Cardiac implantable electronic devices (CIEDs) have an unquestionable evidence base in patients with reduced left ventricular ejection fraction (LVEF), already on optimal medical therapy. Implantable cardioverter defibrillators (ICDs) effectively treat ventricular arrhythmias, which account for up to 50% of mortality in patients with reduced LVEF.1 Likewise in appropriately selected patients, cardiac resynchronisation therapy (CRT) reduces hospitalisation rates, improves symptoms and prolongs life-expectancy.2
Despite clear benefits, UK implant rates remain among the lowest in Europe, with wide regional variability seen. This variability is complex and poorly understood.3 One area of inconsistency is between local implementation of international and National Institute for Health and Care Excellence (NICE) guidance. In 2014, NICE released new guidance (TA314) on the use of ICDs and CRT that are significantly more inclusive than previous versions (TA95/TA120).4-6 There is no longer a need for QRS duration, evidence of non-sustained ventricular tachycardia (VT) or electrophysiological studies for ICD eligibility; furthermore, patients suffering non-ischaemic cardiomyopathy are now endorsed for device therapy. Within the CRT guidance, patients with atrial fibrillation (AF) and New York Heart Association (NYHA) class I–II symptoms are now included. This updated guideline has finally brought the UK in line with international societal guidance.7
In this issue, Mahendiran and colleagues examine the potential effect the ‘new’ NICE guidance may have on projected implant rates within a single-centre setting in the UK, and also the potential financial implications. The authors have used a dataset of 396 consecutive patients admitted to their hospital and referred to the heart failure service over a 19-month period. The records of the 143 patients with a LVEF ≤35% were further considered to determine their outcome post-discharge following a period of pharmacological optimisation. Of this group, 43 patients received no review following discharge. The remaining 100 records were analysed. Comparison of old and new NICE guidance suggested a significant increase in total device need. This corresponded primarily to a significant increase in CRT with defibrillation (CRT-D) implants (greatest absolute change seen in the ICD to CRT-D group). The population was older than most contemporary device trials, median age 79 years, with greater female representation (41%). The majority of patients were NYHA class II–III at follow-up and pharmacological use of angiotensin-converting enzyme inhibitors (ACEIs) and beta blockers was high.
The authors conclude that NICE TA314 may significantly increase implant rates and this could have financial implications. Of course this is true. The new guidelines are more inclusive to the point that any patient with severe left ventricular systolic dysfunction (LVSD) has a potential device indication. The authors in their analysis confound matters by using ‘old’ NICE TA95 criteria, relaxed to include patients with non-ischaemic aetiologies of heart failure, and ‘old’ NICE TA120 criteria, relaxed to include patients with AF ‘as per local policies’. As such, the analysis is not a direct comparison between the two sets of NICE guidance, rather an analysis on local practice and implementation. As such, geographical biases are introduced.
For cost analysis, prices quoted in the NICE TA314 guidance were used. This is highly relevant. Based on average selling prices aggregated across all manufacturers of ICDs sold in the UK to the NHS in the financial year of 2011, the cost of a complete ICD, CRT with pacing (CRT-P) and CRT-D system was estimated at £9,692, £3,411 and £12,293, respectively. However, the unit cost, which includes unit overheads in addition to device costs (available from NICE on request), should be used in terms of financial modelling. The two prices differ considerably.
The cost impact of NICE TA314 is more complex than simply the historical cost of CIED systems. Device technology has advanced greatly since 2011. LV quadripolar-lead technology for CRT implants has improved implant success rates, reduced non-responder rates and the need for device revisions. In a recent UK multi-centre registry, all-cause mortality may also be lower in patents with quadripolar leads.8 Trials, such as MADIT RIT (Multicenter Automatic Defibrillator Implantation Trial – Reduce Inappropriate Therapy) and Advance III (Avoid Delivering Therapies for Nonsustained Arrhythmias in ICD Patients III) have tested new software algorithms and compared various therapy reduction programming strategies to reduce ICD therapies. These result in a consistent reduction in mortality.9-10 New CRT pacing algorithms have been introduced into clinical practice, e.g. multi-point pacing,11 although need long-term assessment in relation to clinical outcomes. Another significant advancement has been the introduction of remote technology to facilitate follow-up.12 Modern CIED have the ability to monitor patients outside of conventional clinical settings (e.g. at home). Features, such as trend analysis of physiological parameters, enable early detection of deterioration; potentially reducing the number of emergency visits, hospitalisations, and duration of hospital stays. Another factor vital in any cost-effectiveness analysis.
These advancements were not analysed in the NICE cost-effectiveness model and it may be, with modern technology and programming strategies, the prognostic benefit of CIED is greater than initially seen in the landmark trials.
Finally, this is not the first time authors report greater than anticipated increases in device indications following the release of new guidance. Plummer and colleagues reported that ICD indications were three times greater than anticipated by NICE following the release of TA95.13 While this is true, clinical indications do not equate to implants for many reasons. Through shared decision-making, some patients will specifically decline device therapy while others may be too sick to benefit.14 Review of the UK device survey shows that ICD implant rates in England have steadily increased over the last 7–8 years with no significant jump after the introduction of a major guideline change.15
While the latest NICE guidelines on the use of CIEDs in patients with heart failure are warmly welcomed, and will hopefully lead to a greater number of device implantations, barriers remain that will limit the translation of current guidance into daily practice. It is clear that education is required to highlight device indications, however, the biggest difficulty we currently face is that we do not fully understand the reasons for disparity in implantation rates within the UK.
Conflict of interest
AJT has received financial reimbursement to attend international meetings from Medtronic, St. Jude Medical and Boston Scientific.
See also the article by Mahendiran et al. in this issue.
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