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: PAPIRUS (Pulmonary Artery Pressure by Implantable device Responding to Ultrasonic Signal) II trial was a prospective, multicenter 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 2 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±3.4 mmHg 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. Median compliance with daily monitoring was 86%.
Conclusions: Meeting the pre-specified safety objective of this study warrants a randomized trial to fully evaluate the potential of home monitoring by this miniature PA implant in guiding long-term management in CHF.
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