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Aims: Physical activity has shown association with ventricular arrhythmia, however, the role of specific behavioral patterns over a 24 h cycle remains unknown. Therefore, we aimed to explore associations between physical behavior and appropriate implantable cardioverter defibrillator (ICD) therapy., Methods and Results: We included patients with an ICD at two European sites, who wore wrist-based accelerometers capturing 24 h movement and sleep behaviours for 28 days. Behavioural measures included activity volume, duration and intensity, sleep duration, and efficiency. Participants were followed for 12 months for the outcome of appropriate ICD therapy. Cox proportional hazard models with restricted cubic splines were used for the analysis. Lastly, the predictive capacity was tested. A total of 253 ICD patients were included (mean age 63.5 (±10.2), 48 (19.0%) female). During follow-up, 40 participants (15.8%) received appropriate ICD therapy; 32 anti-tachycardia pacing (ATP) only (12.6%), 5 shock only (2.0%), and 3 combined ATP and shock (1.2%). In the adjusted model, high inactive duration (HR 1.40 (95% 1.10-1.78)), peak walking cadence (HR 1.07 (95% 1.03-1.12)), and total sleep duration (HR 1.50 (1.02-2.22)) were associated with the outcome. The dose-response relationship was U-shaped for inactive duration with a cut-off at 16 h, and linear for peak cadence and sleep. The prediction model reached an area under the receiver operating characteristic curve of 0.70 ± 0.03, with highest accuracy in the first months., Conclusion: Wearable-derived 24 h movement and sleep behaviours collected over 28 days were associated with later appropriate ICD therapy risk. Testing of the predictive value of digital biomarkers for enhanced risk stratification of ventricular arrhythmia warrants larger prospective studies., Clinical Trial Registration: National Trial Registration (NL9218, http://onderzoekmetmensen.nl/)., Competing Interests: Conflict of interest: R.E.K. reports consultancy fees and research grants from Boston Scientific, Medtronic, and Abbott and has stock options from AtaCor Medical Inc. F.V.Y.T. has grants or contracts from the Dutch Research Council (NWO) and Amsterdam Cardiovascular Science and received payment or honoraria from Boston Scientific and Abbott (no personal financial gain). S.Z.D. reports consultancy fees and research grants from Acesion Pharma and Cortrium, and has received payment or honoraria from Bristol, Myers Squibb, Pfizer, and Bayer. P.K.J. reports consultancy fees and research grants from Abbott and Medtronic, payment or honoraria from Abbott and Medtronic, and support for attending meetings and/or travel from Abbott and Medtronic. J.H.S. reports grants or contracts from Medtronic (payed to institution), payment or honoraria from Medtronic, support for attending meetings and/or travel from Abbott and Medtronic, and participation in Advisory Board for Medtronic and Vital Beats. J.L. reports having stock or stock option from Activinsights Ltd. T.O.A. reports having stock or stock options from Vital Beats. D.M.F., M.Z.H.K., N.R., and H.L.T. have nothing to declare., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Background: Implantable Cardioverter Defibrillator (ICD) implantation has significantly modified the natural history of patients at high risk of sudden cardiac death (SCD) in various types of heart diseases. However there is a high rate of psychological distress and reduced quality of life in patients with an ICD, more evident in younger individuals. The ICD removal upon patient request is a very rare event and causes many clinical and ethical issues., Methods: The article discusses the case of a young patient affected by hypertrophic obstructive cardiomyopathy, who underwent implantable cardioverter defibrillator (ICD) implantation as a primary prevention of sudden cardiac death (SCD). Two years after the implantation, the patient repeatedly requested removal of the ICD due to of a significant and untreatable psychological device intolerance., Results: Intervention became possible only after extensive psychological evaluation, which excluded specific pathology, and the ratification of Italian law 219/2017 on informed consent and advance directives, which guarantees the patient's independent decisions on current and future medical treatment. The explantation was performed 7 years after the implant. The patient is alive and in good health., Conclusions: The paper debates the issues related to establishing a patient-physician relationship based on respect for the patient's autonomy and experience of illness, in reference to principles such as beneficence and non-maleficence, and the conflicts that sometimes arise between them. If a paternalistic approach in the patient-physician relationship evolves into a patient-centered model, it is more certain that the patient's choice is realistically known and shared, and that it is consistent with the patient's values and life goals. The shared decision making (SDM) process and the use of pathology-specific decision aids are able to transform the informed consent tool, usually related to medical-legal issues, into an aid for true partnership between the patient and the medical care team., (© 2024 Wiley Periodicals LLC.)

Clinical Trial Registration: Clinicaltrials.gov: NCT00522340., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Introduction: In patients with cardiac sarcoidosis (CS), implantable cardioverter-defibrillators (ICDs) are important for preventing sudden cardiac death. This study aimed to investigate sex disparities in CS patients undergoing ICD implantation., Methods: The 2016-2020 National Inpatient Sample (NIS) database compared the characteristics and outcomes of males and females with CS receiving ICDs., Results: Among 760 CS patients who underwent inpatient ICD implantation, 66.4% were male. Males were younger (55.0 vs. 56.9 years, p < .01), had higher rates of diabetes (31.7% vs. 21.6%, p < .01) and chronic kidney disease (CKD) (16.8% vs. 7.8%, p < .01) but lower prevalence of atrial fibrillation (AF) (11.9% vs. 23.5%, p < .01), sick sinus syndrome (4.0% vs. 7.8%, p = .024), ventricular fibrillation (VF) (9.9% vs. 15.7%, p = .02), and black ancestry (31.9% vs. 58.0%, p < .01). Unadjusted major adverse cardiovascular events (MACE), defined as a composite of in-hospital death, myocardial infarction (MI), and ischemic stroke, was higher in females (11.8% vs. 6.9%, p = .024), but when adjusted for age and tCharlson Comorbidity Index (CCI), females demonstrated significantly lower odds of experiencing MACE (aOR: 0.048, 95% CI: 0.006-0.395, p = .005). Incidence of acute kidney injury (AKI) post-ICD was significantly lower in females (15.7% vs. 23.8%, p = .01) as was the adjusted odds (aOR: 0.282, 95% CI: 0.146-0.546, p < .01). There was comparable mean length of stay and hospital charges., Conclusion: ICD utilization in CS patients is more common among males, who have a higher prevalence of diabetes and CKD but a lower prevalence of AF, sick sinus syndrome, and VF. Adjusted MACE and AKI were significantly lower in females., (© 2024 The Author(s). Pacing and Clinical Electrophysiology published by Wiley Periodicals LLC.)

Background: Implantable cardioverter-defibrillators are used globally and are reliable, but complications related to transvenous leads remain a concern. Evidence related to the incidence and costs of those complications is heterogeneous with respect to scope and healthcare system. This analysis aims to create estimates of the incidence and costs of tricuspid valve (TV) complications, lead failures, and lead extractions from a single large real-world data set., Methods and Results: This retrospective longitudinal cohort study used the deidentified Medicare Fee for Service administrative claims database. A total of 116 036 patients with de novo transvenous ICD implant were analyzed. Mean hospital costs were $26 903 for tricuspid valve complications, $20 851 for lead failures, and $22 278 for lead extractions., Conclusions: Transvenous ICD lead complications incur significant costs to patients, hospitals, and payers when they occur. Advancements in lead technology that reduce these complications could bring significant clinical and economic value., (© 2024 The Author(s). Journal of Cardiovascular Electrophysiology published by Wiley Periodicals LLC.)

Asymptomatic paroxysmal atrial fibrillation (AF) is often found in patients implanted with cardiac implantable electronic devices (CIEDs). Second-generation atrial antitachycardia pacing (A-ATP) is effective in managing AF in patients implanted with CIEDs. The purpose of this study was to evaluate the efficacy and safety of A-ATP in patients implanted with CIEDs. This was a single-center retrospective study involving 91 patients (male 46 patients, mean age 74 ± 9 years) implanted with Reactive A-ATP equipped devices (84 patients with pacemakers, 6 with ICDs, and 1 with a CRT-D). The AF burden, rate of AF termination, and details of the activation of the A-ATP were analyzed in each patient. During a mean follow-up period of 21 ± 13 months, A-ATP was activated in 45 of 91 patients (49.5%). No patients had adverse events. Although the efficacy of the A-ATP varied among the patients, the median rate of AF termination was 44%. In comparison to the A-ATP start time, "0 min" had a higher AF termination rate by the A-ATP (39.4% vs. 24.4%, P = 0.011). The rate of termination by the A-ATP was high for AF with a long cycle length and a relatively regular rhythm. A-ATP successfully terminated AF episodes in some patients implanted with CIEDs. The optimal settings of the A-ATP will be determined in future studies., (© 2024. Springer Nature Japan KK, part of Springer Nature.)

