Objective Responders to cardiac resynchronisation therapy whose device has a defibrillator component and who do not receive a therapy in the lifetime of the first generator have a very low incidence of appropriate therapy after box change. We investigated the cost implications of using a risk stratification tool at the time of generator change resulting in these patients being reimplanted with a resynchronisation pacemaker.
Methods A decision tree was created using previously published data which had demonstrated an annualised appropriate defibrillator therapy risk of 2.33%. Costs were calculated at National Health Service (NHS) national tariff rates (2016–2017). EQ-5D utility values were applied to device reimplantations, admissions and mortality data, which were then used to estimate quality-adjusted life-years (QALYs) over 5 years.
Results At 5 years, the incremental cost of replacing a resynchronisation defibrillator device with a second resynchronisation defibrillator versus resynchronisation pacemaker was £5045 per patient. Incremental QALY gained was 0.0165 (defibrillator vs pacemaker), resulting in an incremental cost-effectiveness ratio (ICER) of £305 712 per QALYs gained. Probabilistic sensitivity analysis resulted in an ICER of £313 612 (defibrillator vs pacemaker). For reimplantation of all patients with a defibrillator rather than a pacemaker to yield an ICER of less than £30 000 per QALY gained (current NHS cut-off for approval of treatment), the annual arrhythmic event rate would need to be 9.3%. The budget impact of selective replacement was a saving of £2 133 985 per year.
Conclusions Implanting low-risk patients with a resynchronisation defibrillator with the same device at the time of generator change is not cost-effective by current NHS criteria. Further research is required to understand the impact of these findings on individual patients at the time of generator change.
- Cost effectiveness
- Cardiac Resynchronisation Therapy
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Contributors SC designed the study, wrote the manuscript and acted as guarantor for the overall content. SF performed the data analysis and reviewed the manuscript. BP formatted the figures, advised on the decision tree and reviewed the manuscript. FAS, BS, TJ, ZC, JGo, JW, JMB, MON, JGi and CL collected data, advised on the decision tree and reviewed the manuscript. CAR helped design and oversaw the study, collected data and reviewed the manuscript.
Competing interests SF works for St Jude Medical. SC has previously been a research fellow funded by the Biomedical Research Council and Abbot Medical(formerly St Jude Medical). FS receives grants from Sorin and Abbot Medical (formerly StJude Medical).BP and J Goare research fellows funded by Abbot Medical (formerly St Jude Medical). BS receives funding as a research fellow funded by Medtronic. TJ has previously received funding from Medtronic. JMB has previously received funding from the Rosetrees trust and the Biomedical Research Council.SF is employed by Abbot Medical (formerly St Jude Medical). JGi receives research funding from Abbot Medical (formerly St Jude Medical). CL receives research grants from Medtronic, Abbot Medical (formerly St Jude Medical),Biotronik,Livanova, and Boston Scientific. CR receives receives research funding from Livanova, Abbot Medical (formerly St Jude Medical), Medtronic and Boston Scientific.
Ethics approval The clinical data was taken from Sebag FA, Lellouche N, Chen Z, et al. Positive response to cardiac resynchronisation therapy reduces arrhythmic events after elective generator change in patients with primary prevention CRT-D. J Cardiovasc Electrophysiol 2014;25:1368-75. doi:10.1111/jce.12496. This study received ethical approval from the local NRES Westminster Ethics Committee. We used this data to inform our cost-effective analysis presented here.
Provenance and peer review Not commissioned; externally peer reviewed.