Barriers to cardiac device innovation

Br J Cardiol 2015;22:136doi:10.5837/bjc.2015.040 Leave a comment
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The UK population is getting older and the amount of cardiovascular disease is increasing significantly, fuelled by a steep rise in the incidence of obesity and diabetes. Heart failure is increasing in incidence because of improved survival rates following myocardial infarction and more effective treatments, with an estimated 500,000 sufferers.1 People with heart failure are more at risk of sudden cardiac death and many can benefit from cardiac devices such as implantable cardioverter defibrillators (ICDs) and cardiac resynchronisation devices (CRT-D/Ps). This increasing need was recognised by the National Institute of Health and Care Excellence (NICE) in 2014 with the publication of the revised guidelines for the use of such devices.2 Nevertheless, the UK remains well below the European average for ICD implants, although is improving in terms of CRT devices;3 the latter due to a higher than average implant rate of CRT pacemakers. However, the rate of implantation of all high-energy devices (ICD + CRT-D) is only slightly more than half the European average.

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Dr Nick Linker (President, British Heart Rhythm Society)
Dr Nick Linker (President, British Heart Rhythm Society)

Despite the need to implant more devices in patients and to develop new, innovative, devices there remain major obstacles. The recent report from the Cardiovascular Round Table4 highlights some of these barriers. Delays in implementation of guidelines, and in dissemination of new devices, vary throughout Europe, and are related to a number of factors such as funding, complex R&D lifecycles and regulatory issues. The cumulative result is inconsistent delivery both across Europe and within the UK. In Germany, hospitals can access an innovation fund set up by health insurers to exploit innovative techniques that offer positive outcomes. This enabled transcatheter aortic valve implantation (TAVI) to be available within one year of the devices receiving a CE mark. Implementation of innovative technology in the UK is currently through the Commissioning through Evaluation process, which is, at present, evaluating three cardiology procedures: percutaneous mitral valve leaflet repair (using MitraClip) for mitral regurgitation in patients with heart failure; patent foramen ovale closure for the prevention of recurrent stroke; and left atrial appendage occlusion for the prevention of stroke.5 This process has taken almost two years to set up and will not report until 2017, at the earliest, at which point a decision will be made by NHS England as to whether to commission these procedures. While there are good scientific and economic reasons to develop such a system of evaluation in the absence of large-scale trial data, it does mean that this process could result in UK patients not having access to these technologies, which are already available in other European countries.

The Cardiovascular Round Table argues that an inefficient and inconsistent approach to the introduction and funding of innovative therapies poses a genuine threat to future development, with anecdotal evidence that some companies are already cutting R&D budgets as a response to delays in adoption and low take-up rates of technology, such as TAVI and percutaneous mitral valve repair. They argue for greater involvement of National Societies, such as the British Heart Rhythm Society (BHRS), British Cardiovascular Intervention Society (BCIS), British Cardiovascular Society (BCS) and others with healthcare providers and, furthermore, that the European Commission should establish timescales for the allocation of national funding for new procedures. While it is unlikely that the European Commission will have a significant influence on the NHS, it is important that clinicians, backed by their National Societies, continue to engage and push to get the funding and support to develop these procedures.

Conflict of interest

NJL has received consultancy fees and research grants from Medtronic, St Jude Medical and Boston Scientific.


1. British Heart Foundation Centre on Population Approaches for Non‐Communicable Disease Prevention. Cardiovascular disease statistics 2014. London: British Heart Foundation, 2014. Available from:

2. National Institute for Health and Care Excellence. Implantable cardioverter defibrillators and cardiac resynchronisation therapy for arrhythmias and heart failure. London: NICE, 2014. Available from:

3. British Heart Rhythm Society Audit Group. National audit of cardiac rhythm management devices 2013–2014. London: BHRS, 2014. Available from:

4. Pinto F, Fraser AG, Kautzner J et al. Barriers to cardiovascular device innovation in Europe. Eur Heart J 2015;published online.

5. NHS England. NHS Commissioning: Commissioning through Evaluation. Available at: