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J Am Coll Cardiol, 2008; 52:1834-1843, doi:10.1016/j.jacc.2008.08.027 (Published online 17 September 2008).
© 2008 by the American College of Cardiology Foundation
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EXPEDITED PUBLICATION

Randomized Trial of Cardiac Resynchronization in Mildly Symptomatic Heart Failure Patients and in Asymptomatic Patients With Left Ventricular Dysfunction and Previous Heart Failure Symptoms

Cecilia Linde, MD, PhD*,*, William T. Abraham, MD, FACC{dagger}, Michael R. Gold, MD, PhD{ddagger}, Martin St. John Sutton, MD§, Stefano Ghio, MD, Claude Daubert, MD|| on behalf of the REVERSE (REsynchronization reVErses Remodeling in Systolic left vEntricular dysfunction) Study Group

* Department of Cardiology, Karolinska University Hospital, Stockholm, Sweden
{dagger} Division of Cardiovascular Medicine and the Davis Heart and Lung Research Institute, Ohio State University, Columbus, Ohio
{ddagger} Division of Cardiology, Medical University of South Carolina, Charleston, South Carolina
§ University of Pennsylvania Medical Center, Philadelphia, Pennsylvania
Policlinico San Matteo, Pavia, Italy
|| Département de Cardiologie, CHU, Rennes, France

Manuscript received June 13, 2008; revised manuscript received July 31, 2008, accepted August 14, 2008.

* Reprint requests and correspondence: Dr. Cecilia Linde, Department of Cardiology, Karolinska University Hospital, S-17176 Stockholm, Sweden (Email: cecilia.linde{at}ki.se).

Objectives: We sought to determine the effects of cardiac resynchronization therapy (CRT) in New York Heart Association (NYHA) functional class II heart failure (HF) and NYHA functional class I (American College of Cardiology/American Heart Association stage C) patients with previous HF symptoms.

Background: Cardiac resynchronization therapy improves left ventricular (LV) structure and function and clinical outcomes in NYHA functional class III and IV HF with prolonged QRS.

Methods: Six hundred ten patients with NYHA functional class I or II heart failure with a QRS ≥120 ms and a LV ejection fraction ≤40% received a CRT device (±defibrillator) and were randomly assigned to active CRT (CRT-ON; n = 419) or control (CRT-OFF; n = 191) for 12 months. The primary end point was the HF clinical composite response, which scores patients as improved, unchanged, or worsened. The prospectively powered secondary end point was LV end-systolic volume index. Hospitalization for worsening HF was evaluated in a prospective secondary analysis of health care use.

Results: The HF clinical composite response end point, which compared only the percent worsened, indicated 16% worsened in CRT-ON compared with 21% in CRT-OFF (p = 0.10). Patients assigned to CRT-ON experienced a greater improvement in LV end-systolic volume index (–18.4 ± 29.5 ml/m2 vs. –1.3 ± 23.4 ml/m2, p < 0.0001) and other measures of LV remodeling. Time-to-first HF hospitalization was significantly delayed in CRT-ON (hazard ratio: 0.47, p = 0.03).

Conclusions: The REVERSE (REsynchronization reVErses Remodeling in Systolic left vEntricular dysfunction) trial demonstrates that CRT, in combination with optimal medical therapy (±defibrillator), reduces the risk for heart failure hospitalization and improves ventricular structure and function in NYHA functional class II and NYHA functional class I (American College of Cardiology/American Heart Association stage C) patients with previous HF symptoms. (REsynchronization reVErses Remodeling in Systolic Left vEntricular Dysfunction [REVERSE]; NCT00271154 [ClinicalTrials.gov] ).

Key Words: cardiac resynchronization therapy • heart failure • randomized controlled trial • biventricular pacing • reverse remodeling

Abbreviations and Acronyms
  AEAC = Adverse Event Advisory/Endpoint Committee
  CRT = cardiac resynchronization therapy
  HF = heart failure
  ICD = implantable cardioverter-defibrillator
  LV = left ventricular
  LVESVi = left ventricular end-systolic volume index
  NYHA = New York Heart Association


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B. Merkely, A. Roka, V. Kutyifa, L. Boersma, A. Leenhardt, A. Lubinski, A. Oto, A. Proclemer, J. Brugada, P. E. Vardas, et al.
Tracing the European course of cardiac resynchronization therapy from 2006 to 2008
Europace, May 1, 2010; 12(5): 692 - 701.
[Abstract] [Full Text] [PDF]

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 Eur J Heart FailHome page
S. A. Lubitz, P. Leong-Sit, N. Fine, D. B. Kramer, J. Singh, and P. T. Ellinor
Effectiveness of cardiac resynchronization therapy in mild congestive heart failure: systematic review and meta-analysis of randomized trials
Eur J Heart Fail, April 1, 2010; 12(4): 360 - 366.
[Abstract] [Full Text] [PDF]

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 Eur J Heart FailHome page
B. Vidal, V. Delgado, L. Mont, S. Poyatos, E. Silva, M. Angeles Castel, J. M. Tolosana, A. Berruezo, J. Brugada, and M. Sitges
Decreased likelihood of response to cardiac resynchronization in patients with severe heart failure
Eur J Heart Fail, March 1, 2010; 12(3): 283 - 287.
[Abstract] [Full Text] [PDF]

