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.
The LATITUDE NXT Patient Management System (including the LATITUDE Communicator and the Communicator accessory and literature kit) is a class III device. Boston Scientific was first awarded a CE mark in March 2012. The most recent renewal was in June 2015.
Boston Scientific was awarded a class IIa CE mark for the LATITUDE NXT server software in May 2012.
The LATITUDE NXT Patient Management System is designed to communicate remotely with a compatible Boston Scientific implanted cardiac device and transfer information to a central database where it can be accessed by authorised clinicians. The main component of the system is the LATITUDE Communicator, an in-home monitoring device for patients that periodically collects information on the function of the device and the heart function of the person. The device information is collected from a number of diagnostic tests. These include sensing, which assesses the ability of the device to detect intrinsic cardiac activity; impedance, which measures lead integrity; and threshold, which measures the amount of electrical energy needed to stimulate the heart muscle. The physiological information stored on the device is based on criteria set by the clinician and is specific to the individual patient. Information is transferred to a secure server through either a telephone line or mobile line (using a built-in 2G modem in later Communicator models or a separate 3G dongle) or through a wired Ethernet connection. The ability to transmit data using wireless broadband networks is being introduced. The Communicator measures 20.3×11.4×6.9 cm and weighs 0.38 kg. It is designed be set up at home by the patient or a carer, and needs to be connected to a power supply and potentially a telephone socket. It should be placed at the patient's bedside or, if this is not practicable, where they spend a lot of time each day.
The clinician decides when the data should be collected and transmitted. This can be done manually for specified dates, or automatically at predetermined intervals that may be as often as every day. The clinician sets the schedules and configuration through the LATITUDE NXT website and the Communicator updates when it next connects to the server. The system also supports non-scheduled patient-initiated interrogations, which collect the same information as the scheduled collections. This feature needs to be enabled by the clinic, and allows patients to initiate up to a maximum of 5 interrogations per week by pressing the designated button on the Communicator. Use of this feature increases the total number of interrogations, and may decrease the lifetime of the device battery. The Communicator can also send body weight and blood pressure information collected from the compatible wireless weighing scales and blood pressure cuffs supplied by Boston Scientific, as part of the LATITUDE NXT Heart Failure Management System. This feature is intended to alert clinicians to other changes in a patient's clinical status, such as increases in their body weight, which might indicate the early stages of heart failure decompensation
The server is a centralised computer database managed by Boston Scientific that receives, stores, and manages the data from the implanted device and the optional blood pressure monitor and weighing scales, alongside patient details. The system collects sensitive personal data. Patients must consent to data collection and sharing before they are registered on the system. Individual patient data may be accessed only by authorised users via the LATITUDE NXT website or the mobile app for iPhone. Access via the mobile app is read-only and allows the clinician to review patient and device information and generate reports. The website allows clinicians to access pacemaker device and patient health information. The system also issues alerts when it detects adverse clinical events or problems with the device function. The conditions that prompt an alert include clinical issues such as arrhythmia, and technical or mechanical problems with the device such as low battery life and impaired lead performance. The clinician needs to log on to the LATITUDE NXT website in order to receive alerts, which may appear as often as daily. Secondary notification of alerts may be through email or text message, although these depend on external systems. Implanted device issues that could potentially leave the patient without therapy trigger an automatic alert. Less serious alerts for other events can be configured by the clinician for individual patients. Designated Boston Scientific personnel, covered by a confidentiality agreement, also have access to patient data which is used for technical, research and clinical reporting purposes.
LATITUDE NXT can be used only with compatible Boston Scientific devices, which include: the Advantio, Ingenio, Vitalio, Essentio, Proponent, and Accolade pacemakers; the Invive, Inliven, Valitude and Visionist cardiac resynchronisation therapy-pacemakers; the Incepta, Energen, Punctua, Autogen and Inogen defibrillators; and Emblem subcutaneous implantable cardioverter defibrillators. Not all Boston Scientific devices are compatible with the system. Devices from other manufacturers are not compatible with the system. LATITUDE customer support has a telephone helpline and provides technical and general maintenance support to customers using the LATITUDE NXT system.
