This briefing describes the regulated use of the technology for the indication specified, in the setting described, and with any other specific equipment referred to. It is the responsibility of healthcare professionals to check the regulatory status of any intended use of the technology in other indications and settings.
Medtronic was awarded an active implantable medical device CE mark for the CareLink network service in 2012. The CE mark covers various models of the CareLink monitor, and includes the MyCareLink patient monitoring system, MyCareLink Smart patient reader and device data management application software.
The CareLink network service allows Medtronic implantable cardiac devices to be remotely monitored through a network that is accessible to a clinician at all times. Data is collected from a person's implanted cardiac device and stored on the Medtronic CareLink Clinician website. This website provides secure internet access to data received from implantable pacemakers, implantable cardioverter defibrillators, cardiac resynchronisation therapy with pacing devices, cardiac resynchronisation therapy with defibrillator devices, and implantable loop recorders. Clinicians can also receive CareAlert notifications, which are generated in response to clinical events, to quickly identify potential device problems before they become more serious. The CareLink network service may reduce the need for the person to attend face-to-face follow‑up appointments with their clinician.
The service can be used with the MyCareLink or MyCareLink Smart patient monitors:
The MyCareLink patient monitor can be used with implanted devices with or without wireless functionality. It collects data from the implanted device and transfers it to the CareLink network. The monitor is made up of the following components:
monitor base with monitor screen, cursor and accept buttons
The MyCareLink Smart patient monitor is used with devices without wireless functionality. It uses a person's smartphone or tablet to collect and transmit device data. A hand-held smart reader is used to collect data from the implanted device. The smart reader communicates with the person's smartphone or tablet, via bluetooth and through a software application (available for iOS and Android), to transfer the data to the CareLink network.
Data collection using the CareLink network service depends on the type of Medtronic device that has been implanted. Some devices can transfer data wirelessly to the secure website at intervals scheduled by the person's clinician, and need little user interaction with the monitor. Wireless transmission from the device usually happens at night, which is why the monitor should be placed 0–3 metres from the person's bed. People can also start data transfer when they have symptomatic episodes.
For implantable cardiac devices without wireless transmission functionality, a reader is used. The person holds the reader over their implanted device, either against clothing or bare skin. The process typically takes less than 3 minutes but can take up to 12 minutes. The monitor, smartphone or tablet screen shows a green progress bar to indicate that the data is being read. Once all the device data has been read, the monitor, smartphone or tablet emits 2 short tones with an on-screen prompt to signal that data collection is complete.
The collected data is immediately sent to the CareLink network over Vodafone's worldwide data network (MyCareLink monitor) or via the person's smartphone or tablet mobile operator or wifi connectivity (MyCareLink Smart monitor). A green progress bar will indicate that the data is being transmitted followed by a green 'tick' if the transmission is successful.
The MyCareLink monitor or MyCarelink Smart collect and send data from a person's implanted Medtronic cardiac device to the CareLink network for clinicians to access. The CareLink network service is usually used in the person's home for remote management and monitoring of their implanted Medtronic cardiac device. The MyCareLink monitor needs to be plugged into an electricity supply to send and receive data and it can be used in another location if needed (such as, a hotel room when on holiday). The MyCareLink monitor also transfers CareAlert notifications to the person's clinician to give an early warning of a clinical event.
Current NHS options for post-implantation follow‑up of implantable cardiac devices include face-to-face outpatient device evaluations, remote management and remote monitoring.
NICE is aware of the following CE‑marked devices that appear to fulfil a similar function to the CareLink network service:
Latitude (Boston Scientific). NICE has also published a medtech innovation briefing on the Latitude NXT system for remote monitoring of implanted cardiac devices.
Merlin@home (St Jude Medical).
BIOTRONIK Home Monitoring (Biotronik).
The CareLink network service is currently used by 163 NHS hospitals across the UK and Northern Ireland.
The price of the CareLink network service is subject to the EU Tender process through the Official Journal of the European Union. There is also a National Framework Agreement through the NHS Supply Chain (SC) as well as other collaborative tenders via procurement hubs. If a trust uses the NHS SC Agreement, they place an order for CareLink with the NHS SC and Medtronic ships the CareLink network service directly to the trust. For other collaborative tenders, the collaborative sets up the contract and pricing, but the trust places the order directly with Medtronic, and CareLink is shipped directly to the trust. In addition, some trusts have individual tendering processes. These decisions are made at a trust level in line with their local and regional policy for procurement in general.
The list price, excluding VAT, for the CareLink network service is £970 per patient. This includes:
administration for hospital CareLink network service set-up
access to secure server space for data hosting of any recent active patient data using CareLink
unlimited healthcare professional users per hospital
access to Vodafone worldwide data network and their roaming partners
MyCareLink hardware (MyCareLink monitor or MyCareLink Smart monitor smartphone or tablet solution for Android and iOS)
hardware shipment and distribution
direct technical service telephone support for patients and healthcare professionals
6‑monthly CareLink hospital website upgrades
3‑monthly CareLink monitor software upgrades
training of healthcare professionals and patient groups
online access for healthcare professionals to the Medtronic Academy for training on website updates
access to the MyCareLink Connect patient website for personalised follow‑up information, education and shared care with family and carers.
