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

Abstract

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.

Progressive volume reduction and long-term aneurysmal collapse following flow diversion treatment of giant and symptomatic cerebral aneurysms

“…Although our study conceptualization and applied methods were not aimed at analyzing and discussing the angiographic occlusion results, the observed obliteration rates were consistent with those reported in the available FD literature ( 39 – 43 ). Our angiographic results suggested the unequivocal effect of flow diversion on giant aneurysms; however, the complications associated with this approach should not be overlooked.…”

Will Coiling Survive through the Next Decade?

“…Intracranial haemorrhage after extrasaccular flow diversion remains a concern, particularly when treating blister aneurysms [ 15 ] and aneurysms with a fundus diameter ≥10 mm [ 16 , 17 ]. The rate of complete aneurysm occlusion within one year is >80% with combined morbidity and mortality <5% [ 18 ]. Aneurysm recurrence and (re-)bleeding after complete occlusion secondary to flow diversion are exceedingly rare.…”

Coating (Coating to Optimize Aneurysm Treatment in the New Flow Diverter Generation) study. The first randomized controlled trial evaluating a coated flow diverter (p64 MW HPC): study design

“…Flow diversion is associated with great efficacy for complete aneurysm occlusion in the short-, mid-, and long-term follow-up. In PUFS, SAFE, and Diversion-p64, the rates of complete aneurysm occlusion at 1 year were 86.8%, 73.3%, and 83.7%, respectively 3 6–8. Due to this promising efficacy, treatment indications have expanded to include small aneurysms, distal aneurysms, and bifurcation aneurysms 6 8…”

“…The p64 flow diverter has been evaluated in the largest clinical study dedicated to this kind of EVT (Diversion-p64) 8. Diversion-p64 included 420 patients, showed a very low morbidity/mortality rate at the 6-month follow-up (2.42%), and a high rate of complete aneurysm occlusion at 12 months (83.7%) 8.…”