We report the case of a family afflicted with cardiac laminopathy who showed atrial fibrillation (AF) and complete atrioventricular block across three generations. Implantable cardioverter defibrillators (ICDs) implantation, or cardiac resynchronization therapy (CRT) were delivered to the three patients (proband; 61 years old, proband's mother: 84 years old, and proband's daughter; 38 years old) to prevent sudden cardiac death or suppress heart failure progression. A novel frameshift mutation (LMNA Exon 9: c.1550dupA;p. N518Efs*34) was found in all three cases through genetic testing, and this mutation may potentially result in the relatively late appearance of a phenotype of left ventricular systolic dysfunction.

Aims: International studies have examined patients' views concerning the discussion of deactivating an implantable cardioverter defibrillator (ICD). Findings reported that many patients were either not informed about the subject or were informed late in their illness trajectory. This study aimed to explore healthcare professionals' perspectives on discussing ICD deactivation and identify priorities for clinical practice and future research., Methods and Results: Eleven interviews were conducted, involving heart failure nurses, physicians, and an allied professional. All were responsible for the care of patients with an ICD, from the UK or Sweden. A semi-structured guide was used. All interviews were audio-recorded, transcribed, translated (as applicable), and analysed independently by experienced researchers, using framework analysis. Findings were presented, along with published work at a stakeholder meeting, and a consensus agreement was reached on priorities for clinical practice and future research. Four themes emerged from the exploratory interviews. Healthcare professionals described the discussion about deactivation as challenging, requiring compassion and involvement of family members. They agreed that the topic should be initiated prior to, or shortly after, device implantation. This was reflected in the priorities to improve communication, through the increased availability and implementation of prompts and tools, as well as the provision of tailored information to patients and family members. Stakeholders recognized the future potential of digital technology in device education., Conclusion: Discussing deactivation remains challenging. Healthcare professionals recognized the need to initiate the discussion early, with compassion and involvement of family members. Priorities were agreed by stakeholders, which require clinical implementation and further research., Competing Interests: Conflict of interest: LH: Honorarium from AstraZeneca and Vifor. None disclosed by other co-authors., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Competing Interests: Conflict of interest: none declared.

Historically, patients with myocarditis were considered for implantable cardioverter defibrillator (ICD) utilization only in the chronic phase of the disease following the development of persistent cardiomyopathy refractory to medical therapy or occurrence of a major ventricular arrhythmic event. However, recent literature has indicated that ventricular arrhythmias are frequently reported even in the acute phase of the disease, challenging the long-standing perception that this disease process was largely reversible. Given this changing environment of information, the latest US and European guidelines were recently updated in 2022 to now consider ICD implantation during the acute phase which has significantly increased the number of individuals eligible for these devices. Additionally, several studies with small subgroups of patients have demonstrated a possible benefit of wearable cardioverter defibrillators (WCDs) in this patient demographic. Assuming that larger studies confirm their utility, it is possible that WCDs can assist in detection of ventricular arrhythmias and selection of high-risk candidates for ICD implantation, while providing temporary protection for a small percentage of patients before the development of a major arrhythmic event. This review ultimately serves as a comprehensive review of the most recent guidelines for defibrillator use in acute and chronic myocarditis. OPINION STATEMENT: The latest US and European guidelines support ICD use for myocarditis patients following the development of persistent cardiomyopathy refractory to medical therapy or occurrence of a major ventricular arrhythmic event. Previously, patients in the acute phase were excluded from ICD utilization even after experiencing malignant ventricular tachycardia or ventricular fibrillation due to the long-standing perception that this disease process was largely reversible. However, recent literature has indicated that ventricular arrhythmias are frequently reported even in the acute phase of the disease. Additionally, we found that the myocardial damage that is inflicted persists many years after the initial episode. Given this changing environment of information, guidelines were recently updated in 2022 to now consider ICD implantation during the acute phase which has significantly increased the number of individuals eligible for these devices. We support possible ICD utilization for secondary prevention during the acute phase of myocarditis given the elevated risk of arrhythmia recurrence and the fact that any ventricular arrhythmia can induce sudden cardiac death. Future prospective studies are needed to assess which patients may benefit most from early ICD implantation. WCDs have improved survival in patient populations at high-risk for sudden cardiac death who are not candidates for ICD implantation. After analyzing several recent studies with small subgroups of patients, WCDs appear to demonstrate similar efficacy for myocarditis patients as well. Assuming that larger studies confirm their utility, we believe that WCDs can assist in detection of ventricular arrhythmias and selection of high-risk candidates for ICD implantation. Furthermore, WCDs have the additional benefit of acting as primary prevention by providing temporary protection for a small percentage of myocarditis patients before they develop a major arrhythmic event., Competing Interests: Declaration of competing interest None., (Published by Elsevier Ltd.)

Aims: The decisions about placing an ICD in a child are more difficult than in an adult due to longer expected lifespan and the complication risk. Young patients gain the most years from ICDs, despite higher risk of device-related complications. The secondary prevention ICD indication is clear, and device is implanted regardless of potential complications. For primary prevention, risk of sudden cardiac death and complications need to be evaluated. We aimed to compare outcomes for primary and secondary prevention ICDs., Methods and Results: Retrospective nationwide cohort study including paediatric patients identified from the Danish ICD registry with ICD implanted at an age ≤ 15 from 1982-21. Demographics, complications (composite of device-related infections or lead-failure requiring re-operation, mortality because of arrhythmia, or unknown cause), and mortality were retrieved from medical charts. Endpoint was appropriate therapy (shock or anti-tachycardia pacing for ventricular tachycardia or fibrillation). Of 72 receiving an ICD, the majority had channelopathies (n = 34) or structural heart diseases (n = 28). ICDs were implanted in 23 patients for primary prevention and 49 for secondary prevention, at median ages of 13.8 and 11.6 years (P-value 0.01), respectively. Median follow-up was 9.0 (interquartile ranges: 4.7-13.5) years. The 10-year cumulative incidence of first appropriate therapy was 70%, with complication and inappropriate therapy rates at 41% and 15%, respectively. No difference was observed between prevention groups for all outcomes. Six patients died during follow-up., Conclusion: In children, two-thirds are secondary prevention ICDs. Children have higher appropriate therapy and complication rates than adults, while the inappropriate therapy rate was low., Competing Interests: Conflict of interest: C.J. receives lecturing fees from Abbott and Biosense Webster. P.S.B. receives educational grant from Abbott, fellowship/scholarship grant from Boston Scientific, and an external research support (ERP-2021-12822) from Medtronic. LS. is chief medical officer and divisional vice president at Medical Affairs, Abbott Structural Heart. J.C.N. received institutional research grants from the Novo Nordisk Foundation and the Danish Heart Foundation outside this work. The remaining authors have no conflicts of interest to declare., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Competing Interests: Funding Support and Author Disclosures Dr Friedman has received research grants from Abbott, the American Heart Association, Biosense Webster, Boston Scientific, Medtronic, Merit Medical, National Cardiovascular Data Registry, Phillips, and the National Institutes of Health; and has received consulting fees from Abbott, Alleviant, Boston Scientific, NI Medical, Microport, and Sanofi.