People usually attend an outpatient department 4–6 weeks after a cardiac device has been implanted, so that the device can be checked. If this post-implantation follow‑up shows that it is working correctly, the person will need to attend routine appointments with a cardiologist or cardiac physiologist. These visits are scheduled at 3- to 12‑month intervals.
The CareLink network service is used to remotely manage and monitor a person's implanted Medtronic cardiac device. It is used to reduce routine out-patient appointments with a cardiologist or cardiac physiologist, because data are collected from the person's device at home and sent to their clinician. The person's clinician can then review the data using a secure website. If the data suggest a problem or if a CareAlert notification is sent to the person's clinician, an out-patient appointment can be scheduled if needed.
Implanted cardiac devices have an inbuilt alarm system that is triggered when a fault develops. One specialist commentator explained that patients can often miss the alarm because they mistakenly identify the sound as a digital watch or a clock alarm. This commentator explained that the CareLink network service is useful because it also sends an alert email to the patient's clinician if there is a device fault. Two other specialist commentators also noted that the CareLink network service is useful for monitoring implantable cardioverter defibrillator battery life and problems with leads as they develop; one of the commentators also stated that CareLink can be used in planning implantable cardiac device replacements.
Three specialist commentators noted that CareLink network service can be used with implantable loop recorders to monitor symptomatic and non-symptomatic arrhythmias, blackouts, or intermittent palpitations. Two of these specialist commentators highlighted that patients do not need to attend a face-to-face appointment to download and clear the data, which is a more convenient way of capturing events on their loop recorders.
Two specialist commentators commented on using the CareLink system as an alternative to routine face-to-face appointments. One of these specialist commentators noted that the CareLink network service allows people using an implanted cardiac device, who are expected to have little or no change in their health condition, to have routine follow‑up checks in their own home. In the specialist commentator's NHS trust, many patients live in rural areas with poor transport links and so benefit from remote monitoring. In this trust, devices are routinely checked twice a year with one check being remote and one a face-to-face assessment. The other specialist commentator noted that remote monitoring can safely reduce the number of routine clinic visits because the objective of these visits is to monitor device function. One of the specialist commentators noted that remote checks using the CareLink network service are technical follow‑ups and may not include clinical questioning or drug reviews, and no physical assessment can be carried out.
One specialist commentator noted that the CareLink network service offers reassurance to patients with implantable cardioverter defibrillators.
One specialist commentator noted that the alert system is well-used in their hospital trust. They added that the alert system helps to identify ventricular arrhythmia and atrial arrhythmias, particularly atrial fibrillation, atrial flutter and atrial tachycardia.
One specialist commentator noted that the CareLink network service is useful in some patients for pre-empting implantable cardioverter defibrillator shocks, by allowing the need for early intervention with changes to medication or VT ablation. They added that the service can then be used to monitor the efficacy of treatment after discharge by monitoring arrhythmia frequency and duration.
Two specialist commentators highlighted that the CareLink network service offers another level of reassurance to patients with implantable cardioverter defibrillators because the CareLink network service monitors devices outside of scheduled face-to-face follow‑up visits.
One specialist commentator stated that remote monitoring does allow earlier identification of atrial arrhythmias and this may translate into earlier intervention. The commentator argued that this benefit is largely in patients not already on anticoagulation therapy or those with no history of atrial fibrillation.
One specialist commentator stated that the tariffs for remote follow‑ups and face-to-face follow‑ups are similar for hospital reimbursement.
NICE is committed to promoting equality, and eliminating unlawful discrimination and fostering good relations between people with particular protected characteristics and others. In producing guidance and advice, NICE aims to comply fully with all legal obligations to:
promote race and disability equality and equality of opportunity between men and women
eliminate unlawful discrimination on grounds of race, disability, age, sex, gender reassignment, marriage and civil partnership, pregnancy and maternity (including women post-delivery), sexual orientation, and religion or belief (these are protected characteristics under the Equality Act 2010).
Implantable cardiac devices may be used in people of any age, but are more commonly used in those over 60 years. Age is a protected characteristic under the Equality Act 2010.
The Arrhythmia Alliance, a not-for-profit coalition of charities, patient groups, patients, carers, medical groups and allied professionals, was asked to comment on the CareLink network service. The organisation surveyed and carried out one-to-one interviews with over 100 CareLink network service users and their carers. All users and their carers gave positive feedback.
Some CareLink network service users felt that it provides them with reassurance and allows them to live a normal life, because they know that their cardiac nurse will contact them if CareLink detects that something is wrong. They added that if they are worried, they can contact their cardiac nurse who can review the downloaded data to find out if there are any problems.
The Arrythmia Alliance believes that arrhythmia services have improved in and out of hospital since the introduction of the CareLink network service and that the data collected by it over time could be used to further improve outcomes for people with cardiac arrhythmias. The Arrythmia Alliance also states that the CareLink network service enables patients to be at the centre of their healthcare and self-manage their condition.