A Viewpoint on the Impact of Device Advisories on Patient‐Centered Outcomes

Abstract

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.

Psychological Adjustment in ICD Patients Living With Advisory Fidelis Leads

“…However, all of these papers examined small numbers of patients (33–86 patients, see Ref. 17 for review).…”

Impact of a Recent Lead Recall on Utilization of Implantable Cardioverter Defibrillators: Data from the NCDR ICD Registry™

“…The 2 prospective studies in this meta‐analysis showed that device advisory may lead to increased anxiety and decreased confidence in the device. In case control studies, patients with devices under a class I advisory reported poorer quality of life than those with a device under a class II advisory 26 …”

ACCF 2012 Health Policy Statement on Patient-Centered Care in Cardiovascular Medicine

“…Hedblad et al (30), who studied causes for failure to reach target goals in the management of hypertension, found that frequent blood pressure measuring and patient communication with physicians, a PCC approach, correlated with attaining blood pressure goals. Pedersen et al (31) have discussed the need to consider a PCC approach to patients with implanted devices (32). They suggested that PCC involving behavior measures be included in device databases.…”