Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomised controlled trial
Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomised controlled trial
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DOI：
10.1016/s0140-6736(11)60101-3
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发表时间：
2011-02-19
期刊：
影响因子：
168.9
通讯作者：
Yadav, Jay S.
中科院分区：
文献类型：
--
作者：
Abraham, William T.;Adamson, Philip B.;Yadav, Jay S.
背景 先前的研究结果支持这样的假设：植入式血流动力学监测系统可能会降低心力衰竭患者的住院率。我们进行了一项单盲试验来评估这种方法。方法在美国 64 个中心招募了患有纽约心脏协会 (NYHA) III 级心力衰竭的患者，无论左心室射血分数如何，并且之前因心力衰竭入院。通过使用中央电子系统将他们随机分配到无线植入式血流动力学监测 (W-IHM) 系统的管理组（治疗组）或对照组，为期至少 6 个月。只有患者对他们的分配组不知情。在治疗组中，临床医生除了标准护理外还每日测量肺动脉压力，而对照组仅使用标准护理。主要疗效终点是 6 个月时因心力衰竭相关的住院率。 6 个月时评估的安全终点是无设备相关或系统相关并发症 (DSRC) 以及无压力传感器故障。所有分析均按意向治疗进行。该试验已在 ClinicalTrials.gov 注册，编号为 NCT00531661。 结果 6 个月内，治疗组报告了 83 例因心力衰竭相关的住院治疗 (n=270)，而对照组报告了 120 例（n=280；比率 0.31 vs 0-44，风险比 [HR] 0.70，95% CI 0.60-0.84，p
Background Results of previous studies support the hypothesis that implantable haemodynamic monitoring systems might reduce rates of hospitalisation in patients with heart failure. We undertook a single-blind trial to assess this approach.Methods Patients with New York Heart Association (NYHA) class III heart failure, irrespective of the left ventricular ejection fraction, and a previous hospital admission for heart failure were enrolled in 64 centres in the USA. They were randomly assigned by use of a centralised electronic system to management with a wireless implantable haemodynamic monitoring (W-IHM) system (treatment group) or to a control group for at least 6 months. Only patients were masked to their assignment group. In the treatment group, clinicians used daily measurement of pulmonary artery pressures in addition to standard of care versus standard of care alone in the control group. The primary efficacy endpoint was the rate of heart-failure-related hospitalisations at 6 months. The safety endpoints assessed at 6 months were freedom from device-related or system-related complications (DSRC) and freedom from pressure-sensor failures. All analyses were by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00531661.Findings In 6 months, 83 heart-failure-related hospitalisations were reported in the treatment group (n=270) compared with 120 in the control group (n=280; rate 0.31 vs 0-44, hazard ratio [HR] 0.70, 95% CI 0.60-0.84, p