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Aim: To define the effect of defibrillator paddle position on technical success and dc shock energy requirements of external cardioversion of atrial fibrillation.Methods: 301 patients (mean (SD) age 62 (11) years) with stable atrial fibrillation were randomly assigned to elective external cardioversion using anterolateral paddle position (ventricular apex-right infraclavicular area; group AL (151 patients)) or anteroposterior paddle position (sternal body-angle of the left scapula; group AP (150 patients)). A step up protocol was used, delivering a 3 J/kg body weight dc shock, then a 4 J/kg shock (maximum 360 J), and finally a second 4 J/kg shock using the alternative paddle location.Results: The two groups were comparable for the all clinical variables evaluated. The cumulative percentage of patients successfully converted to sinus rhythm was 58% in group AL and 67% in group AP with low energy dc shock (NS); this rose to 76% in group AL and to 87% in group AP with high energy dc shock (p = 0.013). Thirty seven patients in group AL and 19 in group AP experienced dc shock with the alternative paddle position; atrial fibrillation persisted in 10/37 in group AL and in 10/19 in group AP. Mean dc shock energy requirements were lower for group AP patients than for group AL patients, at 383 (235) v 451 (287) J, p = 0.025. Arrhythmia duration was the only factor that affected the technical success of external cardioversion (successful: 281 patients, 80 (109) days; unsuccessful: 20 patients, 193 (229) days; p < 0.0001). The success rate was lower if atrial fibrillation persisted for > 6 months: 29 of 37 (78%) v 252 of 264 (95%); p = 0.0001.Conclusions: An anteroposterior defibrillator paddle position is superior to an anterolateral location with regard to technical success in external cardioversion of stable atrial fibrillation, and permits lower dc shock energy requirements. Arrhythmia duration is the only clinical variable that can limit the restoration of sinus rhythm. [ABSTRACT FROM AUTHOR]

Background: Atrial fibrillation (AF) is the most common sustained arrhythmia encountered in clinical practice. The natural history of this disturbance and its effect on survival is still not known in patients with implantable cardioverter defibrillators (ICDs). Methods and Results: Several controlled trials for both secondary and primary prevention of sudden death using ICDs have been published in literature, and meta-analysis of them provided useful clinical information on the outcome during the follow-up of this population. AF occurs in about 25% of the patients with secondary prevention indication for ICD implantation. The prevalence of AF in patients with primary prevention indication for ICD implantation is much more difficult to define; it seems to be higher in patients with left ventricular dysfunction due to nonischemic etiology (ranging from 15% to 25%), and is lower in patients with ischemic etiology (about 5-10%). However, data from clinical registries, which are expected to better reflect clinical practice than randomized trials, seem to show a substantial difference as compared to the latter ones. A history of AF episodes in patients with an ICD indication for both primary and secondary prevention is probably associated with a higher risk of death. This is particularly evident in secondary prevention in ICD recipients, while it is still controversial in patients who received an ICD for primary prevention, particularly when patients with nonischemic etiology of their left ventricular dysfunction are considered. In a population of patients implanted with an ICD, there are several other clinical factors (ejection fraction, New York Heart Association functional class, age) that can interfere with the risk of death much more than AF itself. Conclusions: Further large-scale registries are needed to further characterize the population receiving ICD implantation, assessing the course of risk of death with regard to clinical variables and to evaluate the degree of acceptance of trials in clinical practice. [ABSTRACT FROM AUTHOR]

