Wireless Pulmonary Artery Pressure Monitoring Guides Management to Reduce Decompensation in Heart Failure With Preserved Ejection Fraction
No treatment strategies have been demonstrated to be beneficial for the population for patients with heart failure (HF) and preserved ejection fraction (EF). The CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients (CHAMPION) trial was a...
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| Published in | Circulation. Heart failure Vol. 7; no. 6; pp. 935 - 944 |
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| Main Authors | , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
United States
01.11.2014
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| Subjects | |
| Online Access | Get full text |
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| Abstract | No treatment strategies have been demonstrated to be beneficial for the population for patients with heart failure (HF) and preserved ejection fraction (EF).
The CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients (CHAMPION) trial was a prospective, single-blinded, randomized controlled clinical trial testing the hypothesis that hemodynamically guided HF management decreases decompensation leading to hospitalization. Of the 550 patients enrolled in the study, 119 had left ventricular EF ≥40% (average, 50.6%), 430 patients had low left ventricular EF (<40%; average, 23.3%), and 1 patient had no documented left ventricular EF. A microelectromechanical system pressure sensor was permanently implanted in all participants during right heart catheterization. After implant, subjects were randomly assigned in single-blind fashion to a treatment group in whom daily uploaded pressures were used in a treatment strategy for HF management or to a control group in whom standard HF management included weight-monitoring, and pressures were uploaded but not available for investigator use. The primary efficacy end point of HF hospitalization rate >6 months for preserved EF patients was 46% lower in the treatment group compared with control (incidence rate ratio, 0.54; 95% confidence interval, 0.38-0.70; P<0.0001). After an average of 17.6 months of blinded follow-up, the hospitalization rate was 50% lower (incidence rate ratio, 0.50; 95% confidence interval, 0.35-0.70; P<0.0001). In response to pulmonary artery pressure information, more changes in diuretic and vasodilator therapies were made in the treatment group.
Hemodynamically guided management of patients with HF with preserved EF reduced decompensation leading to hospitalization compared with standard HF management strategies.
http://www.clinicaltrials.gov. Unique identifier: NCT00531661. |
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| AbstractList | No treatment strategies have been demonstrated to be beneficial for the population for patients with heart failure (HF) and preserved ejection fraction (EF).BACKGROUNDNo treatment strategies have been demonstrated to be beneficial for the population for patients with heart failure (HF) and preserved ejection fraction (EF).The CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients (CHAMPION) trial was a prospective, single-blinded, randomized controlled clinical trial testing the hypothesis that hemodynamically guided HF management decreases decompensation leading to hospitalization. Of the 550 patients enrolled in the study, 119 had left ventricular EF ≥40% (average, 50.6%), 430 patients had low left ventricular EF (<40%; average, 23.3%), and 1 patient had no documented left ventricular EF. A microelectromechanical system pressure sensor was permanently implanted in all participants during right heart catheterization. After implant, subjects were randomly assigned in single-blind fashion to a treatment group in whom daily uploaded pressures were used in a treatment strategy for HF management or to a control group in whom standard HF management included weight-monitoring, and pressures were uploaded but not available for investigator use. The primary efficacy end point of HF hospitalization rate >6 months for preserved EF patients was 46% lower in the treatment group compared with control (incidence rate ratio, 0.54; 95% confidence interval, 0.38-0.70; P<0.0001). After an average of 17.6 months of blinded follow-up, the hospitalization rate was 50% lower (incidence rate ratio, 0.50; 95% confidence interval, 0.35-0.70; P<0.0001). In response to pulmonary artery pressure information, more changes in diuretic and vasodilator therapies were made in the treatment group.METHODS AND RESULTSThe CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients (CHAMPION) trial was a prospective, single-blinded, randomized controlled clinical trial testing the hypothesis that hemodynamically guided HF management decreases decompensation leading to hospitalization. Of the 550 patients enrolled in the study, 119 had left ventricular EF ≥40% (average, 50.6%), 430 patients had low left ventricular EF (<40%; average, 23.3%), and 1 patient had no documented left ventricular EF. A microelectromechanical system pressure sensor was permanently implanted in all