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.

中文翻译：

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表面改性分流器 p48-MW-HPC：在两个中心接受治疗的 28 名患者的初步临床经验

背景和目的

分流越来越多地用于远端颅内动脉瘤的血管内治疗，并导致了小直径分流器的发展，例如 p48-MW（phenox，Bochum，德国）。然而，分流器的使用是有限的，因为患者需要双重抗血小板治疗以避免血栓栓塞并发症。开发亲水聚合物涂层以减少 p48-MW (p48-MW-HPC) 上的血小板聚集。本研究报告了两个中心在动脉瘤治疗中使用 p48-MW-HPC 的初步经验。

材料和方法

前瞻性纳入了使用 p48-MW-HPC 治疗的破裂、未破裂和再通动脉瘤患者，并对其安全性和有效性进行了回顾性分析。通过分析术后 72 小时内 DWI 描述的术中和术后并发症以及血栓栓塞事件来评估安全性。在 6 个月时根据动脉瘤闭塞评估疗效。

结果

2019 年 4 月至 2020 年 5 月，共收治了 28 名 25-82 岁的动脉瘤患者，共 29 个动脉瘤。报告了两个血栓栓塞事件 (7.1%)，具有良好的临床结果。最终发病率和死亡率均为 0.0%。术后 DWI-MRI 显示 70.0% 患者的病变。短期（6 个月）解剖结果是 87.0% 的动脉瘤完全闭塞，8.7% 的颈部残留和 4.3% 的动脉瘤残留。

结论

在相对较小的样本量中进行的初步临床评估表明，p48-MW-HPC 动脉瘤治疗具有很高的可行性 (100.0%)，没有发病率或死亡率，并且疗效高（90.0% 的完全闭塞）。需要更多更大规模的比较研究来证实这些结果并优化围手术期抗血小板治疗。