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 J Am Coll CardiolHome page
W.H. W. Tang and G. S. Francis
The Year in Heart Failure
J. Am. Coll. Cardiol., February 16, 2010; 55(7): 688 - 696.
[Full Text] [PDF]

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 J Am Coll Cardiol ImgHome page
T. P. Abraham and N. T. Olsen
QRS Width and Mechanical Dyssynchrony for Selection of Patients for Cardiac Resynchronization Therapy: One Can't Do Without the Other
J. Am. Coll. Cardiol. Img., February 1, 2010; 3(2): 141 - 143.
[Full Text] [PDF]

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 Eur J Heart FailHome page
E. Huvelle, R. Fay, F. Alla, A. Cohen Solal, A. Mebazaa, and F. Zannad
Left bundle branch block and mortality in patients with acute heart failure syndrome: a substudy of the EFICA cohort
Eur J Heart Fail, February 1, 2010; 12(2): 156 - 163.
[Abstract] [Full Text] [PDF]

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 EuropaceHome page
I. E. van Geldorp, K. Vernooy, T. Delhaas, M. H. Prins, H. J. Crijns, F. W. Prinzen, and B. Dijkman
Beneficial effects of biventricular pacing in chronically right ventricular paced patients with mild cardiomyopathy
Europace, February 1, 2010; 12(2): 223 - 229.
[Abstract] [Full Text] [PDF]

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 J Am Coll CardiolHome page
S. K. Dhir
Cardiac Resynchronization in Mildly Symptomatic Heart Failure and Asymptomatic Patients
J. Am. Coll. Cardiol., January 19, 2010; 55(3): 257 - 258.
[Full Text] [PDF]

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 Postgrad. Med. J.Home page
K. Albouaini, A. Alkarmi, and D. J. Wright
Cardiac resynchronisation therapy: what a hospital practitioner needs to know?
Postgrad. Med. J., January 1, 2010; 86(1011): 12 - 17.
[Abstract] [Full Text] [PDF]

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 Eur J Heart FailHome page
D. J. van Veldhuisen, A. H. Maass, S. G. Priori, P. Stolt, I. C. van Gelder, K. Dickstein, and K. Swedberg
Implementation of device therapy (cardiac resynchronization therapy and implantable cardioverter defibrillator) for patients with heart failure in Europe: changes from 2004 to 2008
Eur J Heart Fail, December 1, 2009; 11(12): 1143 - 1151.
[Abstract] [Full Text] [PDF]

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 Eur J Heart FailHome page
J. G.F. Cleland, A. P. Coletta, A. Yassin, L. Buga, A. Torabi, and A. L. Clark
Clinical trials update from the European Society of Cardiology Meeting 2009: AAA, RELY, PROTECT, ACTIVE-I, European CRT survey, German pre-SCD II registry, and MADIT-CRT
Eur J Heart Fail, December 1, 2009; 11(12): 1214 - 1219.
[Abstract] [Full Text] [PDF]

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 J Am Coll CardiolHome page
C. Daubert, M. R. Gold, W. T. Abraham, S. Ghio, C. Hassager, G. Goode, T. Szili-Torok, C. Linde, and on behalf of the REVERSE Study Group
Prevention of Disease Progression by Cardiac Resynchronization Therapy in Patients With Asymptomatic or Mildly Symptomatic Left Ventricular Dysfunction: Insights From the European Cohort of the REVERSE (Resynchronization Reverses Remodeling in Systolic Left Ventricular Dysfunction) Trial
J. Am. Coll. Cardiol., November 10, 2009; 54(20): 1837 - 1846.
[Abstract] [Full Text] [PDF]

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 J Am Coll CardiolHome page
D. V. Exner
Is it Time to Expand the Use of Cardiac Resynchronization Therapy to Patients With Mildly Symptomatic Heart Failure?
J. Am. Coll. Cardiol., November 10, 2009; 54(20): 1847 - 1849.
[Full Text] [PDF]

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 CirculationHome page
M. St. John Sutton, S. Ghio, T. Plappert, L. Tavazzi, L. Scelsi, C. Daubert, W. T. Abraham, M. R. Gold, C. Hassager, J. M. Herre, et al.
Cardiac Resynchronization Induces Major Structural and Functional Reverse Remodeling in Patients With New York Heart Association Class I/II Heart Failure
Circulation, November 10, 2009; 120(19): 1858 - 1865.
[Abstract] [Full Text] [PDF]

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 CirculationHome page
G. S. Francis and W.H. Wilson Tang
Early Cardiac Resynchronization Therapy and Reverse Remodeling in Patients With Mild Heart Failure: Is It Time?
Circulation, November 10, 2009; 120(19): 1845 - 1846.
[Full Text] [PDF]

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 Eur Heart JHome page
G. Breithardt
MADIT-CRT (Multicenter Automatic Defibrillator Implantation Trial-Cardiac Resynchronization Therapy): cardiac resynchronization therapy towards early management of heart failure
Eur. Heart J., November 1, 2009; 30(21): 2551 - 2553.
[Full Text] [PDF]

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 EuropaceHome page
J. C. Daubert, C. Leclercq, and P. Mabo
Cardiac resynchronization therapy in combination with implantable cardioverter-defibrillator
Europace, November 1, 2009; 11(suppl_5): v87 - v92.
[Abstract] [Full Text] [PDF]


 
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