Pub Date : 2026-02-03DOI: 10.1093/europace/euag005
Dongtao Zhou, Mengmeng Li, Zhigang Song, Chenxi Jiang, Wei Wang, Ribo Tang, Xin Zhao, Changyi Li, Songnan Li, Xueyuan Guo, Changqi Jia, Man Ning, Li Feng, Dan Wen, Jing Lin, Fang Liu, Tong Liu, Hui Zhu, Yuexin Jiang, Ping Guo, Lin Yuan, Caihua Sang, Deyong Long, Jianzeng Dong, Changsheng Ma
Aims: Though pulsed-field ablation (PFA) has demonstrated an excellent safety profile in reducing collateral injury to the oesophagus and phrenic nerve, it is still associated with specific effects, including electrode heating, haemolysis, and electrolysis due to excessive energy dispersion. This study aims to assess whether saline irrigation during PFA application could mitigate these risks.
Methods and results: To comprehensively evaluate the effect of irrigation with the variable-loop circular catheter (VLCC), the following experiments were performed: (i) ex-vivo potato model: to evaluate the lesion depth, bubble formation, and thermal effects in different irrigation regimens; (ii) in vitro blood pool and cardiac ablation: to determine the haemolysis status and tissue temperature change after PFA; (iii) in vivo swine ablation (n = 8), and (iv) clinical randomized trial (n = 25): to compare the efficacy and safety profile between low (4 mL/min) and high (30 mL/min) flow irrigation using the VLCC. Though peak core temperatures at 5 mm depth were all < 50°C under low- and high-irrigation, high irrigation significantly mitigated the instant electrode and deep tissue heating both in the potato and isolated cardiac models. Ex vivo potato slices showed that high-flow irrigation produced the deepest lesion sets when compared to low-flow irrigation (5.94 ± 0.29 mm vs. 5.36 ± 0.33 mm, P = 0.043). Assessment from a high-speed camera and bubble detector demonstrated that high-flow irrigation significantly reduced the total number of gaseous bubbles (54.50 IQR 53.00-56.75 vs. 82.00 IQR 72.00-83.00, P < 0.001) and eliminated the occurrence of larger bubbles. The high-flow irrigation group showed a smaller increase in the level of free haemoglobin immediately after the procedure across the blood pool, swine, and clinical models. Haptoglobin and lactate dehydrogenase levels were also attenuated by high irrigation in the in vivo swine model and clinical trial. One swine in the low-irrigation group developed an acute cerebral lesion (3 mm). The clinical trial confirmed that the incidence of silent cerebral lesions was significantly lower in the high-flow irrigation group (16.7% vs. 66.7%, P = 0.036).
Conclusion: Proper saline irrigation during PFA with VLCC may mitigate electrode-associated haemolysis, reduce electrode and tissue temperature, limit bubble aggregation, and be associated with a lower incidence of silent cerebral lesions, the clinical significance of which remains unclear.
背景:虽然脉冲场消融(PFA)在减少食管和膈神经侧支损伤方面表现出良好的安全性,但它仍然与特定效应有关,包括电极加热、溶血和由于过度能量分散引起的电解。在PFA应用期间是否盐水灌溉可以减轻这些风险尚不清楚。方法:为综合评价可变回路圆导管(VLCC)灌洗的效果,采用离体马铃薯模型:评价不同灌洗方案下病变深度、气泡形成及热效应;b)体外血池及心脏消融术:测定PFA后溶血状态及组织温度变化;c)猪体内消融术(n=8)和d)临床随机试验(n=25):比较使用VLCC进行低流量(4 ml/min)和高流量(30 ml/min)灌洗的有效性和安全性。结果:虽然在低灌洗和高灌洗条件下,5 mm深度的核心温度峰值均< 50℃,但高灌洗显著减轻了马铃薯和离体心脏模型的瞬间电极和深层组织加热。离体马铃薯切片显示,与低流量灌洗相比,高流量灌洗产生的病变组最深(5.94±0.29 mm vs. 5.36±0.33 mm, P=0.043)。高速摄像机和气泡探测器的评估表明,高流量冲洗可显著减少气泡总数(54.50 IQR 53.00-56.75 vs. 82.00 IQR 72.00-83.00)。结论:在PFA合并VLCC期间,适当的盐水冲洗可减轻电极相关溶血,降低电极和组织温度,限制气泡聚集,并可降低无症状脑病变的发生率,其临床意义尚不清楚。
{"title":"Impact of saline irrigation on haemolysis, silent cerebral lesion incidence, thermal dynamics, and bubble formation in pulsed field ablation with a variable-loop circular catheter.","authors":"Dongtao Zhou, Mengmeng Li, Zhigang Song, Chenxi Jiang, Wei Wang, Ribo Tang, Xin Zhao, Changyi Li, Songnan Li, Xueyuan Guo, Changqi Jia, Man Ning, Li Feng, Dan Wen, Jing Lin, Fang Liu, Tong Liu, Hui Zhu, Yuexin Jiang, Ping Guo, Lin Yuan, Caihua Sang, Deyong Long, Jianzeng Dong, Changsheng Ma","doi":"10.1093/europace/euag005","DOIUrl":"10.1093/europace/euag005","url":null,"abstract":"<p><strong>Aims: </strong>Though pulsed-field ablation (PFA) has demonstrated an excellent safety profile in reducing collateral injury to the oesophagus and phrenic nerve, it is still associated with specific effects, including electrode heating, haemolysis, and electrolysis due to excessive energy dispersion. This study aims to assess whether saline irrigation during PFA application could mitigate these risks.