An acute comparative study of right ventricular (RV) pacing and echocardiographically guided cardiac resynchronization pacing (CRP) was performed in patients who underwent "ablate and pace" therapy for permanent atrial fibrillation. It was hypothesized that optimized CRP guided by tissue Doppler echocardiography would exert an additive beneficial hemodynamic effect to that of rate regularization achieved through atrioventricular junction ablation. An acute intrapatient comparison of echocardiographic parameters was performed between baseline preablation values and RV pacing and CRP (performed <24 hours after ablation) in 50 patients. Optimized CRP configuration was defined as the modality of pacing corresponding to that of the shortest intra-left ventricular (LV) delay among simultaneous biventricular pacing, sequential biventricular pacing, and single-chamber pacing. The intra-LV delay was defined as the difference between the longest and the shortest activation time in the six basal segments of the left ventricle. Compared with preablation measures, the ejection fraction increased by 10.8% during RV pacing (19% in patients with intra-LV delays <47.5 ms and 3% in those with intra-LV delays >47.5 ms). Compared with RV pacing, CRP caused a 9.2% increase in the ejection fraction, a 6.8% decrease in LV systolic diameter, and a 17.3% decrease in mitral regurgitation area; LV dyssynchrony was reduced from 52 +/- 27 to 21 +/- 12 ms. Similar results were observed in patients with and without depressed systolic function and in patients with and without left bundle branch block. In conclusion, rate regularization achieved through atrioventricular junction ablation and RV pacing provides a favorable hemodynamic effect that is inversely related to the level of LV dyssynchrony. Minimizing LV dyssynchrony by means of optimized CRP yields an additional important benefit. [ABSTRACT FROM AUTHOR]

Background: Frailty and comorbidity influence the therapeutic approach in everyday clinical practice. The DOACs genericization opens a reflection on their differences from a pharmacological and bioavailability point of view, particularly in elderly frail patients. The aim of this project was to create a national Delphi consensus on the topic of the use of DOACs for atrial fibrillation (AF) in such patients, in light of the genericization of the class., Methods and Results: The consensus dealt with 3 main topics: a) efficacy and safety of DOACs in elderly and/or frail patients; b) therapeutic choice in specific frailty scenarios; c) DOACs genericization. 56 cardiologists, two internists and two neurologists from Italy expressed their level of agreement on each statement by using a 5-point Likert scale (1: strongly disagree, 2: disagree, 3: uncertain, 4: agree, 5: strongly agree). A positive consensus was reached if the percentage of agreement (vote 1-2, positive consensus) or disagreement (votes 4-5, negative consensus) was >66%; otherwise, no consensus was reached. Results are displayed accordingly., Conclusions: After 10 years of everyday clinical management of DOACs for AF, specific elements differentiating a molecule from another, either for efficacy or for safety, are consolidated. However, some uncertainties still exist in particular contexts, such as chronic kidney disease or cancer patients. Clinicians have an unsure attitude towards generic drugs, because clinical practice is lacking as well as a proper knowledge of the topic. Albeit being an alternative, the choice of the generic drug must remain the responsibility of the clinician., Competing Interests: Declaration of competing interest GLB declared speaker fees (small amount) from Bayer Healthcare, Boheringer, Daiichi-Sankyo, Pfizer/BMS, Sanofi. PCa has nothing to declare. PCo participates in Daiichi Sankyo, Inc.-funded research; is a coauthor of ESC guidelines on AF (versions 2010 and 2012) and received institutional research grants from Bayer, Boehringer, and Daiichi Sankyo, Inc.; and speaker honoraria from Bayer, Boehringer Ingelheim, Pfizer-BMS, and Daiichi Sankyo, Inc. In the last two years DMMF has received fees for partecipations as expert in Advisory Boards or as speaker in Congress and meeting or as consultant, from the following companies: Abiogen, Alfasigma, Angelini, Agave, Bayer, Daiichi-Sankyo, Grunenthal, Janssen, Lundbeck, Molteni, Sandoz, SPA, Zambon. ES has nothing to declare. LR is a speaker and a scientific research partner for Bayer, BMS/Pfizer, Boehringer Ingelheim and Daiichi-Sankyo; no fees are directly received personally., (Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)

