Impairment of Quality of Life among Patients with Wearable Cardioverter Defibrillator Therapy (LifeVest®): A Preliminary Study

Abstract

Background Wearable cardioverter defibrillator (WCD) therapy is feasible and safe in patients as a transient protection against sudden cardiac death (SCD). However, the impact of WCD therapy on quality of life (QoL) has not been studied. Methods In our single-centre study, 109 consecutive patients with a prescription of WCD were retrospectively analysed. Quality of life has been assessed by a standardized questionnaire (EQ-5D-3L, modified). Additionally, clinical baseline and follow-up data and recorded arrhythmic episodes were evaluated. Results Mean WCD therapy time was 56.2 (± 42.4) days, with a daily wear time of 19.7 (± 5) hours. A total of 3441 arrhythmia episodes were detected. Of these, 27 (1%) were adequate but did not require shock therapy. Likewise, no inadequate shock therapy occurred. WCD therapy negatively affected quality of life: 43% of patients reported mental health issues. 37% reported pain or discomfort. Self-care, usual activities, and mobility were restricted in 17%, 48%, and 36%, respectively. 29% were afraid of receiving shock therapy, and 48% suffered from sleep disturbance. However, 64% indicated having felt safe during WCD therapy. Accordingly, average quality of life was rated 70/100 points. Conclusion In our cohort, no SCD was prevented by WCD therapy. In contrast, in this preliminary study quality of life was reduced. Thus, careful recommendation of WCD therapy for high risk patients should be considered.

Effectiveness, efficacy, and safety of wearable cardioverter-defibrillators in the treatment of sudden cardiac arrest – Results from a health technology assessment

“…These results correspond with the results of the study of Zylla et al (54) who report no relationship between inadequate alarms and compliance ( r = .055, p = .578). As the study of Lackermair et al (44) had no comparator arm it remains unclear how patients without a WCD rate their QoL in a situation with a high risk for SCD and strong dependence on bystanders and their adequate reaction in the case of a SCA. Results of the VEST trial regarding QoL are not published yet but might help for a better understanding of patient's point of view in the future.…”

“…Currently, QoL during the WCD usage has not been investigated sufficiently. Only one trial (44) reported the results of a validated QoL assessment tool, namely EQ-5D-3L. Most patients had no problems in one of the five dimensions of the EQ-5D-3L but anxiety and/or depression was a relevant topic for 43 percent of patients.…”

Collaborative care for the wearable cardioverter defibrillator patient: Getting the patient and medical team “vested and active”

“…12 A small retrospective study of 109 German WCD patients found that 64% of the patients felt "safer" with their WCD. 13 On the other hand, the mental awareness of the threat of sudden cardiac arrest and the need for a WCD may stimulate thoughts of fear and mortality. 14 Moreover, Lackermair 2018 also reported that 43% reported a "mental health problem" during WCD use using a dichotomous response format.…”

“…On the one hand, the physical presence of the WCD with active monitoring and treatment capacities provides the patient with awareness of protection 12 . A small retrospective study of 109 German WCD patients found that 64% of the patients felt “safer” with their WCD 13 . On the other hand, the mental awareness of the threat of sudden cardiac arrest and the need for a WCD may stimulate thoughts of fear and mortality 14 .…”

“…On the other hand, the mental awareness of the threat of sudden cardiac arrest and the need for a WCD may stimulate thoughts of fear and mortality 14 . Moreover, Lackermair 2018 also reported that 43% reported a “mental health problem” during WCD use using a dichotomous response format 13 . Given these mixed results and the limited information available on the psychological impact of wearing a WCD, additional research using patient‐reported outcomes are needed.…”