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<span class="paragraphSection"><div class="boxTitle">Abstract</div><div class="boxTitle">Aims</div>Right ventricular (RV) pacing may promote left ventricular (LV) dysfunction. Particularly in patients with preserved LV ejection fraction (LVEF), narrow QRS, and anticipated high ventricular pacing burden (HVPB), evidence is missing that biventricular (BiV) pacing can improve clinical outcome. We therefore evaluated whether implantation of a BiV pacing device (BiVPD) compared with a RV pacing device (RVPD) may improve clinical outcome in predominantly this kind of patients.<div class="boxTitle">Methods and results</div>In the <strong>B</strong>iventricular Pac<strong>i</strong>ng for atri<strong>o</strong>ventricular Block to <strong>P</strong>revent C<strong>a</strong>rdia<strong>c</strong> D<strong>e</strong>synchronization (BioPace) trial [multicentre, single-blinded (patients), randomized, parallel group], patients were equally allocated to either receive a BiVPD or a RVPD. Co-primary endpoints were (i) the composite of time to death or first heart failure hospitalization and (ii) survival time. We analysed 1810 randomized patients (median age: 73.5 years; female sex: 31.7%; mean LVEF 55.4%; mean QRS 118.4 ms), 902 to BiV and 908 to RV pacing. During mean follow-up of 68.8 months, the difference in the primary composite endpoint between both groups [346 vs. 363 events, hazard ratio (HR) 0.878; 95% confidence interval (CI) 0.756–1.020; <span style="font-style:italic;">P</span> = 0.0882) or in mortality (305 vs. 307 deaths, HR 0.926; 95% CI 0.789-1.088; <span style="font-style:italic;">P</span> = 0.3492) was smaller than 20%.<div class="boxTitle">Conclusion</div>In patients, predominantly with preserved LVEF, narrow QRS, and HVPB, superiority of implanting BiVPDs compared with RVPDs could not be proven. Right ventricular pacing may be less harmful for this kind of patients than often suggested and primary BiV pacing does not clearly improve their clinical outcome.<div class="boxTitle">Clinical trial registration</div>Registered in <a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a>, number NCT00187278 (<a href="https://clinicaltrials.gov/ct2/show/study/NCT00187278">https://clinicaltrials.gov/ct2/show/study/NCT00187278</a>).</span>
<span class="paragraphSection">This issue of <span style="font-style:italic;">Europace</span> presents the results of the Biventricular Pacing for atrioventricular Block to Prevent Cardiac Desynchronization (BioPace) trial. The main findings of the completed BioPace trial were presented as a late breaking clinical trial and abstract over 10 years ago. Now, the full data are available to review in a well-written manuscript.<sup><a href="#euaf005-B1" class="reflinks">1</a></sup> Provocative questions emerge.</span>
<span class="paragraphSection"><div class="boxTitle">Abstract</div>Atrial fibrillation (AF) is one of the most common cardiac diseases and a complicating comorbidity for multiple associated diseases. Many clinical decisions regarding AF are currently based on the binary recognition of AF being present or absent with the categorical appraisal of AF as continued or intermittent. Assessment of AF in clinical trials is largely limited to the time to (first) detection of an AF episode. Substantial evidence shows, however, that the quantitative characteristic of intermittent AF has a relevant impact on symptoms, onset, and progression of AF and AF-related outcomes, including mortality. Atrial fibrillation burden is increasingly recognized as a suitable quantitative measure of intermittent AF that provides an estimate of risk attributable to AF, the efficacy of antiarrhythmic treatment, and the need for oral anticoagulation. However, the diversity of assessment methods and the lack of a consistent definition of AF burden prevent a wider clinical applicability and validation of actionable thresholds of AF burden. To facilitate progress in this field, the AF burden Consensus Group, an international and multidisciplinary collaboration, proposes a unified definition of AF burden. Based on current evidence and using a modified Delphi technique, consensus statements were attained on the four main areas describing AF burden: Defining the characteristics of AF burden, the recording principles, the clinical relevance in major clinical conditions, and implementation as an outcome in the clinic and in clinical trials. According to this consensus, AF burden is defined as the proportion of time spent in AF expressed as a percentage of the recording time, undertaken during a specified monitoring duration. A pivotal requirement for validity and comparability of AF burden assessment is a continuous or near-continuous duration of monitoring that needs to be reported together with the AF burden assessment. This proposed unified definition of AF burden applies independent of comorbidities and outcomes. However, the disease-specific actionable thresholds of AF burden need to be defined according to the targeted clinical outcomes in specific populations. The duration of the longest episode of uninterrupted AF expressed as a time duration should also be reported when appropriate. A unified definition of AF burden will allow for comparability of clinical study data to expand evidence and to establish actionable thresholds of AF burden in various clinical conditions. This proposed definition of AF burden will support risk evaluation and clinical treatment decisions in AF-related disease. It will further promote the development of clinical trials studying the clinical relevance of intermittent AF. A unified approach on AF burden will finally inform the technology development of heart rhythm monitoring towards validated technology to meet clinical needs.</span>