Aims: Subclinical atrial fibrillation (AF) is associated with increased risk of progression to clinical AF, stroke, and cardiovascular death. We hypothesized that in pacemaker patients requiring dual-chamber rate-adaptive (DDDR) pacing, closed loop stimulation (CLS) integrated into the circulatory control system through intra-cardiac impedance monitoring would reduce the occurrence of atrial high-rate episodes (AHREs) compared with conventional DDDR pacing., Methods and Results: Patients with sinus node dysfunctions (SNDs) and an implanted pacemaker or defibrillator were randomly allocated to dual-chamber CLS (n = 612) or accelerometer-based DDDR pacing (n = 598) and followed for 3 years. The primary endpoint was time to the composite endpoint of the first AHRE lasting ≥6 min, stroke, or transient ischaemic attack (TIA). All AHREs were independently adjudicated using intra-cardiac electrograms. The incidence of the primary endpoint was lower in the CLS arm (50.6%) than in the DDDR arm (55.7%), primarily due to the reduction in AHREs lasting between 6 h and 7 days. Unadjusted site-stratified hazard ratio (HR) for CLS vs. DDDR was 0.84 [95% confidence interval (CI), 0.72-0.99; P = 0.035]. After adjusting for CHA2DS2-VASc score, the HR remained 0.84 (95% CI, 0.71-0.99; P = 0.033). In subgroup analyses of AHRE incidence, the incremental benefit of CLS was greatest in patients without atrioventricular block (HR, 0.77; P = 0.008) and in patients without AF history (HR, 0.73; P = 0.009). The contribution of stroke/TIA to the primary endpoint (1.3%) was low and not statistically different between study arms., Conclusion: Dual-chamber CLS in patients with SND is associated with a significantly lower AHRE incidence than conventional DDDR pacing., Competing Interests: Conflict of interest: G.L.B. received speaker’s fee from Abbott, Biotronik, Boston Scientific, Medtronic, and MicroPort. M.D.M., D.G., and A.G. are employees of Biotronik Italia S.p.A., an affiliate of Biotronik SE & Co. KG (study sponsor and manufacturer of investigational devices). All remaining authors have declared no conflicts of interest., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Background: The mechanism of typical slow-fast atrioventricular nodal re-entrant tachycardia (AVNRT) and its anatomical and electrophysiological circuit inside the right atrium (RA) and Koch's Triangle (KT) are not well known., Objective: To identify the potentials of the compact AV node and inferior extensions and to perform accurate mapping of the RA and KT in sinus rhythm (SR) and during AVNRT, to define the tachycardia circuit., Methods: Consecutive patients with typical AVNRT were enrolled in 12 Italian centers and underwent mapping and ablation by means of a basket catheter with small electrode spacing for ultrahigh-density mapping and a modified signal-filtering toolset to record the potentials of the AV nodal structures., Results: Forty-five consecutive cases of successful ablation of typical slow-fast AVNRT were included. The mean SR cycle length (CL) was 784.1 ± 6 ms and the mean tachycardia CL was 361.2 ± 54 ms. The AV node potential had a significantly shorter duration and higher amplitude in sinus rhythm than during tachycardia (60 ± 40 ms vs. 160 ± 40 ms, p < .001 and 0.3 ± 0.2 mV vs. 0.09 ± 0.12 mV, p < .001, respectively). The nodal potential duration extension was 169.4 ± 31 ms, resulting in a time-window coverage of 47.6 ± 9%. The recording of AV nodal structure potentials enabled us to obtain 100% coverage of the tachycardia CL during slow-fast AVNRT., Conclusion: Detailed recording of the potentials of nodal structures is possible by means of multipolar catheters for ultrahigh-density mapping, allowing 100% of the AVNRT CL to be covered. These results also have clinical implications for the ablation of right-septal and para-septal arrhythmias., (© 2024 Wiley Periodicals LLC.)

