AimsThis trial was designed to test the hypothesis that shock efficacy during follow-up is not impaired in patients implanted without defibrillation (DF) testing during first implantable cardioverter-defibrillator (ICD) implantation.Methods and resultsBetween February 2011 and July 2013, 1077 patients were randomly assigned (1 : 1) to first time ICD implantation with (n = 540) or without (n = 537) DF testing. The intra-operative DF testing was standardized across all participating centres, and all ICD shocks were programmed to 40 J irrespective of DF test results. The primary end point was the average first shock efficacy (FSE) for all true ventricular tachycardia and fibrillation (VT/VF) episodes during follow-up. The secondary end points included procedural data, serious adverse events, and mortality. During a median follow-up of 22.8 months, the model-based FSE was found to be non-inferior in patients with an ICD implanted without a DF test, with a difference in FSE of 3.0% in favour of the no DF test [confidence interval (CI) −3.0 to 9.0%, Pnon-inferiority <0.001 for the pre-defined non-inferiority margin of −10%). A total of 112 procedure-related serious adverse events occurred within 30 days in 94 patients (17.6%) tested compared with 89 events in 74 patients (13.9%) not tested (P = 0.095).ConclusionDefibrillation efficacy during follow-up is not inferior in patients with a 40 J ICD implanted without DF testing. Defibrillation testing during first time ICD implantation should no longer be recommended for routine left-sided ICD implantation.

The HAWAI registry evaluated the role of heart rate variability in predicting the occurrence of ventricular tachycardia and fibrillation (VT/VF) and sinus tachycardia in patients with an implantable cardioverter-defibrillator (45 patients with 155 RR recordings). A significant decrease of the mean value of all RR intervals (MeanNN) was observed in the period starting 20 and 40 min prior to VT/VF and sinus tachycardia, respectively. The standard deviation of RR intervals (SDNN) and the power at low frequency (LF) were the only parameters with significant changes prior to VT/VF. For sinus tachycardia, the root mean square of successive differences of all successive RR intervals (r-MSSD) and the power at low and high frequency (HF) decreased, whereas SDNN and the power at very low frequency increased. Comparison of RR recordings preceding VT/VF and sinus tachycardia revealed significant differences of the MeanNN, SDNN, r-MSSD, LF and HF. Based on a classification and regression tree analysis, MeanNN, SDNN and r-MSSD showed a sensitivity of 94.4% and a specificity of 50.6% as predictors of VT/VF. Our results suggest that the temporal changes in heart rate before an arrhythmic event can be used to predict the occurrence of VT/VF. These parameters may be used to optimize pacing therapies designed to prevent VT/VF recurrences as well as for improving device-based discriminators for VT/VF and sinus tachycardia.

NCT01282918.

Atrial fibrillation (AF) is a relevant comorbidity in recipients of implantable cardioverter-defibrillators (ICD). Latest generation single-chamber ICD allow the additional sensing of atrial tachyarrhythmias and, therefore, contribute to the early detection and treatment of AF, potentially preventing AF-related stroke. The present study aimed to measure the impact on patient-related costs of this new ICD compared to conventional ICD. A Markov model was developed to simulate the long-term incidence of stroke in patients treated with a single-chamber ICD with or without atrial sensing capabilities. The median annual cost per patient and its difference, the number of strokes avoided, and the cost per stroke avoided were estimated. During a 9-year horizon, the costs for the ICD and stroke treatment were €570 per patient-year for an ICD with atrial sensing capabilities and €491 per patient-year for a conventional ICD. Per 1,000 patients, 4.6 strokes per year are assumed to be avoided by the new device. Higher CHA2DS2-VASc scores are associated with higher numbers of avoided strokes and larger potential for cost savings. Apart from clinical advantages, the use of ICD with atrial sensing capabilities may reduce the incidence of stroke and, in high-risk patients, may also contribute to reduce overall health care costs.

Aim During the early phase of the COVID-19 pandemic, hospital admissions for several medical and surgical conditions have declined. Few data are available with respect to elective cardiac implantable electronic devices (CIEDs) implantation. The aim of the present study was to determine the impact of the COVID-19 pandemic on the monthly CIED implantation rates in Germany. Methods and Results The monthly rates of CIED implantation for the 2019 pre- and 2020 pandemic periods were retrieved from the “Institute für das Entgeltsystem im Krankenhaus” (InEK) using OPS codes to identify pacemakers (PMs), implantable cardioverter/defibrillators (ICDs) and cardiac resynchronisation therapy (CRT) systems. Compared with 2019, the COVID-19 pandemic was associated with an overall decline of CIED implantation rates of -2.6%, reaching -22,9% in April 2020. Stratified by device type, the patterns of implantation were similar between PMs and ICDs, with maximal declines of -24.3% and -23.2% in April, respectively. Thereafter, the implantation rates gradually increased before stabilizing to rates similar to those observed in 2019. CRT implantation rates also declined in the early pandemic wave, but the overall 2020 rates increased by +4.3% likely driven by an increase of +16.5% (June to September). All observed percentage differences of monthly device type related implantation rates demonstrated a statistical significance. Conclusions The COVID-19 pandemic had a significant impact on the implantation of CIEDs in Germany. A differential pattern of resource utilization was observed with a catch-up effect for PMs and ICDs. The implantation rates of CRT also declined, but they increased rapidly and remained higher than those of 2019.