Long-term Quality of Life and Safety in Remote Monitoring of Patients with Pacemakers

Abstract

Abstract Introduction Health-related quality of life (HRQoL) and functional capacity values immediately after pacemaker implantation have been well established; however, not much has been known about its long-term effects. The present study compared the long-term effectiveness and safety of remote monitoring (RM) plus a clinic visit versus clinic visits alone during follow-up of adults implanted with PMs. Methods This study was a single-centre, controlled, non-randomised, non-blinded clinical trial. Data were collected pre-implantation and after 60 months. The patients in the PONIENTE study were assigned to two different groups: RM and conventional monitoring (CM). The EuroQol-5D (EQ-5D) questionnaire was used to assess HRQoL and Duke Activity Status Index was used for the functional capacity. Results After five years, 55 patients completed the study (RM = 21; CM = 34). EuroQol-5D and functional capacity values were improved; however, significant differences were observed only in the EQ5D visual analogue scale (p < 0.001). Conclusions Remote monitoring was equally feasible, reliable, safe, and clinically useful as CM. The frequencies of rehospitalisations and emergency visits did not differ between the groups. RM was found to be safe and effective in early detection and treatment of medical- and device-related events and in reducing hospital visits. Improved HRQoL was described not only immediately after PM implantation but also extended over a long time. Key messages Remote monitoring of patients with pacemakers was found to be safe and effective in early detection and treatment of medical- and device-related events and in reducing hospital visits. Patients included in both groups of follow-up were equally feasible, reliable, safe, and clinically useful.