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The use of implantable cardioverter defibrillators (ICDs) has proven to be effective in treating cardiac arrhythmias in subgroups of patients with heart disease, and has become the treatment of choice in the prevention of sudden cardiac death. Expanding indications for primary prevention led to an increase in ICD implants, with approximately 5.000 new implants per year in the Netherlands alone. Over the past years, the impact of ICD therapy on patients’ psychosocial wellbeing received more and more attention in research and clinical practice. However, insight into the patient perspective is still limited in some areas, especially with regard to the driving restrictions and remote patient monitoring. This dissertation aims to further enhance the understanding of the patient perspective on heart failure and ICD therapy. The first part discusses patients’ illness perceptions, their emotional responses to ICD implantation in general and to the subsequent driving restrictions, and describes the feasibility of a psycho-educational group program. The second part is devoted to the patient perspective on remote device follow-up in particular. This dissertation reports findings from three studies; the European multicenter REMOTE-CIED trial (N=595), a Dutch multicenter prospective cohort study (N=413), and a Dutch multicenter feasibility study (N=41). All studies included an elaborative set of questionnaires to assess patient-reported outcomes, and information on clinical characteristics was collected from electronic patient records. The first part of this dissertation shows that comorbidities, stress, smoking, and heredity were most frequently mentioned by patients as heart failure causes. However, patients often failed to recognize physical risk factors and tended to underestimate their own risk. Furthermore, 20-25% of patients with heart failure and an ICD suffers from psychological distress (i.e. anxiety and/or depression) during the first weeks after implantation. Psychological characteristics – and not clinical characteristics – are associated with patients’ distress levels and heart failure perceptions, emphasizing the importance of early psychological screening to timely identify and treat patients at risk for distress. This part also shows that the driving restriction negatively influenced patients’ psychological wellbeing, with 28% of patients reporting to be non-compliant, and 49% reporting a decreased quality of life due to these restrictions. To support patients and partners in coping with heart failure and an ICD, we developed an ICD-specific psycho-education group program and tested its feasibility in six Dutch hospitals. A recruitment rate of 26% and drop-out rate of 7% shows indicates that this program can be implemented in Dutch clinical practice. The second part describes longitudinal data from the REMOTE-CIED trial, showing that remote patient monitoring leads to comparable levels of health status, ICD acceptance, and heart failure self-care behavior compared to regular in-hospital follow-up during the first two years after implantation. Both quantitative and qualitative data indicate that patients are generally satisfied with the Latitude® remote monitoring system from Boston Scientific. However, patients with a lower educational level, without work, and with chronic obstructive pulmonary disease more often prefer in-hospital follow-up. This emphasizes the importance to discuss patients’ preferences and needs with regard to ICD follow-up during in-clinic consultations in a shared-decision making process.

Background: Studies have shown that remote patient monitoring (RPM) of implantable cardioverter defibrillators (ICDs) is at least comparable to in-clinic follow-up with regard to clinical outcomes and might be cost-effective, yet RPM is not standard clinical practice within Europe. Better insight into the patient perspective on RPM may aid in its acceptance, implementation, and reimbursement. This narrative review (1) summarizes existing evidence on the impact of RPM on patient-reported outcomes and (2) discusses future directions in examining the patient perspective. Methods and Results: Literature review indicated that only five randomized trials on RPM in ICD patients included patient-reported outcomes, with inconclusive results. Observational studies show a trend toward good patient satisfaction and acceptation of RPM. Yet, results should be interpreted with caution due to a number of limitations including a potential selection bias, use of generic/nonvalidated questionnaires, relatively short follow-up durations, and a lack of subgroup identification. Conclusion: Although RPM seems to be safe, effective, timely, and efficient, the patient perspective has received little attention so far. The scarce evidence on patient-reported outcomes in RPM studies seems to be positive, but future trials with a follow-up of ≥12 months and validated patient-reported outcome measures are needed. The REMOTE-CIED study from our group is the first prospective randomized controlled trial primarily designed to examine the patient perspective on RPM, and is powered to identify characteristics associated with RPM satisfaction and benefit. Results are expected in 2018 and will add valuable information to the current evidence.