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Review
. 2018 Apr;16(2):177-186.
doi: 10.1007/s40258-017-0354-6.

ENDURALIFE-Powered Cardiac Resynchronisation Therapy Defibrillator Devices for Treating Heart Failure: A NICE Medical Technology Guidance

James Michael Evans  1 , Andrew Cleves  2 , Helen Morgan  3 , Liesl Millar  4 , Grace Carolan-Rees  2
Affiliations
Review

ENDURALIFE-Powered Cardiac Resynchronisation Therapy Defibrillator Devices for Treating Heart Failure: A NICE Medical Technology Guidance

James Michael Evans et al. Appl Health Econ Health Policy. 2018 Apr.

Abstract

ENDURALIFE™-powered cardiac resynchronisation therapy defibrillator (CRT-D) devices were the subject of an evaluation by the National Institute for Health and Care Excellence, through its Medical Technologies Evaluation Programme, for the treatment of heart failure. Boston Scientific (manufacturer) submitted a case for the adoption of the technology, claiming that it has a longer battery life resulting in a longer time to CRT-D replacement. Other claimed benefits were fewer complications associated with replacement procedures, fewer hospital admissions, less time spent in hospital and reduced demand on cardiology device implantation rooms. The submission was critiqued by Cedar, an external assessment centre. The submitted clinical evidence showed that ENDURALIFE-powered devices implanted during the period 2008-2010 were superior, in terms of longevity, to other devices at that time. Submitted economic evidence indicated that, because of a reduction in the need for replacement procedures, ENDURALIFE-powered devices were cost saving when compared to comparator devices. Cedar highlighted uncertainty of the applicability of the clinical evidence to devices marketed today. The Medical Technologies Advisory Committee noted that this was unavoidable due to the follow-up time required to study battery life. Clinical experts noted that increased battery life is an important patient benefit. However, centres use devices from multiple manufacturers to negate pressure on clinical services in the event of a major device recall. The clinical and economic evidence showed benefits to the patient, and further analysis requested by the committee suggested that ENDURALIFE-powered CRT-Ds may save between £2120 and £5627 per patient over 15 years through a reduction in the need for replacement procedures. ENDURALIFE-powered CRT-D devices received a positive recommendation in Medical Technologies Guidance 33.

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Conflict of interest statement

Cedar is funded by the NICE Medical Technologies Evaluation Programme to act as an EAC for the Medical Technologies Evaluation Programme. AC and GCR are NHS employees, and the NHS has a financial interest in the guidance on which this project is based. LM is a NICE employee and had no role in the production of the EAC assessment report but contributed to the preparation of this manuscript. JE and HM declare no conflicts of interest. This summary of Medical Technology Guidance was produced following the publication of the final guidance report. The article has not been externally peer reviewed by Applied Health Economics and Health Policy.

Figures

Fig. 1
Fig. 1
Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) diagram showing the EAC’s literature search results. CRT-D cardiac resynchronisation therapy defibrillator
See this image and copyright information in PMC

References

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