p64 flow diverter: Results in 108 patients from a single center

Beule, Tom De; Boulanger, T.; Heye, Sam; Rooij, W.J. van; Zwam, Wim H van; Stockx, L

doi:10.1177/1591019920932048

Cited by 10 publications

(16 citation statements)

References 29 publications

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“…The efficacy at one year is also largely variable with means of around 80%. 11,12,30 Since its introduction a decade ago, the WEB has proven to be a safe and effective device for both ruptured and unruptured (wide-necked) aneurysms. The WEB is increasingly used for all types of aneurysms, bifurcation or sidewall, wide-necked, or smallnecked.…”

Section: Discussionmentioning

confidence: 99%

“…The efficacy at one year is also largely variable with means of around 80%. [11][12][13][14][15][16] Recently, the intrasaccular flow disruptor Woven EndoBridge (WEB, MicroVention, Tustin, CA, USA) device has been developed, primarily for the treatment of (bifurcation) wide-necked aneurysms without the need for adjunctive devices and antiplatelet medication. The first clinical results of the WEB device show good safety and efficacy profiles.…”

Section: Introductionmentioning

confidence: 99%

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The Woven EndoBridge for unruptured intracranial aneurysms: Results in 95 aneurysms from a single center

et al. 2021

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Background and purpose The Woven EndoBridge (WEB) is an intrasaccular flowdisruptor that is increasingly used for the treatment of (wide-necked) aneurysms. We present our experience with the WEB for unruptured aneurysms. Materials and methods Between April 2014 and August 2019, 93 patients with 95 unruptured aneurysms were primarily treated with the WEB. There were 69 women and 24 men, mean age 61 years (median 58, range 37–80). Results Of 95 aneurysms, 86 had been discovered incidentally, 3 were symptomatic and 6 were additional to another ruptured aneurysm. Location was anterior communicating artery 33, middle cerebral artery 29, basilar tip 19, carotid tip 8, posterior communicating artery 4, posterior inferior cerebellar artery 1, superior cerebellar artery 1. Mean aneurysm size was 6 mm (median 6, range 3–13 mm). In one aneurysm additional coils were used and in another, a stent was placed. There was one procedural rupture without clinical sequelae. There were two thrombo-embolic complications leading to permanent deficit in one patient (mRS 2). Morbidity rate was 1.0% (1 of 93, 95%CI 0.01–6.5%) and mortality was 0% (0 of 93, 95%CI 0.0–4.8%). Angiographic follow-up at six months was available in 85 patients with 87 aneurysms (91%). Of 87 aneurysms, 68 (78%) were completely occluded, 14 (16%) had a neck remnant and 5 were incompletely occluded. Four aneurysms were retreated. Retreatment rate was 4.5% (4 of 87, 95%CI 1.7–13.6%). Conclusion WEB treatment of unruptured aneurysms is safe and effective. Additional devices are needed only rarely and retreatment at follow-up is infrequent.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

The Woven EndoBridge for unruptured intracranial aneurysms: Results in 95 aneurysms from a single center

et al. 2021

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“…The device is approved for the treatment of intracranial aneurysms and dissections in Europe, and a growing body of literature supports its longterm efficacy. [5][6][7][8][9][10][11][12] Diversion-p64 was a single-arm, international, multicenter, prospective study to assess the safety and efficacy of the p64 FMD and is the largest prospective study on flow diversion to date.…”

Section: Introductionmentioning

confidence: 99%

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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“…18 The aneurysm occlusion rates in this study were comparable to those reported in the current literature. 4,8,10,29 At the last follow-up we found a persistent patency of the aneurysm in 6 cases. Grade 0 occlusions (2 cases) were due to an incomplete overlap of the aneurysm neck by the implanted FD on the one hand and the growth of the treated aneurysm on the other.…”

Section: Discussionmentioning

confidence: 91%

Retrospective analysis of intracranial aneurysms after flow diverter treatment including color-coded imaging (syngo iFlow) as a predictor of aneurysm occlusion

et al. 2021

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Purpose Flow Diverters (FD) have immensely extended the treatment of cerebral aneurysms in the past years. Complete aneurysm occlusion is a process that often takes a certain amount of time and is usually difficult to predict. Our aim was to investigate different syngo iFlow parameters in order to predict aneurysm occlusion. Methods Between 2014 and 2018 patients with unruptured cerebral aneurysms treated with a FD were reviewed. Aneurysm occlusion and complication rates have been assessed. In addition, various quantitative criteria were assessed using syngo iFlow before, after the intervention, and after short and long-term digital subtraction angiography (DSA). Results A total of 66 patients hosting 66 cerebral aneurysms were included in this study. 87.9% (n = 58) aneurysms in the anterior and 12.1% (n = 8) in the posterior circulation were treated. Adequate aneurysm occlusion at long-term follow-up (19.05 ± 15.1 months) was achieved in 90.9% (n = 60). Adequately occluded aneurysm revealed a significantly greater peak intensity delay (PI-D, p = 0.008) and intensity decrease ratio (ID-R, p < 0.001) compared to insufficiently occluded aneurysms. Increased intra-aneurysmal contrast agent intensity (>100%) after FD implantation resulted in an ID-R < 1, which was associated with aneurysm growth during follow-up DSA. Retreatment with another FD due to foreshortening and/or aneurysm growth was performed in 10.6% (n = 7). Overall morbidity and mortality rates were 1.5% (n = 1) and 0%. Conclusion The applied syngo iFlow parameters were found to be useful in predicting adequate aneurysm occlusion and foresee aneurysm growth, which might indicate the implantation of another FD.

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p64 flow diverter: Results in 108 patients from a single center

Cited by 10 publications

References 29 publications

The Woven EndoBridge for unruptured intracranial aneurysms: Results in 95 aneurysms from a single center

The Woven EndoBridge for unruptured intracranial aneurysms: Results in 95 aneurysms from a single center

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

Retrospective analysis of intracranial aneurysms after flow diverter treatment including color-coded imaging (syngo iFlow) as a predictor of aneurysm occlusion

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