Effectiveness of Medtronic CareLink Express System in identifying patients with high-energy electrotherapy devices requiring clinically significant intervention.

BACKGROUND: The number of patients with implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy and defibrillator (CRT-D) is growing. This results in high workloads for centers performing standard controls (SC) of these systems. Medtronic CareLink Express® (MCLE) is a solution enabling remote controls (RC) of implantable devices. In cases of detecting arrhythmias or device malfunctioning, it automatically generates alarms transmitted to the controlling physician. The objective of the study was to evaluate the effectiveness of alarms generated by MCLE in identification of patients that require clinically significant intervention during SC.

METHODS: A total of 119 patients (age 64 ± 14, 17 women) implanted with ICD/CRT-D were included in the trial. Device reprogramming or pharmacological treatment modifications during SC were as-sessed as significant if they were required for optimal clinical management of the patient (effectiveness of antiarrhythmic and resynchronization therapy, also patient safety). Analysis of generated alarms was then performed to assess the effectiveness (sensitivity and specificity) of MCLE in identifying patients that require changes in therapy.

RESULTS: Data from 129 transmissions and 129 subsequent SCs were analyzed. 179 alarms were recorded during 96 (74%) transmissions. A total of 333 program changes of implanted devices took place during 107 (83%) SCs. Device reprogramming was considered clinically significant in 27 cases Additionaly, 13 pharmacological treatment modifications were performed. Sensitivity and specificity of alarms generated by MCLE with regards to identification of patients requiring clinically significant intervention was 87% and 31%, respectively. Finally, a statistically significant difference was observed in the number of clinically significant interventions among patients with and without MCLE alarms (33 [86.8%] vs. 5 [13.2%], p = 0.037).

CONCLUSIONS: Medtronic CareLink Express® is an RC system enabling high-sensitivity supervision of patients with cardiac.