Aims: To predict worsening heart failure hospitalizations (WHFHs) in patients with implantable defibrillators and remote monitoring, the HeartInsight algorithm (Biotronik, Berlin, Germany) calculates a heart failure (HF) score combining seven physiologic parameters: 24 h heart rate (HR), nocturnal HR, HR variability, atrial tachyarrhythmia, ventricular extrasystoles, patient activity, and thoracic impedance. We compared temporal trends of the HF score and its components 12 weeks before a WHFH with 12-week trends in patients without WHFH, to assess whether trends indicate deteriorating HF regardless of alert status., Methods and Results: Data from nine clinical trials were pooled, including 2050 patients with a defibrillator capable of atrial sensing, ejection fraction ≤ 35%, NYHA class II/III, no long-standing atrial fibrillation, and 369 WHFH from 259 patients. The mean HF score was higher in the WHFH group than in the no WHFH group (42.3 ± 26.1 vs. 30.7 ± 20.6, P < 0.001) already at the beginning of 12 weeks. The mean HF score further increased to 51.6 ± 26.8 until WHFH (+22% vs. no WHFH group, P = 0.003). As compared to the no WHFH group, the algorithm components either were already higher 12 weeks before WHFH (24 h HR, HR variability, thoracic impedance) or significantly increased until WHFH (nocturnal HR, atrial tachyarrhythmia, ventricular extrasystoles, patient activity)., Conclusion: The HF score was significantly higher at, and further increased during 12 weeks before WHFH, as compared to the no WHFH group, with seven components showing different behaviour and contribution. Temporal trends of HF score may serve as a quantitative estimate of HF condition and evolution prior to WHFH., Competing Interests: Conflict of interest: G.L.B. received speaker’s fee from Abbott, Biotronik, Boston Scientific, Medtronic, and Microport. A.B. received consultant fees and/or grant support from Abbott, Biotronik, and Boston Scientific. A.G. and D.G. are employees of Biotronik Italy. T.T. is employee of Biotronik SE & Co. KG, Berlin, Germany. L.G.-M. received fees for lectures and/or consulting from Novartis, Microport, Boston Scientific, and Medtronic outside the submitted work. Lille University Hospital Center received grants from BMS, Abbott, Biotronik, Boston Scientific, Microport, and Medtronic outside the submitted work. All remaining authors have declared no conflicts of interest., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)

(200 w) Introduction. Remote monitoring (RM) of cardiac implantable electronic device (CIED) diagnostics helps to identify patients potentially at risk of worsening heart failure (HF). Additionally, knowledge of patient HF-related symptoms is crucial for decision making. Patient smartphone applications may represent an ideal option to remotely collect this information., Purpose: To assess real-world HF patient access, acceptance, and adherence to use of an HF-dedicated smartphone application (HF app)., Methods: In this study, 10 Italian hospitals administered a survey on smartphone/app use to HF patients with CIED. The subgroup who accepted it downloaded the HF app. Mean 1-year adherence of the HF app use was evaluated., Results: A total of 495 patients (67 ± 13 years, 79% males, 26% NYHA III-IV) completed the survey, of which 84% had access to smartphones and 85% were willing to use the HF app. In total, 311/495 (63%) downloaded the HF app. Patients who downloaded the HF app were younger and had higher school qualification. Patients who were ≥60 years old had higher mean 1-year adherence (54.1%) than their younger counterparts (42.7%; p < 0.001). Hospitals with RM-dedicated staff had higher mean 1-year patient adherence (64.0% vs. 33.5%; p < 0.001). Adherence to HF app decreased from 63.3% (weeks&#95;1-13) to 42.2% (weeks&#95;40-52, p < 0.001)., Conclusions: High access and acceptance of smartphones/apps by HF patients with CIED allow HF app use for RM of patient signs/symptoms. Younger patients with higher school qualifications are more likely to accept HF app; however, older patients have higher long-term adherence.