</p><p><strong>Methods and results: </strong>To comprehensively evaluate the effect of irrigation with the variable-loop circular catheter (VLCC), the following experiments were performed: (i) ex-vivo potato model: to evaluate the lesion depth, bubble formation, and thermal effects in different irrigation regimens; (ii) in vitro blood pool and cardiac ablation: to determine the haemolysis status and tissue temperature change after PFA; (iii) in vivo swine ablation (n = 8), and (iv) clinical randomized trial (n = 25): to compare the efficacy and safety profile between low (4 mL/min) and high (30 mL/min) flow irrigation using the VLCC. Though peak core temperatures at 5 mm depth were all < 50°C under low- and high-irrigation, high irrigation significantly mitigated the instant electrode and deep tissue heating both in the potato and isolated cardiac models. Ex vivo potato slices showed that high-flow irrigation produced the deepest lesion sets when compared to low-flow irrigation (5.94 ± 0.29 mm vs. 5.36 ± 0.33 mm, P = 0.043). Assessment from a high-speed camera and bubble detector demonstrated that high-flow irrigation significantly reduced the total number of gaseous bubbles (54.50 IQR 53.00-56.75 vs. 82.00 IQR 72.00-83.00, P < 0.001) and eliminated the occurrence of larger bubbles. The high-flow irrigation group showed a smaller increase in the level of free haemoglobin immediately after the procedure across the blood pool, swine, and clinical models. Haptoglobin and lactate dehydrogenase levels were also attenuated by high irrigation in the in vivo swine model and clinical trial. One swine in the low-irrigation group developed an acute cerebral lesion (3 mm). The clinical trial confirmed that the incidence of silent cerebral lesions was significantly lower in the high-flow irrigation group (16.7% vs. 66.7%, P = 0.036).</p><p><strong>Conclusion: </strong>Proper saline irrigation during PFA with VLCC may mitigate electrode-associated haemolysis, reduce electrode and tissue temperature, limit bubble aggregation, and be associated with a lower incidence of silent cerebral lesions, the clinical significance of which remains unclear.</p>","PeriodicalId":11981,"journal":{"name":"Europace","volume":" ","pages":""},"PeriodicalIF":7.4,"publicationDate":"2026-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12866922/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145965586","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-02-03DOI: 10.1093/europace/euag002
Paschalis Karakasis, Stylianos Tzeis, Konstantinos Pamporis, Konstantinos Vlachos, Konstantinos C Siontis, Antonios P Antoniadis, Karim Benali, Panagiotis Theofilis, Dimitrios Tsiachris, Julian K R Chun, Pierre Jaïs, Nikolaos Fragakis
Aims: Intracardiac echocardiography (ICE) is increasingly incorporated into atrial fibrillation (AF) ablation workflows, enabling real-time anatomic guidance and procedural precision. Nevertheless, ICE utilization shows substantial geographic variability, and its clinical benefit remains incompletely understood. This meta-analysis evaluated the efficacy, safety, and procedural performance of ICE-guided vs. non-ICE-guided AF ablation.
Methods and results: MEDLINE, the Cochrane Library, and Scopus were systematically searched through 3 August 2025. Three reviewers independently performed study selection, data extraction, and risk-of-bias assessment. Random-effects models were used to pool data from 44 AF ablation studies comprising 482 043 patients. ICE guidance was associated with lower odds of any complication (OR 0.69; 95% CI 0.53-0.89), including significant reductions in cardiac tamponade (OR 0.58; 95% CI 0.53-0.62) and mortality (OR 0.21; 95% CI 0.16-0.27). ICE-guided ablation was also associated with shorter total procedure and fluoroscopy times, reduced radiation exposure, and lower contrast agent utilization. Atrial tachyarrhythmia (AT) recurrence did not differ between groups (OR 0.92; 95% CI 0.79-1.06). However, ICE use was associated with higher odds of first-pass pulmonary vein isolation (OR 1.62; 95% CI 1.09-2.41) and successful isolation of all pulmonary veins at the end of the procedure (OR 2.12; 95% CI 1.37-3.27), and lower odds of repeat ablation (OR 0.65; 95% CI 0.59-0.72).
Conclusion: ICE-guided AF ablation is associated with superior procedural safety and efficiency and a similar risk of AT recurrence compared to non-ICE-guided approaches.
