Issue
Improving cardiac outcomes is a major clinical priority across many countries. Reductions in coronary heart disease and stroke is a national priority across the UK, and sudden cardiac death a leading cause of death in the United States.  While cardiac patients benefit globally from implanted devices such as pacemakers and implantable cardioverter-defibrillators (ICDs) that help regulate their heart rate, new technologies are now available that enable providers to interrogate these devices remotely, reducing the need for face-to-face patient visits.

Remote monitoring technology allows patients to transmit full cardiac device information from their home to their clinicians via a secure server. For example, the CareLink® system, now used by more than 130,000 American patients, was launched in the US in 2002 by Medtronic, a global producer and supplier of implantable devices.  Data is sent from their implanted device to a cardiology clinic through a range of communication technologies.  The data received are similar to what is typically obtained during an in-person visit to the clinic, enabling efficient access by physicians to comprehensive patient device and physiological information to make informed clinical decisions. 

The remote monitoring of implantable devices is clearly a sign of the times – demonstrating the potential of new technology to transform where and how medical care is provided.  Expected benefits include increased convenience to patients, increased provider capacity, and improved clinical outcomes.  The majority of patients do not want to spend time in hospitals.  As the patient choice agenda begins to influence funding flows, remote monitoring could provide a real advantage in an increasingly competitive NHS market.  Remote monitoring services also present advantages in treating cardiac rhythm patients living in more isolated communities.

Challenges
So what are the possible barriers to embracing this technology and do they differ between countries? There are four key areas: technological capability, patient acceptability, clinician opportunity and the case for investment.

Technological Capability
This is probably the easiest to address. Remote monitoring services offer a proven, reliable technology and, with the general availability of a range of communication media (web, phone, cell, satellite) there are few places where it could not be applied.  Systems within the hospital need not even be joined up with other solutions; they can operate in stand-alone mode.

America, Canada and the UK all have similar and sufficient capabilities in this regard.  Technology capability is not the constraint to deploying remote monitoring services in the US, UK and Canada.

Patient Acceptability
Is the public ready for remote monitoring services?  Society currently relies on a range of implantable devices, from stents to tobacco patches to birth control devices.  However, the debate has yet to adequately focus on the public acceptability of more active health technologies, ones which communicate, automatically or not, back to providers.  Drug companies are already keen to make further inroads into patient’s lives through the promotion of electronic medication schedule reminders, particularly for mental health and diabetes patients, but these are not the same as having a device inside your body communicating with the outside world about you. 

Looking to a future where science offers even greater potential through nanotechnologies with nanobots pro-actively monitoring our health and taking remedial action inside our organs and blood vessels, the need for debate becomes even more pertinent.  Will these technologies exacerbate people’s perceptions of an Orwellian society, or encourage irresponsible behaviours, or are they the next natural leap forward to longer healthier lives?  What is clear is the potential power that this active device-based patient tracking and communication to do great good but at what cost to privacy?  With the recent issues surrounding information governance in the UK, institutions would need to inspire public confidence and provide assurances that personal information will only be used in their best interests.

Clinician Opportunity
Does the application of this remote monitoring of implantable cardiac devices benefit the clinician?  There is a simple relationship between benefits and diffusion, where low gain equals low adoption.  This is where countries do differ.  For example, in the US a strong business driver for the adoption of remote monitoring technology by cardiology clinics has been the ability to replace two out of four in-person clinic visits each year with scheduled remote transmissions.  Reducing the number of in-person clinic visits eases clinic capacity issues, improves the efficiency of routine device interrogations, and reduces often lengthy patient trips to clinics
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However, while the standard of care for ICD monitoring in the US is four patient visits a year, ICD patients in Canada only routinely visit electro physiologists twice annually. Straight away this has a different benefits profile for clinicians and patients.  Therefore it is important to look beyond these simple metrics and consider the wider implications, for example the opportunity to provide exception reporting leading to fewer acute episodes and fewer periods of hospitalisation.

The Case for Investment
Remote monitoring of ICDs and pacemaker devices is available, and in some countries doctors and patients already accept it, yet adoption remains low. Why? What is the final barrier to overcome?  Despite their demonstrated superiority over medications in preventing sudden cardiac deaths1, numerous studies of ICD implant rates suggest that ICDs are underutilised.  ICD rates in Canada and the UK lag well behind several other G8 countries2.  These is partly due to financial considerations – in Canada, provinces have annual caps on the number of ICDs implanted due to the relatively high costs of devices. 
           
Who pays and who benefits economically is an ongoing challenge in healthcare change.  Many cardiac centres in the US are stand-alone clinics, whereas device implants in Canada are generally within hospitals, leaving the cost-benefit implications less transparent.  Economic models should consider the full complement of benefits across the entire economy if they are to provide a clearer picture of the true value of such interventions, to patients, the health economy, and society. In turn, this work can steer decisions on the appropriate incentive and reimbursement structures.

Conclusion
The fundamental nature of a health system will determine the applicability of remote monitoring services for implantable devices.  However, policy-makers and clinicians should remain aware of their potential to transform the way care is delivered and to provide high-tech solutions to managing the burden of cardiac illness.  These technological opportunities could enable a shift in care, yet the organisational constructs and economic processes often obscure or confound the real benefit opportunities.

The way forward, particularly in the UK and Canada, will be to explore the whole system benefit opportunities from such technologies to the broader management of Long-Term Conditions and to consider the case for change from a patient and health system perspective, not that of individual organisations.

References

February 2008