Long-term clinical and angiographic follow-up results of the dual-layer flow diverter device (FRED) for the treatment of intracranial aneurysms in a multicenter study

Dinç, Hasan; Saatçi, Işıl; Oguz, Sukru; Baltacıoğlu, Feyyaz; Yıldız, Altan; Dönmez, Halil; Belet, Ümit; Önal, Baran; Andıç, Çağatay; Koç, Osman; Koçak, Ömer Faruk; Köroğlu, Mert; Çetin, Mustafa; Cekirge, H Saruhan

doi:10.1007/s00234-020-02627-1

Cited by 11 publications

(12 citation statements)

References 34 publications

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“…In the earlier publication of John et al , 22 38% of patients had some degree of luminal narrowing post PED implantation with 9.8% having >25% in-stent stenosis. Similar rates of in-stent stenosis have been reported for the FRED (7.6%) 23 and the DED (6.6%). 24 …”

Section: Discussionsupporting

confidence: 83%

Diversion-p64: results from an international, prospective, multicenter, single-arm post-market study to assess the safety and effectiveness of the p64 flow modulation device

Bonafé

Pérez

Henkes

et al. 2021

J NeuroIntervent Surg

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BackgroundThe use of flow diversion to treat intracranial aneurysms has increased in recent years.ObjectiveTo assess the safety and angiographic efficacy of the p64 flow modulation device.MethodsDiversion-p64 is an international, prospective, multicenter, single-arm, study conducted at 26 centers. The p64 flow modulation device was used to treat anterior circulation aneurysms between December 2015 and January 2019. The primary safety endpoint was the incidence of major stroke or neurologic death at 3–6 months, with the primary efficacy endpoint being complete aneurysm occlusion (Raymond-Roy Occlusion Classification 1) on follow-up angiography.ResultsA total of 420 patients met the eligibility criteria and underwent treatment with the p64 flow modulation device (mean age 55±12.0 years, 86.2% female). Mean aneurysm dome width was 6.99±5.28 mm and neck width 4.47±2.28 mm. Mean number of devices implanted per patient was 1.06±0.47, with adjunctive coiling performed in 14.0% of the cases. At the second angiographic follow-up (mean 375±73 days), available for 343 patients (81.7%), complete aneurysm occlusion was seen in 287 (83.7%) patients. Safety data were available for 413 patients (98.3%) at the first follow-up (mean 145±43 days) with a composite morbidity/mortality rate of 2.42% (n=10).ConclusionsDiversion-p64 is the largest prospective study using the p64 flow modulation device. The results of this study demonstrate that the device has a high efficacy and carries a low rate of mortality and permanent morbidity.

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Section: Discussionsupporting

confidence: 83%

Diversion-p64: results from an international, prospective, multicenter, single-arm post-market study to assess the safety and effectiveness of the p64 flow modulation device

Bonafé

Pérez

Henkes

et al. 2021

J NeuroIntervent Surg

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“…Twenty-two studies published between January 1, 2013 and April 30, 2021 are included in this review. [1][2][3][5][6][7][8][9][10][11][12][13][14][15][16][17][18][19][20][21][22][23][24] One study published results in 2 separate papers. 2,3 Table 1 outlines the characteristics of each study.…”

Section: Study Characteristicsmentioning

confidence: 99%

Flow redirection endoluminal device (FRED) for treatment of intracranial aneurysms: A systematic review

