Adverse Events With Transvenous Implantable Cardioverter-Defibrillators

Abstract

on behalf of the European 7219 Jewel ICD InvestigatorsBackground-A newly developed classification system relates adverse events to the surgical procedure or the function of the implantable defibrillator. Methods and Results-Adverse events were monitored during prospective clinical evaluation of the Medtronic model 7219Jewel ICD and were classified according to the definitions of the ISO 14155 standard for device clinical trials into 3 groups: severe and mild device-related and severe non-device-related adverse events. In addition, events were related to the surgical procedure, treatment with the device, or cardiac function. Seven hundred seventy-eight patients were followed up for an average of 4.0 months after ICD implantation. In total, 356 adverse events were observed in 259 patients. At 1, 3, and 12 months after ICD implantation, 99%, 98%, and 97% of the patients, respectively, survived; 95%, 93%, and 92%, respectively, were free of surgical reintervention; and 79%, 68%, and 51%, respectively, were free of any adverse event. Twenty patients died: 6 deaths were related to the surgical procedure, 12 deaths were considered unrelated to ICD treatment, and 2 patients died of an unknown cause. Of 111 nonlethal severe adverse device effects, 47 required surgical intervention, 19 times for correction of a dislodged lead. Inappropriate delivery of therapy was observed 128 times in 111 patients, and the events were typically resolved by reprogramming or drug adjustment. Nine of these required rehospitalization. Conclusions-Approximately 50% of patients experience an adverse event within the first year after ICD implantation.The observed adverse event rate depends on the definitions and the prospective monitoring. The incidence of inappropriate therapy emphasizes the need for improved detection algorithms and for quality-of-life evaluations, especially when considering ICD treatment in high-risk but arrhythmia-free patients. (Circulation. 1998;98:663-670.)

2015 HRS/EHRA/APHRS/SOLAECE expert consensus statement on optimal implantable cardioverter-defibrillator programming and testing

“…With the advent and then dominance of primary prevention indications, avoidable shocks assumed a relatively larger proportion of total therapy [78][79][80][81][82][83]. Gradually, publications have increased awareness of the frequency and the diverse range of adverse outcomes associated with avoidable ICD therapy, and have demonstrated that avoidable ICD shocks can be reduced by evidence-based programming of the detection rate, detection duration, antitachycardia pacing (ATP), algorithms that discriminate supraventricular tachycardia (SVT) from VT, and specific programming to minimize the sensing of noise [81][82][83][84][85][86][87][88][89][90][91][92].…”

Predicting Sudden Death Risk for Heart Failure Patients in the Implantable Cardioverter-Defibrillator Age

“…Approximately one-third of patients will experience some adverse effect, including inappropriate shocks, lead problems, and infection. 4,5 The implantation and testing procedure occasionally precipitates hemodynamic deterioration. 6 DDD or VVI pacing from the right ventricular lead of the ICD may have adverse hemodynamic effects, including increasing dyssynchrony of left ventricular contraction, and may have contributed to the aggravation of heart failure observed in the Multicenter Automatic Defibrillator Implantation Trial II (MADIT II).…”

Inappropriate Discharges From an Intravenous Implantable Cardioverter Defibrillator Due to T-Wave Oversensing

“…1,2 Tachycardia is identified primarily from the measurement of heart rate and/or the morphology of an intraventricular electrogram, so ICD therapy can be prescribed for supraventricular tachycardia or other causes of increased heart rate. [3][4][5] However, for supraventricular tachycardia, a dual-chamber ICD would decrease the frequency of inappropriate shocks from the ICD. Other mechanisms of inappropriate discharge of the ICD include non-sustained VT, pacemaker interference or T-wave oversensing.…”