Telemonitoring and Quality of Life in Patients after 12 Months Following a Pacemaker Implant: the Nordland Study, a Randomised Trial

Abstract

The purpose of this study was to analyse the health-related quality of life (HRQoL) of patients followed up using a remote device-monitoring system (TM) compared to patients followed up through standard outpatient visits (HM), 12 months after the implantation of a pacemaker. This was a trial design that used the EuroQol-5D Questionnaire and the Minnesota Living with Heart Failure Questionnaire (MLHF). The HRQoL of a cohort of 50 consecutive patients randomly allocated to one of the two follow-up modalities was measured at baseline and then during follow-up, 12 months after the pacemaker implantation. Eventually, 23 patients were followed-up through standard outpatient visits, while 23 used a remote monitoring system. Results: The baseline clinical characteristics and health-related quality of life of the patients from both groups were observed to be statistically similar. Twelve months after the pacemaker implantation, both groups showed statistically significant improvements in the baseline parameters based on the MLHF. The patients followed up through hospital visits showed a greater increase in MLHF-HRQoL after 12 months, although the increase was not significantly greater than that of the TM group. Furthermore, the frequencies of emergency visits and re-hospitalisations did not differ between the groups.

Cost–utility analysis of telemonitoring versus conventional hospital-based follow-up of patients with pacemakers. The NORDLAND randomized clinical trial

“…Baseline data were published previously [38,39]. The mean age of the patients was 74.8 years (CI: 71.50 to 78.18) and 48% were women, with no significant differences between both groups (Table 1).…”

“…The NORDLAND study was designed as an open-label, 1:1, randomized, non-masked, controlled trial (S1 Appendix) to compare health-related quality of life (HRQoL) and costs with respect to the follow-up of users with an implanted PM who are assigned either telemonitoring-through electronic data transmission (intervention group, TM)-or conventional follow-up visits in the hospital (control group, CM) with 12 months' follow-up from the date of implantation, and includes an associated cost-utility analysis. Detailed information on the trial's design, inclusion and exclusion criteria, population characteristics, and the HRQoL preliminary results have been published elsewhere [38,39]. Briefly, between August 2014 and October 2015, 50 patients were randomized to either TM (n = 25) or CM (n = 25) in Nordland Hospital (Fig 1), which is a center with a pacemaker specialized unit serving a population of 170,000 inhabitants of Bodø (Nordland, Arctic Circle, Norway) that performs around 80-90 pacemaker implantations per year.…”

“…Furthermore, the majority of previous studies are non-randomized, which introduces the potential bias of selecting patients who are prone to the use of these technologies for some reason, whereby biasing comparisons with traditional alternatives. The Nordland study [38,39], with the accompanying economic evaluation, was designed to prospectively compare the effectiveness and cost-utility of pacemaker telemonitoring in relation to conventional hospital monitoring.…”

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

“…These results are very similar to those of the Nordland study, where based on the Minnesota Living with Heart Failure questionnaire (MLHF) both follow-up groups showed statistically significant improvements in the baseline parameters, 12 months after the PM implantation. However, no significant differences were found in these parameters or any of the EQ-5D utility dimensions between the RM and CM groups at the enrolment and 12 months [37].…”

“…Other indications included heart block, sinus node dysfunction and bundle branch block [20,[32][33][34][35][36]. A recent study from Norway, with a similar design, described a mean age of 75 years with the most common pacing indication being sick sinus syndrome, followed by atrioventricular block and chronic atrial fibrillation with bradycardia [37]. Another study with CHF described mostly elderly patients in considerably good health and with little comorbidity [5].…”