The use of FD-HPC in Ruptured and Unruptured Aneurysms, the Italian Dataset (RUAID): Preliminary results on feasibility and safety.

Abstract

BackgroundThe introduction of flow diverters (FDs) has revolutionized the treatment of complex intracranial aneurysms; subsequent surface modifications have extended their indications to ruptured, bifurcation, and distal aneurysms. The aim of this study is to assess the real-world feasibility and safety of HPC surface-modified devices in the treatment of ruptured and unruptured aneurysms.MethodsThis independent, multicenter, prospective observational study evaluated the outcomes of patients treated with implanted Phenox p64 or p48 MW-HPC-FDs between 2020 and 2022. The sub-analysis of the procedures, complications (clinical and technical), and additional treatment requirements assessed the devices' feasibility and safety in the peri-procedural period.ResultsOne hundred and forty aneurysms (35% ruptured and 65% unruptured) were treated in 140 patients (37 females and 103 males) using 153 HPC-FDs (111 p64 and 42 p48): 100 aneurysms were saccular (71%), 22 dissecting (16%), 13 fusiform (9%), and five blister-like (3.6%). The successful deployment rate was 97.9%. The overall peri-procedural mortality rate was 9%, including three device-related deaths (2.2%); the overall morbidity rate was 12.1% (6.4% severe, 3.6% mild, and 2.1% asymptomatic adverse events); 4.4% of the clinical adverse events were certainly device related, and 2.2% were probably device related.ConclusionsThe use of p64 and p48 HPC-FDs is highly feasible and acceptably safe, although further data are needed to assess the impact of the coating on safety in emergency and elective procedures.