Background: With increasing constraints on healthcare resources, greater attention is being focused on improved resource utilization. Prior studies have demonstrated safety of same-day discharge following CIED implantation but are limited by vague protocols with long observation periods. In this study, we evaluate the safety of an expedited 2 hour same-day discharge protocol following CIED implantation., Methods: Patients undergoing CIED implantation at three centers between 2015 and 2021 were included. Procedural, demographic, and adverse event data were abstracted from the electronic health record. Patients were divided into same-day discharge (SDD) and delayed discharge (DD) cohorts. The primary outcome was complications including lead malfunction requiring revision, pneumothorax, hemothorax, lead dislodgement, lead perforation with tamponade, and mortality within 30 days of procedure. Outcomes were compared between the two cohorts using the χ 2 test., Results: A total of 4543 CIED implantation procedures were included with 1557 patients (34%) in the SDD cohort. SDD patients were comparatively younger, were more likely to be male, and had fewer comorbidities than DD patients. Among SDD patients, the mean time to post-operative chest X-ray was 2.6 h. SDD had lower rates of complications (1.3% vs 2.1%, p = 0.0487) and acute care utilization post-discharge (9.6% vs 14.0%, p < 0.0001). There was no difference in the 90-day infection rate between the cohorts., Conclusions: An expedited 2 hour same-day discharge protocol is safe and effective with low rates of complications, infection, and post-operative acute care utilization., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Introduction: Remote patient monitoring (RPM) of heart failure patients has the potential to reduce healthcare resource use and costs, but current evidence has been inconclusive. This study aims assess the impact of RPM of heart failure patients with an implantable cardioverter defibrillator on medical resource use, direct medical costs, quality-adjusted life years (QALYs), and travel time of patients, and to estimate its commercial headroom in the Netherlands and Germany., Methods: Data from the REMOTE-CIED randomized controlled trial were used to calculate differences in length of hospital stay, outpatient clinic visits, telephone consults, emergency room visits, and travel time between patients on in-clinic follow-up and RPM in the Netherlands, Germany, and France. Incremental cardiac-related healthcare costs and QALYs were calculated and used to calculate the commercial headroom of RPM in the Netherlands and Germany. The impact of imputation, parameter, and case-mix uncertainty on these outcomes was explored using probabilistic analysis., Results: Length of hospitalization, number of unscheduled admissions, and number of outpatient visits were lower in the remote monitoring group in all three countries. Number of hospital admissions was higher, and number of calls was lower in the Netherlands and Germany but not in France. Costs were lower in both the Netherlands (-€1041, 95% confidence interval (CI): -€3308, €1005) and Germany (-€2865, 95% CI: -€7619, €1105), while incremental effectiveness differed: -0.003 (95% CI: -0.114, 0.107) QALY in the Netherlands and +0.086 (95% CI: -0.083, 0.256) in Germany. Commercial headroom was estimated at €881 (95% CI: -€5430, €7208) in the Netherlands and €5005 (95% CI: -€1339, €11,960) in Germany., Discussion: RPM was found to result in reduced medical resource use and travel time. Whether it is cost saving or cost effective strongly depends on the costs of remote monitoring., Trial Registration Number and Trial Register: ClinicalTrials.gov: NCT01691586., Competing Interests: Declaration of conflicting interestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Infections associated with cardiac implantable electronic devices (CIEDs) are increasing and are a cause of significant morbidity and mortality. This article summarizes the latest updates with respect to the epidemiology, microbiology, and risk factors for CIED-related infections. It also covers important considerations regarding the diagnosis, management, and prevention of these infections. Newer technologies such as leadless pacemakers and subcutaneous implantable cardioverters and defibrillators are discussed., Competing Interests: Disclosure C. Bielick: there are no competing interests, personal financial interests, or other competing interests. Funding support was through the National Institute of Allergy and Infectious Diseases, United States at the National Institutes of Health (grant number T32 AI007046 to C.B.) while employed at the University of Virginia Division of Infectious Diseases and International Health. Christopher Arnold: there are no competing interests, personal financial interests, or other competing interests. Vivian Chu: UpToDate contributor., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Purpose: Wideband phase-sensitive inversion recovery (PSIR) late gadolinium enhancement (LGE) enables myocardial scar imaging in implantable cardioverter defibrillators (ICD) patients, mitigating hyperintensity artifacts. To address subendocardial scar visibility challenges, a 2D breath-hold single-shot electrocardiography-triggered black-blood (BB) LGE sequence was integrated with wideband imaging, enhancing scar-blood contrast., Methods: Wideband BB, with increased bandwidth in the inversion pulse (0.8-3.8 kHz) and T 2 preparation refocusing pulses (1.6-5.0 kHz), was compared with conventional and wideband PSIR, and conventional BB, in a phantom and sheep with and without ICD, and in six patients with cardiac devices and known myocardial injury. ICD artifact extent was quantified in the phantom and specific absorption rate (SAR) was reported for each sequence. Image contrast ratios were analyzed in both phantom and animal experiments. Expert radiologists assessed image quality, artifact severity, and scar segments in patients and sheep. Additionally, histology was performed on the sheep's heart., Results: In the phantom, wideband BB reduced ICD artifacts by 62% compared to conventional BB while substantially improving scar-blood contrast, but with a SAR more than 24 times that of wideband PSIR. Similarly, the animal study demonstrated a considerable increase in scar-blood contrast with wideband BB, with superior scar detection compared with wideband PSIR, the latter confirmed by histology. In alignment with the animal study, wideband BB successfully eliminated severe ICD hyperintensity artifacts in all patients, surpassing wideband PSIR in image quality and scar detection., Conclusion: Wideband BB may play a crucial role in imaging ICD patients, offering images with reduced ICD artifacts and enhanced scar detection., (© 2024 The Authors. Magnetic Resonance in Medicine published by Wiley Periodicals LLC on behalf of International Society for Magnetic Resonance in Medicine.)

Background: Black patients meeting indications for implantable cardioverter-defibrillators (ICDs) have lower rates of implantation compared with White patients. There is little understanding of how mental health impacts the decision-making process among Black patients considering ICDs. Our objective was to assess the association between depressive symptoms and ICD implantation among Black patients with heart failure., Methods and Results: This is a secondary analysis of the VIVID (Videos to Address Racial Disparities in ICD Therapy via Innovative Designs) randomized trial, which enrolled self-identified Black individuals with chronic systolic heart failure. Depressive symptoms were assessed by the Patient Health Questionnaire-2 and the Mental Component Summary of the 12-Item Short-Form Health Survey. Decisional conflict was measured by an adapted Decisional Conflict Scale (DCS). ANCOVA was used to assess differences in Decisional Conflict Scale scores. Multivariable logistic regression was used to examine the association between depressive symptoms and ICD implantation. Among 306 participants, 60 (19.6%) reported depressed mood, and 142 (46.4%) reported anhedonia. Participants with the lowest Mental Component Summary of the 12-Item Short-Form Health Survey scores (poorer mental health and higher likelihood of depression) had greater decisional conflict regarding ICD implantation compared with those with the highest Mental Component Summary of the 12-Item Short-Form Health Survey scores (adjusted mean difference in Decisional Conflict Scale score, 3.2 [95% CI, 0.5-5.9]). By 90-day follow-up, 202 (66.0%) participants underwent ICD implantation. There was no association between either the Patient Health Questionnaire-2 score or the Mental Component Summary of the 12-Item Short-Form Health Survey score and ICD implantation., Conclusions: Depressed mood and anhedonia were prevalent among ambulatory Black patients with chronic systolic heart failure considering ICD implantation. The presence of depressive symptoms did not impact the likelihood of ICD implantation in this population.

Aims: Significant changes in tricuspid regurgitation (TR) and mitral regurgitation (MR) post-cardiac implantable electronic devices (CIEDs) are increasingly recognized. However, uncertainty remains as to whether the risk of CIED-associated TR and MR differs with right ventricular pacing (RVP) via CIED with trans-tricuspid RV leads, compared with cardiac resynchronization therapy (CRT), conduction system pacing (CSP), and leadless pacing (LP). The study aims to synthesize extant data on risk and prognosis of significant post-CIED TR and MR across pacing strategies., Methods and Results: We searched PubMed, EMBASE, and Cochrane Library databases published until 31 October 2023. Significant post-CIED TR and MR were defined as ≥ moderate. Fifty-seven TR studies (n = 13 723 patients) and 90 MR studies (n = 14 387 patients) were included. For all CIED, the risk of post-CIED TR increased [pooled odds ratio (OR) = 2.46 and 95% CI = 1.88-3.22], while the risk of post-CIED MR reduced (OR = 0.74, 95% CI = 0.58-0.94) after 12 and 6 months of median follow-up, respectively. Right ventricular pacing via CIED with trans-tricuspid RV leads was associated with increased risk of post-CIED TR (OR = 4.54, 95% CI = 3.14-6.57) and post-CIED MR (OR = 2.24, 95% CI = 1.18-4.26). Binarily, CSP did not alter TR risk (OR = 0.37, 95% CI = 0.13-1.02), but significantly reduced MR (OR = 0.15, 95% CI = 0.03-0.62). Cardiac resynchronization therapy did not significantly change TR risk (OR = 1.09, 95% CI = 0.55-2.17), but significantly reduced MR with prevalence pre-CRT of 43%, decreasing post-CRT to 22% (OR = 0.49, 95% CI = 0.40-0.61). There was no significant association of LP with post-CIED TR (OR = 1.15, 95% CI = 0.83-1.59) or MR (OR = 1.31, 95% CI = 0.72-2.39). Cardiac implantable electronic device-associated TR was independently predictive of all-cause mortality [pooled hazard ratio (HR) = 1.64, 95% CI = 1.40-1.90] after median of 53 months. Mitral regurgitation persisting post-CRT independently predicted all-cause mortality (HR = 2.00, 95% CI = 1.57-2.55) after 38 months., Conclusion: Our findings suggest that, when possible, adoption of pacing strategies that avoid isolated trans-tricuspid RV leads may be beneficial in preventing incident or deteriorating atrioventricular valvular regurgitation and might reduce mortality., Competing Interests: Conflict of interest: none declared., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Background: To preserve the benefit of atrial sensing without the implantation of an additional lead, a single-lead ICD system with a floating atrial dipole (DX ICD) has been developed. The purpose of this nationwide survey was to provide an overview of the current key influences of device selection focusing on DX ICD and to test the applicability of a previously published decision-making flowchart of ICD-type selection., Methods: An online questionnaire was sent to all implanting centers in Hungary. Eleven centers reported data from 361 DX ICD and 10 CRT-DX systems implantations between February 2021 and May 2023., Results: The most important influencing clinical factors indicated by the participating doctors were elevated risk of atrial fibrillation (AF)/stroke (56%), risk of sinus/supraventricular tachycardias (SVT) (42%), and a potential need for CRT upgrade in the future (36%). The DX ICD was considered in the majority of cases instead of the VVI system (87%), and only in a small proportion instead of a DDD ICD (13%). 60% of the patients with DX ICDs were also included into remote monitoring-based follow-up. In 83% of the cases, good (>2 mV) or excellent (>5) atrial signal amplitude was recorded within 6 weeks after the implantation., Conclusion: In the current national survey, the most important influencing factors indicated by the implanters for selecting a DX ICD were the elevated risk of stroke or sinus/SVT and a potential need for CRT upgrade in the future. These findings support the use of a previously published decision-making flowchart., (© 2024 The Author(s). Pacing and Clinical Electrophysiology published by Wiley Periodicals LLC.)