Aims: Patients with cardiomyopathies and channelopathies are usually younger and have a predominantly arrhythmia-related prognosis; they have nearly normal life expectancy thanks to the protection against sudden cardiac death provided by the implantable cardioverter defibrillator (ICD). The subcutaneous ICD (S-ICD) is an effective alternative to the transvenous ICD and has evolved over the years. This study aimed to evaluate the rate of inappropriate shocks (IS), appropriate therapies, and device-related complications in patients with cardiomyopathies and channelopathies who underwent modern S-ICD implantation., Methods and Results: We enrolled consecutive patients with cardiomyopathies and channelopathies who had undergone implantation of a modern S-ICD from January 2016 to December 2020 and who were followed up until December 2022. A total of 1338 S-ICD implantations were performed within the observation period. Of these patients, 628 had cardiomyopathies or channelopathies. The rate of IS at 12 months was 4.6% [95% confidence interval (CI): 2.8-6.9] in patients with cardiomyopathies and 1.1% (95% CI: 0.1-3.8) in patients with channelopathies (P = 0.032). No significant differences were noted over a median follow-up of 43 months [hazard ratio (HR): 0.76; 95% CI: 0.45-1.31; P = 0.351]. The rate of appropriate shocks at 12 months was 2.3% (95% CI: 1.1-4.1) in patients with cardiomyopathies and 2.1% (95% CI: 0.6-5.3) in patients with channelopathies (P = 1.0). The rate of device-related complications was 0.9% (95% CI: 0.3-2.3) and 3.2% (95% CI: 1.2-6.8), respectively (P = 0.074). No significant differences were noted over the entire follow-up. The need for pacing was low, occurring in 0.8% of patients., Conclusion: Modern S-ICDs may be a valuable alternative to transvenous ICDs in patients with cardiomyopathies and channelopathies. Our findings suggest that modern S-ICD therapy carries a low rate of IS., Clinical Trial Registration: URL: http://clinicaltrials.gov/Identifier: NCT02275637., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Aims: After an ischaemic stroke, atrial fibrillation (AF) detection allows for improved secondary prevention strategies. This study aimed to compare AF detection and oral anticoagulant (OAC) initiation in patients with an insertable cardiac monitor (ICM) vs. external cardiac monitor (ECM) after ischaemic stroke., Methods and Results: Medicare Fee-for-Service (FFS) insurance claims and Abbott Labs device registration data were used to identify patients hospitalized with an ischaemic stroke in 2017-2019 who received an ICM or ECM within 3 months. Patients with continuous Medicare FFS insurance and prescription drug enrolment in the prior year were included. Patients with prior AF, atrial flutter, cardiac devices, or OAC were excluded. Insertable cardiac monitor and ECM patients were propensity score matched 1:4 on demographics, comorbidities, and stroke hospitalization characteristics. The outcomes of interest were AF detection and OAC initiation evaluated with Kaplan-Meier and Cox proportional hazard regression analyses. A total of 5702 Medicare beneficiaries (ICM, n = 444; ECM, n = 5258) met inclusion criteria. The matched cohort consisted of 2210 Medicare beneficiaries (ICM, n = 442; ECM, n = 1768) with 53% female, mean age 75 years, and mean CHA₂DS₂-VASc score 4.6 (1.6). Insertable cardiac monitor use was associated with a higher probability of AF detection [(hazard ratio (HR) 2.88, 95% confidence interval (CI) (2.31, 3.59)] and OAC initiation [HR 2.91, CI (2.28, 3.72)] compared to patients monitored only with ECM., Conclusion: Patients with an ischaemic stroke monitored with an ICM were almost three times more likely to be diagnosed with AF and to be prescribed OAC compared to patients who received ECM only., Competing Interests: Conflict of interest: G.B. received small speaker’s fees from Abbott, Bayer, Boston, Boehringer, Daiichi Sankyo, Janssen, and Sanofi, outside of the submitted work. A.A, is a consultant to Abbott, Boston Scientific, Cairdac, EP Solutions, Hylomorph, Medtronic, and XSpline; has received speaker fees from Boston Scientific, Medtronic, Microport CRM, and Philips; participates in clinical trials sponsored by Abbott, Boston Scientific, EPD-Philips, EP Solutions, Medtronic, Philips, and XSpline; and holds intellectual properties with Boston Scientific, Biosense Webster, and Microport CRM. G.L.B. has received speaker fees (small amount) from Abbott, Biotronik, Boston Scientific, Medtronic, and Microport CRM. J.P.P. is