Impact of Cardiac Resynchronization Therapy on Exercise Performance, Functional Capacity, and Quality of Life in Systolic Heart Failure With QRS Prolongation: COMPANION Trial Sub-Study

Teresa De Marco, Eugene Wolfel, Arthur M. Feldman, Brian Lowes, Michael B. Higginbotham, Jalal K. Ghali, Lynne Wagoner, Philip C. Kirlin, Jerry D. Kennett, Satish Goel, Leslie A. Saxon, John P. Boehmer, David Mann, Elizabeth Galle, Fred Ecklund, Patrick Yong, Michael R. Bristow

Research output: Contribution to journalArticle

51 Citations (Scopus)

Abstract

Background: A total of 405 participants in the Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure trial were prospectively enrolled in an exercise sub-study designed to study the influence of cardiac resynchronization therapy (CRT) on measures of exercise capacity, functional capacity, and quality of life (QOL). Methods and Results: Substudy eligibility included New York Heart Association (NYHA) functional Class III or IV heart failure, left ventricular ejection fraction ≤0.35, QRS interval of ≥120 ms, normal sinus rhythm, a heart failure hospitalization (or equivalent) within 1 year, a peak VO2 ≤22 mL·kg·min, the ability to walk 150 to 425 meters in 6 minutes, forced expiratory volume in 1 second/forced vital capacity ≥50%, and no clinical indication for a pacemaker or implantable cardioverter-defibrillator. Patients were randomized in a 1:4 ratio to optimal medical therapy (OPT) or to OPT plus CRT. Cardiopulmonary exercise testing (peak VO2 and 6-minute walk distance [6MWD]) and assessment of NYHA functional class and QOL were assessed at baseline and at 3 and 6 months of assigned therapy. There was no significant improvement in peak VO2 at 6 months in the CRT group compared with the OPT group (+0.63 mL·kg·min) by unadjusted analysis (P = .05) or by analyses adjusted for missing data. Thus the primary end point of the study was not met. There was significantly greater improvement in the 6MWD in the CRT group compared with the OPT group at both 3 and 6 months by both statistical methods (P ≤ .045). Likewise, a greater proportion of CRT patients improved by 1 or more NYHA functional classes (P < .01) at 3 months and had better QOL scores (P < .01) at 3 and 6 months compared with the OPT patients. Baseline peak VO2 predicted clinical events (time to death, time to death or first hospitalization, or time to death and first heart failure hospitalization: P < .05) in CRT participants. Conclusion: CRT patients with moderate to advanced symptoms of systolic heart failure and prolonged QRS intervals benefit from the addition of CRT to OPT in terms of exercise capacity, functional status, and QOL. CRT should be considered standard therapy in this select group of heart failure patients.

Original languageEnglish (US)
Pages (from-to)9-18
Number of pages10
JournalJournal of Cardiac Failure
Volume14
Issue number1
DOIs
StatePublished - Feb 1 2008

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Systolic Heart Failure
Cardiac Resynchronization Therapy
Quality of Life
Exercise
Heart Failure
Hospitalization
Group Psychotherapy
Therapeutics
Aptitude
Implantable Defibrillators
Vital Capacity
Forced Expiratory Volume
Stroke Volume

Keywords

  • 6-minute walk distance
  • New York Heart Association functional class
  • Peak VO

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Impact of Cardiac Resynchronization Therapy on Exercise Performance, Functional Capacity, and Quality of Life in Systolic Heart Failure With QRS Prolongation : COMPANION Trial Sub-Study. / De Marco, Teresa; Wolfel, Eugene; Feldman, Arthur M.; Lowes, Brian; Higginbotham, Michael B.; Ghali, Jalal K.; Wagoner, Lynne; Kirlin, Philip C.; Kennett, Jerry D.; Goel, Satish; Saxon, Leslie A.; Boehmer, John P.; Mann, David; Galle, Elizabeth; Ecklund, Fred; Yong, Patrick; Bristow, Michael R.

In: Journal of Cardiac Failure, Vol. 14, No. 1, 01.02.2008, p. 9-18.

Research output: Contribution to journalArticle

De Marco, T, Wolfel, E, Feldman, AM, Lowes, B, Higginbotham, MB, Ghali, JK, Wagoner, L, Kirlin, PC, Kennett, JD, Goel, S, Saxon, LA, Boehmer, JP, Mann, D, Galle, E, Ecklund, F, Yong, P & Bristow, MR 2008, 'Impact of Cardiac Resynchronization Therapy on Exercise Performance, Functional Capacity, and Quality of Life in Systolic Heart Failure With QRS Prolongation: COMPANION Trial Sub-Study', Journal of Cardiac Failure, vol. 14, no. 1, pp. 9-18. https://doi.org/10.1016/j.cardfail.2007.08.003
De Marco, Teresa ; Wolfel, Eugene ; Feldman, Arthur M. ; Lowes, Brian ; Higginbotham, Michael B. ; Ghali, Jalal K. ; Wagoner, Lynne ; Kirlin, Philip C. ; Kennett, Jerry D. ; Goel, Satish ; Saxon, Leslie A. ; Boehmer, John P. ; Mann, David ; Galle, Elizabeth ; Ecklund, Fred ; Yong, Patrick ; Bristow, Michael R. / Impact of Cardiac Resynchronization Therapy on Exercise Performance, Functional Capacity, and Quality of Life in Systolic Heart Failure With QRS Prolongation : COMPANION Trial Sub-Study. In: Journal of Cardiac Failure. 2008 ; Vol. 14, No. 1. pp. 9-18.
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AU - De Marco, Teresa

AU - Wolfel, Eugene

AU - Feldman, Arthur M.

