BACKGROUND:Catheter-based closure of the left atrial appendage is an alternative to oral anticoagulation for stroke prevention in patients with atrial fibrillation. The effectiveness of this strategy, as compared with physician-directed best medical care, in patients at high risk for stroke and bleeding is unknown. METHODS:In this multicenter randomized trial conducted in Germany, we assigned patients with atrial fibrillation and a high risk of stroke and bleeding to undergo left atrial appendage closure or to receive physician-directed best medical care (including direct oral anticoagulants, if eligible). The primary end point, tested for noninferiority, was a composite of stroke (ischemic or hemorrhagic), systemic embolism, major bleeding, or cardiovascular or unexplained death, assessed in a time-to-event analysis. The noninferiority margin was a hazard ratio of 1.3. RESULTS:A total of 912 adult patients underwent randomization. The primary end-point analysis included 446 patients who were assigned to undergo left atrial appendage closure (device group) and 442 who were assigned to physician-directed best medical care (medical-therapy group). The mean (±SD) age was 77.9±7.1 years; 38.6% of the patients were women, the mean CHA2DS2-VASc score was 5.2±1.5 (range, 0 to 9, with higher scores indicating a greater risk of stroke), and the mean HAS-BLED score was 3.0±0.9 (range, 0 to 9, with higher scores indicating higher risk of bleeding). After a median follow-up of 3 years (interquartile range, 1.7 to 4.7), a first primary end-point event had occurred in 155 patients (incidence per 100 patient-years, 16.8) in the device group and in 127 patients (incidence per 100 patient-years, 13.3) in the medical-therapy group (difference in restricted mean survival time, -0.36 years; 95% confidence interval, -0.70 to -0.01; P = 0.44 for noninferiority). Serious adverse events occurred in 368 patients (82.5%) in the device group and 342 (77.4%) in the medical-therapy group. CONCLUSIONS:Among patients with atrial fibrillation at high risk for stroke and bleeding, left atrial appendage closure was not noninferior to physician-directed best medical care with regard to a composite end point of stroke, systemic embolism, major bleeding, or cardiovascular or unexplained death. (Funded by the German Center for Cardiovascular Research; CLOSURE-AF ClinicalTrials.gov number, NCT03463317.).

Pulmonary vein isolation (PVI) is the cornerstone of interventional treatment for atrial fibrillation. Patients with persistent atrial fibrillation have relatively high recurrence rates after catheter ablation irrespective of treatment strategy. Randomized data suggest that adding substrate modification to PVI at the first ablation procedure does not improve arrhythmia-free survival. To date, real-world data from experienced centers is limited. The German Ablation registry maintained by the Institut für Herzinfarktforschung Ludwigshafen, Germany included 909 patients with persistent atrial fibrillation (AF). 645 underwent isolated PVI (PVI-only) and 264 received additional substrate modification (PVI-plus). The primary endpoint was defined as freedom from AF after 1 year documented by ECG. Mean procedure time was longer in the PVI-plus group (203 ± 75 min vs. 186 ± 68 min; p = 0.002) with no significant difference in acute procedural success (94

