de Castro-Afonso Luis Henrique, Nakiri Guilherme Seizem, Abud Thiago Giansante, Monsignore Lucas Moretti, de Freitas Rafael Kiyuze, Abud Daniel Giansante
1Division of Interventional Neuroradiology, Department of Medical Imaging, Hematology and Oncology, Universidade de Sao Paulo Faculdade de Medicina de Ribeirao Preto, Ribeirao Preto, São Paulo, Brazil.
Interventional Neuroradiology, Hospital Israelita Albert Einstein, Sao Paulo, Brazil.
J Neurointerv Surg. 2021 Apr;13(4):336-341. doi: 10.1136/neurintsurg-2020-017024. Epub 2021 Jan 29.
Flow diverters (FDs) result in high occlusion rates of aneurysms located distally to the carotid artery. However, the complications reported are not negligible. New modified surface FDs have low thrombogenic properties that may reduce ischemic complications related to the treatment. In addition, a modified surface FD may allow for the use of a single antiplatelet medication to reduce hemorrhagic risk during the procedure. The aim of this study was to assess the safety and efficacy of the p48 MW HPC (phenox, Bochum, Germany) to treat distal intracranial aneurysms under the use of aspirin monotherapy.
The primary endpoint was the incidence of any neurologic deficit after treatment after 6 months of follow-up. The secondary endpoint was the rate of the complete occlusion of the aneurysms at the 6-month follow-up. Enrollment of 20 patients was planned, but after inclusion of seven patients the study was stopped due to safety issues.
Seven patients with eight aneurysms were included. Among the seven patients, three (42.8%) had ischemic complications on the second day after FD deployment. Two patients experienced complete recovery at discharge (National Institutes of Health Stroke Scale (NIHSS) score=0), while one patient maintained mild dysarthria at discharge (NIHSS score=1) which improved after 6 months (NIHSS score=0). All three patients had no new symptoms during the 6-month follow-up. Complete aneurysm occlusion occurred in six (75%) of the eight aneurysms at the 6-month follow-up.
Antiplatelet monotherapy with aspirin for the treatment of distal intracranial aneurysms with this modified surface FD resulted in a significant incidence of ischemic complications after treatment.
血流导向装置（FDs）可使位于颈动脉远端的动脉瘤实现较高的闭塞率。然而，所报道的并发症并非可以忽略不计。新型改良表面FDs具有低血栓形成特性，这可能会降低与治疗相关的缺血性并发症。此外，改良表面FDs可能允许使用单一抗血小板药物以降低手术期间的出血风险。本研究的目的是评估p48 MW HPC（德国波鸿菲尼克斯公司）在使用阿司匹林单一疗法治疗颅内远端动脉瘤时的安全性和有效性。
主要终点是随访6个月后治疗后任何神经功能缺损的发生率。次要终点是6个月随访时动脉瘤的完全闭塞率。计划招募20名患者，但在纳入7名患者后，由于安全问题该研究停止。
纳入了7名患有8个动脉瘤的患者。在这7名患者中，3名（42.8%）在FDs植入后第二天出现缺血性并发症。2名患者出院时完全恢复（美国国立卫生研究院卒中量表（NIHSS）评分为0），而1名患者出院时仍有轻度构音障碍（NIHSS评分为1），6个月后有所改善（NIHSS评分为0）。所有3名患者在6个月的随访期间均无新症状。6个月随访时，8个动脉瘤中有6个（75%）实现了完全闭塞。
使用这种改良表面FDs，采用阿司匹林抗血小板单一疗法治疗颅内远端动脉瘤，治疗后缺血性并发症的发生率较高。
