Abstract
Introduction
Randomised clinical trials (RCTs) have suffered from criticisms including a lack of generalisability as well as a lack of cost-effectiveness analysis of the different interventions being studied. Such analyses are used by organisations including the UK's National institute for Health and Care Excellence (NICE) to inform system-level decisions regarding which treatments are funded. There is the potential for a growing chasm to exist between what is the latest innovation in cardiology and what can be afforded.
Purpose
To evaluate the cost-effectiveness of ventricular tachycardia (VT) catheter ablation versus anti-arrhythmic drug (AAD) therapy in ischemic heart disease.
Methods
A decision-analytic Markov model was used to calculate the costs and health outcomes of catheter ablation or AAD treatment of VT for a hypothetical cohort of patients with ischaemic cardiomyopathy andan implantable cardioverter defibrillator (ICD). Model inputs where informed using RCT-level evidence [Table 1] wherever possible. Costs were calculated from a UK perspective.
Results
Catheter ablation vs. AAD therapy had an incremental cost-effectiveness ratio (ICER) of £144,150 (€161,448) per quality adjusted life year (QALY) gained, over a five-year time horizon. The ICER for a ten-year time horizon was £75,074 (€84,083) and £69,986 (€78,384) over the cohort's lifetime. Using probabilistic sensitivity analyses to account for model parameter uncertainty, the likelihood of catheter ablation being cost-effective was only 11%, assuming a willingness to pay threshold of £30,000 used by the NICE [Figure 1].
Table 1. Summary of RCT level source data used to inform Markov model inputs Name of trial SMASH VT VTACH SMS CALYPSO VANISH VISTA Sample size 128 110 111 27 259 118 Mean age 67 66 67 64 68 66 Control AAD AAD AAD AAD AAD Clinical ablation Intervention Ablation Ablation Ablation Ablation Ablation Substrate ablation Length of follow up 22 months 24 months 28 months 6 months 28 months 12 months Mortality (%) 11% [AAD] 7% [AAD] 19% [AAD] 14% [AAD] 28% [AAD] 15% [C-ablation] vs. vs. vs. vs. vs. vs. 9% [Ablation] 10% [Ablation] 17% [Ablation] 15% [Ablation] 27% [Ablation] 9% [S-Ablation] Readmission (%) 19% [AAD] 55% [AAD] 44% [AAD] 50% [AAD] 31% [AAD] 32% [C-ablation] vs. vs. vs. vs. vs. vs. 12% [S-ablation] 6% [Ablation] 33% [Ablation] 39% [Ablation] 38% [Ablation] 25% [Ablation]
Cost-effectiveness acceptability curve
Conclusion
Catheter ablation of VT is unlikely to be cost-effective compared with AAD therapy alone in patients with ischaemic cardiomyopathy implanted with an ICD based on pooled trial evidence. However, better designed studies incorporating detailed and more frequent quality of life assessment are needed to advise health policy in this field and to provide more informed cost-effectiveness analyses.
Acknowledgement/Funding
NIHR Academic Clinical Fellowship
Substrate modification or ventricular tachycardia induction, mapping, and ablation as the first step? A randomized study