目的:心内超声心动图(ICE)越来越多地纳入心房颤动(AF)消融工作流程,实现实时解剖指导和程序精度。然而,ICE的使用表现出很大的地理差异,其临床益处仍不完全清楚。本荟萃分析评估了ice引导与非ice引导的房颤消融的疗效、安全性和程序性能。方法与结果:系统检索到2025年8月3日的MEDLINE、Cochrane图书馆和Scopus。三位审稿人独立进行研究选择、数据提取和偏倚风险评估。随机效应模型用于汇总来自44项房颤消融研究的数据,包括482,043名患者。ICE指导与任何并发症的发生率较低相关(OR 0.69; 95% CI 0.53-0.89),包括心脏填塞(OR 0.58; 95% CI 0.53-0.62)和死亡率(OR 0.21; 95% CI 0.16-0.27)的显著降低。ice引导消融还与更短的总手术和透视时间、更少的辐射暴露和更低的造影剂使用有关。房性心动过速(AT)复发在两组间无差异(OR 0.92; 95% CI 0.79-1.06)。然而,ICE的使用与首次肺静脉分离的几率较高(OR 1.62; 95% CI 1.09-2.41)和手术结束时所有肺静脉的成功分离的几率较高(OR 2.12; 95% CI 1.37-3.27)以及重复消融的几率较低(OR 0.65; 95% CI 0.59-0.72)相关。结论:与非ice引导的方法相比,ice引导的房颤消融具有更高的手术安全性和有效性,且房颤复发风险相似。
{"title":"Safety and efficacy of intracardiac echocardiography in atrial fibrillation ablation: a meta-analysis.","authors":"Paschalis Karakasis, Stylianos Tzeis, Konstantinos Pamporis, Konstantinos Vlachos, Konstantinos C Siontis, Antonios P Antoniadis, Karim Benali, Panagiotis Theofilis, Dimitrios Tsiachris, Julian K R Chun, Pierre Jaïs, Nikolaos Fragakis","doi":"10.1093/europace/euag002","DOIUrl":"10.1093/europace/euag002","url":null,"abstract":"<p><strong>Aims: </strong>Intracardiac echocardiography (ICE) is increasingly incorporated into atrial fibrillation (AF) ablation workflows, enabling real-time anatomic guidance and procedural precision. Nevertheless, ICE utilization shows substantial geographic variability, and its clinical benefit remains incompletely understood. This meta-analysis evaluated the efficacy, safety, and procedural performance of ICE-guided vs. non-ICE-guided AF ablation.</p><p><strong>Methods and results: </strong>MEDLINE, the Cochrane Library, and Scopus were systematically searched through 3 August 2025. Three reviewers independently performed study selection, data extraction, and risk-of-bias assessment. Random-effects models were used to pool data from 44 AF ablation studies comprising 482 043 patients. ICE guidance was associated with lower odds of any complication (OR 0.69; 95% CI 0.53-0.89), including significant reductions in cardiac tamponade (OR 0.58; 95% CI 0.53-0.62) and mortality (OR 0.21; 95% CI 0.16-0.27). ICE-guided ablation was also associated with shorter total procedure and fluoroscopy times, reduced radiation exposure, and lower contrast agent utilization. Atrial tachyarrhythmia (AT) recurrence did not differ between groups (OR 0.92; 95% CI 0.79-1.06). However, ICE use was associated with higher odds of first-pass pulmonary vein isolation (OR 1.62; 95% CI 1.09-2.41) and successful isolation of all pulmonary veins at the end of the procedure (OR 2.12; 95% CI 1.37-3.27), and lower odds of repeat ablation (OR 0.65; 95% CI 0.59-0.72).</p><p><strong>Conclusion: </strong>ICE-guided AF ablation is associated with superior procedural safety and efficiency and a similar risk of AT recurrence compared to non-ICE-guided approaches.</p>","PeriodicalId":11981,"journal":{"name":"Europace","volume":" ","pages":""},"PeriodicalIF":7.4,"publicationDate":"2026-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12931560/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146017889","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Aims: Electromechanical coupling and mechano-electrical feedback (MEF) are crucial for cardiac function, but their pro-arrhythmic roles in short and long QT syndromes (SQT1 and LQT2) are not fully understood. We aimed to evaluate MEF-induced electrical changes, their arrhythmic impact, and the involvement of stretch-activated channels (SACs) in transgenic rabbit models of SQT1 and LQT2.
Methods and results: Patch-clamp and fluorescence imaging were used to analyse action potential duration (APD), Ca²⁺ transients, and contractility in ventricular cardiomyocytes (VCMs) from LQT2, SQT1 and wild-type (WT) rabbits. LQT2 cells showed prolonged APD and Ca²⁺ transients, increased early afterdepolarizations, Ca²⁺ oscillations, and impaired mechanics compared to WT and SQT1. The cellular electromechanical window (Ca²⁺-transient duration minus APD) was more negative in LQT2 and more positive in SQT1 than in WT. QTc prolonged with preload/afterload increase and decreased with preload reduction across all genotypes, but MEF-induced QTc changes and dispersion were most pronounced in LQT2. Ex vivo Langendorff experiments showed that increased right ventricular (RV) pressure prolonged APD and QTc in WT hearts. This was attenuated by the SAC blocker GSMTx4, suggesting a role for SACs in MEF. In silico models of human VCMs including SACs confirmed higher vulnerability to stretch/MEF-induced arrhythmias, including re-entry, in SQT1 and LQT2.
Conclusion: Mechano-electrical feedback-induced electrical changes, partly mediated by SACs, occur in WT, SQT1, and LQT2, but MEF effects are strongest in LQT2. Mechano-electrical feedback induces pro-arrhythmic effects in silico more prominently in LQT2 and SQT1 than in WT, highlighting the potential pro-arrhythmic role of MEF in a vulnerable electrophysiological substrate.