Background: The axillary artery (AX) access for intra-aortic balloon pump (IABP) as a bridge to heart transplant (HT) allows mobility while awaiting a suitable donor. As end-stage heart failure patients often have an implantable cardioverter defibrillator (ICD) on the left side, the left AX approach may be avoided due to the perception of difficult access and proximity of two devices. We aimed to evaluate the outcomes of patients bridged to HT with a left-sided AX IABP with or without ipsilateral ICDs., Methods: We retrospectively reviewed HT candidates at our institution supported by left-sided axillary IABP from November 2019 to February 2024, dividing them into two groups based on the presence (Group ICD, n = 48) or absence (Group No-ICD, N = 19) of an ipsilateral left-sided ICD. The exposure time was defined as the time from skin incision to the beginning of anastomoses of a Dacron graft., Results: Technical success was achieved in 100% of the cohort, with median exposure times for AX access similar between groups (ICD, 12 [7.8, 18.2] vs. No ICD, 11 [7, 19] min; p = 0.75). The rate of procedural adverse events, such as significant access site bleeding and ipsilateral limb ischemia, did not significantly differ between both groups. Device malfunction rates were comparable (ICD, 29.2% vs. No ICD, 15.8%; p = 0.35). Posttransplant, in-hospital mortality, severe primary graft dysfunction, and stroke rates were comparable in both groups., Conclusion: The presence of an ipsilateral left-sided ICD does not adversely impact the procedural efficacy, complication rates, or posttransplant outcomes of left-sided AX IABP insertion in HT candidates., (© 2024 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

Background: Despite an increased incidence of chronic heart failure (HF) and sudden cardiac death (SCD), the use of implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy (CRT) is much lower in Japan than in Western countries. The HF Indication and SCD Prevention Trial Japan (HINODE) prospectively assessed the mortality rate, appropriately treated ventricular arrhythmias (VA), and HF in Japanese patients with a higher risk of HF., Methods and results: HINODE consisted of ICD, CRT-defibrillator (CRT-D), pacing, and non-device treatment cohorts. This subanalysis evaluated the impact of the implantation of high-voltage devices (HVD; ICD and CRT-D) in 171 Japanese patients. We compared all-cause mortality, VA, and HF events between elderly (age >70 years at study enrollment) and non-elderly HVD recipients. The estimated survival rate through 24 months in the HVD cohort was 85.8% (97.5% lower control limit 77.6%). The risk of all-cause mortality was increased for the elderly vs. non-elderly (hazard ratio [HR] 2.82; 95% confidence interval [CI] 1.01-7.91; P=0.039), but did not differ after excluding ICD patients with CRT-D indication (HR 2.32; 95% CI 0.79-6.78; P=0.11). There were no differences in VA and HF event-free rates between elderly and non-elderly HVD recipients (P=0.73 and P=0.55, respectively)., Conclusions: Although elderly patients may have a higher risk of mortality in general, the benefit of HVD therapy in this group is comparable to that in non-elderly patients.

Background and Aim: There are a paucity of studies investigating workforce affiliation in connection with first-time implantable cardioverter defibrillator (ICD)-implantation. This study explored workforce affiliation and risk markers associated with not returning to work in patients with ICDs., Methods: Using the nationwide Danish registers, patients with a first-time ICD-implantation between 2007 and 2017 and of working age (30-65 years) were identified. Descriptive statistic and logistic regression models were used to describe workforce affiliation and to estimate risk markers associated with not returning to work, respectively. All analyses were stratified by indication for implantation (primary and secondary prevention)., Results: Of the 4659 ICD-patients of working age, 3300 patients (71%) were members of the workforce (employed, on sick leave or unemployed) (primary: 1428 (43%); secondary:1872 (57%)). At baseline, 842 primary and 1477 secondary prevention ICD-patients were employed. Of those employed at baseline, 81% primary and 75% secondary prevention ICD-patients returned to work within 1 year, whereof more than 80% remained employed the following year. Among patients receiving sick leave benefits at baseline, 25% were employed after 1 year. Risk markers of not returning to work were 'younger age' in primary prevention ICD-patients, while 'female sex', left ventricular ejection fraction 'LVEF ≤40', 'lower income', and '≥3 comorbidities' were risk markers in secondary prevention ICD-patients. Lower educational level was a risk marker in both patient groups., Conclusion: High return-to-work proportions following ICD-implantation, with a subsequent high level of employment maintenance were found. Several significant risk markers of not returning to work were identified including 'lower educational level' that posed a risk in both patient groups., Trial Registration Number: Capital Region of Denmark, P-2019-051., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Competing Interests: Conflict of interest: T.F. reports personal fees for statistical consultancies (including data monitoring committees) from Actimed, Bayer, BiosenseWebster, BMS, Coherex Medical, CSL, Behring, Enanta, Fresenius Kabi, Galapagos, IQVIA, Janssen, KyowaKirin, LivaNova, Minoryx, Novartis, r-connect, Recardio, Relaxera, Roche, Servier, Viatris and Vifor; all outside the submitted work.

Aims: Pacemaker (PM) patients may require a subsequent upgrade to an implantable cardioverter defibrillator (ICD). Limited data exists on this patient population. We sought to characterize this population, to assess predictors for ICD upgrade, and to report the outcome., Methods: From our prospective PM and ICD implantation registry, all patients who underwent PM and/or ICD implantations at our center were analyzed. Patient characteristics and outcomes of PM patients with subsequent ICD upgrade were compared to age- and sex-matched patients with de novo ICD implantation, and to PM patients without subsequent upgrade., Results: Of 1'301 ICD implantations, 60 (5%) were upgraded from PMs. Median time from PM implantation to ICD upgrade was 2.6 years (IQR 1.3-5.4). Of 2'195 PM patients, 28 patients underwent subsequent ICD upgrades, corresponding to an estimated annual incidence of an ICD upgrade of at least 0.33%. Lower LVEF (p = .05) and male sex (p = .038) were independent predictors for ICD upgrade. Survival without death, transplant and LVAD implantation were worse both for upgraded ICD patients compared to matched patients with de novo ICD implantation (p = .05), as well as for PM patients with subsequent upgrade compared to matched PM patients not requiring an upgrade (p = .036)., Conclusions: One of 20 ICD implantations are upgrade of patients with a PM. At least one of 30 PM patients will require an ICD upgrade in the following 10 years. Predictors for ICD upgrade are male sex and lower LVEF at PM implantation. Upgraded patients have worse outcomes., (© 2024 The Authors. Pacing and Clinical Electrophysiology published by Wiley Periodicals LLC.)

Background: Due to suspected pro-arrhythmic effects and increased mortality associated with class-IC antiarrhythmic drugs (AADs) in previous trials, AAD therapy in structural heart disease (SHD) is mainly restricted to amiodarone. In the presence of diagnostic and therapeutic advancements in cardiovascular medicine, it remains unclear if previous studies adequately reflect contemporary patients. In clinical practice, class-IC-AADs are occasionally used in individual cases, particularly in patients with an implantable cardioverter defibrillator (ICD)., Methods: This study retrospectively investigated outcome in ICD-carriers with SHD in whom class-IC-AADs were used as an individualized therapy due to failure, side effects, or unacceptable risk of alternative therapeutic options., Results: Fifty patients from four tertiary centers were included (median age 48.5 years; 52% female). The most common underlying SHD were dilated (42%) or ischemic cardiomyopathy (26%) (median LVEF = 45%). Indications for AAD were sustained ventricular arrhythmias (VA) (58%), symptomatic premature ventricular contractions (26%), or atrial arrhythmias (16%). Median follow-up was 27.8 months. Freedom from sustained VA was 72%, and freedom from ICD therapy was 80%. In 19 patients (38%), AAD therapy was terminated. The most common reason was insufficient efficacy (n = 8). Pro-arrhythmia was suspected in three patients. Five patients died during follow-up (10.0%), two of cardiovascular cause (4.0%)., Conclusion: In a multicenter cohort of ICD-carriers with SHD, class-IC-AADs were associated with a low rate of pro-arrhythmic effects or cardiovascular mortality. The majority of patients remained free from sustained VA during a follow-up of > 2 years. Further efforts should be made to evaluate the safety of class-IC-AADs in SHD patients receiving contemporary cardiovascular therapy., (© 2024. The Author(s).)

