Cited by 1,744Heart Failure Treatment and ManagementCardiac pacing and defibrillation studiesMechanical Circulatory Support Devices

Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomised controlled trial

Abraham, William T, Adamson, Philip B, Bourge, Robert C, Aaron, Mark F, Costanzo, Maria Rosa, Stevenson, Lynne W, Strickland, Warren, Neelagaru, Suresh +6 more·2011·The Lancet

Abstract

Background Results of previous studies support the hypothesis that implantable haemodynamic monitoring systems might reduce rates of hospitalisation in patients with heart failure. We undertook a single-blind trial to assess this approach.Methods Patients with New York Heart Association (NYHA) class III heart failure, irrespective of the left ventricular ejection fraction, and a previous hospital admission for heart failure were enrolled in 64 centres in the USA. They were randomly assigned by use of a centralised electronic system to management with a wireless implantable haemodynamic monitoring (W-IHM) system (treatment group) or to a control group for at least 6 months. Only patients were masked to their assignment group. In the treatment group, clinicians used daily measurement of pulmonary artery pressures in addition to standard of care versus standard of care alone in the control group. The primary efficacy endpoint was the rate of heart-failure-related hospitalisations at 6 months. The safety endpoints assessed at 6 months were freedom from device-related or system-related complications (DSRC) and freedom from pressure-sensor failures. All analyses were by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00531661.Findings In 6 months, 83 heart-failure-related hospitalisations were reported in the treatment group (n=270) compared with 120 in the control group (n=280; rate 0·31 vs 0·44, hazard ratio [HR] 0·70, 95% CI 0·60-0·84, p<0·0001). During the entire follow-up (mean 15 months [SD 7]), the treatment group had a 39% reduction in heart-failure-related hospitalisation compared with the control group (153 vs 253, HR 0·64, 95% CI 0·55-0·75; p<0·0001). Eight patients had DSRC and overall freedom from DSRC was 98·6% (97·3-99·4) compared with a prespecified performance criterion of 80% (p<0·0001); and overall freedom from pressure-sensor failures was 100% (99·3-100·0).Interpretation Our results are consistent with, and extend, previous findings by definitively showing a significant and large reduction in hospitalisation for patients with NYHA class III heart failure who were managed with a wireless implantable haemodynamic monitoring system. The addition of information about pulmonary artery pressure to clinical signs and symptoms allows for improved heart failure management.Funding CardioMEMS.

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Crossref · 10.1016/s0140-6736(11)60101-3

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Authors
Abraham, W. T., Adamson, P. B., Bourge, R. C., Aaron, M. F., Costanzo, M. R., Stevenson, L. W., Strickland, W., Neelagaru, S., Raval, N., Krueger, S., Weiner, S., Shavelle, D., Jeffries, B., & Yadav, J. S.
Affiliations
  • The Ohio State University Wexner Medical Center (US)
  • Oklahoma Heart Hospital (US)
  • University of Alabama at Birmingham (US)
  • Brigham and Women's Hospital (US)
  • Huntsville Hospital (US)
  • Piedmont Atlanta Hospital (US)
  • Bryan Health (US)
  • University of Southern California (US)
Corresponding author
Abraham, William T
Venue
The Lancet
Publisher
Elsevier BV
Published
2011-02
Volume
377
Issue
9766
Pages
658-666
ISSN
  • 0099-5355 (ISSN-L)
  • 0140-6736
OpenAlex
W2102814494
Cited by
1,744
References
35
Citations by year
2026: 85 · 2025: 128 · 2024: 155 · 2023: 137 · 2022: 133 · 2021: 152 · 2020: 133 · 2019: 127 · 2018: 108 · 2017: 146 · 2016: 105 · 2015: 91 · 2014: 56 · 2013: 77 · 2012: 69
FWCI
52.38
Type
journal article
Language
en
Update notices
erratum (2012-02-04)
Open access
closed
Locations
  • The Lancet (publishedVersion)
  • PubMed (publishedVersion)
Funders
Medical Research Council
Topics
  • Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Heart Failure Treatment and Management
  • Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac pacing and defibrillation studies
  • Physical Sciences › Engineering › Biomedical Engineering › Mechanical Circulatory Support Devices
Keywords
chronic heart failure, pulmonary artery pressure, heart failure hospitalization, NYHA class III heart failure, device safety, cardiac implantable electronic devices, remote monitoring, hospital readmission prevention, device complications, left ventricular ejection fraction, heart failure with reduced ejection fraction, heart failure with preserved ejection fraction
MeSH terms
Aged, Electrodes, Implanted, Equipment Design, Follow-Up Studies, Cardiac Catheterization, Heart Failure, Hemodynamics, Hospitalization, Humans, Middle Aged, Pulmonary Artery, Pulmonary Wedge Pressure, Single-Blind Method, Blood Pressure Monitoring, Ambulatory, Equipment Failure Analysis, Lab-On-A-Chip Devices, Remote Sensing Technology

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