{"title":"Mechano-electrical feedback in transgenic rabbit models of long QT syndrome Type 2 and short QT syndrome Type 1.","authors":"Nicolò Alerni, Melania Buonocunto, Saranda Nimani, Julien Louradour, Miriam Barbieri, Lucilla Giammarino, Lluis Matas, Joost Lumens, Tammo Delhaas, Gideon Koren, Ruben Lopez, Manfred Zehender, Michael Brunner, Balázs Ördög, Jordi Heijman, Katja E Odening","doi":"10.1093/europace/euag011","DOIUrl":"10.1093/europace/euag011","url":null,"abstract":"<p><strong>Aims: </strong>Electromechanical coupling and mechano-electrical feedback (MEF) are crucial for cardiac function, but their pro-arrhythmic roles in short and long QT syndromes (SQT1 and LQT2) are not fully understood. We aimed to evaluate MEF-induced electrical changes, their arrhythmic impact, and the involvement of stretch-activated channels (SACs) in transgenic rabbit models of SQT1 and LQT2.</p><p><strong>Methods and results: </strong>Patch-clamp and fluorescence imaging were used to analyse action potential duration (APD), Ca²⁺ transients, and contractility in ventricular cardiomyocytes (VCMs) from LQT2, SQT1 and wild-type (WT) rabbits. LQT2 cells showed prolonged APD and Ca²⁺ transients, increased early afterdepolarizations, Ca²⁺ oscillations, and impaired mechanics compared to WT and SQT1. The cellular electromechanical window (Ca²⁺-transient duration minus APD) was more negative in LQT2 and more positive in SQT1 than in WT. QTc prolonged with preload/afterload increase and decreased with preload reduction across all genotypes, but MEF-induced QTc changes and dispersion were most pronounced in LQT2. Ex vivo Langendorff experiments showed that increased right ventricular (RV) pressure prolonged APD and QTc in WT hearts. This was attenuated by the SAC blocker GSMTx4, suggesting a role for SACs in MEF. In silico models of human VCMs including SACs confirmed higher vulnerability to stretch/MEF-induced arrhythmias, including re-entry, in SQT1 and LQT2.</p><p><strong>Conclusion: </strong>Mechano-electrical feedback-induced electrical changes, partly mediated by SACs, occur in WT, SQT1, and LQT2, but MEF effects are strongest in LQT2. Mechano-electrical feedback induces pro-arrhythmic effects in silico more prominently in LQT2 and SQT1 than in WT, highlighting the potential pro-arrhythmic role of MEF in a vulnerable electrophysiological substrate.</p>","PeriodicalId":11981,"journal":{"name":"Europace","volume":" ","pages":""},"PeriodicalIF":7.4,"publicationDate":"2026-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12866997/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145997823","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-02-03DOI: 10.1093/europace/euaf325
Michal M Farkowski, Sebastian Szmit, Giuseppe Boriani, Sergio Castrejon, Michael Fradley, Avirup Guha, Josè L Merino, Giacomo Mugnai, Geraldine A Lee, Alexander R Lyon, Diego Penela, Laura Perrotta, Teresa Lopez-Fernandez, Julian K R Chun
Aims: This study aimed to assess current clinical practices in the diagnosis and management of atrial fibrillation (AF) among patients with active cancer or a history of cancer therapy.
Methods and results: A 25-item, physician-based survey was developed by the European Heart Rhythm Association in collaboration with the European Society of Cardiology Council of Cardio-Oncology and the International Cardio-Oncology Society. The survey was disseminated electronically. A total of 380 participants from 74 countries completed the questionnaire, with respondents primarily working as electrophysiologists (30%), general cardiologists (25%), and cardio-oncologists (22%). Nearly two-thirds reported that active cancer 'definitely' or 'most probably' influenced clinical decisions regarding AF diagnosis and management. When AF was diagnosed, rhythm control was the preferred management strategy for symptomatic patients, while rate control was favoured for asymptomatic individuals. A little over 40% reported that a history of cancer therapy 'definitely' or 'most probably' influenced clinical decisions regarding AF. The rhythm control was the most common strategy (40%). In both populations, opportunistic screening for AF and direct oral anticoagulants (DOACs) were preferred strategies. A high level of uncertainty was noted concerning the role of invasive treatment options.
Conclusion: The survey revealed that, despite the lack of robust evidence specific to this patient cohort, contemporary treatment of AF in patients with active cancer or a history of cancer therapy generally follows guidelines developed for the broader AF population. These findings highlight the urgent need for more dedicated data to inform clinical decision-making in cardio-oncology patients with AF.
{"title":"Contemporary management of atrial fibrillation in patients with cancer-the 2025 European Heart Rhythm Association survey.","authors":"Michal M Farkowski, Sebastian Szmit, Giuseppe Boriani, Sergio Castrejon, Michael Fradley, Avirup Guha, Josè L Merino, Giacomo Mugnai, Geraldine A Lee, Alexander R Lyon, Diego Penela, Laura Perrotta, Teresa Lopez-Fernandez, Julian K R Chun","doi":"10.1093/europace/euaf325","DOIUrl":"10.1093/europace/euaf325","url":null,"abstract":"<p><strong>Aims: </strong>This study aimed to assess current clinical practices in the diagnosis and management of atrial fibrillation (AF) among patients with active cancer or a history of cancer therapy.</p><p><strong>Methods and results: </strong>A 25-item, physician-based survey was developed by the European Heart Rhythm Association in collaboration with the European Society of Cardiology Council of Cardio-Oncology and the International Cardio-Oncology Society. The survey was disseminated electronically. A total of 380 participants from 74 countries completed the questionnaire, with respondents primarily working as electrophysiologists (30%), general cardiologists (25%), and cardio-oncologists (22%). Nearly two-thirds reported that active cancer 'definitely' or 'most probably' influenced clinical decisions regarding AF diagnosis and management. When AF was diagnosed, rhythm control was the preferred management strategy for symptomatic patients, while rate control was favoured for asymptomatic individuals. A little over 40% reported that a history of cancer therapy 'definitely' or 'most probably' influenced clinical decisions regarding AF. The rhythm control was the most common strategy (40%). In both populations, opportunistic screening for AF and direct oral anticoagulants (DOACs) were preferred strategies. A high level of uncertainty was noted concerning the role of invasive treatment options.</p><p><strong>Conclusion: </strong>The survey revealed that, despite the lack of robust evidence specific to this patient cohort, contemporary treatment of AF in patients with active cancer or a history of cancer therapy generally follows guidelines developed for the broader AF population. These findings highlight the urgent need for more dedicated data to inform clinical decision-making in cardio-oncology patients with AF.</p>","PeriodicalId":11981,"journal":{"name":"Europace","volume":"28 2","pages":""},"PeriodicalIF":7.4,"publicationDate":"2026-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12917238/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146219014","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-02-03DOI: 10.1093/europace/euag009
Fengwei Zou, Sarah Xu, Sanjana Nagraj, Sheetal Mathai, Ariel Gidon, Nay Yee Wint Kyaw, Jose Matias, Giuseppe Ammirati, Jacopo Marazzato, Aung Lin, Domingo Y Ynoa, Marco Schiavone, Vincenzo Mirco La Fazia, Sanghamitra Mohanty, Andrea Natale, Pasquale Santangeli, Xiaodong Zhang, Luigi Di Biase
Aims: Intracardiac echocardiography-based electroanatomical mapping (EAM) improves procedural efficiency and safety in atrial fibrillation (AF) ablation and remains the standard of care. The CARTOSOUND FAM (AI FAM) module uses a deep-learning algorithm that automates left atrial reconstruction without manual contouring. This study aims to evaluate the 1-year outcomes of AI FAM compared to standard-of-care EAM in AF ablation.
Methods and results: This study included 298 patients undergoing radiofrequency AF ablation between January 2021 and December 2023. Patients treated before January 2023 underwent standard-of-care EAM, while those in 2023 utilized AI FAM-based reconstruction. Baseline demographics, comorbidities, AF type, and medication use were recorded. Procedural characteristics, acute success, complications, and AF recurrence at 1-year follow-up were analysed. Of the 298 patients, 115 underwent mapping with AI FAM and 183 with EAM. Baseline characteristics were comparable. AI FAM reduced mean total procedure time (122.5 ± 23.5 vs. 129.0 ± 30.4 min, P = 0.040) and left atrial (LA) dwell time (78.3 ± 21.45 vs. 87.5 ± 28.2 min, P = 0.001). Acute procedural success was 98.3% in AI FAM vs. 98.9% in EAM with fewer complications observed in the AI FAM group (1 vs. 4). At 1 year, freedom from AF recurrence was comparable (80.0% AI FAM vs. 81.4% EAM at 1 year, LogRank P = 0.610).
Conclusion: AI FAM was associated with incremental but significant procedural advantages over conventional contouring via reduced total procedure time and LA dwell time, without compromising acute and long-term safety and rhythm control efficacy. AI FAM integration with pulsed field ablation will mark another step towards making AF ablation more streamlined and accessible.
