A randomized controlled clinical trial of pacemaker follow-up in clinic and by telemedical interpretation of the pacemakers' magnet mode

Abstract

We assessed a two-stage follow-up procedure for cardiac pacemakers, where in-clinic follow-ups were partly replaced by telemedical follow-ups. This was compared with the standard follow-up regime (in-clinic follow-up only). The new procedure required an electronic patient record, a telemedical follow-up unit for recording ECGs while the pacemaker was temporarily set to magnet mode, an ECG processing unit, and a reviewing and reporting unit. A total of 177 (86 female) patients were randomized to the control group and 182 (98 female) patients to the telemedicine group. In the telemedicine group, 234 telemedical follow-ups were performed. Out of these, 68 required an additional in-clinic follow-up, while 166 were sufficient for assessing the pacemakers' working status. During the study, there were 19 deaths in the telemedicine group and 20 in the control group. There was no significant difference between the two groups( P = 0.40). The probability that an individual patient’s pacemaker would not to be replaced over time was analysed in a similar way to the Kaplan-Meier survival function. Fewer pacemakers were replaced in the telemedicine group (14) than in the control group (18), but the difference was not significant ( P = 0.26). We conclude that alternating telemedical and in-clinic follow-ups brings no additional risks for patients. The follow-up procedure is feasible and interpretation of the pacemakers’ magnet effect provides an easy-to-use, manufacturer-independent method of assessing the pacemakers’ working status. This should reduce the patient load on pacemaker centres and decrease the overall costs of pacemaker therapy.