Surface-modified flow diverter p48-MW-HPC: Preliminary clinical experience in 28 patients treated in two centers

Background and purpose: Flow diversion is increasingly used for endovascular treatment of distal intracranial aneurysms and has led to the development of small diameter flow diverters such as p48-MW (phenox, Bochum, Germany). Use of flow diverters is limited, however, as patients require dual antiplatelet treatment to avoid thromboembolic complications. Hydrophilic Polymer Coating was developed to reduce platelet aggregation on the p48-MW (p48-MW-HPC). This study reports preliminary experience with p48-MW-HPC in aneurysm treatment in two centers.

Materials and methods: Patients with ruptured, unruptured, and recanalized aneurysms treated with p48-MW-HPC were prospectively included and retrospectively analyzed for safety and efficacy. Safety was evaluated by analyzing intra- and postoperative complications as well as thromboembolic events depicted by DWI in the 72 h post-procedure. Efficacy was evaluated at 6 months based on aneurysm occlusion.

Results: From April 2019 to May 2020, 28 patients aged 25-82 years with 29 aneurysms were treated. Two thromboembolic events (7.1%) were reported with good clinical outcome. Final morbidity and mortality were both 0.0%. Post-operative DWI-MRI was depicting lesions in 70.0% of patients. Short-term (6 months) anatomical results were complete aneurysm occlusion in 87.0% of aneurysms, neck remnant in 8.7%, and aneurysm remnant in 4.3%.

Conclusion: This preliminary clinical evaluation conducted in a relatively small sample size shows high feasibility (100.0%) of p48-MW-HPC aneurysm treatment, without morbidity or mortality, and high efficacy (complete occlusion in 90.0%). Additional larger comparative studies are needed to confirm these results and optimize perioperative antiplatelet treatment.