The LATITUDE NXT Patient Management System is intended for use in the person's home for remote monitoring of compatible Boston Scientific implanted cardiac devices. The Communicator can be used in another location (such as a hotel room when on holiday) providing it can be plugged into an electricity supply and the Communicator is able to connect to the LATITUDE NXT server through the configured method. The LATITUDE NXT system collects and sends data from a person's implanted Boston Scientific cardiac device to the secure central database for clinicians to access. The LATITUDE NXT system is intended to reduce the frequency of routine hospital device clinic appointments. The system also issues alerts to give an early warning of a clinical event or device issue.
Current NHS options for the post-implantation monitoring of implantable cardiac devices include outpatient device clinic evaluations, remote management and remote monitoring.
NICE is aware of the following CE‑marked devices that appear to fulfil a similar function to the LATITUDE NXT Patient Management System:
CareLink Network (Medtronic)
Merlin@home (St Jude Medical)
BIOTRONIK Home Monitoring (Biotronik).
NICE has produced a medtech innovation briefing on the CareLink Network.
The LATITUDE Communicator typically costs up to £500 per patient. This is a one-off payment and provides continuing unlimited remote monitoring for as long as needed. The full LATITUDE NXT Heart Failure Management System typically costs up to £1,200 and includes the Communicator, weighing scales and a blood pressure monitor. These prices will vary depending on the specific hospital procurement arrangements. Boston Scientific provides all additional services to set up a hospital with the system at no charge, including product delivery, installation, training, education and software upgrades. All maintenance for the life of the system is also provided by LATITUDE customer services at no extra charge. The Communicator is configured to communicate with a single implanted device. Once a Communicator has been used by a patient, it cannot be reconfigured or used by a different patient. The weighing scales and blood pressure monitor are also designed for use by a single patient, and cannot be reconfigured for a different patient.
The LATITUDE NXT Patient Management System would be used to manage and monitor a person's implanted Boston Scientific cardiac device remotely. It is intended to reduce routine outpatient appointments with a cardiologist or cardiac physiologist. The person's clinician would review data from the device using the secure database. If the data suggest a problem or if an alert is sent to the person's clinician, an outpatient appointment would be scheduled if needed.
One specialist commentator noted that the Communicator is easy to set up and to use, the hardware is robust and reliable, and patients report a great deal of reassurance when using the system. Another specialist commentator noted that there are a number of small switches on the Communicator that need to be correctly positioned in order for the information to be transmitted on a telephone landline, and that patients who are not technically minded or have limited dexterity may need help to set up the Communicator.
One specialist commentator noted differences in the functionality of the LATITUDE system compared with other remote monitoring systems currently available. They stated that the LATITUDE system is the only one that gives alerts for 'accelerated arrhythmias', which the technical staff find useful. However, unlike some other systems it does not have a heart failure impedance-based assessment for pulmonary oedema, which clinicians have also reported to be useful. The commentator added that the system does have a heart-rate variability algorithm which may give data on a patient's daily performance and clinical status, but that hard data and guidance for its usage is not available as yet for the 'real world' setting.
One specialist commentator noted that the system incorporates much of the benefits of remote monitoring – easy follow-up for patients without the need to travel into the implanting centre, and the generation of alerts which are automatically generated by the system when potential clinical, technical or mechanical problems are identified.
One specialist commentator noted that the retrieval of alerts and episodes can be laborious because the system may identify a single prolonged episode of arrhythmia as several different events, each of which needs to be selected, opened and printed individually.
NICE is committed to promoting equality, eliminating unlawful discrimination and fostering good relations between people with particular protected characteristics. In producing guidance, 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).
Implanted cardiac devices can be used by people of any age, but are more commonly used in people over 60 years old. 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 provide comments on the LATITUDE NXT Patient Management System.
The organisation stated that patients and users welcome and embrace remote monitoring systems. Having the monitor at home, or when travelling on business or holidays (subject to an internet connection), reduces anxiety and gives users the reassurance to enable them to live a normal life. They commented that users feel safe in the knowledge that data are backed-up daily and can be accessed by their clinician at any time. If users or their carers have any concerns they can call the clinic and data can be downloaded for the nurse or technician to review immediately. This provides them with the reassurance that if any problems are detected, they will be given a hospital appointment or the hospital will call them in urgently.
The Arrhythmia Alliance believes that home and remote monitoring is good for the patient and healthcare providers, reducing costs, hospital-acquired infections, waiting times in clinics for new and urgent cases and providing increasing confidence for the patient and carer. Monitoring also reduces anxiety and stress for those with or caring for someone with a potentially life-threatening condition and in receipt of life-saving devices.