TY - JOUR
T1 - The p48 flow diverter: First clinical results in 25 aneurysms in three centers
AU - Van den Bergh, F.R.A.
AU - De Beule, T.
AU - van Rooij, W.J.
AU - Voormolen, M.H.
AU - Van der Zijden, T.
AU - Stockx, L.
AU - van Zwam, W.H.
AU - Fransen, H.
N1 - Publisher Copyright:
© The Author(s) 2020.
PY - 2021/6
Y1 - 2021/6
N2 - 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.
AB - 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.
KW - complications
KW - endovascular treatment
KW - flow diversion
KW - flow diverter
KW - interventional radiology
KW - intracranial aneurysms
KW - p48
KW - p48 mw
KW - Flow diverter
KW - p48 MW
UR - https://sage.figshare.com/articles/dataset/sj-xlsx-1-ine-10_1177_1591019920972213_-_Supplemental_material_for_The_p48_flow_diverter_First_clinical_results_in_25_aneurysms_in_three_centers/13256936/1
U2 - 10.1177/1591019920972213
DO - 10.1177/1591019920972213
M3 - Article
C2 - 33164617
SN - 1591-0199
VL - 27
SP - 339
EP - 345
JO - Interventional Neuroradiology
JF - Interventional Neuroradiology
IS - 3
M1 - 1591019920972213
ER -