"Moving to a more continuous follow-up approach would have the tremendous advantages of enhancing patient safety, decreasing physician and nurse work load, and allowing health staff to focus on medical emergencies," urged Professor Angelo Auricchio, from the European Heart Rhythm Association (EHRA) and official spokesperson of the European Society of Cardiology (ESC), adding that such systems may have the additional advantage of being more cost effective for health care providers.
Currently only around 1 % of patients in Europe with implantable cardiac devices are being monitored with remote devices, the majority are still being followed up by routine face to face clinic visits. Despite wide availability of remote monitoring in many European countries, few countries offer patients such systems. "Even in countries that have introduced remote monitoring there are widespread disparities between centres," added Professor Auricchio, who works at the Cardiocentre Ticino (Lugano, Switzerland).
Cardiovascular implantable electronic devices (CIEDs) - which include cardiac pacemakers, implantable cardioverter defibrillators (ICD), cardiac resynchronization therapy (CRT) devices, implantable cardiovascular monitors and implantable loop recorders - have now been developed with numerous programmable features allowing for storage of substantial amounts of diagnostic information.
The European Heart Rhythm Association (EHRA) and Heart Rhythm Society (HRS) expert consensus on monitoring of cardiovascular electronic devices, published last year, estimated that in 2006 approximately 250,000 pacemakers and 50,000 ICDs were implanted in Europe (1). The numbers implanted are estimated to be increasing by 5 to 10 % per year. What has become increasingly apparent, explained Professor Auricchio, is that once the device has been implanted, it needs to be followed up effectively to allow it to work efficiently.
"This means that more than two million follow-up encounters with device patients are now needed in Europe each year, which is pushing the health care system to breaking point. Services are so overstretched by routine follow ups that they do not have much spare capacity to deal with emergencies when they come in," said Professor Auricchio.
The solution, suggests Professor Auricchio, is to increase the number of devices that can be interrogated remotely. Technology is available to download data related to device function, arrhythmia frequency, cardiovascular hemodynamic parameters and patient activity, from specific CIEDs and transmit the encrypted data using telephone technology to remote-secure monitoring centres. Here health care staff can both identify errant device behaviour, as well as patient's physiological response to a multitude of programmable therapies.
There are many advantages for remote devices. With the current face to face visit approach, physicians commonly first learn about critical device malfunctions and physiological changes when the patient returns to the clinic for a regular scheduled follow-up and manual device interrogation, which only takes place two to four times per year, depending on the patient status. With remote monitoring, problems can be identified immediately.
"Continuous control of the device will permit detection of possible device dysfunction at a very early stage which allows us to take immediate action, thus improving patient safety significantly." said Professor Josep Brugada, President of the EHRA.
The European Heart Rhythm Association (EHRA) and Heart Rhythm Society (HRS) expert consensus document, which set out to determine what was needed to provide appropriate levels of care, concluded: "Globalization and new Internet-based technologies for monitoring CIEDs are imposing new rules for patient data management and data-sharing. Competent authorities, national ministries of health, and patient organizations need to find practical and easy solutions for physicians to have rapid and complete access to device relevant data for delivering the most appropriate therapy."
The document adds that payers and regulators need to improve their recognition of the importance of CIED follow-up and develop adequate reimbursement strategies. "There is no point investing in the device without comparable investment in the long-term follow-up and therapy!" write the authors.
To understand the new models of reimbursement, EHRA in conjunction with Eucomed, now plans to survey the costs involved with in hospital CIED follow-up throughout Europe. In addition to the direct medical costs the survey will also include indirect costs, such as those involved in relatives accompanying patients on hospital visits. "We need to have a better idea of the baseline costs so that we can start to understand the cost efficiency of introducing remote monitoring," said Professor Auricchio.
Reference:
HRS/ EHRA Expert Consensus on the Monitoring of Cardiovascular Implantable Electronic Devices (CIEDs): Description of Techniques, Indications, Personnel, Frequency and Ethical Considerations. Wilkoff BL, Auricchio A, et al. Europace. 2008 Jun;10(6):707-25. Epub 2008 May 14.
About EHRA
The European Heart Rhythm Association (EHRA), a registered branch of the European Society of Cardiology (ESC), is an association specialising in electrophysiology and was created from the merger of two former ESC Working Groups on 'Cardiac Pacing' and 'Arrhythmias'. The EHRA mission statement is to improve the quality of life of the European population by reducing the impact of cardiac arrhythmias and reduce sudden cardiac death. Its aim is to serve as the leading organisation in the field of arrhythmias and electrophysiology in Europe, and to attract all physicians from Europe and beyond to foster the development of this area of expertise.
About the ESC
The European Society of Cardiology (ESC) represents 59,000 cardiology professionals across Europe and the Mediterranean. The ESC comprises 5 Councils, 5 Associations, 19 Working Groups and 51 National Cardiac Societies. Its mission is to reduce the burden of cardiovascular disease in Europe. See the European Society of Cardiology Web Site: www.escardio.org
Information on the scientific programme is available at http://spo.escardio.org/Welcome.aspx?eevtid=32
More information on Europace 2009 and on the press releases is available from the ESC press office at press@escardio.org OR on site at +33 (0)6 22 41 84 92.
About Eucomed
Eucomed is the Voice of the medical technology industry in Europe, representing 4,500 designers, manufacturers and suppliers of medical technology used in the diagnosis, prevention, treatment and amelioration of disease and disability. The mission of Eucomed is to improve patient and clinician access to modern, innovative and reliable medical technology.