Clinical Investigation
Congestive Heart Failure
Safety and accuracy of a wireless pulmonary artery pressure monitoring system in patients with heart failure

https://doi.org/10.1016/j.ahj.2010.10.041Get rights and content

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.

Section snippets

System description

The pulmonary artery pressure monitoring system (CardioMEMS Inc, Atlanta, GA) consists of the implantable HF sensor, a delivery catheter, an electronic monitoring unit that contains a barometer to account for ambient atmospheric pressure changes, and a secure Internet database that stores patient hemodynamic data and makes it available to the clinician. The HF sensor is a hermetically sealed circuit encapsulated in fused silica and silicone that has been described previously in detail.9, 10 It

Demographics

Seventeen patients provided informed consent and were enrolled at 5 centers. Of the 17 subjects, there were 14 men; there were 15 whites and 2 African Americans. The mean age of the cohort was 61 years (range 44-86 years). As required, all subjects had NYHA class III HF at the time of implantation. Eleven patients had preexisting implanted cardioverter/defibrillator (ICD) or cardiac resynchronization therapy devices in place.

Procedural and late outcomes

The HF sensor was successfully implanted, and correct readings, as

Discussion

This investigational study demonstrates the safety, feasibility, and accuracy of wireless transmission of pulmonary artery pressures in the routine home care setting using a new hemodynamic monitoring system. The CardioMEMS HF sensor uses novel wireless technology that is currently Food and Drug Administration approved for measuring abdominal and thoracic aortic aneurysm sac pressures and has been used in approximately 7,000 patients.11, 12 The technology uses no internal battery source, which

Conclusion

This trial establishes the CardioMEMS Pulmonary Artery Pressure Monitoring System to be a safe and accurate method for the remote hemodynamic monitoring of patients with HF. There were no adverse device events related to the HF sensor or implant procedure. The HF sensor measurements showed a high degree of agreement with SG catheter measurements, and patients were easily able to use the electronic monitoring unit to transmit daily pressure readings to the database. The safety and clinical

Disclosures

Drs Abraham, Adamson, Hasan, Bourge, Pamboukian, Aaron, and Raval have received research grants and/or consulting fees from CardioMEMS, Inc (Atlanta, GA). This study was funded by CardioMEMS, Inc.

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