Advice

Summary

Summary

The LATITUDE NXT Patient Management System is a remote monitoring system for people with a compatible Boston Scientific implanted cardiac device. The system collects patient and device information and transfers it to a secure central database for review by a clinical team to evaluate both the patient and the device as an alternative to some outpatient visits. The relevant clinical evidence is limited; no prospective studies were identified that compared remote monitoring using LATITUDE NXT with standard in-clinic monitoring. In 1 small non-randomised prospective study LATITUDE NXT showed a low number of false negatives and false positives for detecting adverse patient and device events when compared with other home monitoring systems. In 1 retrospective observational study, remote monitoring using LATITUDE NXT was associated with a statistically significant reduction in all-cause mortality and hospital re-admissions compared with no remote monitoring. In another retrospective observational study, the use of LATITUDE NXT was associated with a statistically significant increase in long-term post-implantation survival compared with in-clinic monitoring. The main component of the system, the LATITUDE Communicator, typically costs up to £500 (excluding VAT) per patient. The LATITUDE NXT Heart Failure Management System, which includes the Communicator, weighing scales and a blood pressure monitor, typically costs up to £1,200 (excluding VAT).

NICE has also published a medtech innovation briefing on the CareLink remote monitoring system (Medtronic) for compatible implanted cardiac devices.

Product summary and likely place in therapy

  • The LATITUDE NXT Patient Management System monitors a person's compatible implanted cardiac device remotely.

  • Information collected from the device is transferred securely to a central database where it can be reviewed by their clinician. The system can also send alerts to the clinician if it detects a clinical event or a problem with the device.

  • LATITUDE NXT is an alternative to face-to-face follow-up, with the aim of reducing the number of hospital visits and earlier detection of adverse events.

Effectiveness and safety

  • The relevant evidence is limited to 1 non-randomised, prospective study (n=211), which compared 4 different monitoring systems, and 2 retrospective observational analyses (n=37,742 and 194,006) from the Boston Scientific ALTITUDE registry.

  • No prospective studies were found that compared remote monitoring using LATITUDE NXT with standard in-clinic monitoring.

  • In the study comparing 4 different remote monitoring systems, all of the systems effectively detected major events. More frequent transmission of data was associated with a higher probability of detecting events early. LATITUDE NXT showed a low number of false negatives and false positives for detecting events when compared with other home monitoring devices and gave 97% event notification.

  • In 1 retrospective observational study, remote patient monitoring was associated with a statistically significant reduction in all-cause mortality and hospital re-admissions compared with no remote monitoring.

  • In 1 retrospective observational study, remote patient monitoring was associated with a statistically significant increase in long-term post-implantation survival compared with in-clinic monitoring.

Technical and patient factors

  • The LATITUDE NXT Patient Management System consists of a LATITUDE Communicator, the Boston Scientific secure central database and the associated server software. The Communicator automatically collects patient and device information from compatible Boston Scientific implantable cardiac devices. This information is transferred securely to the database at intervals determined by the clinician. The system does not provide continuous real-time monitoring.

  • The information is transferred via a standard telephone landline, mobile line (using a built-in 2G modem in later Communicator models or a separate 3G dongle) or through a wired Ethernet connection.

  • Authorised members of a clinic may access the data through the LATITUDE NXT website or through an iPhone app.

Cost and resource use

  • The LATITUDE Communicator for use in the patient's home typically costs up to £500 (excluding VAT).

  • The LATITUDE NXT Heart Failure Management System, which includes the Communicator, and additional weighing scales and a blood pressure monitor, typically costs up to £1,200 per patient (excluding VAT).

  • 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.

  • In 1 abstract, annual cost savings of $323 (about £223) per patient were estimated in a simulated cohort using remote monitoring with the LATITUDE NXT system in the US. The reduction in costs was related to a decrease in hospital admissions, and partially offset by an increase in physician visits and telephone counselling.