从前性,多中心,单臂研究中,对正常压力头症的内血管道的安全性
Pedro Lylyk1, Charles C Matouk2, Ricardo A Hanel3
1Interventional Neuroradiology, Clinical Institute ENERI, Buenos Aires, Argentina.
Journal of neurointerventional surgery
|February 24, 2026
概括
该eShunt植入器提供了一个安全和有效的内血管分流程序,用于正常压力头症 (NPH). 这种微创方法在90天内显著改善了患者的症状.
科学领域:
- 神经学 神经学
- 神经外科 神经外科
- 医疗器械 医疗器械
背景情况:
- 正常压力脑症 (NPH) 是一种影响步态,认知和泌尿功能的神经疾病.
- 传统的分流方法带有风险;内血管方法提供了一个潜在的不那么侵入性的替代方案.
- 临床试验.gov 标识符:NCT05250505和NCT05232838.gov 标识符:NCT05250505 和NCT05232838.gov 标识符:NCT05250505 和NCT05232838.gov 标识符:NCT05250505 和NCT05232838.gov 标识符:NCT05232838.gov 标识符:NCT05250505 和NCT05232838.
研究的目的:
- 评估eShunt植入物用于治疗NPH的初始安全性和有效性.
- 在90天的随访中评估与设备和程序相关的严重不良事件 (SAE).
- 为了测量介入后的步态,认知和尿路症状的变化.
主要方法:
- 一个前性,多中心,单臂试验包括66名NPH参与者,他们有资格接受内血管分流.
- 参与者接受了eShunt手术,这是一种脑脊液 (CSF) 经静脉转移的转移.
- 安全性通过SAE进行评估;有效性使用定时升级和升级 (TUG),蒙特利尔认知评估 (MoCA) 和神经性膀症状得分短表格 (NBSS-SF) 进行测量.
主要成果:
- 没有报告与设备相关的SAE,脑出血,过度排水或感染.
- 发生了两起与手术相关的SAE (3.0%) (西格蒙鼻血栓症,大腿动脉伪动脉瘤) 并得到解决.
- 统计学上显著的改善在TUG时间 (37.2%),MoCA分数 (+2.3) 和NBSS-SF分数 (-2.1) 中被观察到.
结论:
- 使用eShunt植入物进行内血管分流是NPH的可行且安全的治疗方法.
- 该程序显示了可接受的临床反应和低率的SAEs与传统的短路相比.
- 需要在随机对照试验中进行进一步的研究,将内血管分流与标准护理进行比较.
相关概念视频
01:30Blood Pressure
Blood pressure (BP) is the pressure or force of blood exerted on the artery's walls as it circulates through the body. It is essential for maintaining blood flow throughout the body.
The average BP in an adult is typically around 120/80 mmHg (millimeters of mercury). In this measurement, the numerator (120) indicates the systolic pressure, which is the pressure in the arteries during the contraction of the heart's ventricles as blood is expelled. The denominator (80) represents the diastolic...
The average BP in an adult is typically around 120/80 mmHg (millimeters of mercury). In this measurement, the numerator (120) indicates the systolic pressure, which is the pressure in the arteries during the contraction of the heart's ventricles as blood is expelled. The denominator (80) represents the diastolic...
01:15Assessment of blood pressure in brachial artery(one-step method)
This procedural guide systematically measures blood pressure using an oscillometric digital sphygmomanometer, emphasizing accuracy, patient safety, and comfort.
Prepare for the Procedure:
Prepare for the Procedure:
01:23Assessment of blood pressure in brachial artery(two-step method)
Measuring blood pressure is a fundamental skill in healthcare that aids in diagnosing and monitoring hypertension and other cardiovascular conditions. An aneroid sphygmomanometer, commonly used in clinical settings, offers a manual and precise method for blood pressure measurement. The technique for using this instrument involves specific steps that must be carefully executed to ensure accuracy. The following detailed description outlines a two-step technique for assessing blood pressure using...
01:28Special considerations while measuring blood pressure
When assessing blood pressure (BP), healthcare professionals must consider various factors and potential unexpected outcomes to ensure accurate readings and provide proper patient care. Adhering to these guidelines is essential to achieving the most reliable results.
Monitoring Both Arms:
Monitoring BP in both arms during the initial assessment is advisable, as the systolic value may differ by five to ten mm Hg between arms. For subsequent BP assessments, use the arm with the higher reading.
Monitoring Both Arms:
Monitoring BP in both arms during the initial assessment is advisable, as the systolic value may differ by five to ten mm Hg between arms. For subsequent BP assessments, use the arm with the higher reading.
01:10Pre-Procedural Guidelines for Assessing Blood Pressure
Accurate blood pressure assessment is crucial for diagnosing and managing various health conditions. To ensure the reliability of these measurements, healthcare professionals must adhere to standardized pre-procedural guidelines. These guidelines enhance patient safety and improve the overall quality of healthcare. The following steps are essential for obtaining accurate and consistent blood pressure readings, from using the appropriate tools to ensuring effective communication with the patient.
01:24Blood Pressure
The movement of blood in a human body, commonly referred to as blood flow, is determined by the volume of blood that traverses a certain section of the bodily system per unit time. It is the rhythmic contraction of the heart's ventricles that primarily instigates this movement. As the ventricles contract, blood is forced into the prominent arteries, which then flow from areas of greater pressure to lower pressure areas. This movement continues into smaller arteries and arterioles and...