Introduction: Tricuspid regurgitation is associated with significant morbidity and mortality, and occurs at a higher rate in patients with cardiovascular implantable electronic devices. Percutaneous strategies for managing tricuspid regurgitation are evolving, including the development of bicaval valve implantation which has been successfully used in patients with pacing leads., Methods and Results: We present the first documented case of lead failure following TricValve® implantation, a dedicated self-expanding system for bicaval valve implantation, and the first successful lead revision procedure in this setting., Conclusion: The case illustrates important considerations in undertaking percutaneous intervention in patients with cardiovascular implantable electronic devices, and their ongoing management., (© 2024 Wiley Periodicals LLC.)

Background: Implantable cardioverter defibrillator (ICD) use in cardiac sarcoidosis (CS) to prevent sudden cardiac death (SCD) is a potentially life-saving intervention. However, the factors that determine outcome in this cohort remains largely unknown. This review analyses CS patients with an ICD and highlights determinants of poor outcome., Outcomes: Analysis of studies which used the 2014 HRS Consensus, 2017 AHA/ACC/HRS Guideline and 2022 ESC Guidelines showed that those with class I recommendations have higher incidences of ventricular arrhythmia (VA) than those with class II recommendations. Additionally, even those with normal left ventricular ejection fraction (LVEF) and CS are at high risk of VA and SCD., Summary: Compounding research emphasises the importance of cardiac imaging in those with sarcoidosis, with evidence to suggest a possible need for revision of the guidelines. Other variables such as demographics and ventricular characteristics may prove useful in predicting those to benefit most from ICD insertion., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024. Published by Elsevier Inc.)

Background: Chronic total coronary occlusions (CTO) substantially increase the risk for sudden cardiac death. Among patients with chronic ischemic heart disease at risk for sudden cardiac death, an implantable cardioverter defibrillator (ICD) is the favored therapy for primary prevention of sudden cardiac death. This study sought to investigate the impact of CTOs on the risk for appropriate ICD shocks and mortality within a nationwide prospective cohort., Methods and Results: This is a subanalysis of the nationwide Dutch-Outcome in ICD Therapy (DO-IT) registry of primary prevention ICD recipients in The Netherlands between September 2014 and June 2016 (n=1442). We identified patients with chronic ischemic heart disease (n=663) and assessed available coronary angiograms for CTO presence (n=415). Patients with revascularized CTOs were excluded (n=79). The primary end point was the composite of all-cause mortality and appropriate ICD shocks. Clinical follow-up was conducted for at least 2 years. A total of 336 patients were included, with an average age of 67±9 years, and 20.5% was female (n=69). An unrevascularized CTO was identified in 110 patients (32.7%). During a median follow-up period of 27 months (interquartile range, 24-32), the primary end point occurred in 21.1% of patients with CTO (n=23) compared with 11.9% in patients without CTO (n=27; P =0.034). Corrected for baseline characteristics including left ventricular ejection fraction, and the presence of a CTO was an independent predictor for the primary end point (hazard ratio, 1.82 [95% CI, 1.03-3.22]; P =0.038)., Conclusions: Within this nationwide prospective registry of primary prevention ICD recipients, the presence of an unrevascularized CTO was an independent predictor for the composite outcome of all-cause mortality and appropriate ICD shocks.

Background: The emergence of artificial intelligence (AI) in medicine has prompted the development of numerous ethical guidelines, while the involvement of patients in the creation of these documents lags behind. As part of the European PROFID project we explore patient perspectives on the ethical implications of AI in care for patients at increased risk of sudden cardiac death (SCD)., Aim: Explore perspectives of patients on the ethical use of AI, particularly in clinical decision-making regarding the implantation of an implantable cardioverter-defibrillator (ICD)., Methods: Semi-structured, future scenario-based interviews were conducted among patients who had either an ICD and/or a heart condition with increased risk of SCD in Germany (n = 9) and the Netherlands (n = 15). We used the principles of the European Commission's Ethics Guidelines for Trustworthy AI to structure the interviews., Results: Six themes arose from the interviews: the ability of AI to rectify human doctors' limitations; the objectivity of data; whether AI can serve as second opinion; AI explainability and patient trust; the importance of the 'human touch'; and the personalization of care. Overall, our results reveal a strong desire among patients for more personalized and patient-centered care in the context of ICD implantation. Participants in our study express significant concerns about the further loss of the 'human touch' in healthcare when AI is introduced in clinical settings. They believe that this aspect of care is currently inadequately recognized in clinical practice. Participants attribute to doctors the responsibility of evaluating AI recommendations for clinical relevance and aligning them with patients' individual contexts and values, in consultation with the patient., Conclusion: The 'human touch' patients exclusively ascribe to human medical practitioners extends beyond sympathy and kindness, and has clinical relevance in medical decision-making. Because this cannot be replaced by AI, we suggest that normative research into the 'right to a human doctor' is needed. Furthermore, policies on patient-centered AI integration in clinical practice should encompass the ethics of everyday practice rather than only principle-based ethics. We suggest that an empirical ethics approach grounded in ethnographic research is exceptionally well-suited to pave the way forward., (© 2024. The Author(s).)

Introduction: Several implantable cardioverter defibrillators (ICD) programming strategies are applied to minimize ICD therapy, especially unnecessary therapies from supraventricular arrhythmias (SVA). However, it remains unknown whether these optimal programming recommendations only benefit those with SVAs or have any detrimental effects from delayed therapy on those without SVAs. This study aims to assess the impact of SVA on the outcomes of ICD programming based on 2015 HRS/EHRA/APHRS/SOLAECE expert consensus statement and 2019 focused update on optimal ICD programming and testing guidelines., Methods: Consecutive patients who underwent ICD insertion for primary prevention were classified into four groups based on SVA status and ICD programming: (1) guideline-concordant group (GC) with SVA, (2) GC without SVA, (3) nonguideline concordant group (NGC) with SVA, and (4) NGC without SVA. Cox proportional hazard models were analyzed for freedom from ICD therapies, shock, and mortality., Results: Seven hundred and seventy-two patients (median age, 64 years) were enrolled. ICD therapies were the most frequent in NGC with SVA (24.0%), followed by NGC without SVA (19.9%), GC without SVA (11.6%), and GC with SVA (8.1%). Guideline concordant programming was associated with 68% ICD therapy reduction (HR 0.32, p = .007) and 67% ICD shock reduction (HR 0.33, p = .030) in SVA patients and 44% ICD therapy reduction in those without SVA (HR 0.56, p = .030)., Conclusion: Programming ICDs in primary prevention patients based on current guidelines reduces therapy burden without increasing mortality in both SVA and non-SVA patients. A greater magnitude of reduced ICD therapy was found in those with supraventricular arrhythmias., (© 2024 Wiley Periodicals LLC.)

Until recently, implantable cardioverter defibrillators (ICDs) were considered a contraindication to competitive athletics. Recent prospective observational registry data in athletes with ICDs who participated in sports against the societal recommendations at the time have demonstrated the safety of sports participation. While athletes did receive both appropriate and inappropriate shocks, these were not more frequent during sports participation than other activity, and there were no sports-related deaths or need for external resuscitation in the 440 athlete cohort (median followup 44 months). Optimization of medical therapies, device settings and having an emergency action plan allow many athletes to safely continue athletic activity., (Copyright © 2023 Elsevier Inc. All rights reserved.)

The subcutaneous implantable cardioverter defibrillator (S-ICD) was developed as an alternative to the traditional transvenous implantable cardioverter defibrillator (TV-ICD), aiming to provide easier implantation, simplified detection algorithm of malignant ventricular arrhythmias and prevention from placing components in the cardiovascular system. The S-ICD is implanted subcutaneously or intramuscularly with the generator placed in the left midaxillary line and the lead tunneled subcutaneously in the left para-sternal region. Preimplant electrocardiogram screening is recommended to prevent implantation in patients at high risk of T wave over-sensing. Currently, the S-ICD is unsuitable for patients requiring pacing or cardiac resynchronization. Since the beginning, the S-ICD underwent extensive preclinical investigation until the first prospective multicentre trial demonstrating high efficacy and safety led to market release. While earlier studies focused on younger patients with higher ejection fraction, more recent studies showed favorable outcomes even in patients with comorbidities similar to those typically observed in patients receiving TV-ICD. The development of second and third generation devices has contributed to reduce inappropriate shocks and overcome previous limitations. The aim of this paper is to review the evidence in the literature over the past decade supporting S-ICD as a valid alternative to TV-ICD in terms of safety and efficacy, highlighting the improvements in technology, as well as outcomes., (© 2024 The Authors. Journal of Cardiovascular Electrophysiology published by Wiley Periodicals LLC.)

