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Randomized trial of cardiac resynchronization in mildly symptomatic heart failure patients and in asymptomatic patients with left ventricular dysfunction and previous heart failure symptoms.
J Am Coll Cardiol 2008; 52(23):1834-1843JACC

Abstract

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 > or =120 ms and a LV ejection fraction < or =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).

Authors+Show Affiliations

Department of Cardiology, Karolinska University Hospital, Stockholm, Sweden. Electronic address: cecilia.linde@ki.se.Division of Cardiovascular Medicine and the Davis Heart and Lung Research Institute, Ohio State University, Columbus, Ohio.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.No affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

19038680

Citation

Linde, Cecilia, et al. "Randomized Trial of Cardiac Resynchronization in Mildly Symptomatic Heart Failure Patients and in Asymptomatic Patients With Left Ventricular Dysfunction and Previous Heart Failure Symptoms." Journal of the American College of Cardiology, vol. 52, no. 23, 2008, pp. 1834-1843.
Linde C, Abraham WT, Gold MR, et al. Randomized trial of cardiac resynchronization in mildly symptomatic heart failure patients and in asymptomatic patients with left ventricular dysfunction and previous heart failure symptoms. J Am Coll Cardiol. 2008;52(23):1834-1843.
Linde, C., Abraham, W. T., Gold, M. R., St John Sutton, M., Ghio, S., & Daubert, C. (2008). Randomized trial of cardiac resynchronization in mildly symptomatic heart failure patients and in asymptomatic patients with left ventricular dysfunction and previous heart failure symptoms. Journal of the American College of Cardiology, 52(23), pp. 1834-1843. doi:10.1016/j.jacc.2008.08.027.
Linde C, et al. Randomized Trial of Cardiac Resynchronization in Mildly Symptomatic Heart Failure Patients and in Asymptomatic Patients With Left Ventricular Dysfunction and Previous Heart Failure Symptoms. J Am Coll Cardiol. 2008 Dec 2;52(23):1834-1843. PubMed PMID: 19038680.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Randomized trial of cardiac resynchronization in mildly symptomatic heart failure patients and in asymptomatic patients with left ventricular dysfunction and previous heart failure symptoms. AU - Linde,Cecilia, AU - Abraham,William T, AU - Gold,Michael R, AU - St John Sutton,Martin, AU - Ghio,Stefano, AU - Daubert,Claude, AU - ,, Y1 - 2008/11/07/ PY - 2008/06/13/received PY - 2008/07/31/revised PY - 2008/08/14/accepted PY - 2008/11/29/pubmed PY - 2009/1/7/medline PY - 2008/11/29/entrez SP - 1834 EP - 1843 JF - Journal of the American College of Cardiology JO - J. Am. Coll. Cardiol. VL - 52 IS - 23 N2 - 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 > or =120 ms and a LV ejection fraction < or =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). SN - 1558-3597 UR - https://www.unboundmedicine.com/medline/citation/19038680/Randomized_trial_of_cardiac_resynchronization_in_mildly_symptomatic_heart_failure_patients_and_in_asymptomatic_patients_with_left_ventricular_dysfunction_and_previous_heart_failure_symptoms_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0735-1097(08)02913-6 DB - PRIME DP - Unbound Medicine ER -