Clinical Investigations
Outcomes, Health Policy, and Managed Care
Effects of cardiac resynchronization therapy on long-term quality of life: An analysis from the CArdiac Resynchronisation-Heart Failure (CARE-HF) study

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Background

Cardiac resynchronization therapy (CRT) improves quality of life (QoL) when measured 3 to 6 months after implantation, but whether these effects are sustained is unknown. The CArdiac Resynchronisation-Heart Failure study is the only long-term randomized trial of CRT with repeated measures of QoL.

Methods

Quality of life was measured at baseline and 3 months using generic European Quality of Life-5 Dimensions and disease-specific (Minnesota Living with Heart Failure) questionnaires and at 18 months and study-end using the latter instrument. Median follow-up was 29.6 (interquartile range 23.6-34.6) months.

Results

At baseline, patients had a substantially impaired QoL (mean European Quality of Life-5 Dimensions score 0.60, 95% confidence interval [CI] 0.58-0.62) compared to an age-matched general population (0.78, 95% CI 0.76-0.80). Quality of life improved to a greater extent in patients assigned to CRT at each time point (P < .0001). By 18 months, the mean difference in disease-specific QoL score was 10.7 (95% CI 7.6-13.8) in favor of CRT, mostly due to improved physical functioning. Differences were sustained thereafter. Quality-adjusted life-years at 18 months increased by 0.13 (95% CI 0.07-0.182) and by 0.23 (95% CI 0.13-0.33) at study-end (both P < .0001). Little heterogeneity of effect across subgroups was observed.

Conclusion

Cardiac resynchronization therapy improves long-term QoL and survival in patients with moderate to severe heart failure. The effects appear sustained, and therefore, the gain in quality-adjusted life years with CRT should be even greater during longer term follow-up.

Section snippets

Methods

The design and main results of the CARE-HF study have been reported.8, 12, 14, 15 Briefly, patients in sinus rhythm, with moderate to severe chronic heart failure despite conventional pharmacologic therapy, with a left ventricular ejection fraction (LVEF) of <35%, a left ventricle end-diastolic dimension of ≥30 mm (indexed to height), and a QRS interval of >120 milliseconds were enrolled. Patients with a QRS interval of 120 to 149 milliseconds had to meet additional echocardiographic criteria

Results

Patient characteristics at baseline are shown in Table I. Univariate analyses of the relationship between baseline EQ-5D score revealed associations between worse EQ-5D score and being a woman, having worse NYHA class, more mitral regurgitation or higher amino-terminal brain natriuretic peptide, and with use of β-blockers or higher doses of loop diuretics. A forward regression approach was used to generate a final model, in which worse baseline EQ-5D score was associated with female sex, worse

Discussion

This analysis of the CARE-HF study confirms that, in patients with moderate or severe heart failure and markers of dyssynchrony, the addition of CRT to pharmacologic therapy improves symptoms and QoL in the short-term and shows that these effects persist for several years, resulting in an increase in QALY. The effect on the MLWHFQ score in CARE-HF was relatively large (10.6). Quality of life has been measured in only a few randomized trials of treatments now accepted as effective in guidelines

Conclusions

Early gains in health-related quality-of-life with CRT are sustained for ≥2 years, which, combined with increased longevity results in an increase in QALYs. Benefits were observed in most subgroups without convincing heterogeneity of effect.

References (44)

  • ClelandJ.G.F.

    How to assess new treatments for the management of heart failure: composite scoring systems to assess the patients' clinical journey

    Eur J Heart Fail

    (2002)
  • HobbsF.D.R. et al.

    Impact of heart failure and left ventricular systolic dysfunction on quality of life. A cross-sectional study comparing common chronic cardiac and medical disorders and a representative adult population

    Eur Heart J

    (2002)
  • JuengerJ. et al.

    Health related quality of life in patients with congestive heart failure: comparison with other chronic diseases and relation to functional variables

    Heart

    (2002)
  • StewartA.L. et al.

    Functional status and wellbeing of patients with chronic conditions. Results from the medical outcomes study

    JAMA

    (1989)
  • CalvertM.J. et al.

    The impact of chronic heart failure on health-related quality of life data acquired in the baseline phase of the CARE-HF Study

    Eur J Heart Fail

    (2005)
  • AbrahamW.T. et al.

    Cardiac resynchronisation in chronic heart failure

    N Engl J Med

    (2002)
  • BristowM.R. et al.

    Cardiac-resynchronization therapy with or without an implantable defibrillator in advanced chronic heart failure

    N Engl J Med

    (2004)
  • CazeauS. et al.

    Effects of multisite biventricular pacing in patients with heart failure and intraventricular conduction delay

    N Engl J Med

    (2001)
  • ClelandJGF et al.

    The effect of cardiac resynchronization on morbidity and mortality in heart failure

    N Engl J Med

    (2005)
  • GrasD. et al.

    Implantation of cardiac resynchronization therapy systems in the CARE-HF trial: procedural success rate and safety

    Europace

    (2007)
  • ClelandJ.G.F. et al.

    Design and methodology of the CARE-HF trial. A randomised trial of cardiac resynchronisation in patients with heart failure and ventricular dyssynchrony

    Eur J Heart Fail

    (2001)
  • ClelandJ.G. et al.

    Baseline characteristics of patients recruited into the CARE-HF study

    Eur J Heart Fail

    (2005)
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