Sudden Death in Patients With Cardiac Implantable Electronic Devices | Journal Scan
What are the causes of sudden death in patients with cardiac implantable electronic devices (CIEDs)?
San Francisco residents with CIEDs who died suddenly underwent a full autopsy, toxicology, histology, and device interrogation, as part of the POST SCD (Postmortem Systematic Investigation of Sudden Cardiac Death) study.
Among 517 sudden deaths, there were 22 patients with CIEDs (4.3%). Noncardiac cause was found in six patients. Six of 14 pacemaker sudden deaths and seven of eight implantable cardioverter-defibrillator (ICD) sudden deaths were due to ventricular tachycardia or ventricular fibrillation. Fifty percent of deaths were associated with device concerns; four pacemakers and seven ICDs. There were three hardware failures contributing directly to death, five ICDs with ventricular fibrillation undersensing, one ICD with ventricular tachycardia missed due to suboptimal programming, one improper device selection (pacemaker in a high-risk hypertrophic cardiomyopathy patient), and a fatal lead fracture in a pacemaker-dependent patient.
The authors concluded that postmortem device interrogation identifies concerns about CIED function.
Surveillance of CIED malfunctions in the United States is done primarily through the Manufacturer and User Facility Device Experience (MAUDE) database. While the manufacturers and hospitals are required to report adverse outcomes, physicians are not. The vast majority of sudden deaths in patients with CIEDs occur outside of the hospital. Only slightly more than one in five CIEDs are explanted and returned to the manufacturer for analysis, mainly following a generator change-out. The present study reports an incredibly high rate of device-related deaths (50%!!!) due to hardware failures, undersensing of ventricular fibrillation, inappropriate device programming, lead fractures, and selection of inappropriate device for a patient. It is not clear to me if any of the devices with failures in the study were on Food and Drug Administration advisories. Nonetheless, the authors raise a very important issue of quality improvement and adverse event reporting, and hopefully others will follow in their path.
Clinical Topics: Arrhythmias and Clinical EP, Heart Failure and Cardiomyopathies, Prevention, Implantable Devices, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias, Acute Heart Failure
Keywords: Arrhythmias, Cardiac, Autopsy, Cardiomyopathy, Hypertrophic, Death, Sudden, Cardiac, Defibrillators, Implantable, Heart Failure, Pacemaker, Artificial, Quality Improvement, Secondary Prevention, Tachycardia, Ventricular, Ventricular Fibrillation
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