Atrial electrical reverse remodeling occurs in patients with AF who maintain SR post-CV. This remodeling is likely inversely related to the duration of AF and LVH. SAPW duration does not predict recurrence of AF post-CV.
Background
In the past 2 years, multiple implantable cardioverter defibrillator (ICD) manufacturers have issued recalls on ICD models due to the potential for serious malfunction and even patient death. Previous studies examining the relationship between these recalls and patients' psychological well-being have been limited by small sample size and conflicting results. The purpose of this study is to examine the association between ICD recalls and patients' anxiety, depression, and quality of life.
Methods
Patients were drawn from an outpatient electrophysiology clinic at a tertiary care hospital in New York City. Patients who had devices subject to a recall (cases) were identified from lists provided by device manufacturer and controls (patients with ICDs not subjected to a recall) were drawn from a convenience sample of outpatients. The survey instrument consisted of two validated questionnaires-Hospital Anxiety and Depression Score (HADS) and MacNew Heart Disease Health related Quality of Life (QOL) instrument. In addition, a series of Likert type scales were designed to elucidate patients' concerns related to the following domains: anger, trust, hope, concerns regarding ICD shock, fear of death (FOD) and physicians' ability to reduce their concern about the ICD recall. Data were analyzed using simple descriptive statistics and bivariate analyses (chi-square and t-test) as appropriate.
Result
61 cases and 43 control patients were enrolled. Thirty two patients (52%) with devices subject to a recall opted for a generator replacement. There were no significant differences in the mean scores on the HADS scale, or the MacNew QOL scale between these two groups of patients (cases and control). Subgroup analysis within the group of patients whose ICDs were recalled (cases) revealed a reduced QOL amongst patients with a Class I recall (reasonable probability that the product will cause serious adverse health consequences or death) as compared to those with a Class II recall (product may cause temporary or medically reversible adverse health consequences) (p=0.01). Both cases and control patients reported having reduced trust in the health care system. On the whole, however, patients were satisfied with the way their physicians dealt with the recall. There was no significant change in the overall concern of ICD shocks or FOD between the two groups.
Conclusion
In this study of ICD recall, we found no difference in the levels of anxiety, depression or QOL expressed by patients with an ICD subject to a recall as compared to those without. These findings may be a reflection of good physician-patient communication, which might have reduced any anxiety associated with recalls.
The recent advisory of Medtronic Sprint Fidelis leads has resulted in significant controversy over proper management of patients. The current manufacture's guidelines recommend programming specific device alerts with close follow-up and implantable cardioverter-defibrillator lead replacement in patients with evidence of breach in lead integrity. Recently, several studies have identified significant limitations in this method of surveillance. We report the case of a pacemaker-dependent patient with an ischemic cardiomyopathy, who presented with cardiac arrest and evidence of fracture of the pace/sense portion of a Sprint Fidelis lead during postmortem interrogation. Likely mechanisms leading to his ultimate demise are discussed.
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