Continuous flow left ventricular assist devices (CF-LVADs) have been shown to reduce mortality and morbidity in patients with advanced heart failure with reduced ejection fraction. However, ventricular arrhythmias (VA) are common, are mostly secondary to underlying myocardial scar, and have a higher incidence in patients with pre-LVAD VA. Sustained VA is well tolerated in the LVAD patient but can result in implantable defibrillator (ICD) shocks, right ventricular failure, hospitalizations, and reduced quality of life. There is limited data regarding best practices for the medical management of VA as well as the role for procedural interventions in patients with uncontrolled VA and/or ICD shocks. Vast majority of CF-LVAD patients have a preexisting cardiovascular implantable electronic device (CIED) and ICD and/or cardiac resynchronization therapies are continued in many. Several questions, however, remain regarding the efficacy of ICD and CRT following CF-LVAD. Moreover, optimal CIED programming after CF-LVAD implantation. Therefore, the primary objective of this review article is to provide the most up-to-date evidence and to provide guidance on the clinical significance, pathogenesis, predictors, and management strategies for VA and ICD therapies in the CF-LVAD population. We also discuss knowledge gaps as well as areas for future research., (© 2023 Wiley Periodicals LLC.)

The DF-4 defibrillator standard has been rapidly adopted due to its convenience at implantation. There are however trade-offs compared to the traditional DF-1 standard that are underappreciated. This viewpoint outlines the advantages and limitations of current defibrillator lead standards that should be kept in mind, as they impact the options that are available to deal with issues that may arise., Competing Interests: Conflict of interest: C.S. has received speaker honoraria, consulting fees or institutional fellowship/research support from Biosense Webster, Biotronik, Boston Scientific, Medtronic, and Microport. K.A.E. has received speaker honoraria, consulting and research support from Medtronic and Boston Scientific, and consulting fees from Biotronik and Abbott. H.B. has received speaker honoraria, consulting fees or institutional fellowship/research support from Abbot, Biotronik, Boston Scientific, Medtronic, and Microport., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Background: Implantable cardioverter defibrillators (ICD) are often used as primary prevention strategy for sudden cardiac death (SCD) in young individuals. This study analyzed appropriate therapies, complications and inappropriate shocks in the real-world Indian population., Methods: All patients in the cardiomyopathy cohort under follow up who had ICD implanted as a primary prevention strategy were studied. The objective was to assess the incidence of appropriate ICD therapies, inappropriate therapies and complications. ICD was interrogated and stored electrograms analyzed. Underlying arrhythmia or conditions resulting in appropriate or inappropriate ICD therapy were studied. Correlation and regression studies was done to assess for the predictors of appropriate therapy., Results: Fifty patients were followed up for a mean follow-up duration of 4.4 ± 3.1 years with total follow up of 220.2 patient years. Appropriate ICD therapy was delivered in 16 out of 50 (32%) patients, with 65 appropriate therapies (median 2 per patient, range: 0-20). Inappropriate therapy delivered in 7 of the 50 (14%) patients, with 44 inappropriate therapies (median 5 per patient, range: 0-20). Complications occurred in 8 of the 50 (16%) patients. Overall, the rate of appropriate therapy was 29.5 per 100 patient years, that of inappropriate therapy was 19.9 per 100 patient years and the rate of complications was 3.6 per 100 patient years., Conclusions: When implanted for primary prevention in patients with cardiomyopathies over a mean period of 4.4 ± 3.1 years, appropriate ICD therapy was delivered in 32% patients. However, inappropriate therapy (14% patients) and complications (16% patients) were also common., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Cardiological Society of India. Published by Elsevier, a division of RELX India, Pvt. Ltd. All rights reserved.)

Introduction: The extravascular implantable cardioverter defibrillator (EV ICD) has extended projected battery longevity compared to the subcutaneous implantable cardioverter defibrillator (S-ICD). This study used modeling to characterize the need for generator changes, long-term complications, and overall costs for both the EV ICD and S-ICD in healthcare systems of various countries., Methods: Battery longevity data were modeled using a Markov model from averages reported in device labeling for the S-ICD and with engineering estimates based on real life usage from EV ICD Pivotal Study patient data to introduce variability. Clinical demographic data were derived from published literature. The primary outcomes were defined as the number of generator replacement surgeries, complications, and total healthcare system costs due to battery depletion over the expected lifetime of patients receiving EV ICD or S-ICD therapy., Results: Average modeled battery longevity was determined to be 7.3 years for the S-ICD versus 11.8 years for the EV ICD. The probability of a complication after a replacement procedure was 1.4%, with an operative mortality rate of 0.02%. The use of EV ICD was associated with 1.4-1.6 fewer replacements on average over an expected patient lifetime as compared to S-ICD and a 24.3%-26.0% reduction in cost. A one-way sensitivity analysis of the model for the US healthcare system found that use of an EV ICD resulted in a reduction in replacement surgeries of greater than 1 (1.1-1.6) along with five-figure cost savings in all scenarios ($18 602-$40 948)., Conclusion: The longer projected battery life of the EV ICD has the potential to meaningfully reduce long-term morbidity and healthcare resources related to generator changes from the perspective of multiple diverse healthcare systems., (© 2023 The Authors. Journal of Cardiovascular Electrophysiology published by Wiley Periodicals LLC.)

Background: The benefit of implantable cardioverter-defibrillator (ICD) in elderly patients has been questioned. In the present study, we aimed to analyse the outcome of patients of different age groups with ICD implantation., Methods: We included all patients who received an ICD in our hospital from 2011 to 2020. Primary endpoints were (1) death from any cause and (2) appropriate ICD therapy (antitachycardia pacing/shock). A "benefit of ICD implantation" was defined as appropriate ICD therapy before death from any cause/or survival. "No benefit of ICD implantation" was defined as death from any cause without prior appropriate ICD therapy., Results: A total of 422 patients received an ICD (primary prophylaxis n = 323, secondary prophylaxis n = 99). At the time of implantation, 35 patients (8%) were >80 years and 106 patients were >75 years (25%). During the study period of 4.2 ± 3 years, benefit of ICD occurred in 89 patients (21%) and no benefit in 84 patients (20%). In primary prevention, the proportion of patients who had a benefit from ICD implantation decreased with increasing age, and there were no patients who benefited from ICD therapy in the group of patients >80 years. In secondary prophylaxis, the proportion of patients with a benefit from ICD implantation ranged from 20% to 30% in all age groups., Conclusion: Our study suggests that the indication of primary prophylactic ICD in elderly and very old patients should be critically assessed. On the other hand, no patient should be denied secondary prophylactic ICD implantation because of age., (© 2023 The Authors. Clinical Cardiology published by Wiley Periodicals LLC.)

Implantable cardioverter defibrillators (ICDs) reduce sudden cardiac death (SCD) when patients experience life-threatening ventricular arrhythmias (LTVA). However, current strategies determining ICD patient selection and risk stratification are inefficient. We used metabolomics to assess whether dysregulated metabolites are associated with LTVA and identify potential biomarkers. Baseline plasma samples were collected from 72 patients receiving ICDs. Over a median follow-up of 524.0 days (range 239.0-705.5), LTVA occurred in 23 (31.9%) patients (22 effective ICD treatments and 1 SCD). After confounding risk factors adjustment for age, smoking, secondary prevention, and creatine kinase MB, 23 metabolites were significantly associated with LTVA. Pathway analysis revealed LTVA associations with disrupted metabolism of glycine, serine, threonine, and branched chain amino acids. Pathway enrichment analysis identified a panel of 6 metabolites that potentially predicted LTVA, with an area under the receiver operating characteristic curve of 0.8. Future studies are necessary on biological mechanisms and potential clinical use., (© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Unlimited access to ECGs using an over-the-counter smartwatch constitutes a real revolution for our discipline, and the application is rapidly expanding to include patients with cardiac implantable electronic devices (CIEDs) such as pacemakers (PMs) and implantable cardioverter defibrillators (ICDs). CIEDs require periodic evaluation and adjustment by healthcare professionals. In addition, implanted patients often present with symptoms that may be related to their PMs or ICDs. An ECG smartwatch could reveal information about device functioning, confirm normal device function, or aid in the case of device troubleshooting. In this review, we delve into the available evidence surrounding smartwatches with ECG registration and their integration into the care of patients with implanted pacemakers and ICDs. We explore safety considerations and the benefits and limitations associated with these wearables, drawing on relevant studies and case series from our own experience. By analyzing the current landscape of this emerging technology, we aim to provide a comprehensive overview that facilitates informed decision-making for both healthcare professionals and patients.

