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

Abstract

Background

The 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.

Methods

Between 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).

Results

In 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).

Conclusions

Treatment 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.