Patients with implantable devices including pacemakers and implantable defibrillators (ICD) require regular clinical and technical assessment of their devices. In the UK, these patients are currently followed-up in the pacing and ICD clinic. Patients usually, attend in person for annual or bi-annual visits. In some exceptional cases, for example where a battery is ageing, technical reasons or the device is under Medical Health Regulatory Agency (MHRA) advisories, they are seen more regularly. The manufacturers recommend follow-up for ICDs at 3 monthly intervals, irrespective of MHRA advisory advice. There are also clinical situations that may require clinic visits, including patients who have frequent arrhythmic episodes, patients who may have had an episode (ICD shocks), and the involvement of cardiac resynchronization therapy (CRT) algorithms in predications of heart failure.
Home monitoring, which offers an alterative approach to device management, is now available in the UK from most of the device companies,. Home monitoring enables pacemakers and ICDs patients to be remotely ‘followed-up’ via wireless or telephone technology, and could enhance patient safety and reduce pacing clinic visits. Home monitoring has been widely used in the US for several years but in the UK and Europe it has not been well subscribed. This is primarily due to two main reasons: the size of the market and the various data protection acts in each European country that have to be met. However, due to the increasing pressure on UK device follow-up clinics, home monitoring has started to make an increasing appearance in the UK market.
Medtronic CareLink has been evaluated at various UK centres over the last 12 months. “We have 400 patients on active follow-up at present. A large percentage of them have had their devices implanted years ago” says Neil Stevens, Market Development Manager, Medtronic Ltd. The Medtronic CareLink services was officially launched in Europe at last year’s Europace conference and is now available in 14 European countries, with 1,300 patients on active follow-up. In the US, Medtronic Carelink is well established with over 150,000 patients being followed up remotely.
Biotronik cardio-messenger was first used in 2001 and now there are over 60,000 Biotronik devices with home-monitoring implanted worldwide. “More than 50% of all home monitored devices are in the US, 40% are implanted in Europe and 10% for the rest of the world” says Mandy Hall, Territory Manager, Biotronik Ltd. It is expected that by 2010 the uptake of home monitoring of Biotronik devices will increase to 40% of pacemakers and 70% of ICDs.
Guidant/Boston Scientific Latitude home-monitoring system is currently not available in UK or Europe. “There are over 20,000 devices on active follow-up in the US” says Matt Powell, Cardiac Rhythm Manager, Guidant/Boston Scientific.
St Jude Medical’s Home-call was launched in City Hospital Belfast about six months ago. “We have about a thousand devices active in Europe and we plan to roll out in the UK in 2008” says Nigel Hylands-White, Marketing Manager, St Jude Medical, UK.
Home monitoring and how the companies compare
Home monitoring provides limited information with respect to battery status, lead impedance, parameters and diagnostic data. Pacemaker lead testing, which still remains the mainstay of device follow-up, cannot be performed via this technology.
Home-monitoring - device programming and optimization
“Patients will still need to be seen in pacing clinic for reprogramming and clinical assessment” says Mr Stevens. Home monitoring provides an opportunity to remotely monitor patients for arrhythmias, ICD therapies, heart failure therapies and other technical problems. It would be particularly useful for the monitoring of patients who are immobile, have travel issues or for MHRA advisories who requiring intensified follow-up.
“Home monitoring enables cardiac physiologists to prioritise patient follow-up” says Ms Hall. The data provided will enable the physiologists to triage device patients effectively, ensuring the patient is treated promptly. Patients can be brought into device clinic for re-programming, optimisation, clinical assessment, or if they have technical problems and not simply to be checked.
Home-monitoring and integration with current device follow-up
In many UK centres, Pacing and ICD clinics form part of the patient’s total follow-up care package. Many patients’ only contact with the hospital is through their pacing or ICD clinic appointment. Pacing clinic staff very often detect both cardiac and non-cardiac problems, and ensure patients are reviewed by the appropriate medical team. “Remote follow-up is usual for routine patients without complications. Patients with symptoms, changes in clinical status and requiring reprogramming and optimisation need to be seen in pacing clinic. Home-monitoring enables cardiac physiologists to focus on more complicated and symptomatic patients” says Ms Hall.
Home monitoring is designed to supplement device clinics, which face increasing pressure due to the rise is the number of implants, increases in the complexity of devices, and MHRA advisories. “Cardiac Physiologists would be key to the success of home monitoring, and it would require their active involvement. Given the lack of cardiac physiologists in the labour force, home monitoring would help to make them more efficient at managing increasing caseloads” says Mr Powell.
Home monitoring and the law
Home monitoring will raise concerns over legal liability among many health professionals. For example, if a serious complication was detected out of hours and not reviewed by staff until it was too late to intervene. Some devices provide for automatic downloads on a daily basis. “Any legal considerations must be weighed up by the physician and healthcare provider. However, if we look at the current situation, most patients are followed-up 3, 6 or 12 monthly. If a complication arose, for example a lead displacement, it would only be detected at the next follow-up or if the patient presented with symptoms. Home monitoring provides daily lead impedance measurements and would enable that patient to be treated much faster than patients without home monitoring” says Ms Hall.
“Home monitoring is part of the patient follow-up process and this context would be an overall improvement to patient care and safety” Mr Powell.
“St Jude Medical’s Home-call works on demand. It is not permanently activated and therefore cannot be accessed 24 hours. The device clinic makes contacted with the patient at the times and intervals decided by them. On contact with the patient, they activate and access the system” says Mr Hyland-White.