背景:基于心内超声心动图(ICE)的电解剖定位(EAM)提高了心房颤动(AF)消融的手术效率和安全性,仍然是标准的治疗方法。CARTOSOUND FAM (AI FAM)模块使用深度学习算法,无需手动轮廓即可自动进行左心房重建。目的:本研究旨在评估AI FAM与标准护理EAM在房颤消融中的一年结果。方法:该研究包括298例在2021年1月至2023年12月期间接受射频房颤消融的患者。在2023年1月之前接受治疗的患者接受了标准护理EAM,而在2023年接受治疗的患者使用了基于AI fam的重建。记录基线人口统计学、合并症、房颤类型和用药情况。分析手术特点、急性成功、并发症及一年随访时房颤复发情况。结果:298例患者中,115例行AI FAM作图,183例行EAM作图。基线特征具有可比性。AI FAM缩短了平均总手术时间(122.5±23.5 vs 129.0±30.4min, P=0.046)和左心房停留时间(78.3±21.45 vs 87.5±28.2min, P=0.001)。AI FAM组的急性手术成功率为98.3%,而EAM组为98.9%,AI FAM组观察到的并发症较少(1比4)。一年后,AF复发率相当(AI FAM为80.0%,EAM为81.4%,LogRank P=0.610)。结论:AI FAM与传统轮廓术相比,通过减少总手术时间和LA停留时间,具有渐进式但显著的手术优势,而不会影响急性和长期安全性和节律控制效果。AI FAM与PFA的集成将标志着心房纤颤消融更加简化和易于使用的又一步。
{"title":"Atrial fibrillation ablation using three-dimensional artificial intelligence module integration with intracardiac echocardiography.","authors":"Fengwei Zou, Sarah Xu, Sanjana Nagraj, Sheetal Mathai, Ariel Gidon, Nay Yee Wint Kyaw, Jose Matias, Giuseppe Ammirati, Jacopo Marazzato, Aung Lin, Domingo Y Ynoa, Marco Schiavone, Vincenzo Mirco La Fazia, Sanghamitra Mohanty, Andrea Natale, Pasquale Santangeli, Xiaodong Zhang, Luigi Di Biase","doi":"10.1093/europace/euag009","DOIUrl":"10.1093/europace/euag009","url":null,"abstract":"<p><strong>Aims: </strong>Intracardiac echocardiography-based electroanatomical mapping (EAM) improves procedural efficiency and safety in atrial fibrillation (AF) ablation and remains the standard of care. The CARTOSOUND FAM (AI FAM) module uses a deep-learning algorithm that automates left atrial reconstruction without manual contouring. This study aims to evaluate the 1-year outcomes of AI FAM compared to standard-of-care EAM in AF ablation.</p><p><strong>Methods and results: </strong>This study included 298 patients undergoing radiofrequency AF ablation between January 2021 and December 2023. Patients treated before January 2023 underwent standard-of-care EAM, while those in 2023 utilized AI FAM-based reconstruction. Baseline demographics, comorbidities, AF type, and medication use were recorded. Procedural characteristics, acute success, complications, and AF recurrence at 1-year follow-up were analysed. Of the 298 patients, 115 underwent mapping with AI FAM and 183 with EAM. Baseline characteristics were comparable. AI FAM reduced mean total procedure time (122.5 ± 23.5 vs. 129.0 ± 30.4 min, P = 0.040) and left atrial (LA) dwell time (78.3 ± 21.45 vs. 87.5 ± 28.2 min, P = 0.001). Acute procedural success was 98.3% in AI FAM vs. 98.9% in EAM with fewer complications observed in the AI FAM group (1 vs. 4). At 1 year, freedom from AF recurrence was comparable (80.0% AI FAM vs. 81.4% EAM at 1 year, LogRank P = 0.610).</p><p><strong>Conclusion: </strong>AI FAM was associated with incremental but significant procedural advantages over conventional contouring via reduced total procedure time and LA dwell time, without compromising acute and long-term safety and rhythm control efficacy. AI FAM integration with pulsed field ablation will mark another step towards making AF ablation more streamlined and accessible.</p>","PeriodicalId":11981,"journal":{"name":"Europace","volume":" ","pages":""},"PeriodicalIF":7.4,"publicationDate":"2026-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12950898/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145988760","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-02-03DOI: 10.1093/europace/euaf303
Lucilla Giammarino, Raquel Neves, David J Tester, Sahej Bains, Vanessa Karlinski Vizentin, J Martijn Bos, John R Giudicessi, Michael J Ackerman
Aims: Calcium release channel deficiency syndrome (CRCDS) results from loss-of-function (LOF) variants in the RYR2-encoded type 2 ryanodine receptor (RyR2), predisposing patients to sudden cardiac arrest/death (SCA/SCD) without abnormalities on a stress electrocardiogram (ECG). Undetected CRCDS may underlie idiopathic ventricular fibrillation (IVF) and sudden unexplained death in the young (SUDY). We aimed to determine the prevalence of potential CRCDS-causative RYR2 variants in IVF and SUDY.
Methods and results: We reviewed clinical evaluation and RYR2 genetic analysis of 169 IVF patients and 279 SUDY victims. Only ultra-rare (<0.005% in gnomAD) nonsynonymous RYR2 variants were considered potentially pathogenic. Among IVF patients, 6/169 (3%) overall-and 6/67 (9%) with exertion-related SCA-harboured an RYR2 variant and represent potential CRCDS cases. All exhibited normal resting and stress ECGs. Genetic analysis revealed six distinct RYR2 variants, two previously characterized as LOF. In SUDY, 31/279 victims (11%) had a RYR2 variant (30 unique variants), predominantly observed in exertion-related SCD 20/83 (24%) vs. rest-related 11/196 (6%). Of the 14 SUDY victims with functionally characterized RYR2 variants, five (2% of total cohort) had a LOF variant; among the 56 exertion-related SUDY cases, four (7%) had a LOF variant.
Conclusion: CRCDS may account for 3% of IVF overall and 9% of exertion-related SCA in IVF. Ultra-rare RYR2 variants may underlie up to 11% of SUDY, with 65% of RYR2-positive cases occurring during exertion. LOF-RYR2 variants may contribute to ≥7% of exercise-associated SUDY. Accurate identification of the underlying ryanodinopathy is essential for clinical management of affected patients.
