The Pipeline Flex Embolization Device (PED Flex) for the treatment of intracranial aneurysms: Periprocedural outcomes and first-year angiographic results

Oguz, Sukru; Tabakci, Omer Naci; Uysal, Ender; Bulut, Eser; Dinç, Hasan

doi:10.3906/sag-1906-116

Cited by 3 publications

(2 citation statements)

References 22 publications

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“…Literature search was performed on March 21, 2022. After removal of duplicates and screening of titles and abstracts, we sought for the original articles of 82 publications 7 13–93. After completion of literature review and data extraction and before closing the database, the literature search was repeated on PubMed only on May 22, 2022, using the above-mentioned search string to identify additional potentially eligible articles.…”

Section: Resultsmentioning

confidence: 99%

Flow diversion for compressive unruptured internal carotid artery aneurysms with neuro-ophthalmological symptoms: a systematic review and meta-analysis

Kaiser

Cuberi

Linn

et al. 2022

J NeuroIntervent Surg

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BackgroundData on the safety and efficacy of flow diverters (FD) for the treatment of unruptured internal carotid artery (ICA) aneurysms with compressive neuro-ophthalmological symptoms (NOS) are scarce and comprise mainly small case series.MethodsWe performed a search of three databases and included series with ≥10 patients, with unruptured aneurysms of the ICA and NOS, treated with FD. Random-effects analysis of treatment results and safety was performed.ResultsA total of 22 studies reporting on 594 patients were included. Pooled proportions of NOS recovery, improvement, transient and permanent worsening were: 47.4% (95% CI 35.0% to 60.1%); 74.5% (95% CI 67.9% to 80.2%); 7.1% (95% CI 3.3% to 14.7%); and 4.9% (95% CI 3.2% to 7.4%), respectively. Rates of complete recovery and improvement in patients with isolated visual symptoms were 30.6% (95% CI 12.5% to 57.7%) and 56.6% (95% CI 42.3% to 69.9%). Isolated oculomotor symptoms recovered completely in 47.8% (95% CI 29.9% to 66.3%) and improved in 78% (95% CI 69.2% to 84.9%). Morbidity occurred in 5% (95% CI 2.8% to 9%) and mortality in 3.9% (95% CI 2% to 7.5%) of patients. An increased likelihood of symptom improvement was observed when treatment was performed early (<1 month) after symptom onset (OR=11.22, 95% CI 3.9% to 32.5%).ConclusionFlow diversion promotes recovery or improvement of compressive symptoms in a large proportion of patients but is associated with significant rates of morbidity and mortality. Transient and permanent NOS worsening is not uncommon. Early treatment is of utmost importance, as it increases the likelihood of symptom improvement more than 10-fold.

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Section: Resultsmentioning

confidence: 99%

Flow diversion for compressive unruptured internal carotid artery aneurysms with neuro-ophthalmological symptoms: a systematic review and meta-analysis

Kaiser

Cuberi

Linn

et al. 2022

J NeuroIntervent Surg

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“…The use of flow diverters has significantly increased the rate of complete aneurysm occlusion and decreased the rate of periprocedural complications or aneurysm recurrence 1 – 7 . The Pipeline Embolization Device (PED, Medtronic, Irvine, CA, USA) is one of the flow diverters mostly used for the treatment of cerebral aneurysms, with its safety and efficacy being proved by studies indicating a high complete aneurysm occlusion rate and a low rate of major adverse events 3 , 5 , 7 . The PED Classic device is the first-generation of the PED flow diverter approved in 2011, which had been demonstrated to have difficulties in deployment and wall adherence, with increased periprocedural complications, including intracranial hemorrhage, stroke, and arterial dissection 8 – 11 .…”

Section: Introductionmentioning

confidence: 99%

Safety and effect of pipeline flex embolization device for complex unruptured intracranial aneurysms

