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Chronic monitoring of pulmonary artery pressure in patients with severe heart failure: Multicenter experience of the monitoring Pulmonary Artery Pressure by Implantable device Responding to Ultrasonic Signal (PAPIRUS) II Study
  1. Uta C Hoppe (uta.hoppe{at}uni-koeln.de)
  1. University of Cologne, Germany
    1. Marc Venderheyden (marc.vanderheyden{at}aalst.be)
    1. Cardiovascular Center Aalst, Belgium
      1. Horst Sievert (h.sievert{at}cardio.de)
      1. Cardiovascular center Frankfurt, Germany
        1. Mathias C Brandt (m.brandt{at}uk-koeln.de)
        1. University of Cologne, Germany
          1. Ricardo Tobar (r.tobar{at}wolfson.health.gov.il)
          1. Tel-Aviv University, Israel
            1. William Wijns (w.wijns{at}aalst.be)
            1. Cardiovascular Center Aalst, Belgium
              1. Yoseph Rozenman (y.rozenman{at}wolfson.health.gov.il)
              1. Tel-Aviv University, Israel

                Abstract

                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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