{"title":"Calcium release channel deficiency syndrome in patients diagnosed with idiopathic ventricular fibrillation and decedents classified as sudden unexplained death in the young.","authors":"Lucilla Giammarino, Raquel Neves, David J Tester, Sahej Bains, Vanessa Karlinski Vizentin, J Martijn Bos, John R Giudicessi, Michael J Ackerman","doi":"10.1093/europace/euaf303","DOIUrl":"10.1093/europace/euaf303","url":null,"abstract":"<p><strong>Aims: </strong>Calcium release channel deficiency syndrome (CRCDS) results from loss-of-function (LOF) variants in the RYR2-encoded type 2 ryanodine receptor (RyR2), predisposing patients to sudden cardiac arrest/death (SCA/SCD) without abnormalities on a stress electrocardiogram (ECG). Undetected CRCDS may underlie idiopathic ventricular fibrillation (IVF) and sudden unexplained death in the young (SUDY). We aimed to determine the prevalence of potential CRCDS-causative RYR2 variants in IVF and SUDY.</p><p><strong>Methods and results: </strong>We reviewed clinical evaluation and RYR2 genetic analysis of 169 IVF patients and 279 SUDY victims. Only ultra-rare (<0.005% in gnomAD) nonsynonymous RYR2 variants were considered potentially pathogenic. Among IVF patients, 6/169 (3%) overall-and 6/67 (9%) with exertion-related SCA-harboured an RYR2 variant and represent potential CRCDS cases. All exhibited normal resting and stress ECGs. Genetic analysis revealed six distinct RYR2 variants, two previously characterized as LOF. In SUDY, 31/279 victims (11%) had a RYR2 variant (30 unique variants), predominantly observed in exertion-related SCD 20/83 (24%) vs. rest-related 11/196 (6%). Of the 14 SUDY victims with functionally characterized RYR2 variants, five (2% of total cohort) had a LOF variant; among the 56 exertion-related SUDY cases, four (7%) had a LOF variant.</p><p><strong>Conclusion: </strong>CRCDS may account for 3% of IVF overall and 9% of exertion-related SCA in IVF. Ultra-rare RYR2 variants may underlie up to 11% of SUDY, with 65% of RYR2-positive cases occurring during exertion. LOF-RYR2 variants may contribute to ≥7% of exercise-associated SUDY. Accurate identification of the underlying ryanodinopathy is essential for clinical management of affected patients.</p>","PeriodicalId":11981,"journal":{"name":"Europace","volume":"28 2","pages":""},"PeriodicalIF":7.4,"publicationDate":"2026-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12962230/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147364443","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-02-03DOI: 10.1093/europace/euag016
Mehrdad Golian, Zhe Li, Nicolas M Berbenetz, Roupen Odabashian, Mouhannad M Sadek, Vicente Corrales-Medina, Alper Aydin, Darryl R Davis, Martin S Green, Andres Klein, Girish M Nair, Pablo B Nery, F Daniel Ramirez, Calum Redpath, Simon P Hansom, Jodi D Edwards, Andrew D Krahn, David H Birnie
Aims: Cardiac implantable electronic device (CIED) infection carries a substantial burden of morbidity, mortality, and cost. The Prevention of Arrhythmia Device Infection Trial (PADIT) risk score improves identification of high-risk patients and may guide targeted strategies to reduce infection. Recent work has categorized CIED infection into localized pocket vs. systemic infection, with early reports suggesting different risk factors for each. However, no current risk score has been validated for infection subtypes.ObjectivesIndependently validate the PADIT infection risk score.Compare risk factors for infection subtypes.Assess PADIT performance in predicting subtype-specific infection.
Methods and results: A prospective registry was initiated at the University of Ottawa Heart Institute in 2007 to capture all CIED procedures and prospectively identify infections in collaboration with the infection prevention team. PADIT risk score components were documented for each procedure. All suspected infections were adjudicated independently by two physicians (with a third if required), blinded to PADIT score and baseline variables, and subclassified as pocket or systemic infection. Logistic regression models were generated to validate PADIT performance for each subtype, with evaluation using Akaike and Bayesian information criteria (AIC/BIC), C-statistics, and calibration slope. Between 2007 and 2020, 14,225 procedures were performed (mean age 72 ± 14 years, 35% female, 70% new implants, 18% generator changes, 11% upgrades). A total of 103 infections (0.73%) were adjudicated, of which 71 (69%) were pocket and 32 (31%) systemic. The PADIT score showed good predictive performance with a C-statistic of 0.687 (95% CI 0.655-0.743), similar to the derivation cohort (0.702, 95% CI 0.661-0.741). Notably, the number of prior procedures was strongly associated with pocket infection but not systemic infection. PADIT discrimination was consistent across subtypes: pocket infection C-statistic 0.691 (95% CI 0.649-0.761) and systemic infection 0.746 (95% CI 0.707-0.848). Calibration slopes demonstrated good agreement between predicted and observed events, with the best fit for systemic infection.
Conclusion: The PADIT score was independently validated with discrimination and calibration similar to the original derivation cohort. Importantly, prior procedures predicted pocket but not systemic infection. Overall, PADIT performed well in predicting both subtypes, with the strongest model fit observed for systemic infection.