Background: Hypertrophic cardiomyopathy (HCM) is the commonest genetic cardiomyopathy and may result in sudden cardiac death (SCD). Clinical risk stratification scores are utilised to estimate SCD risk and determine potential utility of a primary prevention implantable cardioverter defibrillator (ICD)., Methods: Patients with a confirmed diagnosis of HCM from a quaternary HCM service were defined according to clinical characteristics, genetic profiles and cardiac imaging results. European Risk-SCD score and American Heart Association / American College of Cardiology (AHA/ACC) Score were calculated. The primary outcome was cardiac arrest., Results: 380 patients with HCM were followed up for a median of 6.4 years. 18 patients (4.7%) experienced cardiac arrest, with predictive factors being younger age (37.2 vs 54.4 years, p = 0.0041), unexplained syncope (33.3% vs 9.4%, p = 0.007), non-sustained ventricular tachycardia (50.0% vs 12.7%, p < 0.0001), increased septal thickness (21.5 vs 17.5 mm, p = 0.0003), and presence of a sarcomeric gene mutation (100.0% vs 65.8%, p = 0.038). The Risk-SCD and AHA/ACC scores had poor agreement (kappa coefficient 0.38). Risk-SCD score had poor sensitivity (44.4%), classifying 55.6% of patients with cardiac arrest as low-risk but was highly specific (93.7%). AHA/ACC risk score did not discriminate between groups significantly. 20 patients (5.3%) died, with most >60-year-olds having a non-cardiac cause of death (p = 0.0223)., Conclusion: This study highlights limited (38%) agreement between the Risk-SCD and AHA/ACC scores. Most cardiac arrests occurred in ostensibly low or medium-risk patients under both scores. Appropriate ICD selection remains challenging. Incorporating newer risk markers such as HCM genotyping and myocardial fibrosis quantification by cardiac MRI may assist future risk refinement., Competing Interests: Declaration of Competing Interest The authors have no conflicts of interest to disclose., (Crown Copyright © 2023. Published by Elsevier B.V. All rights reserved.)

Background: Increased risk of severe tachyarrhythmias is reported in patients with type 2 diabetes mellitus (T2DM). The aim of this study was to explore if treatment with cardiac implantable electronic device (CIED) such as implantable cardioverter defibrillator (ICD), cardiac resynchronization therapy- pacemaker and -defibrillator (CRT-P/CRT-D) differed in patients with vs. without T2DM. A secondary aim was to identify patient characteristics indicating an increased CIED treatment., Method: 416 162 adult patients with T2DM from the Swedish National Diabetes Registry and 2 081 087 controls from the Swedish population, matched for age, sex and living area, were included between 1/1/1998 and 31/12/2012 and followed until 31/12/2013. They were compared regarding prevalence of ventricular tachycardia (VT) at baseline and the risk of receiving a CIED during follow-up. Multivariable Cox regression analysis was performed to estimate the risk of CIED-treatment and factors identifying patients with such risk., Results: Ventricular fibrillation (VF) (0.1% vs 0.0004%) and (VT) (0.2% vs. 0.1%) were more frequent among patients with T2DM compared to controls. CIED-treatment was significantly increased in patients with T2DM both in unadjusted and adjusted analyses. HR and 95% CI, after adjustment for sex, age, marital status, income, education, country of birth, coronary artery disease and congestive heart failure, were 1.32 [1.21-1.45] for ICD, 1.74 [1.55-1.95] for CRT-P and 1.69 [1.43-1.99] for CRT-D. Blood-pressure and lipid lowering therapies were independent risk factors associated to receiving CIED, while female sex was protective., Conclusions: Although the proportion of VT/VF was low, patients with T2DM had a higher prevalence of these conditions and increased risk for treatment with CIED compared to controls. This underlines the importance of recognizing that T2DM patients have an increased need of CIED., (© 2024. The Author(s).)

Background: Implantable cardioverter-defibrillators (ICD)/cardiac resynchronization therapy with defibrillation (CRT-D) recipients may be susceptible to the arrhythmic effects of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection., Aims: We aimed to evaluate characteristics and outcomes of patients hospitalized for ICD/CRT-D shocks during the pandemic compared to the pre-pandemic period., Methods: This retrospective study analyzed medical records of patients hospitalized for ICD/CRT-D shock in the pre-pandemic (January 1, 2018-December 31, 2019) and pandemic periods (March 4, 2020-March 3, 2022). Survival data were obtained on October 24, 2022., Results: In total, 198 patients (average age 65.6 years) had 138 pre-pandemic and 124 pandemic visits. Of these patients, 115 were hospitalized during pre-pandemic, 108 during the pandemic, and 25 in both periods. No significant differences were noted in age, sex, number of shocks, or appropriateness of therapy between these periods. During the pandemic, during 14 hospital stays of patients with SARS-CoV-2, 8 (57.1%) received electrical shocks, compared to 12 (10.9%) with negative SARS-CoV-2 tests (P <0.001). The in-hospital mortality rate was 2 of 115 patients hospitalized during the pre-pandemic and 7 of 108 during pandemic periods (4 patients with and 3 without SARS-CoV-2 [P = 0.10]). During the follow-up, there were 66 deaths. Cox regression analysis showed that survival decreased with age and heart failure decompensation in medical history but increased with higher ejection fraction. The pandemic alone was not a survival predictor. However, SARS-CoV-2 infection, older age, and heart failure decompensation in medical history predicted worse outcomes during the pandemic period., Conclusions: The pandemic did not increase the number of hospital visits due to ICD/CRT-D discharges. SARS-CoV-2 infection predicts increased mortality in patients with ICD/CRT-D shocks.

Objectives: Implantable cardioverter defibrillator (ICDs) for primary prevention (PP) of sudden cardiac arrest (SCA) is underutilized in developing countries. The Improve SCA study has identified a subset of 1.5 primary prevention (1.5PP) patients with a higher risk of SCA and a significant mortality benefit from ICD therapy. From the perspective of China's healthcare system, we evaluated the cost-effectiveness of ICD therapy vs. no ICD therapy among 1.5PP patients with a view to informing clinical and policy decisions., Methods: A published Markov model was adjusted and verified to simulate the course of the disease and describe different health states of 1.5PP patients. The patient characteristics, mortality, utility and complication estimates were obtained from the Improve SCA study and other literature. Cost inputs were sourced from government tender prices, medical service prices and clinical experts' surveys in 9 Chinese public hospitals. For both ICD and no ICD therapy, the total medical costs and quality-adjusted life-years (QALYs) were modelled over a lifetime horizon and the incremental cost-effectiveness ratio (ICER) was calculated. Deterministic and probabilistic sensitivity analyses were performed to assess the uncertainty of the model parameters. We used the willingness-to-pay (WTP) threshold recommended by China Guidelines for Pharmacoeconomic Evaluations, one to three times China's GDP per capita (CNY85,698-CNY257,094) in 2022 Chinese Yuan., Results: The incremental cost effectiveness ratio (ICER) of ICD therapy compared to no ICD therapy is 139,652 CNY/QALY, which is about 1-2 times China's GDP per capita. The probability that ICD therapy is cost effective was 92.1%. Results from sensitivity analysis supported the findings of the base case., Conclusions: ICD therapy compared to no ICD therapy is cost-effective for the 1.5PP patients in China.

Background: Appropriate time for ejection fraction (EF) reassessment after revascularization in patients with left ventricular dysfunction has not been investigated comprehensively, although 3 months after revascularization is recommended to stratify the risk of sudden cardiac death (SCD)., Hypothesis: EF reassessed within different timeframe after revascularization may have incosistent contribution for risk stratification of SCD., Methods: Patients who had EF ≤ 40% before revascularization and had EF reassessment at least once during follow-up were included. The role of early (<3 months) versus late (3-12 months) EF measurements in prediction of all-cause mortality and SCD were compared., Results: A total of 1589 patients were identified. EF reassessed <3 months was lower than EF reassessed within 3-12 months (42.1 ± 9.7% vs. 45.8 ± 10.8%; p < .01). Among 1069 patients who had EF reassessed <3 months, EF ≤ 35% was associated with a higher risk of all-cause mortality (hazard ratio [HR], 1.67; 95% confidence interval [CI], 1.22-2.29; p < .01), but had no association with the risk of SCD (HR, 1.44; 95% CI, 0.84-2.48; p = .18). By contrast, among 595 patients who had EF reassessed within 3-12 months, EF ≤ 35% was associated with higher risks of both all-cause death (HR, 1.81; 95% CI, 1.06-3.10; p = .03) and SCD (HR, 2.71; 95% CI, 1.31-5.61; p < .01). The relative contribution of SCD to all-cause death was higher in patients with EF ≤ 35% than patients with EF > 35% when EF was reassessed within 3-12 months (p = .04). However, when EF was reassessed <3 months, the mode of death was similar in patients with EF ≤ 35% versus >35% (p = .85)., Conclusions: 3 to 12 months after revascularization may be appropriate for cardiac function reassessment and SCD risk stratification., (© 2023 The Authors. Clinical Cardiology published by Wiley Periodicals, LLC.)

Background: There are conflicting data on the effect of cardiac resynchronization therapy with a defibrillator (CRT-D) on the risk of life-threatening ventricular tachyarrhythmia in heart failure patients., Objectives: The authors aimed to assess whether QRS morphology is associated with risk of ventricular arrhythmias in CRT recipients., Methods: The study population comprised 2,862 patients implanted with implantable cardioverter defibrillator (ICD)/CRT-D for primary prevention who were enrolled in 5 landmark primary prevention ICD trials (MADIT-II [Multicenter Automated Defibrillator Implantation Trial], MADIT-CRT [Multicenter Automated Defibrillator Implantation Trial-Cardiac Resynchronization Therapy], MADIT-RIT [Multicenter Automated Defibrillator Implantation Trial-Reduction in Inappropriate Therapy], MADIT-RISK [Multicenter Automated Defibrillator Implantation Trial-RISK], and RAID [Ranolazine in High-Risk Patients With Implanted Cardioverter Defibrillators]). Patients with QRS duration ≥130 ms were divided into 2 groups: those implanted with an ICD only vs CRT-D. The primary endpoint was fast ventricular tachycardia (VT)/ventricular fibrillation (VF) (defined as VT ≥200 beats/min or VF), accounting for the competing risk of death. Secondary endpoints included appropriate shocks, any sustained VT or VF, and the burden of fast VT/VF, assessed in a recurrent event analysis., Results: Among patients with left bundle branch block (n = 1,792), those with CRT-D (n = 1,112) experienced a significant 44% (P < 0.001) reduction in the risk of fast VT/VF compared with ICD-only patients (n = 680), a significantly lower burden of fast VT/VF (HR: 0.55; P = 0.001), with a reduced burden of appropriate shocks (HR: 0.44; P < 0.001). In contrast, among patients with non-left bundle branch block (NLBBB) (N = 1,070), CRT-D was not associated with reduction in fast VT/VF (HR: 1.33; P = 0.195). Furthermore, NLBBB patients with CRT-D experienced a statistically significant increase in the burden of fast VT/VF events compared with ICD-only patients (HR: 1.90; P = 0.013)., Conclusions: Our data suggest a potential proarrhythmic effect of CRT among patients with NLBBB. These data should be considered in patient selection for treatment with CRT., Competing Interests: Funding Support and Author Disclosures The MADIT studies were funded by an unrestricted research grant from Boston Scientific to the University of Rochester Medical Center, Rochester, New York. All authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aims: The aim of this study was to investigate the outcomes of catheter ablation (CA) in preventing arrhythmic events among patients with symptomatic Brugada syndrome (BrS) who declined implantable cardioverter defibrillator (ICD) implantation., Methods and Results: A total of 40 patients with symptomatic BrS were included in the study, of which 18 refused ICD implantation and underwent CA, while 22 patients received ICD implantation. The study employed substrate modification (including endocardial and epicardial approaches) and ventricular fibrillation (VF)-triggering pre-mature ventricular contraction (PVC) ablation strategies. The primary outcomes were a composite endpoint consisting of episodes of VF and sudden cardiac death during the follow-up period. The study population had a mean age of 43.8 ± 9.6 years, with 36 (90.0%) of them being male. All patients exhibited the typical Type 1 BrS electrocardiogram pattern, and 16 (40.0%) were carriers of an SCN5A mutation. The Shanghai risk scores were comparable between the CA and the ICD groups (7.05 ± 0.80 vs. 6.71 ± 0.86, P = 0.351). Ventricular fibrillation-triggering PVCs were ablated in 3 patients (16.7%), while VF substrates were ablated in 15 patients (83.3%). Epicardial ablation was performed in 12 patients (66.7%). During a median follow-up of 46.2 (17.5-73.7) months, the primary outcomes occurred more frequently in the ICD group than in the CA group (5.6 vs. 54.5%, Log-rank P = 0.012)., Conclusion: Catheter ablation is an effective alternative therapy for improving arrhythmic outcomes in patients with symptomatic BrS who decline ICD implantation. Our findings support the consideration of CA as an alternative treatment option in this population., Competing Interests: Conflict of interest: none declared., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)

New-onset or worsening tricuspid regurgitation (TR) is a well-established complication encountered after cardiac implantable electronic devices (CIEDs). However, there are limited and conflicting data on the true incidence and prognostic implications of this complication. This study aimed to bridge this current gap in the literature. Electronic databases MEDLINE, Embase, and Web of Science were systematically searched from inception to March 2023, for studies reporting the incidence and/or prognosis of CIED-associated new or worsening TR. Potentially eligible studies were screened and selected according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. A random effect model meta-analysis and meta-regression analysis were performed, and I-squared statistic was used to assess heterogeneity. A total of 52 eligible studies, with 130,759 patients were included in the final quantitative analysis with a mean follow-up period of 25.5 months. The mean age across included studies was 69.35 years, and women constituted 46.6% of the study population. The mean left ventricular ejection fraction was 50.15%. The incidence of CIED-associated TR was 24% (95% confidence interval [CI] 20% to 28%, p <0.001) with an odds ratio of 2.44 (95% CI 1.58 to 3.77, p <0.001). CIED-associated TR was independently associated with an increased risk of all-cause mortality (adjusted hazard ratio [aHR] 1.52, 95% CI 1.36 to 1.69, p <0.001), heart failure (HF) hospitalizations (aHR 1.82, 95% CI 1.19 to 2.78, p = 0.006), and the composite of mortality and HF hospitalizations (aHR 1.96, 95% CI 1.33 to 2.87, p = 0.001) in the follow-up period. In conclusion, CIED-associated TR occurred in nearly one-fourth of patients after device implantation and was associated with an increased risk of all-cause mortality and HF hospitalizations., Competing Interests: Declaration of Competing Interest The authors have no competing interests to declare., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Aims: Modern clinical management of patients with an implantable cardioverter defibrillator (ICD) largely consists of remote device monitoring, although a subset is at risk of mental health issues post-implantation. We compared a 12-month web-based intervention consisting of goal setting, monitoring of patients' mental health-with a psychological intervention if needed-psychoeducational support from a nurse, and an online patient forum, with usual care on participants' device acceptance 12 months after implantation., Methods and Results: This national, multi-site, two-arm, non-blinded, randomized, controlled, superiority trial enrolled 478 first-time ICD recipients from all 6 implantation centres in Denmark. The primary endpoint was patient device acceptance measured by the Florida Patient Acceptance Survey (FPAS; general score range = 0-100, with higher scores indicating higher device acceptance) 12 months after implantation. Secondary endpoints included symptoms of depression and anxiety. The primary endpoint of device acceptance was not different between groups at 12 months [B = -2.67, 95% confidence interval (CI) (-5.62, 0.29), P = 0.08]. Furthermore, the secondary endpoint analyses showed no significant treatment effect on either depressive [B = -0.49, 95% CI (-1.19; 0.21), P = 0.17] or anxiety symptoms [B = -0.39, 95% CI (-0.96; 0.18), P = 0.18]., Conclusion: The web-based intervention as supplement to usual care did not improve patient device acceptance nor symptoms of anxiety and depression compared with usual care. This specific web-based intervention thus cannot be recommended as a standardized intervention in ICD patients., Competing Interests: Conflict of interest: J.C.N. received institutional grants from the Novo Nordisk Foundation and the Danish Heart Foundation. J.B.J. is a consultant for Medtronic. M.V. serves on conduction system pacing advisory boards for Medtronic and Abbott. K.G.S. reports unrestricted research grants from Philips, Abbott, Merck, and Johnson & Johnson, and she is a consultant for Optum Labs and Abbott, Happify, and Haemonetics. K.G.S. is supported by NIH grants 1R21AT012430-01 (NCCIH) and 1R01HL163640-01A1 (NHLBI). J.A.S. has no conflicts of interest for the study but discloses providing consultative services on patient-reported outcomes and evidence evaluation to Alnylam, AstraZeneca, Bayer, Merck, Janssen, Bristol Meyers Squibb, Edwards, Kineksia, 4DT Medical, Terumo, Cytokinetics, Imbria, and United Healthcare. He holds research grants from Bristol Meyers Squibb, Abbott Vascular, and Janssen. He owns the copyright to the Seattle Angina Questionnaire, Kansas City Cardiomyopathy Questionnaire, and Peripheral Artery Questionnaire and serves on the Board of Directors for Blue Cross Blue Shield of Kansas City. All remaining authors have declared no conflicts of interest., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)