Chronic monitoring of pulmonary artery pressure in patients with severe heart failure: multicentre experience of the monitoring Pulmonary Artery Pressure by Implantable device Responding to Ultrasonic Signal (PAPIRUS) II study
Chronic monitoring of pulmonary artery pressure in patients with severe heart failure: multicentre experience of the monitoring Pulmonary Artery Pressure by Implantable device Responding to Ultrasonic Signal (PAPIRUS) II study
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DOI：
10.1136/hrt.2008.153486
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发表时间：
2009-07-01
期刊：
影响因子：
5.7
通讯作者：
Rozenman, Y.
中科院分区：
文献类型：
--
作者：
Hoppe, U. C.;Vanderheyden, M.;Rozenman, Y.
目的：评估使用声学无线通信与直接测量肺动脉（PA）压力的植入物对慢性心力衰竭（CHF）患者进行家庭监测的可行性和安全性。设计：PAPIRUS（肺动脉压力通过植入式装置响应超声信号）II试验是一项前瞻性、多中心I期研究。患者：31名纽约心脏协会III-IV级CHF患者。干预：在右肺动脉（PA）中植入微型装置，对超声信号做出反应，从而能够无线记录完整的PA压力曲线。主要结局指标：主要终点是6个月时严重不良器械或除颤相关事件的发生率。次要终点包括测量PA压力的准确性，该系统的功能和在不同的postures.Results的压力读数的评价：这两个安全性终点均符合没有严重的不良事件相关的设备或植入。6个月时的压力描记与Millar导管同时获得的压力描记几乎相同。观察到PA舒张压的变化与姿势有关（站立比仰卧低6.4（SD 3.4）mmHg，p < 0.001）。共有4627个家庭测量成功地进行了23例患者使用简单的操作手持家庭单位的日常测量。每日监测的中位依从性为86%。结论：满足本研究预先规定的安全性目标，需要进行一项随机试验，以充分评估这种微型PA植入物在指导CHF长期管理中的家庭监测潜力。
Objective: To evaluate the feasibility and safety of home monitoring of chronic heart failure (CHF) patients using acoustic wireless communication with an implant directly measuring pulmonary artery (PA) pressures.Design: The PAPIRUS (Pulmonary Artery Pressure by Implantable device Responding to Ultrasonic Signal) II trial was a prospective, multicentre phase I study.Patients: 31 patients with CHF in New York Heart Association class III-IV.Interventions: Implantation of a miniature device in the right pulmonary artery (PA) responding to ultrasonic signal that enables wireless recording of a complete PA pressure curve.Main outcome measures: The primary end points were rates of serious adverse device- or implantation-related events at 6 months. Secondary end points included accuracy of the measured PA pressure, functionality of the system and evaluation of pressure readings at different postures.Results: The two safety end points were met with no serious adverse events related to the device or implantation. Pressure tracings at 6 months were almost identical to those obtained simultaneously by Millar catheter. Variations of PA diastolic pressure were observed in relation to posture (standing 6.4 (SD 3.4) mm Hg lower than supine, p < 0.001). A total of 4627 home measurements were successfully performed by 23 patients using a simple-to-operate hand-held home-unit for daily measurements. The median compliance with daily monitoring was 86%.Conclusions: Meeting the prespecified safety objective of this study warrants a randomised trial to fully evaluate the potential of home monitoring by this miniature PA implant in guiding long-term management in CHF.