Defibrillator shocks and their effect on objective and subjective patient outcomes: Results of the PainFree SST clinical trial.

BACKGROUND: The effect of implantable cardioverter-defibrillator (ICD) shock on device-measured activity and patient-reported outcomes is unknown. OBJECTIVE: The purpose of this study was to analyze the acute and long-term effects of ICD shock on objective behavioral data (ie, device-based physical activity) and subjective patient-reported outcomes (eg, quality of life and shock anxiety). METHODS: The PainFree Smart Shock Technology (SST) clinical trial included 2770 patients with a single- or dual-chamber ICD or cardiac resynchronization therapy - defibrillator device who were followed for 22 ± 9 months. Participants completed measures of quality of life (EuroQol-5D [EQ-5D] questionnaire) and shock anxiety (Florida Shock Anxiety Scale) at baseline, biannual visits, and monthly for 6 months after an ICD shock. Daily physical activity data were obtained from a built-in device accelerometer. RESULTS: The average daily activity was 185.3 ± 119.4 min/d. Activity was significantly reduced after an ICD shock (P < .0001) and recovered to a normal level after ∼90 days. An ICD shock was also associated with decreased quality of life (EQ5-D health score) and increased EQ-5D anxiety scores, but it did not affect mobility, self-care, activity, or pain. Similarly, shock anxiety (Florida Shock Anxiety Scale) increased in shocked patients and remained significantly elevated at 24 months, regardless of appropriate or inappropriate shock delivery. CONCLUSION: ICD shocks have a long-lasting adverse effect on both objective, device-measured physical activity and subjective patient-reported outcomes of quality of life and shock anxiety. Successful management of patients with an ICD requires attention to clinically relevant behavioral and psychological outcomes to expedite recovery and return to activities of daily living.