ArticlesWireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomised controlled trial
Introduction
Despite current treatments, rates of hospital admissions for heart failure have improved little during the past three decades.1 In the USA, between 1996 and 2006, hospital discharges for heart failure rose from 877 000 to 1 106 000.2 Among beneficiaries of Medicare, 27% of discharged patients with heart failure were readmitted to hospital within 30 days.3 More than half the US$39·2 billion yearly direct cost of care for heart failure in the USA is attributable to the cost of treatment in hospital.2 The estimated average cost of the final 2 years of life for patients with heart failure is greater than $156 000, with more than 75% attributable to hospital admission for heart failure during the last 6 months of life.4 Improvements in outpatient management of patients with chronic heart failure are needed to address the increasing burden of worsening heart failure that requires admission to hospital.
Patients are usually admitted to hospital for heart failure because of worsening signs and symptoms of congestion.5 Previous investigations have shown that increases in intracardiac and pulmonary artery pressures are the cause of this clinical congestion and are apparent several days to weeks before the onset of worsening signs, symptoms, and hospital admission,6, 7 suggesting that early intervention targeting these pressures might reduce the risk of admission to hospital. In a clinical trial,8 increases in intracardiac pressures often arose independently of weight changes, such that monitoring of weight alone was inadequate to identify congestion in time to avert the events associated with heart failure. This finding might account for why telemonitoring systems that rely on patient-reported assessment of general health, symptoms of heart failure, and daily weight change have not reduced readmission or mortality rates.9
Implantable systems for chronic monitoring of intracardiac and pulmonary artery pressures have been developed.10, 11, 12, 13, 14, 15 Preliminary findings with the use of these systems suggest a reduction in hospital admissions for heart failure. The hypothesis in the present study, the CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients (CHAMPION) trial, was that management of heart failure by use of pulmonary artery pressures would greatly reduce the rate of heart-failure-related hospitalisation.
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Patients
Patients (aged ≥18 years) were eligible for participation in the CHAMPION study if they had moderate (New York Heart Association [NYHA] functional class III) heart failure for at least 3 months, irrespective of left ventricular ejection fraction or cause, and a hospitalisation for heart failure within the past 12 months. Patients had to be given drug and device treatments for heart failure at optimum or best-tolerated stable doses, according to national guidelines.16 Exclusion criteria included
Results
Between Sept 6, 2007, and Oct 7, 2009, 550 patients were randomly assigned to the treatment (n=270) and control groups (n=280). Figure 2 shows the trial profile. All patients remained in their assigned group until the last patient completed 6 months of follow-up. The mean follow-up was 15 months (SD 7, total duration 250 176 patient days). The groups were similar with respect to baseline characteristics (table 1). All analyses were undertaken on patients in their original assignment groups.
Both
Discussion
W-IHM is safe and significantly reduces the risk of heart-failure-related hospitalisation in patients with NYHA functional class III heart failure. The 6-month risk of heart-failure-related hospital admission was 30% lower in the W-IHM group, managed with daily measurement of pulmonary artery pressures plus standard of care, than in the control group, managed according to standard-of-care monitoring of heart failure alone. This reduction in risk lasted the entire period of the randomised
References (29)
- et al.
The cost of medical management in advanced heart failure during the final two years of life
J Card Fail
(2008) - et al.
Characteristics and outcomes of patients hospitalized for heart failure in the United States: rationale, design, and preliminary observations from the first 100,000 cases in the Acute Decompensated Heart Failure National Registry (ADHERE)
Am Heart J
(2005) - et al.
Randomized controlled trial of an implantable continuous hemodynamic monitor in patients with advanced heart failure: the COMPASS-HF Study
J Am Coll Cardiol
(2008) - et al.
Continuous ambulatory right heart pressure measurements with an implantable hemodynamic monitor: a multicenter, 12-month follow-up study of patients with chronic heart failure
J Card Fail
(2002) - et al.
Comparison of a radiofrequency-based wireless pressure sensor to Swan-Ganz catheter and echocardiography for ambulatory assessment of pulmonary artery pressure in heart failure
J Am Coll Cardiol
(2007) - et al.
A wireless pressure sensor for monitoring pulmonary artery pressure in advanced heart failure: initial experience
J Heart Lung Transplant
(2007) - et al.
Ongoing right ventricular hemodynamics in heart failure: clinical value of measurements derived from an implantable monitoring system
J Am Coll Cardiol
(2003) - et al.
American College of Cardiology Foundation/American Heart Association 2009 focused update incorporated into the ACC/AHA 2005 guidelines for the diagnosis and management of heart failure in adults: a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines developed in collaboration with the International Society for Heart and Lung Transplantation
J Am Coll Cardiol
(2009) - et al.
CHAMPION trial rationale and design: the long-term safety and clinical efficacy of a wireless pulmonary artery pressure monitoring system
J Card Fail
(2011) - et al.
Current evidence supporting the role of diuretics in heart failure: a meta analysis of randomised controlled trials
Int J Cardiol
(2002)
Multidisciplinary strategies for the management of heart failure patients at high risk for admission: a systematic review of randomized trials
J Am Coll Cardiol
Comparison of carvedilol and metoprolol on clinical outcomes in patients with chronic heart failure in the Carvedilol Or Metoprolol European Trial (COMET): randomised controlled trial
Lancet
Recent national trends in readmission rates after heart failure hospitalization
Circ Heart Fail
Heart disease and stroke statistics 2010 update: a report from the American Heart Association
Circulation
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