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.

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.