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      Cost-Effectiveness of Remote Cardiac Monitoring With the CardioMEMS Heart Failure System : Cost-effectiveness of CardioMEMS

      1 , 2 , 3
      Clinical Cardiology
      Wiley

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          Abstract

          <p class="first" id="clc22696-para-0001">Heart failure ( <span style="fixed-case">HF</span>) is a leading cause of cardiovascular mortality in the United States and presents a substantial economic burden. A recently approved implantable wireless pulmonary artery pressure remote monitor, the <span style="fixed-case">CardioMEMS HF</span> System, has been shown to be effective in reducing hospitalizations among New York Heart Association ( <span style="fixed-case">NYHA</span>) class <span style="fixed-case">III HF</span> patients. The objective of this study was to estimate the cost‐effectiveness of this remote monitoring technology compared to standard of care treatment for <span style="fixed-case">HF</span>. A Markov cohort model relying on the <span style="fixed-case">CHAMPION</span> ( <span style="fixed-case">CardioMEMS</span> Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in <span style="fixed-case">NYHA</span> Class <span style="fixed-case">III</span> Heart Failure Patients) clinical trial for mortality and hospitalization data, published sources for cost data, and a mix of <span style="fixed-case">CHAMPION</span> data and published sources for utility data, was developed. The model compares outcomes over 5 years for implanted vs standard of care patients, allowing patients to accrue costs and utilities while they remain alive. Sensitivity analyses explored uncertainty in input parameters. The <span style="fixed-case">CardioMEMS HF</span> System was found to be cost‐effective, with an incremental cost‐effectiveness ratio of $44,832 per quality‐adjusted life year ( <span style="fixed-case">QALY</span>). Sensitivity analysis found the model was sensitive to the device cost and to whether mortality benefits were sustained, although there were no scenarios in which the cost/ <span style="fixed-case">QALY</span> exceeded $100,000. Compared with standard of care, the <span style="fixed-case">CardioMEMS HF</span> System was cost‐effective when leveraging trial data to populate the model. </p>

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          Most cited references26

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

          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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            Effectiveness of Remote Patient Monitoring After Discharge of Hospitalized Patients With Heart Failure: The Better Effectiveness After Transition -- Heart Failure (BEAT-HF) Randomized Clinical Trial.

            It remains unclear whether telemonitoring approaches provide benefits for patients with heart failure (HF) after hospitalization.
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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.

              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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                Author and article information

                Journal
                Clinical Cardiology
                Clin Cardiol
                Wiley
                01609289
                July 2017
                July 2017
                March 08 2017
                : 40
                : 7
                : 430-436
                Affiliations
                [1 ]Department of Health Sciences Exponent; Alexandria Virginia
                [2 ]Department of Biomedical Engineering, Exponent; Philadelphia Pennsylvania
                [3 ]Division of Cardiology, Department of Medicine, Ronald Reagan UCLA Medical Center; Los Angeles California
                Article
                10.1002/clc.22696
                6490396
                28272808
                c6b55062-78ff-4634-b728-08a1c83f61f8
                © 2017

                http://doi.wiley.com/10.1002/tdm_license_1.1

                http://onlinelibrary.wiley.com/termsAndConditions

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