内动脉瘤的突破栓塞:从一个为期2年的纵向随访研究的角度来看,这是在大量的综合性中风中心进行的
Gaurav Gupta1, Sanjeev Sreenivasan1, Ian Kane2
1Department of Neurosurgery, RUTGERS, Robert Wood Johnson Medical School & University Hospital, New Brunswick, NJ, USA.
概括
这项研究发现,Surpass Streamline (SS) 流量转移器在现实使用中具有14.5%的重大并发症率和4.3%的死亡率. 在程序期间的技术挑战与增加的并发症有关,突出显示需要进一步的安全数据.
科学领域:
- 内血管神经外科手术 血管内血管神经外科
- 脑血管疾病管理的管理
- 医疗器械安全性和有效性 医疗器械安全性和有效性
背景情况:
- 超速流线 (SS) 是第一代无线流量转移器 (FD),具有有限的现实世界结果数据.
- 在临床环境中评估SS FD的安全性和有效性对于理解其实用性至关重要.
研究的目的:
- 评估与Surpass Streamline流量转移器相关的现实世界结果和并发症.
- 确定预测SS FD治疗患者并发症的因素.
主要方法:
- 两家综合性中风中心在2019年1月至2021年7月期间连续治疗SS的病例的回顾性审查.
- 对动脉瘤特征,手术细节,并发症和长期结果的分析.
主要成果:
- 在55名患者中治疗了69例动脉瘤,主要是内动脉 (96%) 和大小小小于10毫米 (88%) 的动脉瘤.
- 观察到的一年封闭率为79.7%. 14.5%的患者出现严重并发症,死亡率为4.3%.
- 技术挑战是主要 (p=0.0002) 和眼科并发症 (p=0.049) 的重要预测因素.
结论:
- 在现实应用中,Surpass Streamline流量转移器表现出了显著的重大并发症和死亡率.
- 在手术过程中的技术挑战与不良结果有关,强调需要仔细选择患者和程序技术.
- 建议以国家数据为重点的未来大规模注册,以进一步阐明SS FD的安全概况和技术挑战.
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