Elsevier

International Journal of Cardiology

Volume 137, Issue 3, November–December 2009, Pages 206-215
International Journal of Cardiology

Is combined resynchronisation and implantable defibrillator therapy a cost-effective option for left ventricular dysfunction?

https://doi.org/10.1016/j.ijcard.2008.05.073Get rights and content

Abstract

Objective

To evaluate the cost-effectiveness of combined resynchronisation and implantable defibrillator therapy for left ventricular dysfunction and explore subgroups in which such devices might be most cost-effective.

Design

Markov model-based economic evaluation.

Setting

UK NHS.

Participants

A simulated mixed age cohort of NYHA class III and IV patients with left ventricular systolic dysfunction and prolonged QRS interval.

Main outcome measures

Cost per quality adjusted life year gained over the patient lifetime.

Results

The incremental cost-effectiveness of resynchronisation therapy alone compared with optimal medical therapy was £16,735 (95% CI: £14,630 to £20,333) with a 91% probability of being cost-effective at a willingness to pay threshold of £30,000. Compared with resynchronisation alone, the incremental cost-effectiveness of combined implantable defibrillator was £40,160 (95% CI: £26,645 to £59,391) with only a 26% probability of cost-effectiveness at the £30,000 threshold. In a direct comparison across three treatments (medical treatment, resynchronisation alone and combined resynchronisation with implantable defibrillator therapy) resynchronisation alone was found to be the most cost-effective option.

Conclusion

Combined resynchronisation and implantable defibrillator therapy is not cost-effective for left ventricular dysfunction. Instead resynchronisation alone remains the most cost-effective policy option in this population. Combined devices are more likely to be cost-effective in the subgroups of younger patients or those with high risk of sudden cardiac death who would qualify for resynchronisation therapy.

Introduction

Meta-analyses have shown the addition of cardiac resynchronisation (CRT) to medical therapy that reduces the risk of mortality and hospitalisation and results in clinically important improvement in exercise capacity and health related quality of life of NYHA class III and IV patients with left ventricular dysfunction and prolonged QRS interval receiving optimal medical therapy [1], [2], [3], [4], [5], [6]. Furthermore, CRT has consistently been shown to be cost-effective in this population [7], [8], [9], [10], [11], [12], [13].

In addition to their standalone application, CRT devices can be combined with an implantable cardioverter defibrillator (CRT–ICD). Although a recent network meta-analysis showed no significant overall survival benefit of CRT–ICD over CRT [6], in the one head-to-head trial to date, CRT–ICD treated patients experienced an additional reduction in the risk of sudden cardiac death compared to those treated by CRT alone [14]. That ICD is the best therapy for the prevention of sudden cardiac death has been established by numerous primary and secondary prevention trials [15].

Nevertheless as highlighted in a recent BMJ editorial, the question remains as to whether the additional clinical and health benefit of CRT–ICD in patients indicated for CRT therapy is sufficient to justify these more costly devices (£5074 for CRT versus £17,266 for CRT–ICD devices) [16], [17], [18], [19]. Using a decision analytic model independently commissioned for the National Institute for Health and Clinical Excellence (NICE) in the United Kingdom we examine this question and also explore whether there is a subgroup of ventricular dysfunction patients for whom CRT–ICD may be more cost-effective.

Section snippets

Methods

A Markov model with a Monte Carlo simulation developed in Microsoft Excel® (Microsoft Corporation, Redmond, WA, USA) was used to compare the outcomes and costs of CRT over the patient lifetime [20]. The model simulated a mixed age cohort of patients with NYHA class III and IV heart failure, evidence of left ventricular systolic dysfunction (left ventricular ejection fraction  35%) and evidence of electrical dysynchrony (QRS direction > 120 ms). The starting age of patients was drawn from a mixed

Clinical events

The predicted mean survival using our model was 4.7, 5.8 and 6.2 years for medical therapy, CRT and CRT–ICD respectively. The predicted rates of heart failure hospitalisation and sudden cardiac death during these periods of patient survival are also shown in Table 3. These predications are in accord with clinical trial data and clinical experience.

CRT versus medical therapy

CRT conferred an estimated additional 0.70 QALYs for an additional £11,630 per person, giving an incremental cost-effectiveness ratio of £16,735, 95%

Discussion

Although the incremental cost-effectiveness of CRT alone compared to medical therapy falls below a notional maximum willingness to pay threshold of £30,000 per QALY currently applied in UK, combined CRT–ICD devices are not a cost-effective option for left ventricular dysfunction patients indicated for resynchronisation therapy. Instead, our findings show that combined CRT–ICD devices should be restricted to younger patients (less than 60 years) and those with a high risk of sudden cardiac death

Conclusion

On the basis of synthesising current best evidence, combined resynchronisation and implantable defibrillator therapy is not cost-effective for patients with left ventricular dysfunction indicated for rsynchornisation therapy. Instead resynchronisation alone devices alone remain the most cost-effective policy option in this population. Combined devices may be cost-effective in the subgroups of younger patients or those with high risk of sudden cardiac death.

Role of funding source

This study was funded by the NIHR HTA programme and commissioned by the National Institute for Health and Clinical Excellence. Neither the funder nor the commissioner had any role in the collection, analysis or interpretation of the data or in the decision to submit the manuscript for publication.

Acknowledgements

We thank: the external advisory panel that provided advice to this project — Dr. RG Charles, Dr. M Gammage, Dr. D Hildick-Smith, Dr. F Leyva, Dr. FA McAlister, Dr. V Paul and Prof. M Sculpher; Alison Price, Wessex Institute for Health Research and Development, University of Southampton for her assistance in the literature searches and Dr. Martin Pitt in the development of the decision model.

The authors of this manuscript have certified that they comply with the Principles of Ethical Publishing

References (41)

  • S.K. Lam et al.

    Combined resynchronisation and implantable defibrillator therapy in left ventricular dysfunction: Bayesian network meta-analysis of randomised controlled trials

    BMJ

    (2007)
  • G. Fattore et al.

    Economic impact of cardiac resynchronization therapy in patients with heart failure. Available evidence and evaluation of the CRT-Eucomed model for analysis of cost-effectiveness

    Ital Heart J Suppl

    (2005)
  • M.J. Calvert et al.

    Cost-effectiveness of cardiac resynchronization therapy: results from the CARE-HF trial

    Eur Heart J

    (2005)
  • J.J. Caro et al.

    Modelling the economic and cost sequences of cardiac resynchronization in the UK

    Curr Med Res Opin

    (2006)
  • A. Heevey et al.

    Cost-effectiveness of biventricular pacemakers in heart failure patients

    Am J Cardiovasc Drugs

    (2006)
  • G. Yao et al.

    The long-term cost-effectiveness of cardiac resynchronization therapy with or without an implantable cardioverter-defibrillator

    Eur Heart J

    (2007)
  • M.D. Rawlins et al.

    National Institute for Clinical Excellence and its value judgments

    BMJ

    (2004)
  • M.R. Bristow et al.

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

    N Eng J Med

    (2004)
  • M. Buxton et al.

    A review of the evidence on the effects and costs of implantable cardioverter defibrillator therapy in different patient groups, and modelling of cost-effectiveness and cost-utility for these groups in a UK context

    Health Technol Assess

    (2006)
  • F. Braunschweig

    Devices in heart failure: building the evidence

    Eur Heart J

    (2006)
  • Cited by (8)

    View all citing articles on Scopus
    View full text