supported by R01AG074185 from the National Institutes of Aging. He also receives grants from Abbott, the American Heart Association, the Association for the Advancement of Medical Instrumentation, Bayer, Boston Scientific, iRhythm, and Philips and serves as a consultant to Abbott, Abbvie, ARCA biopharma, Bayer, Boston Scientific, Element Science, LivaNova, Medtronic, Milestone, ElectroPhysiology Frontiers, Sanofi, Philips, and Up-to-Date. J.M.J., G.J.R., A.G., and Y.N. are employed by Abbott., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Aims: Subcutaneous implantable cardioverter-defibrillator (S-ICD) therapy is expanding rapidly. However, there are few data on the S-ICD extraction procedure and subsequent patient management. The aim of this analysis was to describe the procedure, management, and outcome of S-ICD extractions in clinical practice., Methods and Results: We enrolled consecutive patients who required complete S-ICD extraction at 66 Italian centres. From 2013 to 2022, 2718 patients undergoing de novo implantation of an S-ICD were enrolled. Of these, 71 required complete S-ICD system extraction (17 owing to infection). The S-ICD system was successfully extracted in all patients, and no complications were reported; the median procedure duration was 40 (25th-75th percentile: 20-55) min. Simple manual traction was sufficient to remove the lead in 59 (84%) patients, in whom lead-dwelling time was shorter [20 (9-32) months vs. 30 (22-41) months; P = 0.032]. Hospitalization time was short in the case of both non-infectious [2 (1-2) days] and infectious indications [3 (1-6) days]. In the case of infection, no patients required post-extraction intravenous antibiotics, the median duration of any antibiotic therapy was 10 (10-14) days, and the re-implantation was performed during the same procedure in 29% of cases. No complications arose over a median of 21 months., Conclusion: The S-ICD extraction was safe and easy to perform, with no complications. Simple traction of the lead was successful in most patients, but specific tools could be needed for systems implanted for a longer time. The peri- and post-procedural management of S-ICD extraction was free from complications and not burdensome for patients and healthcare system., Clinical Trial Registration: URL: http://clinicaltrials.gov/Identifier: NCT02275637., Competing Interests: Conflict of interest: R.R. received speaker fees from Abbot and Boston Scientific. L.O. is a consultant for Boston Scientific. P.F. received speaker fees from Boston Scientific and research or educational grants from Abbott and Boston Scientific. G.L.B. reports speaker fees (small amount) from Boston Scientific, Medtronic, Biotronik, Abbot, Microport, and Zoll. M.L. and S.V. are employees of Boston Scientific. The other authors report no conflicts., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Aims: In subcutaneous implantable cardioverter defibrillator (S-ICD) recipients, the UNTOUCHED study demonstrated a very low inappropriate shock rate on programming a conditional zone between 200 and 250 bpm and a shock zone for arrhythmias >250 bpm. The extent to which this programming approach is adopted in clinical practice is still unknown, as is its impact on the rates of inappropriate and appropriate therapies., Methods and Results: We assessed ICD programming on implantation and during follow-up in a cohort of 1468 consecutive S-ICD recipients in 56 Italian centres. We also measured the occurrence of inappropriate and appropriate shocks during follow-up. On implantation, the median programmed conditional zone cut-off was set to 200 bpm (IQR: 200-220) and the shock zone cut-off was 230 bpm (IQR: 210-250). During follow-up, the conditional zone cut-off rate was not significantly changed, while the shock zone cut-off was changed in 622 (42%) patients and the median value increased to 250 bpm (IQR: 230-250) (P < 0.001). UNTOUCHED-like programming of detection cut-offs was adopted in 426 (29%) patients immediately after device implantation, and in 714 (49%, P < 0.001) at the last follow-up. UNTOUCHED-like programming was independently associated with fewer inappropriate shocks (hazard ratio 0.50, 95%CI 0.25-0.98, P = 0.044), and had no impact on appropriate and ineffective shocks., Conclusions: In recent years, S-ICD implanting centres have increasingly programmed high arrhythmia detection cut-off rates, at the time of implantation in the case of new S-ICD recipients, and during follow-up in the case of pre-existing implants. This has contributed