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 < 0.001). 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.

A non-randomized clinical trial to examine patients’ experiences and communication during telemonitoring of pacemakers after five years follow-up

“…SD: Standard Deviation; AF: Atrial Fibrillation; PM: Pacemakers; VAS: Visual Analogue Scale; Friedrich: Pacemaker wound infection. Source: López-Liria et al 2020 [ 24 ].…”

“…Regardless of these limitations, the authors believe that the PONIENTE project is a unique study providing long-term data in an area lacking research. As the study showed no differences between the telemonitoring and conventional monitoring groups in terms of health effectiveness and safety [ 24 ], and no significant differences were found concerning patient’s experiences and communication; telemonitoring may prove to be a good option for patients with difficulties in traveling to the hospital especially nowadays that healthcare services are shifting into virtual environments wherever possible. As remote healthcare services become a central solution in the current coronavirus pandemic, patients need to adopt these new technologies [ 44 ].…”

“…This study is a part of a larger project, The PONIENTE study, a controlled, single-center, non-randomized, or masked clinical trial in the Hospital de Poniente, El Ejido, Spain. The study compares a group of telemonitored PM users with another group following conventional monitoring, through a comprehensive assessment involving different perspectives like socioeconomic evaluation [ 23 ], effectiveness, and safety [ 24 ]. This project entails collaboration among chronic heart patients with a pacemaker, their relatives, cardiologists, nurses, psychologists, and health communication experts.…”

“…Participants were recruited through a convenience sampling method. The inclusion and exclusion criteria have recently been published in two papers [ 23 , 24 ]. In total, 89 patients were eligible and invited to participate, of which 55 participated in the five-year follow-up.…”

Remote Monitoring of CIEDs—For Both Safety, Economy and Convenience?

“…However, detailed information regarding response time and to what extent the systems are monitored is essential, as some patients have the misunderstanding that their heart rhythm is under real-time surveillance 24/7/365. Whether an increased feeling of confidence can be translated into standard measures of quality of life is, however, uncertain, as results have been conflicting in nonrandomized [ 55 ] and randomized trials [ 42 , 56 , 57 ]. However, patient satisfaction with RM is, in general, high [ 8 , 58 , 59 ].…”