A viewpoint on the impact of device advisories on patient-centered outcomes

Device advisories due to potential hardware failure comprise one of the downsides of implantable cardioverter defibrillator (ICD) therapy. The impact of advisories on patient-centered outcomes has largely been overlooked. We examined the impact of ICD advisories on patient-centered outcomes via a systematic literature review. PubMed was searched in the period from 1980 to present using a combination of at set of a priori search terms. The reference lists of the included papers were searched by hand. A total of six studies were identified. All advisories were Class I, Class II, or a combination. The sample size across studies varied between 30 and 86 patients subject to an advisory; four of six studies used a case-control design and two of six a prospective study design. There was considerable variability between notification of the advisory and assessment of the patient-centered outcomes, ranging from 1 to 24 months. A mixture of generic and disease-specific patient-centered outcome measures was used. The evidence for an impact on device advisories was mixed, with the two prospective studies showing an increase in anxiety over time, whereas none of the larger case-control studies found a difference in patient-centered outcomes between cases and controls. Evidence for an impact of device advisories on patient-centered outcomes is mixed. In order to incorporate a patient-centered approach in clinical care, patient-centered outcomes should form part of standard clinical practice and if available the assessments entered into ICD registries. Such registries would provide important insights into the impact of ICD advisories on patients' well being.

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