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      Implantable devices for heart failure monitoring: the CardioMEMS™ system

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          Abstract

          Several devices have been developed for heart failure (HF) treatment and monitoring. Among device-based monitoring tools, CardioMEMS™ has received growing research attention. This document reflects the key points of an ESC consensus meeting on implantable devices for monitoring in HF, with a particular focus on CardioMEMS™.

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

          William T. Abraham, Philip B. Adamson, Robert Bourge … (2011)
          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. 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. 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). 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. CardioMEMS. Copyright © 2011 Elsevier Ltd. All rights reserved.
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            Sustained efficacy of pulmonary artery pressure to guide adjustment of chronic heart failure therapy: complete follow-up results from the CHAMPION randomised trial.

            William T. Abraham, Lynne W Stevenson, Robert Bourge … (2016)
            In the CHAMPION trial, significant reductions in admissions to hospital for heart failure were seen after 6 months of pulmonary artery pressure guided management compared with usual care. We examine the extended efficacy of this strategy over 18 months of randomised follow-up and the clinical effect of open access to pressure information for an additional 13 months in patients formerly in the control group.
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              Wireless pulmonary artery pressure monitoring guides management to reduce decompensation in heart failure with preserved ejection fraction.

              Philip B. Adamson, William T. Abraham, Robert Bourge … (2014)
              No treatment strategies have been demonstrated to be beneficial for the population for patients with heart failure (HF) and preserved ejection fraction (EF).
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                Author and article information

                Journal
                Journal ID (nlm-ta): Eur Heart J Suppl
                Journal ID (iso-abbrev): Eur Heart J Suppl
                Journal ID (publisher-id): ehjsupp
                Title: European Heart Journal Supplements : Journal of the European Society of Cardiology
                Publisher: Oxford University Press
                ISSN (Print): 1520-765X
                ISSN (Electronic): 1554-2815
                Publication date (Print): December 2019
                Publication date (Electronic): 31 December 2019
                Publication date PMC-release: 31 December 2019
                Volume: 21
                Issue: Suppl M , Physiological Monitoring of the Complex Multi-morbid Heart Failure Patient
                Pages: M50-M53
                Affiliations
                [1 ] Department of Medical Sciences, Centre for Clinical and Basic Research, IRCCS San Raffaele Pisana , via della Pisana, 235, 00163 Rome, Italy
                [2 ] Department of Medicine I, Cardiology and Comprehensive Heart Failure Center, University Hospital and University of Würzburg , Würzburg, Germany
                Author notes
                Corresponding author. Email: maurizio.volterrani@ 123456sanraffaele.it
                Article
                Publisher ID: suz265
                DOI: 10.1093/eurheartj/suz265
                PMC ID: 6937499
                SO-VID: cd4ba18c-4e2e-4f7a-9714-c4fc9843d962
                Copyright © Published on behalf of the European Society of Cardiology. © The Author(s) 2019.
                License:

                This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence ( http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited. For commercial re-use, please contact journals.permissions@oup.com

                History
                Page count
                Pages: 4
                Categories
                Subject: Articles

                Keywords: heart failure,implantable device,physiological monitoring,cardiomems™
                Data availability:
                Keywords: heart failure, implantable device, physiological monitoring, cardiomems™

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