Chen

Gao

et al. 2023

Sci Rep

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To investigate the safety and short-term effect of Pipeline Flex devices in the treatment of complex unruptured intracranial aneurysms, a retrospective study was performed for patients with complex unruptured intracranial aneurysms who were treated with the Pipeline Flex embolization device (PED Flex device) combined with or without coiling. The clinical, endovascular, and follow-up data were analyzed. One hundred and thirty-one patients with 159 complex unruptured cerebral aneurysms were treated with the PED Flex device, with 144 Flex devices deployed. Periprocedural complications occurred in four patients, resulting in the complication rate of 3.1%, including ischemic complications in three patients (2.3%) and hemorrhagic complication in one (0.8%). At discharge, the mRS was 0 in 101 (77.1%) patients, 1 in 25 (19.1%), 2 in four (3.1%), and 4 in one (0.8%), with the good prognosis rate (mRS 0–2) of 99.2%. Clinical follow-up was carried out in 87 (66.4%) patients 3–42 months after the procedure, with the mRS of 0 in 78 (89.7%), 1 in five (5.7%), 2 in three (3.4%), and 4 in one (1.1%). No significant (P = 0.16) difference existed in the mRS at discharge compared with that at clinical follow-up. Angiographic follow-up was performed in 61 (46.7%) patients with 80 (50.3%) aneurysms at 3–40 months, with the OKM grade of D in 57 (71.3%) aneurysms, C in eight (10%), and B in 15 (18.8%). Asymptomatic instent stenosis occurred in four patients (6.6%). In conclusion: The treatment of complex intracranial aneurysms with the Pipeline Flex embolization device may be safe and effective, with a high complete occlusion rate, a decreased complication rate, and a good prognosis rate at medium follow-up.

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Comparison of pipeline classic and flex embolization devices in endovascular performance for intracranial aneurysms

Gao

et al. 2023

Medicine

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To investigate the endovascular performance of the Pipeline Classic embolization device (PED Classic) and PED Flex device (PED Flex) in the treatment of intracranial aneurysms. Fifty-three patients with intracranial aneurysms treated with the PED Classic were retrospectively enrolled into the PED Classic group, and 118 patients with intracranial aneurysms treated with the PED Flex were enrolled into the PED Flex group. The Procedure time, contrast dosage, fluoroscopy time, and perioperative complications were analyzed. The success rate of the stenting procedure was 100% in both groups. In the PED Classic group, 58 PED Classic devices were implanted, and 26 aneurysms underwent coil embolization. In the PED Flex group, 126 PED Flex devices were implanted, and 35 aneurysms underwent concomitant coil embolization. The procedure time was significantly (P < .001) greater in the PED Classic (159.0 ± 42.0 minutes) than in the PED Flex (121.9 ± 4.0 minutes) group. The dosage of contrast agent (156.4 ± 39.4 vs 110.1 ± 38.5 mL) and the total fluoroscopic time (34.7 ± 5.7 minutes vs 22.8 ± 7.6 minutes) were significantly (P < .001) greater in the PED Classic than in the PED Flex group. Peri-procedural complications occurred in 5 (9.4%) patients in the PED Classic group and in 3 (2.5%) patients in the Flex group, without a statistically significant (P = .11) difference. The performance of the PED Flex device may be safer and easier than that of the PED Classic device in the treatment of intracranial aneurysms despite some serious complications which remain to be prevented.

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The Pipeline Flex Embolization Device (PED Flex) for the treatment of intracranial aneurysms: Periprocedural outcomes and first-year angiographic results

Cited by 3 publications

References 22 publications

Flow diversion for compressive unruptured internal carotid artery aneurysms with neuro-ophthalmological symptoms: a systematic review and meta-analysis

Flow diversion for compressive unruptured internal carotid artery aneurysms with neuro-ophthalmological symptoms: a systematic review and meta-analysis

Safety and effect of pipeline flex embolization device for complex unruptured intracranial aneurysms

Comparison of pipeline classic and flex embolization devices in endovascular performance for intracranial aneurysms

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