Effectiveness and Safety in Remote Monitoring of Patients with Pacemakers Five Years after an Implant: The Poniente Study.

Abstract

Health-related quality of life (HRQoL) and functional capacity values immediately after pacemaker (PM) 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 plus a clinic visit versus clinic visits alone during follow-up of adults implanted with PMs. 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: remote monitoring (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. 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