CLINICAL RESEARCH: HEART FAILURE
Randomized Controlled Trial of an Implantable Continuous Hemodynamic Monitor in Patients With Advanced Heart FailureThe COMPASS-HF Study
Robert C. Bourge, MD*,1,*,
William T. Abraham, MD, FACC ,2,
Philip B. Adamson, MD, FACC ,3,
Mark F. Aaron, MD ,4,
Juan M. Aranda, Jr, MD||,5,
Anthony Magalski, MD¶,
Michael R. Zile, MD#,6,
Andrew L. Smith, MD, FACC**,7,
Frank W. Smart, MD,8,
Mark A. O’Shaughnessy, MD,
Mariell L. Jessup, MD,9,
Brandon Sparks, MS||||,10,
David L. Naftel, PhD*,
Lynne Warner Stevenson, MD¶¶,11 on behalf of the COMPASS-HF Study Group
* Division of Cardiovascular Disease, University of Alabama at Birmingham, Birmingham, Alabama
Division of Cardiovascular Medicine, The Ohio State University, Columbus, Ohio
Oklahoma Heart Hospital, Oklahoma City, Oklahoma
Tennessee Cardiovascular Research Institute at St. Thomas Hospital, Nashville, Tennessee
|| Division of Cardiovascular Medicine, University of Florida College of Medicine, Gainesville, Florida
¶ Mid-America Heart Institute, Kansas City, Missouri
# Medical University of South Carolina, Charleston, South Carolina
** Crawford Long Hospital/Emory University Hospital, Atlanta, Georgia
Morristown Memorial Hospital, Morristown, New Jersey
Parkview Memorial, Fort Wayne, Indiana
Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania
|||| Medtronic, Inc., Minneapolis, Minnesota
¶¶ Brigham and Women’s Hospital, Boston, Massachusetts.
Manuscript received June 7, 2007;
revised manuscript received October 16, 2007,
accepted October 22, 2007.
* Reprint requests and correspondence: Dr. Robert C. Bourge, Division of Cardiovascular Disease, 311 THT, 1900 University Boulevard, University of Alabama at Birmingham, Birmingham, Alabama 35294. (Email: bbourge{at}uab.edu).
Objectives: The purpose of this study was to determine whether a heart failure (HF) management strategy using continuous intracardiac pressure monitoring could decrease HF morbidity.
Background: Patients with HF may experience frequent decompensations that require hospitalization despite intensive treatment and follow-up.
Methods: The COMPASS-HF (Chronicle Offers Management to Patients with Advanced Signs and Symptoms of Heart Failure) study was a prospective, multicenter, randomized, single-blind, parallel-controlled trial of 274 New York Heart Association functional class III or IV HF patients who received an implantable continuous hemodynamic monitor. Patients were randomized to a Chronicle (Medtronic Inc., Minneapolis, Minnesota) (n = 134) or control (n = 140) group. All patients received optimal medical therapy, but the hemodynamic information from the monitor was used to guide patient management only in the Chronicle group. Primary end points included freedom from system-related complications, freedom from pressure-sensor failure, and reduction in the rate of HF-related events (hospitalizations and emergency or urgent care visits requiring intravenous therapy).
Results: The 2 safety end points were met with no pressure-sensor failures and system-related complications in only 8% of the 277 patients who underwent implantation (all but 4 complications were successfully resolved). The primary efficacy end point was not met because the Chronicle group had a nonsignificant 21% lower rate of all HF-related events compared with the control group (p = 0.33). A retrospective analysis of the time to first HF hospitalization showed a 36% reduction (p = 0.03) in the relative risk of a HF-related hospitalization in the Chronicle group.
Conclusions: The implantable continuous hemodynamic monitor-guided care did not significantly reduce total HF-related events compared with optimal medical management. Additional trials will be necessary to establish the clinical benefit of implantable continuous hemodynamic monitor-guided care in patients with advanced HF.