AU - Lowes, Brian

AU - Higginbotham, Michael B.

AU - Ghali, Jalal K.

AU - Wagoner, Lynne

AU - Kirlin, Philip C.

AU - Kennett, Jerry D.

AU - Goel, Satish

AU - Saxon, Leslie A.

AU - Boehmer, John P.

AU - Mann, David

AU - Galle, Elizabeth

AU - Ecklund, Fred

AU - Yong, Patrick

AU - Bristow, Michael R.

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N2 - Background: A total of 405 participants in the Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure trial were prospectively enrolled in an exercise sub-study designed to study the influence of cardiac resynchronization therapy (CRT) on measures of exercise capacity, functional capacity, and quality of life (QOL). Methods and Results: Substudy eligibility included New York Heart Association (NYHA) functional Class III or IV heart failure, left ventricular ejection fraction ≤0.35, QRS interval of ≥120 ms, normal sinus rhythm, a heart failure hospitalization (or equivalent) within 1 year, a peak VO2 ≤22 mL·kg·min, the ability to walk 150 to 425 meters in 6 minutes, forced expiratory volume in 1 second/forced vital capacity ≥50%, and no clinical indication for a pacemaker or implantable cardioverter-defibrillator. Patients were randomized in a 1:4 ratio to optimal medical therapy (OPT) or to OPT plus CRT. Cardiopulmonary exercise testing (peak VO2 and 6-minute walk distance [6MWD]) and assessment of NYHA functional class and QOL were assessed at baseline and at 3 and 6 months of assigned therapy. There was no significant improvement in peak VO2 at 6 months in the CRT group compared with the OPT group (+0.63 mL·kg·min) by unadjusted analysis (P = .05) or by analyses adjusted for missing data. Thus the primary end point of the study was not met. There was significantly greater improvement in the 6MWD in the CRT group compared with the OPT group at both 3 and 6 months by both statistical methods (P ≤ .045). Likewise, a greater proportion of CRT patients improved by 1 or more NYHA functional classes (P < .01) at 3 months and had better QOL scores (P < .01) at 3 and 6 months compared with the OPT patients. Baseline peak VO2 predicted clinical events (time to death, time to death or first hospitalization, or time to death and first heart failure hospitalization: P < .05) in CRT participants. Conclusion: CRT patients with moderate to advanced symptoms of systolic heart failure and prolonged QRS intervals benefit from the addition of CRT to OPT in terms of exercise capacity, functional status, and QOL. CRT should be considered standard therapy in this select group of heart failure patients.

AB - Background: A total of 405 participants in the Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure trial were prospectively enrolled in an exercise sub-study designed to study the influence of cardiac resynchronization therapy (CRT) on measures of exercise capacity, functional capacity, and quality of life (QOL). Methods and Results: Substudy eligibility included New York Heart Association (NYHA) functional Class III or IV heart failure, left ventricular ejection fraction ≤0.35, QRS interval of ≥120 ms, normal sinus rhythm, a heart failure hospitalization (or equivalent) within 1 year, a peak VO2 ≤22 mL·kg·min, the ability to walk 150 to 425 meters in 6 minutes, forced expiratory volume in 1 second/forced vital capacity ≥50%, and no clinical indication for a pacemaker or implantable cardioverter-defibrillator. Patients were randomized in a 1:4 ratio to optimal medical therapy (OPT) or to OPT plus CRT. Cardiopulmonary exercise testing (peak VO2 and 6-minute walk distance [6MWD]) and assessment of NYHA functional class and QOL were assessed at baseline and at 3 and 6 months of assigned therapy. There was no significant improvement in peak VO2 at 6 months in the CRT group compared with the OPT group (+0.63 mL·kg·min) by unadjusted analysis (P = .05) or by analyses adjusted for missing data. Thus the primary end point of the study was not met. There was significantly greater improvement in the 6MWD in the CRT group compared with the OPT group at both 3 and 6 months by both statistical methods (P ≤ .045). Likewise, a greater proportion of CRT patients improved by 1 or more NYHA functional classes (P < .01) at 3 months and had better QOL scores (P < .01) at 3 and 6 months compared with the OPT patients. Baseline peak VO2 predicted clinical events (time to death, time to death or first hospitalization, or time to death and first heart failure hospitalization: P < .05) in CRT participants. Conclusion: CRT patients with moderate to advanced symptoms of systolic heart failure and prolonged QRS intervals benefit from the addition of CRT to OPT in terms of exercise capacity, functional status, and QOL. CRT should be considered standard therapy in this select group of heart failure patients.

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