Impact of Implantable Cardioverter‐Defibrillator Recalls on Patients' Anxiety, Depression, and Quality of Life

Abstract

Background In the past 2 years, multiple implantable cardioverter defibrillator (ICD) manufacturers have issued recalls on ICD models due to the potential for serious malfunction and even patient death. Previous studies examining the relationship between these recalls and patients' psychological well-being have been limited by small sample size and conflicting results. The purpose of this study is to examine the association between ICD recalls and patients' anxiety, depression, and quality of life. Methods Patients were drawn from an outpatient electrophysiology clinic at a tertiary care hospital in New York City. Patients who had devices subject to a recall (cases) were identified from lists provided by device manufacturer and controls (patients with ICDs not subjected to a recall) were drawn from a convenience sample of outpatients. The survey instrument consisted of two validated questionnaires-Hospital Anxiety and Depression Score (HADS) and MacNew Heart Disease Health related Quality of Life (QOL) instrument. In addition, a series of Likert type scales were designed to elucidate patients' concerns related to the following domains: anger, trust, hope, concerns regarding ICD shock, fear of death (FOD) and physicians' ability to reduce their concern about the ICD recall. Data were analyzed using simple descriptive statistics and bivariate analyses (chi-square and t-test) as appropriate. Result 61 cases and 43 control patients were enrolled. Thirty two patients (52%) with devices subject to a recall opted for a generator replacement. There were no significant differences in the mean scores on the HADS scale, or the MacNew QOL scale between these two groups of patients (cases and control). Subgroup analysis within the group of patients whose ICDs were recalled (cases) revealed a reduced QOL amongst patients with a Class I recall (reasonable probability that the product will cause serious adverse health consequences or death) as compared to those with a Class II recall (product may cause temporary or medically reversible adverse health consequences) (p=0.01). Both cases and control patients reported having reduced trust in the health care system. On the whole, however, patients were satisfied with the way their physicians dealt with the recall. There was no significant change in the overall concern of ICD shocks or FOD between the two groups. Conclusion In this study of ICD recall, we found no difference in the levels of anxiety, depression or QOL expressed by patients with an ICD subject to a recall as compared to those without. These findings may be a reflection of good physician-patient communication, which might have reduced any anxiety associated with recalls.

The prevalence of anxiety and depression in adults with implantable cardioverter defibrillators: A systematic review

“…Most studies reported data on secondary prevention patients. Only 6 studies [22,23,[33][34][35][36] reported data by indication, but all had less than, or equal to, 20 patients in the primary or secondary groups, and none found significant primary versus secondary differences in symptoms of anxiety or depression (not shown).…”

Educational and Psychological Interventions to Improve Outcomes for Recipients of Implantable Cardioverter Defibrillators and Their Families

“…The impact of device recall has been assessed in 6 studies. Four studies found no difference in psychological response between those with and without a device recall, 71,[73][74][75] whereas 2 studies reported a heightened level of anxiety at the time of evaluation after a device recall. 72,75 Collectively, ICD recalls remain under study, but more recent data suggest that ICD patients can generally tolerate the specter of recall and appreciate receiving information from the physician or manufacturer 96 but have more significant distress if that recall results in an adverse event such as a shock.…”

Perspectives of patients with cardiovascular implantable electronic devices who received advisory warnings

“…Several studies showed that patients with CIEDs affected by advisories experienced higher levels of anxiety, ICD concerns, and distress than patients with CIEDs unaffected by advisories (10,12,14,15). In the other studies, device advisories had no adverse psychological impact on affected patients (9,11,13,16,17). …”