PMID- 35686479
OWN - NLM
STAT- MEDLINE
DCOM- 20221209
LR  - 20221227
IS  - 2055-5822 (Electronic)
IS  - 2055-5822 (Linking)
VI  - 9
IP  - 5
DP  - 2022 Oct
TI  - Safety and efficacy of a wireless pulmonary artery pressure sensor: primary 
      endpoint results of the SIRONA 2 clinical trial.
PG  - 2862-2872
LID - 10.1002/ehf2.14006 [doi]
AB  - AIMS: Implantable pulmonary artery pressure (PAP) sensors have been shown to 
      reduce heart failure hospitalizations (HFH) in selected patients. The goal of 
      this study was to evaluate the safety and efficacy of a novel wireless PAP 
      monitoring system in patients with heart failure (HF). METHODS AND RESULTS: This 
      is a prospective, multi-centre, open-label, single-arm trial evaluating the 
      safety and efficacy of the Cordella PA Sensor System including the comprehensive 
      Cordella Heart Failure System (CHFS) in patients with New York Heart Association 
      (NYHA) Class III heart failure with a heart failure hospitalization and/or 
      increase of N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) within 12 months 
      of enrolment. The primary efficacy endpoint was the accuracy of PA sensor mean 
      PAP measurements, compared with fluid-filled catheter mean PAP measurements 
      obtained by standard right heart catheterization (RHC) at 90 days post-implant, 
      assessed in all patients with a successful implant. The primary safety endpoint 
      was freedom from adverse events associated with use of the Cordella PA Sensor 
      System through 30 days post-implant, assessed in all patients who entered the 
      cath lab for PA sensor implant. The PA sensor was successfully implanted in 70 
      patients. Equivalence between the PA sensor and RHC for mean pulmonary artery 
      pressures was excellent with measurements confined within the equivalence bounds 
      of -4.0 to 4.0 mmHg (mean PAP: 0.0 to 2.9 mmHg, P = 0.003). The device safety 
      profile was excellent with 98.6% freedom from Device System Related 
      Complications, defined as invasive treatment, device explant or death. There were 
      no pressure sensor failures. Patients' adherence to daily measurement 
      transmissions of PAP and vital signs was 94%. CONCLUSIONS: This trial supports 
      the safety and efficacy of the Cordella PA Sensor System and in conjunction with 
      the CHFS enables comprehensive HF management in NYHA class III heart failure 
      patients.
CI  - (c) 2022 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on 
      behalf of European Society of Cardiology.
FAU - Sharif, Faisal
AU  - Sharif F
AD  - Department of Cardiology, Galway University Hospital, Saolta Group, CURAM and 
      BioInnovate Ireland, National University of Ireland Galway, Galway, Ireland.
FAU - Rosenkranz, Stephen
AU  - Rosenkranz S
AD  - Clinic III for Internal Medicine, University of Cologne Heart Center and Cologne 
      Cardiovascular Research Center (CCRC), Cologne, Germany.
FAU - Bartunek, Jozef
AU  - Bartunek J
AD  - Cardiovascular Center Aalst, OLV Ziekenhuis Aalst, Aalst, Belgium.
FAU - Kempf, Tibor
AU  - Kempf T
AD  - Department of Cardiology and Angiology, Centre for Internal Medicine, Hannover 
      Medical School, Hannover, Germany.
FAU - Assmus, Birgit
AU  - Assmus B
AD  - Department of Cardiology and Angiology, University Hospital Giessen and Marburg 
      GmbH, Giessen, Germany.
FAU - Mahon, Niall G
AU  - Mahon NG
AD  - Department of Cardiovascular Medicine, Mater University Hospital and University 
      College Dublin, Dublin, Ireland.
FAU - Mullens, Wilfried
AU  - Mullens W
AD  - Department of Cardiovascular Medicine, Ziekenhuis Oost Limburg, University 
      Hasselt, Genk, Belgium.
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
DEP - 20220610
PL  - England
TA  - ESC Heart Fail
JT  - ESC heart failure
JID - 101669191
SB  - IM
MH  - Humans
MH  - Cardiac Catheterization
MH  - *Heart Failure/diagnosis/therapy
MH  - Monitoring, Physiologic
MH  - Prospective Studies
MH  - *Pulmonary Artery
PMC - PMC9715805
OTO - NOTNLM
OT  - GDMT
OT  - Heart failure
OT  - Pulmonary artery pressure
OT  - Remote patient monitoring
EDAT- 2022/06/11 06:00
MHDA- 2022/12/06 06:00
PMCR- 2022/06/10
CRDT- 2022/06/10 04:13
PHST- 2022/05/11 00:00 [received]
PHST- 2022/05/19 00:00 [accepted]
PHST- 2022/06/11 06:00 [pubmed]
PHST- 2022/12/06 06:00 [medline]
PHST- 2022/06/10 04:13 [entrez]
PHST- 2022/06/10 00:00 [pmc-release]
AID - EHF214006 [pii]
AID - 10.1002/ehf2.14006 [doi]
PST - ppublish
SO  - ESC Heart Fail. 2022 Oct;9(5):2862-2872. doi: 10.1002/ehf2.14006. Epub 2022 Jun 
      10.