Remote monitoring versus conventional follow-up for implantable cardiac devices: Rationale and design of the PORTLink (PORTuguese Research on Telemonitoring with CareLink) trial

Abstract

With expanding indications for cardiac implantable electronic devices (CIEDs) capable of treating bradycardias, complex cardiac tachyarrhythmias and heart failure, the number of patients requiring regular long-term specialized care is growing rapidly. Currently, routine face-to-face follow-up consultations for patients with CIEDs are a significant burden on hospital services. Remote telemonitoring appears to offer a safe and effective alternative to conventional follow-up in this area. The Medtronic CareLink Network enables remote monitoring of CIED patients, and thus has the potential to improve the efficiency of medical care in this population. The objective of the PORTLink (PORTuguese Research on Telemonitoring with CareLink) multicenter randomized trial is to assess the safety, efficacy and costs of remote CIED monitoring compared to traditional face-to-face follow-up. It will evaluate aspects such as physicians’ and patients’ acceptance of and satisfaction with reviewing device data via the website, the complexity for troubleshooting calls to the support center, the use of emergency resources by symptomatic patients, the incidence of unscheduled consultations after remote interrogations, levels of anxiety, depression and quality of life, and the main resources used by the CareLink system. Approximately 200 patients will be randomized in up to five centers, with clinical follow-up of 12 months. Enrollment began in 2012 and is expected to be completed in early 2014.