Importance:Current guidelines do not recommend primary prevention implantable cardioverter-defibrillators (ICDs) unless a patient's left ventricular ejection fraction (LVEF) is 35% or less. Many sudden cardiac deaths (SCD) occur when LVEF is 36% to 50%. Myocardial scar (a key arrhythmic substrate) can be assessed by late gadolinium enhancement on cardiovascular magnetic resonance (CMR), but robust evidence is lacking regarding a scar-based approach to ICD insertion. Objective:To determine whether implantation of ICDs reduces SCD or hemodynamically significant ventricular arrhythmia (HSVA) in patients with an LVEF of 36% to 50% and myocardial scar. Design, Setting, and Participants:An open-label randomized clinical trial enrolled adults between 2015 and 2022 who had ischemic or nonischemic cardiomyopathy, an LVEF of 36% to 50%, CMR-defined myocardial scar, and were receiving guideline-directed medical therapy at 18 sites in Australia, Germany, and the UK. Follow-up assessments were completed in 2026. Interventions:A primary prevention ICD (n = 180) vs an implantable loop recorder (ILR) (n = 173). Main Outcomes and Measures:The primary composite outcome was SCD or HSVA. Five secondary outcomes were evaluated: SCD, HSVA, heart failure-related hospitalization, cardiovascular mortality, and all-cause mortality. Results:Of 353 patients randomized (median age, 65 years [IQR, 57-61 years]; 18% female; and 72% had an ischemic etiology), 70% had an LVEF of 40% or greater. The median follow-up was 6.3 years (IQR, 4.8-7.6 years). The primary composite outcome occurred in 14 patients (7.8%) in the ICD group compared with 16 patients (9.2%) in the ILR group (hazard ratio [HR], 0.76 [95% CI, 0.37-1.58]). For the individual components of the primary composite outcome, SCD occurred in 3 patients (1.7%) vs 10 patients (5.8%) in the ILR group (HR, 0.26 [95% CI, 0.07-0.95]) and HSVA occurred in 12 patients (6.7%) vs 6 patients (3.5%), respectively (HR, 1.77 [95% CI, 0.65-4.81]). The rates for all-cause mortality, cardiovascular mortality, and heart failure-related hospitalization were similar between groups. In a prespecified analysis of 6 subgroups, the primary outcome occurred less often in patients younger than 70 years in the ICD group (3.3%) vs patients in the ILR group (10.0%) (HR, 0.28 [95% CI, 0.09-0.89]) but not in those aged 70 years or older (16.9% vs 7.5%, respectively) (HR, 2.33 [95% CI, 0.75-7.26]; P = .01 for interaction). Conclusions and Relevance:Implantation of an ICD did not reduce the composite outcome of SCD or HSVA in patients with an LVEF of 36% to 50% and myocardial scar. Trial Registration:ClinicalTrials.gov Identifier: NCT01918215.

Implantable cardioverter-defibrillator (ICD) is a cornerstone therapy for the prevention of sudden cardiac death. However, clinical profiles and in-hospital outcomes may differ according to device type—single-chamber ICD, dual-chamber ICD, or cardiac resynchronization therapy defibrillator (CRT-D). This study aimed to compare hospitalization parameters and peri-procedural complications among patients receiving these device types. We retrospectively analyzed 2,001 consecutive ICD recipients (single-chamber: 815; dual-chamber: 463; CRT-D: 723). Baseline characteristics, intensive care unit (ICU) utilization, procedure-related complications, and discharge outcomes were compared across groups. The main endpoint was defined as major adverse cardiovascular and cerebrovascular events (MACCE), and the second endpoint was defined as an extended MACCE including both MACCE and intensive care unit (ICU) admission. CRT-D recipients were older (67.5 ± 10.4 years, p < 0.01) and had a higher prevalence of comorbidities, including obesity (12.3

The CMR Guide trial aims to determine whether the insertion of an Implantable Cardioverter Defibrillator based on the presence of ventricular scar/fibrosis will reduce sudden cardiac death or syncopal ventricular arrhythmia in patients with mild moderate left ventricle systolic dysfunction compared to standard care. This statistical analysis plan pre-specifies the method of analysis for every outcome and key variables collected in the trial. The primary outcome is a composite of sudden cardiac death or haemodynamically significant ventricular arrhythmia defined as ventricular arrhythmia producing syncope (loss of consciousness) or associated with hypotension (SBP<90mmHg) except directly associated with device implant procedure. The main analysis will consist of a Fine and Gray survival model of time to first occurrence of a primary outcome treating deaths other than sudden cardiac deaths as competing risks. The analysis plan also includes planned sensitivity analyses including covariate adjustments and subgroup analyses. ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial NCT01918215 ### Funding Statement The study is funded by: - Biotronik Australia Pty Ltd - Bayer Australia Ltd ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The following ethical approvals were obtained: Southern Adelaide Clinical Human Research Ethics Committee - Host institution: Joint partnership, Southern Adelaide Local Health Network and Flinders University - Approval number: 430.14 (HREC/14/SAC/449) University of Tasmania Human Research Ethics Committee - Host institution: University of Tasmania - Approval number: H0016170 Sir Charles Gairdner and Osborne Park Health Care Group Human Research Ethics Committee - Host institution: WA Department of Health - Approval number: RGS0000001765 WA Health Central HREC (new central HREC for WA sites effective 7 May 2025) - Host institution: WA Department of Health - Approval number: RGS0000001765 (same as above migrated from SCGOPHCG to WA Central HREC) Ethics Committee State Chamber of Physicians of Baden Wurttemberg - Host institution: State Chamber of Physicians of Baden Wurttemberg - Approval number: F-2015-095-RS South East Scotland Research Ethics Committee 01 - Host institution: National Health Service Lothian (Lothian NHS Board) - Approval number: 16/SS/0153 I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes No relevant

