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.
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Funding: Remon Medical Technologies, (Caesarea, Israel) now part of Boston Scientific (Natick, Massachusetts) funded the trial.
Competing interests: YR is a part-time employee of Remon Medical Technologies.
Ethics approval: Ethics approval was provided by University of Cologne, Cardiovascular Center Aust, Freiburger Ethik-Kommission International and Tel Aviv University.
Patient consent: Obtained.
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