Han Hyun Jin, Park Keun Young, Kim Byung Moon, Kim Yong Bae, Jeon Hong-Jun, Suh Sang Hyun, Suh Sangil, Kim Jung-Jae, Kim Jun-Hwee, Jang Chang Ki, Kim Dong Joon, Lee Jung Keun, Kim Sunghan, Chung Kyu Seon, Kim Solbi, Yoon Sun, Kim Min Jeoung
Department of Neurosurgery, Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.
Department of Radiology, Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.
Korean J Radiol. 2025 Jul;26(7):716-726. doi: 10.3348/kjr.2024.1212. Epub 2025 Jun 13.
We evaluated the safety and efficacy of a new flow diverter in the treatment of unruptured wide-neck aneurysms.
Patients who had unruptured intracranial aneurysms with a neck diameter ≥4 mm or dome-to-neck ratio <2 and who met other eligibility criteria were enrolled from seven institutions. The patients were treated with a new flow diverter (FloWise; Taewoong Medical, Seoul, Korea) and followed at 1, 3, 6, and 12 months after treatment. The primary efficacy endpoint was the complete occlusion of the target aneurysm at 12 months. Safety endpoints included ipsilateral stroke (National Institutes of Health Stroke Scale score ≥5), newly developed neurological deficit (modified Rankin Scale score ≥3), death at 30 days, and ≥50% parent artery stenosis or occlusion at the 12-month follow-up. The superiority of FloWise over the predefined reference value (56.7%) was investigated using a one-sided binomial test with a statistical significance of < 0.025.
Seventy patients (59.0 ± 9.9 years; male:female = 16:54) with 93 aneurysms (median diameter, 5.2 mm [range, 1.6-26.1 mm]; median neck diameter, 4.1 mm [range, 1.2-22.4 mm]) were included. Of these, 69 patients who completed the follow-up as planned constituted the efficacy analysis set. Complete aneurysm occlusion was achieved in 56 target aneurysms (81.2%; 95% confidence interval [CI], 69.9-89.6; < 0.001). Procedural success and ≥50% aneurysm volume reduction were observed in 69 (100%) and 66 (95.7%; 95% CI, 87.8-99.1) target aneurysms, respectively. No ipsilateral strokes occurred in any of the 70 patients. Serious adverse events occurred in 6 patients; these events were causally related to the treatment in 4 (5.7%) cases and possibly related to the device in 2 (2.9%) cases.
FloWise flow diverter is safe and effective for the treatment of unruptured wide-neck aneurysms.
我们评估了一种新型血流导向装置治疗未破裂宽颈动脉瘤的安全性和有效性。
从7家机构招募患有未破裂颅内动脉瘤、颈部直径≥4mm或瘤颈比<2且符合其他入选标准的患者。患者接受新型血流导向装置（FloWise；韩国首尔Taewoong Medical公司）治疗，并在治疗后1、3、6和12个月进行随访。主要疗效终点是治疗12个月时目标动脉瘤完全闭塞。安全终点包括同侧卒中（美国国立卫生研究院卒中量表评分≥5）、新出现的神经功能缺损（改良Rankin量表评分≥3）、30天内死亡以及12个月随访时≥50%的载瘤动脉狭窄或闭塞。使用单侧二项式检验研究FloWise相对于预定义参考值（56.7%）的优越性，统计学显著性为<0.025。
纳入70例患者（年龄59.0±9.9岁；男:女 = 16:54），共93个动脉瘤（中位直径5.2mm [范围1.6 - 26.1mm]；中位颈部直径4.1mm [范围1.2 - 22.4mm]）。其中，69例按计划完成随访的患者构成疗效分析集。56个目标动脉瘤实现了完全闭塞（81.2%；95%置信区间[CI]，69.9 - 89.6；<0.001）。69个（100%）和66个（95.7%；95%CI，87.8 - 99.1）目标动脉瘤分别观察到手术成功和动脉瘤体积减少≥50%。70例患者中无一例发生同侧卒中。6例患者发生严重不良事件；其中4例（5.7%）事件与治疗有因果关系，2例（2.9%）事件可能与器械有关。
FloWise血流导向装置治疗未破裂宽颈动脉瘤安全有效。