Artificial intelligence (AI) has shown strong performance in cardiology, but most approaches rely on sensing modalities whose physical limitations constrain available information. Magnetocardiography (MCG) records the cardiac magnetic field with less tissue distortion than surface potentials and may preserve higher-dimensional spatiotemporal electrophysiological structure. Here, we investigated whether combining MCG with self-supervised learning enables physiologically meaningful cardiac representations. We developed MCG2Vec, a contrastive encoder trained directly on raw 64-channel MCG recordings. Using recordings from 1732 consecutive patients, learned embeddings were evaluated with task-specific probes for multivessel coronary artery disease, reduced left ventricular ejection fraction, and paroxysmal atrial fibrillation risk from sinus-rhythm recordings. The representations enabled discrimination of multivessel coronary artery disease (area under the receiver operating characteristic curve (AUC) 0.89), reduced left ventricular ejection fraction (AUC 0.81), and atrial fibrillation risk (AUC 0.77). Attribution analyses revealed probe-specific temporal and spatial patterns corresponding to ventricular depolarization, repolarization, atrial activation dynamics, and coronary territories, supporting physiological interpretability. These findings suggest that higher-fidelity sensing combined with self-supervised representation learning can yield structured and explainable embeddings from non-invasive cardiac magnetic field recordings. More broadly, the study highlights measurement physics as an important determinant of what medical AI systems can learn.

Objective and Background: With the increasing use of catheter ablation for tachyarrhythmias, continuous evaluation of in-hospital complications is essential. This study aimed at analyzing complications associated with catheter ablation for atrial fibrillation (AF), atrial flutter (AFL), and ventricular tachycardia (VT) using nationwide administrative data. Methods: We conducted a retrospective multicentric data analysis from large German ablation centers between 2018 and 2023. Patients were identified using ICD and OPS codes for AF, AFL, and VT regarding predefined in-hospital complications: mortality, stroke, pericardial tamponade, pulmonary embolism, and vascular complications requiring intervention. Results: Among 19,258 ablation procedures from 11 centers, AF was most common (n = 12,241), followed by AFL (n = 5582) and VT (n = 1435). Major complications occurred in 2.2% (n = 433) of cases. VT ablations had the highest complication rate (9.8%), followed by AF (1.6%) and AFL (1.7%). Pericardial tamponade occurred in 0.9% patients, most commonly in VT ablations (4.0%). Vascular complications requiring intervention were reported in 1.1%, while stroke (0.3%) and pulmonary embolism (0.05%) were rare. In-hospital mortality was highest in VT patients (2.4%), compared to AF (0.08%) and AFL (0.13%). Higher AFL mortality as compared to AF was associated with older age and more comorbidities. Upon exploratory analysis, no statistical association between hospital volume and complication rates could be seen. Conclusions: In this multicenter analysis, catheter ablation was associated with a low overall complication rate. VT ablations carried the highest risk, highlighting the impact of structural heart disease and comorbidities.