participants during right heart catheterization. After implant, subjects were randomly assigned in single-blind fashion to a treatment group in whom daily uploaded pressures were used in a treatment strategy for HF management or to a control group in whom standard HF management included weight-monitoring, and pressures were uploaded but not available for investigator use. The primary efficacy end point of HF hospitalization rate >6 months for preserved EF patients was 46% lower in the treatment group compared with control (incidence rate ratio, 0.54; 95% confidence interval, 0.38-0.70; P<0.0001). After an average of 17.6 months of blinded follow-up, the hospitalization rate was 50% lower (incidence rate ratio, 0.50; 95% confidence interval, 0.35-0.70; P<0.0001). In response to pulmonary artery pressure information, more changes in diuretic and vasodilator therapies were made in the treatment group.Hemodynamically guided management of patients with HF with preserved EF reduced decompensation leading to hospitalization compared with standard HF management strategies.CONCLUSIONSHemodynamically guided management of patients with HF with preserved EF reduced decompensation leading to hospitalization compared with standard HF management strategies.http://www.clinicaltrials.gov. Unique identifier: NCT00531661.CLINICAL TRIAL REGISTRATION URLhttp://www.clinicaltrials.gov. Unique identifier: NCT00531661. No treatment strategies have been demonstrated to be beneficial for the population for patients with heart failure (HF) and preserved ejection fraction (EF). The CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients (CHAMPION) trial was a prospective, single-blinded, randomized controlled clinical trial testing the hypothesis that hemodynamically guided HF management decreases decompensation leading to hospitalization. Of the 550 patients enrolled in the study, 119 had left ventricular EF ≥40% (average, 50.6%), 430 patients had low left ventricular EF (<40%; average, 23.3%), and 1 patient had no documented left ventricular EF. A microelectromechanical system pressure sensor was permanently implanted in all participants during right heart catheterization. After implant, subjects were randomly assigned in single-blind fashion to a treatment group in whom daily uploaded pressures were used in a treatment strategy for HF management or to a control group in whom standard HF management included weight-monitoring, and pressures were uploaded but not available for investigator use. The primary efficacy end point of HF hospitalization rate >6 months for preserved EF patients was 46% lower in the treatment group compared with control (incidence rate ratio, 0.54; 95% confidence interval, 0.38-0.70; P<0.0001). After an average of 17.6 months of blinded follow-up, the hospitalization rate was 50% lower (incidence rate ratio, 0.50; 95% confidence interval, 0.35-0.70; P<0.0001). In response to pulmonary artery pressure information, more changes in diuretic and vasodilator therapies were made in the treatment group. Hemodynamically guided management of patients with HF with preserved EF reduced decompensation leading to hospitalization compared with standard HF management strategies. http://www.clinicaltrials.gov. Unique identifier: NCT00531661. |
| Author | Stevenson, Lynne Warner Yadav, Chethan Adamson, Philip B. Abraham, William T. Cowart, Pam Hasan, Ayesha Bourge, Robert C. Costanzo, Maria Rosa Henderson, John |
| Author_xml | – sequence: 1 givenname: Philip B. surname: Adamson fullname: Adamson, Philip B. organization: From the Heart Failure Institute, Oklahoma Heart Hospital, Department of Physiology, University of Oklahoma Health Sciences Center, Oklahoma City (P.B.A.); Division of Cardiovascular Medicine, Department of Internal Medicine, The Ohio State University, Columbus (W.T.A., A.H.); Department of Medicine, University of Alabama at Birmingham (R.C.B.); Advocate Medical Group-Midwest Heart Specialists Heart Failure and Pulmonary Arterial Hypertension Programs, Edward Hospital Center for Advanced Heart – sequence: 2 givenname: William T. surname: Abraham fullname: Abraham, William T. organization: From the Heart Failure Institute, Oklahoma Heart Hospital, Department of Physiology, University of Oklahoma Health Sciences Center, Oklahoma City (P.B.A.); Division of Cardiovascular Medicine, Department of Internal Medicine, The Ohio State University, Columbus (W.T.A., A.H.); Department of Medicine, University of Alabama at Birmingham (R.C.B.); Advocate Medical Group-Midwest Heart Specialists Heart Failure and Pulmonary Arterial Hypertension Programs, Edward Hospital Center for Advanced Heart – sequence: 3 givenname: Robert C. surname: Bourge fullname: Bourge, Robert C. organization: From the Heart Failure Institute, Oklahoma Heart Hospital, Department of Physiology, University of Oklahoma Health Sciences Center, Oklahoma City (P.B.A.); Division of Cardiovascular Medicine, Department of Internal Medicine, The Ohio State University, Columbus (W.T.A., A.H.); Department of Medicine, University of Alabama at Birmingham (R.C.B.); Advocate Medical Group-Midwest Heart Specialists Heart