Characteristics of patients and implantable defibrillators associated with failure to sense device alert systems

Abstract

In the era of increasing implantable cardioverter defibrillator (ICD) complexity, the ICD patient alert is deemed to be an important feature in the early detection of ICD system malfunction and is either an audible or a vibratory alert. We sought to evaluate the patient's ability to detect these ICD alerts in the device clinic setting as a surrogate endpoint of clinical utility. From 1 November 2006 to 31 March 2008, 563 patients with an ICD equipped with either an audible patient alert (APA, Medtronic and Guidant; n = 485) or a vibratory monitoring alert ([VMA, St Jude Medical; n = 78) had their alarm demonstrated in the quiet clinic setting. The ability to recognize the alert was analysed and then stratified by gender, age, manufacturer, type of alert, and pocket location. The average patient age was 63.3 (± 13.6) years and 82.8% of patients were male. Implantable cardioverter defibrillator manufacturers were Medtronic (n = 464), Boston Scientific (n = 21), and SJM (n = 78). The APA was heard in 86.0% of patients. This was less likely in patients who were older, male, and where the device was placed in the submuscular position. Every patient with a VMA sensed their alert. In the current ICD alert technology, the ability to sense the ICD alert in the device clinic appears to be higher for the VMA than for the APA. In particular, older patients and male patients are less likely to sense the APA.