significantly to reducing the incidence of inappropriate shocks in clinical practice. Rordorf: Programming of the S-ICD., Clinical Trial Registration: URL: http://clinicaltrials.gov/Identifier: NCT02275637., Competing Interests: Conflict of interest: R.R. received speaker fees from Abbot and Boston Scientific. P.F. received speaker fees from Boston Scientific and research or educational grants from Abbott and Boston Scientific. G.L.B. reports speaker fees (small amount) from Boston Scientific, Medtronic, Biotronik, Abbot, Microport, Zoll. M.L. and S.V. are employees of Boston Scientific. The other authors report no conflicts., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Aims: A previous randomized study demonstrated that the subcutaneous implantable cardioverter defibrillator (S-ICD) was noninferior to transvenous ICD with respect to device-related complications and inappropriate shocks. However, that was performed prior to the widespread adoption of pulse generator implantation in the intermuscular (IM) space instead of the traditional subcutaneous (SC) pocket. The aim of this analysis was to compare survival from device-related complications and inappropriate shocks between patients who underwent S-ICD implantation with the generator positioned in an IM position in comparison with an SC pocket., Methods and Results: We analysed 1577 consecutive patients who had undergone S-ICD implantation from 2013 to 2021 and were followed up until December 2021. Subcutaneous patients (n = 290) were propensity matched with patients of the IM group (n = 290), and their outcomes were compared. : During a median follow-up of 28 months, device-related complications were reported in 28 (4.8%) patients and inappropriate shocks were reported in 37 (6.4%) patients. The risk of complication was lower in the matched IM group than in the SC group [hazard ratio 0.41, 95% confidence interval (CI) 0.17-0.99, P = 0.041], as well as the composite of complications and inappropriate shocks (hazard ratio 0.50, 95% CI 0.30-0.86, P = 0.013). The risk of appropriate shocks was similar between groups (hazard ratio 0.90, 95% CI 0.50-1.61, P = 0.721). There was no significant interaction between generator positioning and variables such as gender, age, body mass index, and ejection fraction., Conclusion: Our data showed the superiority of the IM S-ICD generator positioning in reducing device-related complications and inappropriate shocks., Clinical Trial Registration: Clinical Trial Registration: ClinicalTrials.gov; NCT02275637., Competing Interests: Conflict of interest: M.L. and S.V. are employees of Boston Scientific. G.L.B. received speaker’s fee from Abbott, Biotronik, Boston Scientific, Medtronic, and Microport; P.F. received speaker’s fees and educational grants from Boston Scientific and research grants from Abbott. R.R. received speaker’s fees from Abbot and Boston Scientific. The other authors report no conflicts of interest., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Sudden cardiac death (SCD) is the most frequent cause of cardiovascular death in industrialized nations. Patients with cardiomyopathy are at increased risk for SCD and may benefit from an implantable cardioverter-defibrillator (ICD). The risk of SCD is highest in the first months after myocardial infarction or first diagnosis of severe non-ischemic cardiomyopathy. On the other hand, left ventricular function may improve in a subset of patients to such an extent that an ICD might no longer be needed. To offer protection from a transient risk of SCD, the wearable cardioverter-defibrillator (WCD) is available. Results of the first randomized clinical trial investigating the role of the WCD after myocardial infarction were recently published. This review is intended to provide insight into data from the VEST trial, and to put these into perspective with studies and clinical experience. As a non-invasive, temporary therapy, the WCD may offer advantages over early ICD implantation. However, recent data demonstrate that patient compliance and education play a crucial role in this new concept of preventing SCD., (© 2022. The Author(s).)

Competing Interests: Conflict of interest: The authors have provided declaration of interest information for all relationships that might be perceived as real or potential sources of conflicts of interest. The full disclosures can be viewed in the supplementary material for this article, available online at http://academic.oup.com/europace/article-lookup/doi/10.1093/europace/euac066#supplementary-data.

