基于导管和基于支架的分娩右心室隔膜节奏的中期结果:多中心,前性,随机研究的后续结果
Naoki Tsurumi1,2, Yoshihisa Naruse3, Nobutake Kurebayashi1
1Department of Cardiology Chutoen General Medical Center Kakegawa Shizuoka Japan.
Journal of arrhythmia
|June 28, 2024
概括
富士山FUJI研究发现,用于右心室导管放置的输送导管和 stylet 系统在一年内显示出类似的安全性和有效性. 导管组的QRS持续时间节奏明显较短,这表明对心脏功能有潜在的益处.
科学领域:
- 心脏病学 心脏病学
- 医疗器械 医疗器械
- 临床试验 临床试验
背景情况:
- Mt FUJI研究是一项多中心,前性,随机,单盲,受控试验.
- 它比较了以导管为基础的输送与以风笔为基础的右心室 (RV) 在RV隔膜上的置.
- 这种分析将随访时间延长到植入后的一年.
研究的目的:
- 为了比较交付导管式和支架式RV放置的中期疗效和安全性.
- 为了评估左心室喷射分数 (LVEF),脑内尿素 (BNP) 水平,参数和步调QRS持续时间在一年内发生的变化.
- 评估两种置方法之间的不良事件发生率.
主要方法:
- 七十名患有心脏起器迹象的患者被随机分为两个组:输送导管和支架.
- 主要结果:一年后LVEF的变化.
- 二次结果:BNP的变化,参数,节奏QRS持续时间和不良事件率.
主要成果:
- 两组之间没有观察到LVEF变化 (+1.0% vs. +3.1%,p=.332) 或BNP水平 (+8.0 vs. -8.7 pg/mL,p=.193) 的显著差异.
- 输送导管和风笔组之间的性能是可比的.
- 输送导管组的QRS持续时间节奏显著缩短 (128±23毫秒对146±17毫秒,p<.001).
- 不良事件 (全因死亡,HF住院,AF,节奏诱导心肌病变) 在导管组的7名患者和5名风笔组患者中发生.
结论:
- 在中期随访时,输送导管系统与 stylet 系统相比,表现出类似的有用性和安全性.
- 导管组QRS持续时间显著缩短,需要进一步调查.
- 长期评估是必要的,以充分确定每个方法的好处和风险.
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