心力衰竭患者无线肺动脉压监测系统的安全性和准确性。

Safety and accuracy of a wireless pulmonary artery pressure monitoring system in patients with heart failure.

机构信息

The Ohio State University Heart Center, Columbus, USA.

出版信息

Am Heart J. 2011 Mar;161(3):558-66. doi: 10.1016/j.ahj.2010.10.041. Epub 2011 Jan 31.

DOI:10.1016/j.ahj.2010.10.041

PMID:21392612

Abstract

BACKGROUND

Implantable hemodynamic monitoring to guide heart failure (HF) therapy is a promising area of active research. The goal of this investigation was to evaluate the safety and technical performance of a novel wireless pulmonary artery pressure monitoring system in 17 patients with symptomatic HF.

METHODS

The monitoring system consists of a sensor, delivery catheter, interrogator, and home monitoring device. The HF sensor was implanted into a distal branch of the pulmonary artery. Pulmonary artery pressures were monitored using the external device, which powers the HF sensor and transmits the hemodynamic data from the patient's home to a secure Internet database. The accuracy of the system was assessed by comparison with standard right heart catheterization (RHC).

RESULTS

The HF sensor was safely and successfully implanted in all patients. Agreement between the HF sensor and RHC for systolic, diastolic, and mean pulmonary artery pressures was excellent, with correlation coefficients of 0.94, 0.85, and 0.95, respectively (all P < .0001). Using Bland-Altman plots, the average differences for systolic, diastolic, and mean pulmonary artery pressures for the HF sensor vs RHC were -4.4 ± 0.3, 2.5 ± 1.0, and -0.8 ± 1.3 mm Hg, respectively. There were no serious device-related adverse events. A postmortem analysis of the HF sensor in a patient who died 12 months after implant demonstrated complete endothelialization and no evidence of thrombosis.

CONCLUSIONS

This trial supports the safety and accuracy of this pulmonary artery pressure monitoring system in patients with HF and the conduct of randomized trials of implantable hemodynamic monitoring in HF, using this system.

摘要

背景

植入式血流动力学监测以指导心力衰竭（HF）治疗是一个活跃的研究领域。本研究的目的是评估一种新型无线肺动脉压力监测系统在 17 例有症状 HF 患者中的安全性和技术性能。

方法

监测系统由传感器、输送导管、询问器和家庭监测设备组成。HF 传感器植入肺动脉的远端分支。使用外部设备监测肺动脉压力，该设备为 HF 传感器供电，并将患者家中的血流动力学数据传输到安全的互联网数据库。通过与标准右心导管检查（RHC）比较来评估系统的准确性。

结果

所有患者均安全、成功地植入了 HF 传感器。HF 传感器与 RHC 之间的收缩压、舒张压和平均肺动脉压力的一致性非常好，相关系数分别为 0.94、0.85 和 0.95（均 P<0.0001）。使用 Bland-Altman 图，HF 传感器与 RHC 相比收缩压、舒张压和平均肺动脉压力的平均差值分别为-4.4±0.3、2.5±1.0 和-0.8±1.3mmHg。没有严重的与器械相关的不良事件。在植入后 12 个月死亡的患者中对 HF 传感器进行的死后分析显示完全内皮化，没有血栓形成的证据。