Home monitoring and public opinion
“Home-monitoring will have an important impact on the future role of device clinics. The follow-up intervals for lead integrity and battery checks are currently arbitrarily assigned according to technician capacity and historical data on battery longevity. Daily electronic checks with preset warning levels are clearly the safest and most cost-efficient method to perform these tasks. This is the reason for the rapid take-up of this technology in the US, and no doubt Europe will follow this trend. It will have a positive effect on device clinics, which will evolve to focus on ensuring that implanted devices are working optimally, with the best settings for biventricular devices, and reducing unnecessary ICD therapies, rather than performing routine safety checks.”
Dr Prapa Kanagaratnum, Consultant Cardiologist, London
“Remote follow-up has the potential to completely revolutionise the way patients have their implantable devices followed up. Ultimately, device clinics should be more efficient and patients can benefit from a reduction in unnecessary clinic visits. Remote follow-up is not about saving staff costs. However, with device follow up expected to rise by 150% over the next few years, remote follow up can help offset some of the device clinic staffing issues that will arise from this increase. Remote follow-up is about managing your patients more effectively and not about replacing in-hospital visits entirely. With the ever increasing amount of automaticity within devices, the need for performing tests during in-hospital visit is becoming less, and therefore the number of times a patient needs to visit the hospital can be reduced.
A number of our follow up patients still want to attend clinic every 3 or 6 months as they always have done, and we expect that remote follow-up is more useful for reducing unscheduled clinic visits. When a patient calls on Friday afternoon reporting they have passed out and they might have had a shock, our normal practice would to be book the patient an in-hospital visit the following week, which often means overbooking the clinic (some of our clinics may have up to 5 or 6 unscheduled patients). Remote follow-up allows you to prioritise the management of that patient and reduce any worry the patient might have had waiting for a clinic visit. In some patients I have arranged a remote follow up once a week to check the effectiveness of a recent drug change; this may be impossible to do by in-hospital visits if the patient has to travel long distances, or without overbooking your clinic. With the increase in CRT implants, we are finding remote follow-up can be very useful if you wish to utilise heart failure algorithms such as Medtronic’s Optivol, or the Boston Scientific weight and blood pressure monitors designed to prevent admissions due to heart failure.
Not all of our patients will immediately be able to have access to remote follow-up due to the model and age of their device. There is also often an extra cost associated with the model of device needed for remote monitoring or the use of the device company’s website, and this can be a limiting factor.
The aim at Southampton is to have 500 patients on remote follow-up by the end of this year; this will be about fifth of our device population (in the US some hospitals have over 10,000 patients on remote follow up). New remote follow up patients will be assessed on a prescriptive basis, i.e. distance to clinic or frequency of episodes.”
Stuart Allen, Technical Head, Cardiology Department, Southampton
“Although home monitoring, seems very convenient from a patient perspective, caution must be applied to ensure patient follow-up from a clinical cardiac perspective is not lost . In my experience many patients, who have been discharged from cardiac outpatients, return to the cardiac outpatient clinic via the pacing clinic, where cardiac-related problems are often detected.”
Dr Bhavesh Sanchdev, Specialist Registrar: Cardiology, London
“Home monitoring has interesting potential for improving demand on pacing services, particularly at a time where demand is ever increasing. My concern is that often pacing clinics are the first port of call for a patient’s cardiology needs, and the loss of direct contact with patients may be to their detriment. However, by using home monitoring for straight forward cases, there will be more time in clinic for complex devices, which is an important prospective development.”
Sophie Blackman, Chief Cardiac Physiologist, London
“I think this is a good idea in principle, especially for patients who have to travel a great distance to their nearest device follow-up center. However, many patients benefit from the visit to a device clinic and not just the mechanical follow-up. Patients benefit from the input and advice provided by cardiac physiologists and other health workers. There is also the opportunity to discuss any problems, and have medications reviewed. Just having contact with a health professional is beneficial to some patients, especially those with diminished quality of life. This technology would be suitable for certain patient groups. Patients will have to be evaluated individually.”
Diane Snowdon, Arrhythmia Nurse Specialist, London
“Yes, I think it’s a good idea because many patients have far to travel. But I would prefer to be seen in ICD clinic.”
A BIV ICD Patient, 63 years, London
“I am positive and would welcome home monitoring. Travelling to London for device follow-ups is not always easy. Train fares, congestions charges and car parking can make ICD follow-up expensive for patients. Home monitoring will allow the team to concentrate on and prioritise the patients in need of urgent care.”
ICD patient, 41, Bedfordshire
“Interesting, but I wish to continue with attending the pacing clinic in person.”
A Pacemaker Patient, 69 years, London
“In principle I think home monitoring is a good idea, but in the early stages of having a pacemaker I think it is important for a patient to go to the clinic and be able to talk about any problems or queries they may have.”
Pacemaker Patient, 67 years, Windsor
Home monitoring and the future
NICE guidelines indicate that implanting rates in the UK are below European averages. It is envisaged that implants will increase over the next few years, as will the complexity of device therapies. Many UK device clinics are under increasing pressure to meet the current follow-up burden. Home monitoring will enable cardiac physiologists to triage patients, freeing up clinic visits for more problematic or complex patients. It is estimated that up to 80% of routine follow-ups do not require reprogramming, making home monitoring a suitable alternative for this cohort. Home monitoring could also have a positive effect on the environment “by reducing the carbon footprint associated with the patient hospitals visits” say Ms Hall.
