Department of Radiology, Yonsei University College of Medicine, Severance Stroke Center, Severance Hospital, Seoul, Korea.
Department of Neurosurgery, Yonsei University College of Medicine, Severance Stroke Center, Severance Hospital, Seoul, Korea.
Korean J Radiol. 2019 Mar;20(3):505-512. doi: 10.3348/kjr.2018.0421.
We report the results of a pilot clinical study that evaluated the safety and efficacy of a newly-developed, retrievable flow diverter (FloWise; Taewoong Medical) for the treatment of internal carotid artery (ICA) aneurysm.
A total of 10 patients were enrolled. Inclusion criteria were 1) unruptured aneurysm with a dome size of ≥ 8 mm and a neck size of ≥ 4 mm at the ICA, or 2) two or more unruptured aneurysms of any size able to be spanned by a single FloWise at the ICA. Co-primary effectiveness end points were technical success of FloWise placement, and a 50% or greater decrease in aneurysm volume at the 6-month follow-up angiogram. The primary safety end point was the new development of neurological deficits persisting for more than 1-month post-treatment.
Ten patients harboring 14 ICA aneurysms (median diameter, 9.4 mm; range, 2.3-31.0 mm) were enrolled between January 2016 and July 2017. FloWise placement was successful in all patients. There were no newly-developed neurological deficits during the 6-month clinical follow-up period. One patient did not receive follow-up imaging due to pregnancy. Nine patients with 12 aneurysms received a 6-month angiographic follow-up. Ten aneurysms (83.3%) showed decreases in volume greater than 50% (mean volume decrease, 82.8 ± 32.9%), of which 8 (66.7%, 95% confidence interval, 35.4-98.0%) showed complete occlusion. One patient was retreated due to mass symptom aggravation.
In this pilot study, FloWise appeared to be safe and effective for ICA aneurysm treatment. A prospective multicenter study to validate the effectiveness and safety of FloWise would be worthwhile.
我们报告了一项新开发的可回收血流导向装置（FloWise；Taewoong Medical）治疗颈内动脉（ICA）动脉瘤的安全性和有效性的初步临床研究结果。
共纳入 10 例患者。纳入标准为：1）ICA 瘤颈≥4mm、瘤体≥8mm 的未破裂动脉瘤，或 2）ICA 上可放置单个 FloWise 的两个或多个任何大小的未破裂动脉瘤。主要有效性终点为 FloWise 放置的技术成功率，以及 6 个月血管造影随访时动脉瘤体积减少 50%或以上。主要安全性终点为治疗后持续 1 个月以上的新发神经功能缺损。
2016 年 1 月至 2017 年 7 月，共纳入 10 例 14 个 ICA 动脉瘤患者（中位直径 9.4mm，范围 2.3-31.0mm）。所有患者均成功放置了 FloWise。在 6 个月的临床随访期间，没有新发的神经功能缺损。1 例因妊娠未行随访影像学检查。9 例患者的 12 个动脉瘤接受了 6 个月的血管造影随访。10 个动脉瘤（83.3%）体积减少>50%（平均体积减少 82.8±32.9%），其中 8 个（66.7%，95%置信区间 35.4-98.0%）完全闭塞。1 例因肿块症状加重而再次治疗。
在这项初步研究中，FloWise 似乎安全有效，可用于治疗 ICA 动脉瘤。开展一项前瞻性多中心研究以验证 FloWise 的有效性和安全性是有价值的。