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Abbreviations and Acronyms
| | CRT = cardiac resynchronization therapy | | EF = ejection fraction | | ePAD = estimated pulmonary artery diastolic pressure | | HF = heart failure | | ICD = implantable cardioverter-defibrillator | | ICHM = implantable continuous hemodynamic monitor | | NYHA = New York Heart Association |
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|
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|
|
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|
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|
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|
|
|
|
|
|
|
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|
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|
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|
|
|
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|
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55(17):
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|
|
|
|
|
|
|
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February 1, 2010;
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|
|
|
|
|
|
|
G. Andrikopoulos, S. Tzeis, G. Theodorakis, and P. Vardas
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January 1, 2010;
12(1):
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|
|
|
|
|
|
|
C. Klersy, A. De Silvestri, G. Gabutti, F. Regoli, and A. Auricchio
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|
|
|
|
|
|
|
M. Stahlberg, M. Damgaard, P. Norsk, A. Gabrielsen, A. Sahlen, C. Linde, and F. Braunschweig
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|
|
|
|
|
|
|
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|
|
|
|
|
|
|
U C Hoppe, M Vanderheyden, H Sievert, M C Brandt, R Tobar, W Wijns, and Y Rozenman
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July 1, 2009;
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|
|
|
|
|
|
|
V. M Conraads and C. J Vrints
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July 1, 2009;
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[Full Text]
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|
|
|
|
|
|
|
L. A. Allen, A. F. Hernandez, C. M. O'Connor, and G. M. Felker
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J. Am. Coll. Cardiol.,
June 16, 2009;
53(24):
2248 - 2258.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
F. Braunschweig, C. Linde, P. B. Adamson, A. Magalski, E. Erdmann, B. Kjellstrom, and T. Bennett
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Eur J Heart Fail,
June 1, 2009;
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[Full Text]
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|
|
|
|
|
|
|
D. S. Khoury, M. Naware, J. Siou, A. Blomqvist, N. S. Mathuria, J. Wang, H.-T. Shih, S. F. Nagueh, and D. Panescu
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J. Am. Coll. Cardiol.,
March 24, 2009;
53(12):
1075 - 1081.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
M. R. Mehra, H. A. Rockman, and B. H. Greenberg
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J. Am. Coll. Cardiol.,
February 10, 2009;
53(6):
514 - 522.
[Full Text]
[PDF]
|
|
|
|
|
|
|
J. McMurray, M. Petrie, K. Swedberg, M. Komajda, S. Anker, and R. Gardner
CHAPTER 23 Heart Failure
ESC Textbook of Cardiovascular Medicine,
January 1, 2009;
2(1):
med-9780199566990-chapter - med-9780199566990-chapter.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
M. R. Zile, T. D. Bennett, M. St. John Sutton, Y. K. Cho, P. B. Adamson, M. F. Aaron, J. M. Aranda Jr, W. T. Abraham, F. W. Smart, L. W. Stevenson, et al.
Transition From Chronic Compensated to Acute Decompensated Heart Failure: Pathophysiological Insights Obtained From Continuous Monitoring of Intracardiac Pressures
Circulation,
September 30, 2008;
118(14):
1433 - 1441.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
F. Braunschweig, I. Ford, V. Conraads, M. R. Cowie, G. Jondeau, J. Kautzner, M. Lunati, R. M. Aguilera, C. M. Yu, M. Marijianowski, et al.
Can monitoring of intrathoracic impedance reduce morbidity and mortality in patients with chronic heart failure? Rationale and design of the Diagnostic Outcome Trial in Heart Failure (DOT-HF)
Eur J Heart Fail,
September 1, 2008;
10(9):
907 - 916.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
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Journal Watch Cardiology,
March 26, 2008;
2008(326):
3 - 3.
[Full Text]
|
|
|
|
|
|
|
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March 18, 2008;
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[PDF]
|
|
|
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