Background: According to current guidelines, cardiac resynchronisation therapy (CRT) is recommended in patients with significantly impaired left ventricular systolic function and left bundle branch block. However, the decision between pacemaker (CRT-P) and defibrillator (CRT-D) in patients eligible for CRT remains a matter of debate. Register data have shown a higher all-cause mortality in CRT-P in comparison to patients with a CRT-D. Here, we investigated clinical determinants of the selection of CRT-P vs. CRT-D and clinical outcome in large registry data from a multi-centre ‘real-life’ registry on patients with CRT defibrillator or pacemaker therapy. Methods: The German Device Registry (DEVICE) is a nationwide, prospective registry with one-year follow-up investigating 5451 patients receiving device implantations in 50 German centres. The present analysis of DEVICE focused on all patients from the register receiving cardiac resynchronization therapy. Results: Out of 1603 patients receiving cardiac resynchronisation therapy, 1536 (95.8%) received a CRT defibrillator system and 67 (4.2%) a CRT pacemaker system. Patients in the CRT-P group had a significantly better left ventricular systolic function compared to the CRT-D group (median 35% vs. 25%), and significantly less often had a history of myocardial infarction (9.0% vs. 25.2%). A preexisting pacemaker and a history of stroke/peripheral embolism were identified as determinants for the selection of CRT-P vs. CRT-D. Overall mortality after one-year follow-up was 8.0%. Patients with ischemic cardiomyopathy receiving CRT-P therapy had a higher one-year mortality than patients receiving CRT-D (21.2% vs. 8.9%, p = 0.020). On the other hand, patients with non-ischemic cardiomyopathy did not display differences between these two treatment groups (CRT-P 8.1%, CRT-D 6.6%, p = 0.72). Conclusions: Data from the German device registry show that most patients receiving cardiac synchronization therapy have an implanted CRT-D system. In comparison to patients with CRT-D, those with CRT-P more often had a non-ischemic cardiomyopathy and a preexisting pacemaker system. The outcomes between these two treatment groups were different as regards ischemic cardiomyopathy only.

BACKGROUND:Percutaneous catheter-based left atrial appendage (LAA) closure is a potential alternative to oral anticoagulation for stroke prevention in patients with atrial fibrillation (AF). The effectiveness and safety of LAA closure in patients with AF at high risk of stroke (CHA2DS2-VASc Score ≥2) and high risk of bleeding compared to best medical care including a nonvitamin K antagonist oral anticoagulant [NOAC] when considered eligible is not known. METHODS/DESIGN:The prospective, multicenter, randomized clinical Left atrial appendage CLOSURE in patients with Atrial Fibrillation at high risk of stroke and bleeding compared to medical therapy (CLOSURE-AF) trial compared catheter-based LAA closure to best medical care (including NOAC therapy if considered eligible) in patients with AF at high risk of stroke and with either a history of bleeding or a high estimated bleeding risk (HASBLED ≥ 3). The primary endpoint is time to a composite of first stroke (ischemic or hemorrhagic), systemic embolism, cardiovascular or unexplained death or major bleeding (Bleeding Academic Research Consortium 3-5). Secondary outcomes include components of the primary outcome and total mortality. The primary efficacy analysis will be performed in the intention-to-treat population using Cox regression models for noninferiority with an option to test for superiority once noninferiority has been proven. RESULTS:The first patient in the CLOSURE-AF trial was enrolled in March 2018. By April 2025 the complete study cohort of n = 912 patients had been enrolled in 42 sites. CONCLUSION:CLOSURE-AF will contribute evidence on the effectiveness and safety of LAA occlusion compared to optimal medical therapy in patients with AF at high risk of stroke and bleeding. The trial results will help to define the clinical use of catheter-based LAA closure in the future. TRIAL REGISTRATION:clinicaltrials.gov Identifier: NCT03463317.

Cardiac implantable electronic devices (CIEDs) are increasingly implanted in older patients with multiple comorbidities. The impact of comorbidities on procedural complications and clinical outcomes during and after defibrillator implantation remains a subject of ongoing debate. To investigate the associations of the comorbidity burden on baseline characteristics, periprocedural complications, and on outcomes in patients with implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy with defibrillator (CRT-D) implantations or revisions. Patients who underwent ICD or CRT-D implantations or revisions at 50 centers were prospectively enrolled in the German Device Registry. Data on patient characteristics, periprocedural complications, and outcomes were collected. Patients were categorized into four groups based on cardiometabolic comorbidities (stroke, chronic kidney disease (CKD), diabetes, hypertension): group I (no comorbidities), group II (one), group III (two), and group IV (three or four). Primary outcomes included 1-year all-cause mortality, major adverse cardiac and cerebrovascular events (MACCE), and arrhythmic/non-arrhythmic events. The Kaplan–Meier analysis was used to determine 1-year mortality. Overall, 5329 patients (mean age 65.2 years) underwent 3794 ICD and 1535 CRT-D implantations. Median follow-up was 17 months. Periprocedural complications (group I: 2.1

