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.


METHODS
The PAPIRUS (Pulmonary Artery Pressure by Implantable device Responding to Ultrasonic Signal) II trial was a prospective, multicentre phase I study.


METHODS
31 patients with CHF in New York Heart Association class III-IV.


METHODS
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.


METHODS
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.
Hoppe
U C
UC
Department of Internal Medicine III, University of Cologne, Kerpener Str. 62, Cologne 50937, Germany. uta.hoppe@uni-koeln.de
Vanderheyden
M
M
Sievert
H
H
Brandt
M C
MC
Tobar
R
R
Wijns
W
W
Rozenman
Y
Y
D000368:Aged; D000369:Aged, 80 and over; D001794:Blood Pressure / Q000502:physiology; D018660:Blood Pressure Monitoring, Ambulatory / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D004867:Equipment Design; D005240:Feasibility Studies; D005260:Female; D006333:Heart Failure / Q000503:physiopathology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D011187:Posture / Q000502:physiology; D011651:Pulmonary Artery / Q000503:physiopathology*; D013686:Telemetry / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods