The p48 flow diverter: First clinical results in 25 aneurysms in three centers

F.R.A. Van den Bergh*, T. De Beule, W.J. van Rooij, M.H. Voormolen, T. Van der Zijden, L. Stockx, W.H. van Zwam, H. Fransen

*Corresponding author for this work

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Abstract

BackgroundThe novel low-profile p48 flow diverter has been designed to treat aneurysms on small vessels of 1.75-3mm. We report our first clinical experiences.MethodsBetween March 2018-January 2020, 22 patients with 25 aneurysms were treated with the p48 in 3 centers. One patient had 3 aneurysms covered by one p48 and one patient had 2 aneurysms. There were 5 men, 17 women, with a mean age of 55 years (median 59, range 29-73 years).ResultsIn 25 aneurysms, 24 p48 flow diverters were placed. In 1 patient additional coils were placed in the aneurysm. Procedural vessel rupture by the micro guidewire occurred in 2 patients and vessel rupture during p48 balloon dilatation occurred in 1 patient. Overall, the permanent morbidity rate was 13.6% (3 of 22, 95%CI 3.9-34.2%) and mortality was 4.5% (1 of 22, 95%CI <0.01-23.5%). Most complications were procedure-related and not device-specific. Of 22 patients with 25 aneurysms treated with p48, 18 patients with 20 aneurysms had angiographic follow-up after 5-18 months. Of 19 aneurysms, 10 were occluded and 7 showed a remnant. Two aneurysms were open after 6 months. Three aneurysms were still not occluded after 12, 14, and 18 months and these 3 were retreated. Retreatment rate was 16% (3 of 19) and the adequate occlusion rate was 90% (17 of 19).ConclusionsTreatment of aneurysms in small-caliber vessels with the p48 is feasible and effective but is not without complications. More data is needed to establish indications, safety, and efficacy more accurately.
Original languageEnglish
Article number1591019920972213
Pages (from-to)339-345
Number of pages7
JournalInterventional Neuroradiology
Volume27
Issue number3
Early online date8 Nov 2020
DOIs
Publication statusPublished - Jun 2021

Keywords

  • complications
  • endovascular treatment
  • flow diversion
  • flow diverter
  • interventional radiology
  • intracranial aneurysms
  • p48
  • p48 mw
  • Flow diverter
  • p48 MW

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