Background Magnetocardiography (MCG) captures the magnetic fields generated by myocardial currents, theoretically preserving electrophysiological details lost in surface potentials. However, its clinical application has been hindered by small datasets and the complexity of analysing high-dimensional magnetic field data. We sought to develop a self-supervised deep learning framework to detect high burden coronary artery disease (CAD), left ventricular dysfunction, and arrhythmia risk from resting MCG recordings. Methods We developed MCG2Vec, a contrastive deep learning encoder trained on raw 64-channel MCG signals. The model was pre-trained on unlabeled 10-second segments to learn generalizable signal morphology, then fine-tuned for clinical tasks in a retrospective cohort of 1,732 consecutive patients. The primary endpoints were the detection of significant CAD ( ≥ 70% stenosis), reduced left ventricular ejection fraction (LVEF <55%), and atrial fibrillation (AF) risk, all derived from sinus-rhythm recordings. Model performance was evaluated using patient-stratified five-fold cross-validation and interpreted using Grad-CAM activation mapping. Results In the validation analysis, the model detected significant CAD with an area under the curve (AUC) of 0.89 (95% CI 0.82 - 0.93) and successfully localized ischemia to the left anterior descending (AUC 0.88), right coronary (0.82), and left circumflex arteries (0.82). Reduced LVEF was identified with an AUC of 0.81 (95% CI 0.71 - 0.91). Furthermore, the model predicted a history of paroxysmal AF from sinus-rhythm recordings with an AUC of 0.77 (95% CI 0.69 - 0.85). Explainability analysis confirmed that the model relied on physiologically distinct phases of the cardiac cycle (repolarization heterogeneity for ischemia and P-wave/S-wave morphology for arrhythmia risk )rather than non-specific noise. Conclusion Deep learning-enhanced magnetocardiography enables the accurate, non-invasive detection of ischemia, ventricular dysfunction, and arrhythmia risk from a single resting scan. By unlocking the latent diagnostic information within the cardiac magnetic field, this approach offers a scalable, radiation-free adjunct ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement This study did not receive any funding ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Ethics committee/IRB of Arztekammer Hamburg gave ethical approval for this work (MC-017/09) I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All data in the present study are available upon reasonable request to the authors

BACKGROUND:Pulmonary vein isolation (PVI) is the cornerstone therapy for symptomatic drug-refractory atrial fibrillation yet is not curative in a large segment of patients. Focal and rotational drivers are proposed to be involved in atrial fibrillation mechanisms but their ablation has produced variable outcomes. REAFFIRM (The Randomized Evaluation of Atrial Fibrillation Treatment with Focal Impulse and Rotor Modulation Guided Procedures) trial (NCT-02274857) objective was to compare the safety and effectiveness of conventional ablation with and without Focal Impulse and Rotor Modulated (FIRM) ablation, guided by global basket mapping, for the treatment of persistent atrial fibrillation. METHODS:Three hundred seventy-five patients were enrolled and randomized at 18 centers. The Intent-to-Treat population consisted of 350 patients (171 FIRM, 179 Conventional). Primary effectiveness was defined as single procedure freedom from atrial fibrillation/atrial tachycardia recurrence at 3 to 12 months post index procedure. RESULTS:Three hundred twenty-four patients completed the 12-month follow-up. Patients in the FIRM arm had a larger left atrium (P <0.01). Primary effectiveness at 3 to 12 months was 69.3% in FIRM and 67.5% in Conventional (NS), with no difference in ablation procedure time or safety. A subset of patients (41% FIRM, 49% Conventional) received extra ablation. Primary effectiveness in the on-treatment subgroups was 65% PVI-only, 69.6% PVI +extra, 77.7% FIRM+ PVI-only, and 57.7% FIRM+ PVI +extra (P=0.09). CONCLUSIONS:Intention-to-treat analysis failed to provide evidence for the superiority of adding ablation of focal or rotational sites to conventional ablation. REGISTRATION:URL: https://clinicaltrials.gov; Unique Identifier: NCT-02274857.

Implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy with defibrillation-function (CRT-D) are widely used in patients with life-threatening arrhythmias or heart failure. We aim to investigate the impact of sex-specific differences on defibrillation-capable cardiac devices’ implantation and outcomes. The German DEVICE registry is a prospective, multicentre database of ICD and CRT device implantation. A total of 5330 patients receiving a defibrillation-capable device were prospectively enrolled in 44 centres between March 2007 and February 2014 and followed for 17 (13, 23) months. A minority of patients in this registry was female 1017 (19.1

Introduction: ECG-monitoring covering several days is recommended by current guidelines to detect atrial fibrillation (AF) and other arrhythmias in stroke patients. In practice, the extent of rhythm monitoring varies. Here, we use data from the 24-hour screening-Holter-ECGs of the ongoing randomized multicenter trial Find-AF 2 to assess the rate of AF and other arrhythmias. Methods and Results: Find-AF 2 (NCT04371055) is a randomized and controlled open-label parallel multicenter trial with central AF adjudication (intervention arm) and blinded endpoint assessment. Patients ≥60 years with recent (≤30 days) ischemic strokes according to the AHA/ASA definition of any etiology are screened for eligibility. All eligible patients receive a 24-hour Holter-ECG prior to randomization. Holter ECG data are analyzed by the core laboratory using dedicated analysis software and following a predefined standard operation procedure. In this analysis, we included all 24-hour Holter-ECGs up to June 1, 2023. We analyzed 3742 24-hour-Holter-ECGs from 51 different centers and found new arrhythmias in 120 patients (3.2%). AF was detected in 61 patients (1.6%) with a median duration of the longest episode of 730 minutes [interquartile range (IQR) 220;1180] (see Figure 1). This led to the initiation of anticoagulation in all 61 patients (100%). In 47 patients (1.3%), pauses >2.5 s (mean 3.1s±0.5s; longest pause 4.8s) or relevant bradycardias <40 bpm were diagnosed. This resulted in the implantation of pacemakers in six patients. Finally, we found regular supraventricular tachycardias in 25 patients (0.7%; median duration 7.0 min [IQR 1.0;21.3]) - 24 of them had focal atrial tachycardias and one an AVNRT. Conclusion: Overall, 3.2% of ischemic stroke patients had pathological ECG findings, leading to a therapeutic change in 56%, most commonly anticoagulation for AF detection The number needed to screen for a change in medical management was 56.

ABSTRACT Background Digitalis glycosides are employed for rate control of atrial fibrillation and treatment of heart failure. Previous studies suggested potential harmful effects of digitalis therapy. The aim of the present study was to assess the prevalence and potential impact of digitalis therapy on outcomes in patients with systolic failure who were implanted with an ICD‐ or CRT‐ICD system. Methods and Results The German Device Registry is a nationwide, prospective registry with a 1‐year follow‐up investigating 4384 patients receiving either ICD or CRT systems in 52 German centers. The present analysis focused on the presence of digitalis therapy in 3826 patients undergoing device implantation. Patients receiving digitalis therapy (n = 800) presented a more severely impaired left ventricular function, higher NYHA class, and an increased incidence of left bundle branch block. Consequently, the implantation of CRT systems was more common in this group. One‐year mortality did not significantly differ between both groups (9.1% vs. 7.4%, p = 0.14). Similar results were obtained for the combined endpoint, including death, myocardial infarction, and stroke. ICD shock delivery (19.7% vs. 15.0%, p = 0.006) and device revision (11.4% vs. 7.5%, p < 0.004) were more common in digitalis‐treated patients. Conclusion In this study in patients undergoing ICD or CRT implantation, an association of digitalis therapy with an increased risk of device revision was observed. Of note, mortality or severe cardiovascular events did not differ between both groups. Furthermore, an increased risk of ICD shock delivery was observed in digitalis‐treated patients.

