在慢性心力衰竭中无线肺动脉血动监测:一个随机对照试验
William T Abraham1, Philip B Adamson, Robert C Bourge
1Ohio State University Heart and Vascular Center, Columbus, OH, USA.
Lancet (London, England)
|February 15, 2011
概括
可植入的血液动力学监测显著减少了心力衰竭住院. 这种无线系统测量肺动脉压力,改善了NYHA III类心力衰竭患者的管理.
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:
- 以前的研究表明,可植入的血液动力学监测系统可以降低心力衰竭患者的住院率.
- 这项研究旨在在临床试验环境中严格评估这种系统的疗效.
研究的目的:
- 评估无线植入式血液动力学监测 (W-IHM) 系统在减少心力衰竭相关住院治疗的有效性.
- 评估W-IHM系统的安全性,包括与设备相关的并发症和传感器故障.
主要方法:
- 一个单盲试验招募了550名在64个美国中心的NYHAIII级心力衰竭患者.
- 患者被随机分配到W-IHM系统组或对照组至少6个月.
- 治疗组每天接受肺动脉压力测量,而对照组接受标准护理.
主要成果:
- 在W-IHM组经历了显著减少心力衰竭住院6个月 (0.31对0.44每病人的年,HR0.70,p<0.0001).
- 在平均15个月的随访期间,治疗组的心力衰竭住院病例减少了39% (HR 0.64,p<0.0001).
- W-IHM系统显示出高安全性,98.6%免受设备相关并发症和100%免受传感器故障.
结论:
- 该研究明确表明,W-IHM系统显著减少了NYHAIII类心力衰竭患者的住院治疗.
- 将肺动脉压力数据与临床评估相结合,可以改善心力衰竭管理和患者的治疗结果.
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