<span class="paragraphSection"><div class="boxTitle">Abstract</div><div class="boxTitle">Aims</div>The natural history of congenital or childhood non-immune, isolated atrioventricular block (AVB) is poorly defined. We aimed at clarifying its long-term outcomes.<div class="boxTitle">Methods and results</div>We retrospectively studied 385 children with isolated, non-immune AVB diagnosed from <span style="font-style:italic;">in utero</span> or up to 18 years of age, at 29 French medical centres, between 1980 and 2022. Patients with structural heart disease, endomyocardial fibrosis, or maternal antibodies were excluded. Atrioventricular block was asymptomatic in 314 (81.6%) and complete in 263 (68.3%) patients at the time of diagnosis. There was progression to complete AVB in 84/122 (68.8%) patients with incomplete AVB over 12 years (7–17). A total of 286/385 patients (74.3%) received a permanent pacemaker, implanted in the first year of life in 39 (14%) and before 10 years of age in 172 (60%) children. The pacing indication was prophylactic in 203 children (71%). Genetic screening was performed in 133/385 patients (34.5%), leading to the identification of a clinically actionable variant in 11 (8.3%) patients. After a median follow-up of 10 years (5–17), no patient died or developed endomyocardial fibrosis or dilated cardiomyopathy.<div class="boxTitle">Conclusion</div>In this large nationwide study, the long-term outcome of congenital or childhood non-immune, isolated AVB was excellent. Most children required pacemaker implantation over time, albeit often as a prophylactic measure.</span>
<span class="paragraphSection"><div class="boxTitle">Abstract</div><div class="boxTitle">Aims</div>Current guidelines for the optimal ablation strategy for persistent atrial fibrillation (PerAF) remain unclear. While our previous RCT confirmed the favourable prognosis of aggressive ablation, real-world evidence is still lacking.<div class="boxTitle">Methods and results</div>Among 4833 PerAF patients undergoing catheter ablation at 10 centres, two groups were defined: regular ablation (PVI-only or PVI plus anatomical ablation) and aggressive ablation (anatomical plus electrogram-guided ablation), with 1560 patients each after propensity score (PS) matching. The primary endpoint was 12-month AF/atrial tachycardia (AT) recurrence-free survival off anti-arrhythmic drugs after a single procedure. Additional PS matching was performed within the regular group between PVI-only and anatomical ablation (<span style="font-style:italic;">n</span> = 455 each). Furthermore, anatomical ablation from the regular group was independently matched with aggressive ablation (<span style="font-style:italic;">n</span> = 1362 each). At 12 months, the aggressive group showed superior AF/AT-free survival (66.2% vs. 59.3%, <span style="font-style:italic;">P</span> < 0.001; HR 0.745), similar AT recurrence (12.0% vs. 11.3%, <span style="font-style:italic;">P</span> = 0.539), and significantly higher procedural AF termination (67.0% vs. 21.0%, <span style="font-style:italic;">P</span> < 0.001) than regular group. Moreover, patients with AF termination had improved AF/AT-free survival (72.3% vs. 55.2%, <span style="font-style:italic;">P</span> < 0.001). Safety endpoints did not differ significantly between the two groups. Both the ablation outcomes and AF termination rate showed increasing trends with the extent of ablation aggressiveness but declined with extremely aggressive ablation. After additional PS matching, within the regular group, no statistical differences were observed though AF/AT-free survival in the anatomical group was slightly higher than the PVI-only group (60.7% vs. 55.6%, <span style="font-style:italic;">P</span> = 0.122); while aggressive ablation showed improved AF/AT-free survival compared to anatomical ablation alone from regular group (67.5% vs. 59.9%, <span style="font-style:italic;">P</span> < 0.001).<div class="boxTitle">Conclusion</div>Aggressive ablation achieved more favourable outcomes than regular ablation, and moderately aggressive ablation may be associated with better clinical outcomes. AF termination is a reliable ablation endpoint.</span>
<span class="paragraphSection"><div class="boxTitle">Abstract</div><div class="boxTitle">Aims</div>Pulsed field ablation (PFA) is described as non-thermal, but data from oncology and cardiology show thermal effects occur. The specific waveform parameters influencing thermal energy development during PFA are unclear. The aim of this study is to numerically evaluate the thermal effects of PFA on myocardial and oesophageal tissue at various peak voltage conditions.<div class="boxTitle">Methods and results</div>A three-dimensional computer model of the left atrium quantified thermal effects from PFA at peak voltages of 1, 1.5, and 2 kV. Energy was applied using a bipolar configuration with far-field and symmetry boundaries set as electrically insulating. A monophasic waveform with a 100 μs pulse width and a 1 s gap between pulses was applied for a total of 50 pulses, mimicking clinical conditions. Minimal temperature rise in the oesophagus was observed with 1 kV pulses (214.5 J). At 1.5 and 2 kV (570.3 and 1.23 kJ), temperatures reached 46.3°C and >62°C, respectively, after a single pulse train. These findings suggest that repeated applications could lead to even higher temperatures, especially if good tissue contact is obtained. These results align with data from other medical fields using pulsed field treatments.<div class="boxTitle">Conclusion</div>Thermal effects from PFA depend on the total energy deposited, with peak voltage being a significant factor. Current commercially available PFA systems have the potential to induce collateral thermal injury with repeated applications of pulsed field energy. This highlights the need for careful monitoring and adjustment of PFA parameters in clinical settings.</span>
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