The INFluence of Remote monitoring on Anxiety/depRession, quality of lifE, and Device acceptance in ICD patients: a prospective, randomized, controlled, single-center trial

Abstract

Background Impact of telemedicine with remote patient monitoring (RPM) in implantable cardioverter-defibrillator (ICD) patients on clinical outcomes has been investigated in various clinical settings with divergent results. However, role of RPM on patient-reported-outcomes (PRO) is unclear. The INFRARED-ICD trial aimed to investigate the effect of RPM in addition to standard-of-care on PRO in a mixed ICD patient cohort. Methods and results Patients were randomized to RPM (n = 92) or standard in-office-FU (n = 88) serving as control group (CTL). At baseline and on a monthly basis over 1 year, study participants completed the EQ-5D questionnaire for the primary outcome Quality of Life (QoL), the Hospital Anxiety and Depression Scale, and the Florida Patient Acceptance Survey questionnaire for secondary outcomes. Demographic characteristics (82% men, mean age 62.3 years) and PRO at baseline were not different between RPM and CTL. Primary outcome analysis showed that additional RPM was not superior to CTL with respect to QoL over 12 months [+ 1.2 vs. + 3.9 points in CTL and RPM group, respectively (p = 0.24)]. Pre-specified analyses could not identify subgroups with improved QoL by the use of RPM. Neither levels of anxiety (− 0.4 vs. − 0.3, p = 0.88), depression (+ 0.3 vs. ± 0.0, p = 0.38), nor device acceptance (+ 1.1 vs. + 1.6, p = 0.20) were influenced by additional use of RPM. Conclusion The results of the present study show that PRO were not improved by RPM in addition to standard-of-care FU. Careful evaluation and planning of future trials in selected ICD patients are warranted before implementing RPM in routine practice.

Analysis of Early Warning Diagnostic Indexes and Influencing Factors of Anxiety and Depression in Patients with Arrhythmia

“…However, excessive anxiety will have a significant negative impact on people, not only as a manifestation of mental illness but also when accompanied by physical illness. If the heart rate accelerates and the blood pressure rises, and then the ventricular fibrillation threshold are lowered, the risk of sudden death from coronary heart disease is greatly increased [ 12 ]. Similar to anxiety, depression is also a common bad mood, which refers to the mental state dominated by a low mood.…”

Gender Differences in Anger Among Hospital Medical Staff Exposed to Patients with COVID-19

“…2,13 These treatments cannot be replaced by telemedicine or online treatment, as is the case with psychotherapy 14 or the remote monitoring of patients with an implantable cardioverter-defibrillator. 15 In a different context, female gender has been found to be a predictor of the onset of PTSD among military health care personnel after deployment. 16 Anger is a common response to work-related life-threatening situations.…”

Selection and outcome of implantable cardioverter‐defibrillator patients with and without cardiac resynchronization therapy: Comparison of 4384 patients from the German Device Registry to randomized controlled trials

“…The overall complication rate was lower than in RCT reflecting the broader experience with complex cardiac devices nowadays 27 . Remote monitoring of ICDs has not yet shown consistent evidence in reducing mortality and impact on quality of life 28,29 . The nonstandardized questions in the registry confirm a high acceptance of the device and safety‐feeling by telemetric surveillance.…”

“…The nonstandardized questions in the registry confirm a high acceptance of the device and safety‐feeling by telemetric surveillance. Nevertheless, selection of patients with clear evidence for telemetric surveillance taking the costs into account is still unclear 28 …”