Background. Cardiac resynchronization therapy (CRT) is a treatment for heart failure (HF) patients with prolonged QRS and impaired left ventricular (LV) systolic function. We aim to evaluate how the baseline PR interval is associated with outcomes (all-cause death or HF hospitalizations) and LV reverse remodeling (>15% relative reduction in LV end-systolic volume). Methods. Among 2224 patients with CRT defibrillators, 1718 (77.2%) had a device programmed at out-of-the-box settings (sensed AV delay: 100 ms and paced AV delay: 130 ms). Results. In this cohort of 1718 patients (78.7% men, mean age 66 years, 71.6% in NYHA class III/IV, LVEF = 27 ± 6%), echocardiographic assessment at 6-month follow-up showed that LV reverse remodeling was not constant as a function of the PR interval; in detail, it occurred in 56.4% of all patients but was more frequent (76.6%) in patients with a PR interval of 160 ms. In a median follow-up of 20 months, the endpoint of death or HF hospitalizations occurred in 304/1718 (17.7%) patients; in the multivariable regression analysis it was significantly less frequent when the PR interval was between 150 and 170 ms (hazard ratio = 0.79, 95% confidence interval (CI): 0.63−0.99, p = 0.046). The same PR range was associated with higher probability of CRT response (odds ratio = 2.51, 95% CI: 1.41−4.47, p = 0.002). Conclusions. In a large population of CRT patients, with fixed AV pacing delays, specific PR intervals are associated with significant benefits in terms of LV reverse remodeling and lower morbidity. These observational data suggest the importance of optimizing pacing programming as a function of the PR interval to maximize CRT response and patient outcome.

Aims: To evaluate the effectiveness and safety of dronedarone compared with other commonly used antiarrhythmic drugs (AADs) for preventing atrial fibrillation (AF) recurrences., Methods and Results: An international observational cohort study in Germany, Spain, Italy, and the USA enrolling patients with AF receiving AAD therapy. Patients with New York Heart Association (NYHA) Class IV heart failure were excluded. Participants were followed for up to 18 months, regardless of discontinuation or subsequent AAD switches. Atrial fibrillation recurrence was captured by hospitalization, emergency room visit, or electrocardiogram-based documentation of AF. Confounding bias was controlled for in the analysis of AF recurrence using multivariate models of 19 variables for adjustment. A total of 1009 participants [mean age 67.2 (10.8) years, male to female ratio 1.3] were recruited from 170 centres, 693 (69%) of which were from across Europe and the remaining 316 (31%) from the USA. At the time of enrolment, participants were taking dronedarone (51%) or other AADs (49%) [flecainide or propafenone (42%), sotalol (11%), and amiodarone (47%)]. No significant differences in the risk of first confirmed AF recurrence with dronedarone vs. other AADs [crude hazard ratio (HR) 1.10 (95% confidence interval 0.85-1.42); adjusted HR 1.16 (0.87-1.55)] were found, irrespective of whether univariate or multivariate models were used. Reported safety events were in accordance with the known safety profile of dronedarone., Conclusion: In this population of patients from either Europe or the USA receiving dronedarone or another AAD, the effectiveness of dronedarone was comparable to that observed for other AADs in preventing first AF recurrence., (© The Author(s) 2021. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Aims: Sudden cardiac death (SCD) causes high mortality and substantial societal burdens for healthcare systems (HSs). The risk of SCD is significantly increased in patients with reduced left ventricular ejection fraction after myocardial infarction (MI). Current guidelines recommend re-evaluation of cardioverter-defibrillator implantation 40 days post-MI, earliest. Medical therapy alone does not provide sufficient protection against SCD, especially in the first month post-MI, and needs time. Consequently, there is a gap in care of high-risk patients upon hospital discharge. The wearable cardioverter defibrillator (WCD) is a proven safe, effective therapy, which temporarily protects from SCD. Little information on WCD cost-effectiveness exists. We conducted this research to demonstrate the medical need of the device in the post-MI setting defining WCD cost-effectiveness., Methods & Results: Based on a randomized clinical trials (RCTs) and Italian and international data, we developed a Markov-model comparing costs, patient survival, and quality-of-life, and calculated the Incremental Cost-Effectiveness Ratio (ICER) of a WCD vs. current standard of care in post-MI patients. The rather conservative base case analysis - based on the RCT intention-to-treat results - produced an ICER of €47,709 per Quality Adjusted Life Year (QALY) gained, which is far lower than the accepted threshold of €60,000 in the Italian National HS. The ICER per Life Year (LY) gained was €38,276., Conclusion: WCD utilization in post-MI patients is clinically beneficial and cost-effective. While improving guideline directed patient care, the WCD can also contribute to a more efficient use of resources in the Italian HS, and potentially other HSs as well., (Copyright © 2022 Elsevier B.V. All rights reserved.)