et al. 2021

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Introduction The Flow Redirection Endoluminal Device (FRED; MicroVention) is a dual-layered flow diverter used for the treatment of intracranial aneurysms. The objective of this systematic review was to compile device-related safety and effectiveness data. Methods The literature from January 1, 2013 to April 30, 2021 was searched for studies describing use of the FRED for intracranial aneurysm treatment irrespective of aneurysm location and morphology. The review included anterior and posterior circulation ruptured and unruptured saccular, fusiform or dissection, and blister aneurysms. MeSH terms related to “flow re-direction endoluminal device” and “FRED for aneurysms” were used. Data related to indication, complications, and rates of aneurysm occlusion were retrieved and analyzed. Results Twenty-two studies with 1729 intracranial aneurysms were included in this review. Overall reported morbidity was 3.9% (range 0–20%). Overall procedure-related mortality was 1.4% (range 0–6%). Complication rates fell into 5 categories: technical (3.6%), ischemic (3.8%), thrombotic or stenotic (6%), hemorrhagic (1.5%), and non-neurological (0.8%). The aneurysm occlusion rate between 0 and 3 months (reported in 11 studies) was 47.8%. The occlusion rate between 4 and 6 months (reported in 14 studies) was 73.8%. Occlusion rates continued to increase to 75.1% at 7–12 months (reported in 10 studies) and 86.6% for follow-up beyond 1 year (reported in 10 studies). Conclusion This review indicated that the FRED is a safe and effective for the treatment of intracranial aneurysms. Future studies should directly compare the FRED with other flow diverters for a better understanding of comparative safety and effectiveness among the different devices.

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“…[4][5][6][7][8] On the other hand, long-term follow-up results are still limited, especially with regard to FRED. 4,9,10 This study aims to evaluate the safety and efficacy of FRED and PED devices in the treatment of distal internal carotid aneurysms, along with long-term results.…”

Section: Introductionmentioning

confidence: 99%

Long-term results and comparison of flow re-direction endoluminal device and pipeline embolization device in endovascular treatment of intracranial carotid aneurysms

et al. 2021

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Objective This study aims to compare the efficacy, safety, and long-term outcomes of two flow diverters, i.e., pipeline embolization device and flow re-direction endoluminal device, in the treatment of distal carotid aneurysms. Methods A total of 138 patients with 175 aneurysms were included from February 2012 to September 2019. Ninety-nine aneurysms were treated with flow re-direction endoluminal device and 76 with pipeline embolization device. Angiographic follow-ups were at the 6th, 12th, 24th, 36th, and 60th months; the O’Kelly-Marotta grading scale was used to assess aneurysms occlusion. Outcomes of two devices were compared; possible associations regarding patient characteristics, aneurysm properties, treatment details, and adverse events were evaluated. Results The mean follow-up period was 33 months, with 10 patients lost to follow-up. Occlusion rates at the 6th and 12th months and during the last follow-up were similar for flow re-direction endoluminal device (81%, 84%, and 90%) and pipeline embolization device (82%, 85%, and 93%). Occlusion rates were also similar after stand-alone use without coiling. There was no significant difference regarding adverse event rates with a 10.9% overall complication rate, 3.6% mortality, and 0.7% permanent morbidity. All the mortality and morbidity were related to hemorrhagic complications. Device deployment failure was observed with five flow re-direction endoluminal devices and two pipeline embolization devices, whereas two severe in-stent stenoses occurred with each device. Conclusions Both flow re-direction endoluminal device and pipeline embolization device are feasible and effective in flow diversion of distal internal carotid artery aneurysms, with similar adverse events rates and aneurysm occlusion success. Aneurysm occlusion rates increase with time, while the presence of an integrated branch significantly decreases treatment success.

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Long-term clinical and angiographic follow-up results of the dual-layer flow diverter device (FRED) for the treatment of intracranial aneurysms in a multicenter study

Cited by 11 publications

References 34 publications

Diversion-p64: results from an international, prospective, multicenter, single-arm post-market study to assess the safety and effectiveness of the p64 flow modulation device

Diversion-p64: results from an international, prospective, multicenter, single-arm post-market study to assess the safety and effectiveness of the p64 flow modulation device

Flow redirection endoluminal device (FRED) for treatment of intracranial aneurysms: A systematic review

Long-term results and comparison of flow re-direction endoluminal device and pipeline embolization device in endovascular treatment of intracranial carotid aneurysms

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