In the Find-AF 2 randomised controlled trial, we investigate whether a risk-adapted intensified heart rhythm monitoring with subsequent initiation of oral anticoagulation in ischaemic stroke patients leads to a reduction of recurrent ischaemic stroke and systemic embolism. The objective of this analysis is to present baseline characteristics of the overall Find-AF 2 study population and stratified by low or high risk for developing AF. The Find-AF 2 trial included acute ischaemic stroke patients ≥ 60 years of age within 30 days of ischaemic stroke of any cause. Before randomisation, patients received a 24-h Holter-ECG to exclude those with easily detectable AF and to determine the presence or absence of enhanced supraventricular ectopic activity (ESVEA), used as a marker indicating high or low risk for developing AF. Those without AF were randomly assigned 1:1 to either usual care diagnostics for AF detection (control group) or enhanced, prolonged and intensified ECG monitoring (intervention group). In the intervention group, patients with ESVEA received an implantable cardiac monitor (ICM), whereas those without ESVEA received repeated annual 7-day Holter ECGs. We present baseline characteristics of the overall Find-AF 2 population and stratified by ESVEA. Between July 2020 and July 2024, 5227 patients (mean age 72.3 ± 7.5 years, 40

Ambulatory cardiac monitoring (ACM) allows long-term electrocardiogram (ECG) monitoring to detect arrhythmias with different modalities, ranging from short-term Holter monitoring (up to 48 h) to long-term continuous patch ECG monitors (up to 14 days), external event recorders (up to 30 days), and implantable loop recorders (ILRs). Access and reimbursement for ACM across Europe are not well understood. We performed a systematic review and analysis to understand ACM reimbursement across Europe, including a review of the reimbursement systems in each country and a detailed inspection of clinical coding and provider reimbursement. Level of reimbursement is dependent on many factors, including clinical setting (inpatient, outpatient, and day case), hospital length of stay, diagnosis, complications/severity, geographical location, hospital type, and device model and manufacturer. In most countries, reimbursement is performed for the monitoring procedure itself, without considering the time extension of monitoring and the specific type of device used for monitoring. The monetary value of reimbursement varies by country for both ACM and ILR [for Holter from €17.49 to €939.78 and for ILR from €416.14 (provider reimbursement only) to €18,718 (provider reimbursement bundled with ILR device)]. Holter and ILR are universally reimbursed, but newer ACM technologies with extended duration of monitoring, including long-term continuous monitoring and event recorders, are not. Across Europe, we found large variation in monetary values for reimbursement for ACM and ILR. We also found limited reimbursement and access to longer-duration ACM technologies. These findings suggest heterogeneous and problematic access to evidence-based tools for longer-duration monitoring.

BACKGROUND The Efficacy of Delayed Enhancement MRI-Guided Fibrosis Ablation vs Conventional Catheter Ablation of Atrial Fibrillation randomized trial showed no difference in atrial fibrillation (AF) recurrence with additional delayed enhancement magnetic resonance imaging (DE-MRI) fibrosis-targeted ablation to pulmonary vein isolation (PVI) in persistent AF. OBJECTIVE We evaluated the effect of lesion delivery on ablation-induced scarring and AF recurrence. METHODS Lesions delivered, targeting fibrotic and nonfibrotic areas identified from preablation DE-MRI, were studied in relation to ablation-induced scarring on 3-month DE-MRI, including their association with arrhythmia recurrence. RESULTS A total of 593 patients treated with radiofrequency were analyzed: 293 (49.4%) underwent PVI and 300 (50.6%) underwent additional fibrosis-guided ablation. Lesion analysis showed that 80.9% in the MRI fibrosis-guided group vs 16.5% in the PVI group (P < .001) had >= 40% of baseline fibrosis targeted. MRI assessment of ablation-induced scar showed that 44.8% of fibrosis-guided ablation and 15.5% of PVI had >= 40% of their fibrosis covered by scar (P < .001), demonstrating significant attenuation from lesions delivered to scar formed. In the overall population, fibrosis coverage with scar was not associated with recurrence (hazard ratio [HR] 0.90; 95% confidence interval [CI] 0.80-1.01; P = .08 per 20% increase). In patients with baseline fibrosis < 20%, fibrosis coverage with scar was associated with lower recurrence than PVI (HR 0.85; 95% CI 0.73-0.97; P = .03), whereas the association was not significant when baseline fibrosis >= 20% (HR 0.97; 95% CI 0.80-1.17; P = .77). Significant center variation was observed in fibrosis targeting and coverage with scarring. CONCLUSION Radiofrequency ablation lesions do not uniformly result in scar formation. A post hoc analysis suggests reduced arrhythmia recurrence when ablation-induced scarring covers fibrotic regions in patients with low baseline fibrosis.