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.

Keywords: Flow-Diverter; HPC; aneurysm; coating; embolization.

Figure 1.

Illustrative case. DSA images during placement of a p64-HPC for treatment of an unruptured p-com aneurysm of the right ICA. DSA left images are unsubtracted, right images are subtracted. Top row DSA LL views, bottom bottom row DSA AP views. (Figure B) Final DSA images showing caudal shift of the p64, compared to Figure A (arrow). DSA left images are unsubtracted, right images are subtracted. Top row DSA LL views, bottom row DSA AP views.

Figure 2.

Illustrative case. The basal CT shows severe SAH (A). The CTA shows a small dissecting right A2 ruptured aneurysm (arrow in B), confirmed by DSA (arrow in C), treated by p48-HPC FD (arrows in D) under single aggregation. After clinical deterioration the perfusional CT demonstrated hypoperfusion in the right parasagittal territory (in E), due to parent artery occlusion at the FD level (white arrow in F), partially recanalized after mechanical thrombolisis (white arrow in G). Unfortunately the patient did not survive.