Failure and Pulmonary Arterial Hypertension Programs, Edward Hospital Center for Advanced Heart – sequence: 4 givenname: Maria Rosa surname: Costanzo fullname: Costanzo, Maria Rosa organization: From the Heart Failure Institute, Oklahoma Heart Hospital, Department of Physiology, University of Oklahoma Health Sciences Center, Oklahoma City (P.B.A.); Division of Cardiovascular Medicine, Department of Internal Medicine, The Ohio State University, Columbus (W.T.A., A.H.); Department of Medicine, University of Alabama at Birmingham (R.C.B.); Advocate Medical Group-Midwest Heart Specialists Heart Failure and Pulmonary Arterial Hypertension Programs, Edward Hospital Center for Advanced Heart – sequence: 5 givenname: Ayesha surname: Hasan fullname: Hasan, Ayesha organization: From the Heart Failure Institute, Oklahoma Heart Hospital, Department of Physiology, University of Oklahoma Health Sciences Center, Oklahoma City (P.B.A.); Division of Cardiovascular Medicine, Department of Internal Medicine, The Ohio State University, Columbus (W.T.A., A.H.); Department of Medicine, University of Alabama at Birmingham (R.C.B.); Advocate Medical Group-Midwest Heart Specialists Heart Failure and Pulmonary Arterial Hypertension Programs, Edward Hospital Center for Advanced Heart – sequence: 6 givenname: Chethan surname: Yadav fullname: Yadav, Chethan organization: From the Heart Failure Institute, Oklahoma Heart Hospital, Department of Physiology, University of Oklahoma Health Sciences Center, Oklahoma City (P.B.A.); Division of Cardiovascular Medicine, Department of Internal Medicine, The Ohio State University, Columbus (W.T.A., A.H.); Department of Medicine, University of Alabama at Birmingham (R.C.B.); Advocate Medical Group-Midwest Heart Specialists Heart Failure and Pulmonary Arterial Hypertension Programs, Edward Hospital Center for Advanced Heart – sequence: 7 givenname: John surname: Henderson fullname: Henderson, John organization: From the Heart Failure Institute, Oklahoma Heart Hospital, Department of Physiology, University of Oklahoma Health Sciences Center, Oklahoma City (P.B.A.); Division of Cardiovascular Medicine, Department of Internal Medicine, The Ohio State University, Columbus (W.T.A., A.H.); Department of Medicine, University of Alabama at Birmingham (R.C.B.); Advocate Medical Group-Midwest Heart Specialists Heart Failure and Pulmonary Arterial Hypertension Programs, Edward Hospital Center for Advanced Heart – sequence: 8 givenname: Pam surname: Cowart fullname: Cowart, Pam organization: From the Heart Failure Institute, Oklahoma Heart Hospital, Department of Physiology, University of Oklahoma Health Sciences Center, Oklahoma City (P.B.A.); Division of Cardiovascular Medicine, Department of Internal Medicine, The Ohio State University, Columbus (W.T.A., A.H.); Department of Medicine, University of Alabama at Birmingham (R.C.B.); Advocate Medical Group-Midwest Heart Specialists Heart Failure and Pulmonary Arterial Hypertension Programs, Edward Hospital Center for Advanced Heart – sequence: 9 givenname: Lynne Warner surname: Stevenson fullname: Stevenson, Lynne Warner organization: From the Heart Failure Institute, Oklahoma Heart Hospital, Department of Physiology, University of Oklahoma Health Sciences Center, Oklahoma City (P.B.A.); Division of Cardiovascular Medicine, Department of Internal Medicine, The Ohio State University, Columbus (W.T.A., A.H.); Department of Medicine, University of Alabama at Birmingham (R.C.B.); Advocate Medical Group-Midwest Heart Specialists Heart Failure and Pulmonary Arterial Hypertension Programs, Edward Hospital Center for Advanced Heart |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/25286913$$D View this record in MEDLINE/PubMed |
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| Cites_doi | 10.1001/jama.1989.03420060100040 10.1007/s12170-011-0184-2 10.1016/j.jacc.2011.09.062 10.1001/jama.294.13.1625 10.1161/circulationaha.108.783910 10.1016/S0140-6736(11)60101-3 10.1016/j.jacc.2012.08.1035 10.1161/circheartfailure.109.923300 10.1161/circheartfailure.109.885210 10.1016/j.jacc.2013.05.019 10.1016/j.cardfail.2008.07.235 10.1007/s11897-009-0010-z 10.1016/j.ejheart.2005.06.003 10.1093/eurheartj/ehs104 10.1056/NEJMe1011769 10.1016/S0735-1097(02)02896-6 10.1016/j.jacc.2007.10.061 10.1016/j.cardfail.2011.01.011 10.1001/archinte.168.8.847 10.1161/cir.0b013e3182009701 10.1016/j.cardfail.2010.08.002 10.1016/j.cardfail.2011.01.010 |
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| SubjectTerms | Blood Pressure Monitoring, Ambulatory - instrumentation Blood Pressure Monitoring, Ambulatory - methods Comorbidity Heart Failure - drug therapy Heart Failure - epidemiology Heart Failure - physiopathology Heart Failure - therapy Hospitalization - statistics & numerical data Humans Pulmonary Wedge Pressure - physiology Remote Sensing Technology - instrumentation Remote Sensing Technology - methods Stroke Volume Treatment Outcome |
| Title | Wireless Pulmonary Artery Pressure Monitoring Guides Management to Reduce Decompensation in Heart Failure With Preserved Ejection Fraction |
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