Advice

Summary

Summary

The CareLink network service is a remote monitoring system for people with a Medtronic implantable cardiac device. The service uses the MyCareLink monitor or MyCareLink Smart (for smartphones or tablets) to collect data remotely from the device. These data are transferred to the patient's clinician through the CareLink network with the aim of reducing the need for face-to-face follow‑up visits. Evidence from prospective studies of mixed quality suggests that the CareLink network service decreases the time from the detection of a clinical event to a clinical decision, and decreases the number of emergency visits and healthcare use in people with heart failure when compared with standard face-to-face follow‑up. The CareLink network service showed a lower number of false negatives when compared with other home monitoring devices and had 100% event notification. The list price of the CareLink network service including all components and software is £970 (excluding VAT) per patient.

NICE has also published a medtech innovation briefing on the LATITUDE NXT remote monitoring system for people with a compatible Boston Scientific implantable cardiac device.

Product summary and likely place in therapy

  • The CareLink network service allows a person's implanted Medtronic cardiac device to be remotely monitored by a health professional. Data collected from the device is transferred securely to their clinician for review. CareAlert notifications are also generated and sent to the clinician if a clinical event or a problem with the device or device leads is detected.

  • The CareLink network service 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 evidence in this briefing is based on 7 prospective studies (total patients n=3,776; CareLink patients n=2,015). Six of the 7 studies were randomised.

  • One randomised study showed no significant difference in a composite outcome of hospitalisation and emergency room visits, in unscheduled electrophysiology clinic visits, or quality of life compared with face-to-face follow‑up.

  • One randomised study reported a shorter delay from device-detected events to clinical decisions, and a reduction in hospital visits for people using CareLink compared with those having face-to-face follow‑up.

  • One randomised study reported earlier detection of potentially important actionable events when using CareLink compared with trans-telephonic monitoring.

  • One randomised study showed that Carelink reduced time to clinical decisions in response to clinical events (predominantly atrial arrhythmias) compared with face-to-face follow‑up.

  • One randomised study reported fewer emergency visits and healthcare resource use by patients with heart failure using CareLink compared with those having face-to-face follow‑up.

  • One randomised study reported no significant difference in heart failure-related hospitalisations, implantable cardioverter defibrillator shocks, or mortality in people using CareLink compared with those having face-to-face follow‑up.

  • One non-randomised study reported fewer false-negative detected events for CareLink than with other remote monitoring devices, 100% event notification and a 21% false-positive rate.

Technical and patient factors

  • The Carelink system uses either the MyCareLink monitor or the MyCarelink Smart to collect data from Medtronic implantable cardiac devices.

  • For people with implanted Medtronic devices with wireless functionality, data are transferred automatically for their clinician to access on the CareLink network service.

  • People who have implanted Medtronic cardiac devices without wireless functionality need to hold a reader over their implantable device to send information manually. This process typically takes less than 3 minutes but may take up to 12 minutes. Data are sent to their clinician immediately after retrieval.

  • Data from the MyCareLink system are transferred securely through the Vodafone worldwide data network or roaming partners. Data from MyCareLink Smart are sent using the connectivity of the person's smartphone or tablet (iOS or Android) to the CareLink Network service. Clinicians access the data through a secure website.

Cost and resource use

  • The list price for the CareLink network service is £970 (excluding VAT), which includes administration for hospital CareLink network service set-up, 6 monthly CareLink hospital website upgrades, patient and clinician training and technical support, software updates, shipment, hardware, and hosting and secure server space.