteristics, procedural details, catheter positions, vessel tortuosity, and catheter related complications. Results: One hundred and ten cases of aneurysm flow diversion were successfully performed using Cat5. Patient age ranged from 21 to 86 years (mean 57 ± 12.5 years) with 84% women. Aneurysm size ranged from 2 to 28 mm (mean 5.7 ± 5.0 mm), with 97% in the anterior circulation. Twenty-four aneurysms (22%) were located beyond the ICA termination. Significant cervical carotid tortuosity was present in 26% of cases, and moderate to severe cavernous tortuosity (cavernous grade ≥2) in 45% of cases. Cat5 was tracked to the intended distal position in all cases with 100% technical success of PED implantation. No iatrogenic catheter-related vessel injury occurred, and major neurological morbidity occurred in 1 patient (1%). Summary: The Cat5 is a novel, multi-durometer cranial distal access catheter designed for use in tri-axial systems. We have demonstrated the utility of Cat5 in 110 successful cases of flow diversion with a wide range of complexity. This catheter is a new tool in the neurointerventionalist's armamentarium to achieve robust and atraumatic distal access.

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“…35 Outcome data for the Pipeline Flex are still limited, but initial results support its safety and short-term efficacy. 36 High rates of occlusion with low rates of short-and long-term disability have been reported from several selected small studies, as follows: in 10 patients with 11 anterior saccular aneurysms, 12 in 42 patients with 44 predominantly anterior saccular aneurysms, 37 and in 30 patients with 30 predominantly anterior saccular aneurysms. 38 The Pipeline Flex device has been shown to reduce total procedure and fluoroscopy times and the rate of deployment failure compared with the original PED.…”

Section: Conventional Braided Mesh Devicesmentioning

confidence: 98%

On Flow Diversion: The Changing Landscape of Intracerebral Aneurysm Management

Dmytriw

Phan

Moore

et al. 2019

AJNR Am J Neuroradiol

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Uptake of flow-diverting technology is rapidly outpacing the availability of clinical evidence. Most current usage is off-label, and the endovascular community is nearer the beginning than the end of the learning curve, given the number of devices in development. A comprehensive overview of technical specifications alongside key outcome data is essential both for clinical decision-making and to direct further investigations. Most-studied has been the Pipeline Embolization Device, which has undergone a transition to the Pipeline Flex for which outcome data are sparse or heterogeneous. Alternative endoluminal devices do not appear to be outperforming the Pipeline Embolization Device to date, though prospective studies and long-term data mostly are lacking, and between-study comparisons must be treated with caution. Nominal technical specifications may be unrelated to in situ performance, emphasizing the importance of correct radiologic sizing and device placement. Devices designed specifically for bifurcation aneurysms also lack long-term outcome data or have only recently become available for clinical use. There are no major studies directly comparing a flow-diverting device with standard coiling or microsurgical clipping. Data on flow-diverting stents are too limited in terms of long-term outcomes to reliably inform clinical decision-making. The best available evidence supports using a single endoluminal device for most indications. Recommendations on the suitability and choice of a device for bifurcation or ruptured aneurysms or for anatomically complex lesions cannot be made on the basis of current evidence. The appropriateness of flow-diverting treatment must be decided on a case-by-case basis, considering experience and the relative risks against standard approaches or observation. ABBREVIATION: MCR ϭ metal coverage ratio T he Pipeline Embolization Device (PED; Covidien, Irvine, California) was approved by the FDA in 2011 and by the European Medicines Agency (EMA) in 2008 for the treatment of large or giant, wide-neck intracranial aneurysms of the internal carotid artery from the petrous to the superior hypophyseal segments. 1 Currently, this is the only device approved in the United States. In Europe, there are additional options, including the PED,

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Evaluation of Pipeline Flex delivery system for the treatment of unruptured aneurysms

Cited by 13 publications

References 102 publications

Prospective study on embolization of intracranial aneurysms with the pipeline device: the PREMIER study 1 year results

Prospective study on embolization of intracranial aneurysms with the pipeline device: the PREMIER study 1 year results

Utilization of a Novel, Multi-Durometer Intracranial Distal Access Catheter: Nuances and Experience in 110 Consecutive Cases of Aneurysm Flow Diversion

On Flow Diversion: The Changing Landscape of Intracerebral Aneurysm Management

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