Key result
A public statement regarding potential ICD malfunctioning significantly increased the proportion of patients experiencing high levels of anxiety from 6.1% at baseline to 24.2% at follow-up (P=0.031).
Why the study?
Does a public statement of potential ICD malfunctioning and subsequent extra device evaluation increase anxiety levels in ICD patients?
Observational (n=33)
Does a public statement of potential ICD malfunctioning and subsequent extra device evaluation increase anxiety levels in ICD patients?
Public statements regarding potential ICD malfunctioning significantly increase anxiety levels among affected patients, highlighting the potential need for psychological support.
Public advisories on potential ICD issues were associated with increased anxiety; leaves open whether targeted support mitigates effects in device recipients.
BACKGROUND: Psychological problems following implantable cardioverter defibrillators (ICD) implantation are diverse and include increased levels of anxiety. Anxiety may even rise further when possible malfunctioning of an ICD is announced, with a higher risk of serious ventricular arrhythmias and death as a consequence. Following the public statement of Medtronic, all patients in the Netherlands with the specific Medtronic ICD were contacted for extra device evaluation. The aim of this exploratory study was to determine whether the proportion of ICD patients with high levels of anxiety would increase after this extra device evaluation. METHODS: Patients were recruited from an ongoing prospective study on psychological effects of ICD implantation. Thirty-three patients completed the State subscale of the State-Trait Anxiety Inventory (STAI) before and after extra device evaluation. The STAI can identify patients with high levels of anxiety. RESULTS: A high level of anxiety was experienced by two patients (6.1%) at baseline and eight patients (24.2%) at follow-up (P=0.031). Hence, ICD patients were significantly more likely to experience high levels of anxiety following the public statement of potential malfunctioning of their device. CONCLUSION: A public statement regarding device safety may increase levels of anxiety among ICD patients. Given the potential triggering effect of high levels of anxiety on arrhythmias, psychological support may be considered for some of the ICD patients after such public statement.
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Broek et al. (2006) conducted an observational in Implantable cardioverter defibrillators (ICD) (n=33). Public statement of potential malfunctioning and extra device evaluation vs. Baseline (before statement and evaluation) was evaluated on High level of anxiety (measured by the State subscale of the State-Trait Anxiety Inventory) (p=0.031). A public statement regarding potential ICD malfunctioning significantly increased the proportion of patients experiencing high levels of anxiety from 6.1% at baseline to 24.2% at follow-up (P=0.031).
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