目的:心脏植入式电子装置(CIED)感染带来了巨大的发病率、死亡率和成本负担。预防心律失常装置感染试验(PADIT)风险评分提高了对高危患者的识别,并可能指导有针对性的策略来减少感染。最近的研究将CIED感染分为局部口袋感染和全身性感染,早期报告表明两者的危险因素不同。然而,目前还没有针对感染亚型的风险评分。目的独立验证PADIT感染风险评分。比较感染亚型的危险因素。评估PADIT在预测亚型特异性感染方面的表现。方法和结果:2007年,渥太华大学心脏研究所启动了一项前瞻性登记,以记录所有CIED程序,并与感染预防团队合作前瞻性地识别感染。每个程序都记录了PADIT风险评分的组成部分。所有疑似感染由两名医生独立判断(如果需要,第三名医生),对PADIT评分和基线变量不知情,并将其细分为口袋或全身感染。生成逻辑回归模型以验证每个子类型的PADIT性能,并使用赤池和贝叶斯信息标准(AIC/BIC), c统计量和校准斜率进行评估。2007年至2020年间,进行了14,225例手术(平均年龄72±14岁,35%为女性,70%为新植入物,18%为发生器更换,11%为升级)。共确诊感染103例(0.73%),其中口袋感染71例(69%),全身性感染32例(31%)。PADIT评分显示出良好的预测性能,c统计量为0.687 (95% CI 0.655-0.743),与衍生队列相似(0.702,95% CI 0.661-0.741)。值得注意的是,先前手术的次数与口袋感染密切相关,而与全身感染无关。不同亚型间PADIT的区别是一致的:口袋感染c统计值为0.691 (95% CI 0.649-0.761),全身感染为0.746 (95% CI 0.707-0.848)。校准斜率在预测和观察事件之间表现出良好的一致性,最适合全身性感染。结论:PADIT评分与原始衍生队列相似,具有独立的判别和校准。重要的是,先前的手术预测的是口袋感染,而不是全身感染。总的来说,PADIT在预测两种亚型方面表现良好,对全身性感染的模型拟合最强。
{"title":"Validation of the PADIT (prevention of arrhythmia device infection trial) risk score for infection and infection subtypes.","authors":"Mehrdad Golian, Zhe Li, Nicolas M Berbenetz, Roupen Odabashian, Mouhannad M Sadek, Vicente Corrales-Medina, Alper Aydin, Darryl R Davis, Martin S Green, Andres Klein, Girish M Nair, Pablo B Nery, F Daniel Ramirez, Calum Redpath, Simon P Hansom, Jodi D Edwards, Andrew D Krahn, David H Birnie","doi":"10.1093/europace/euag016","DOIUrl":"10.1093/europace/euag016","url":null,"abstract":"<p><strong>Aims: </strong>Cardiac implantable electronic device (CIED) infection carries a substantial burden of morbidity, mortality, and cost. The Prevention of Arrhythmia Device Infection Trial (PADIT) risk score improves identification of high-risk patients and may guide targeted strategies to reduce infection. Recent work has categorized CIED infection into localized pocket vs. systemic infection, with early reports suggesting different risk factors for each. However, no current risk score has been validated for infection subtypes.ObjectivesIndependently validate the PADIT infection risk score.Compare risk factors for infection subtypes.Assess PADIT performance in predicting subtype-specific infection.</p><p><strong>Methods and results: </strong>A prospective registry was initiated at the University of Ottawa Heart Institute in 2007 to capture all CIED procedures and prospectively identify infections in collaboration with the infection prevention team. PADIT risk score components were documented for each procedure. All suspected infections were adjudicated independently by two physicians (with a third if required), blinded to PADIT score and baseline variables, and subclassified as pocket or systemic infection. Logistic regression models were generated to validate PADIT performance for each subtype, with evaluation using Akaike and Bayesian information criteria (AIC/BIC), C-statistics, and calibration slope. Between 2007 and 2020, 14,225 procedures were performed (mean age 72 ± 14 years, 35% female, 70% new implants, 18% generator changes, 11% upgrades). A total of 103 infections (0.73%) were adjudicated, of which 71 (69%) were pocket and 32 (31%) systemic. The PADIT score showed good predictive performance with a C-statistic of 0.687 (95% CI 0.655-0.743), similar to the derivation cohort (0.702, 95% CI 0.661-0.741). Notably, the number of prior procedures was strongly associated with pocket infection but not systemic infection. PADIT discrimination was consistent across subtypes: pocket infection C-statistic 0.691 (95% CI 0.649-0.761) and systemic infection 0.746 (95% CI 0.707-0.848). Calibration slopes demonstrated good agreement between predicted and observed events, with the best fit for systemic infection.</p><p><strong>Conclusion: </strong>The PADIT score was independently validated with discrimination and calibration similar to the original derivation cohort. Importantly, prior procedures predicted pocket but not systemic infection. Overall, PADIT performed well in predicting both subtypes, with the strongest model fit observed for systemic infection.</p>","PeriodicalId":11981,"journal":{"name":"Europace","volume":"28 2","pages":""},"PeriodicalIF":7.4,"publicationDate":"2026-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12910619/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146206285","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-02-03DOI: 10.1093/europace/euaf160
Anthony Frosio, Procolo Marchese, Giorgia Bertoli, David Molla, Martina Arici, Chiara Bartolucci, Chiara Piantoni, Giulia Guidi, Claudia Bazzini, Patrizia Benzoni, Raffaella Milanesi, Antonio Fortunato, Pierfrancesco Grossi, Luigi Pianese, Yi Wang, Riccardo Cappato, Marco Nardini, Stefano Severi, Annalisa Bucchi, Marcella Rocchetti, Mirko Baruscotti
Aims: Loss-of-function (LOF) mutations of the cardiac Na+ channel (SCN5A) are causatively associated with the Brugada Syndrome (BrS). However, the onset of Ventricular Fibrillation (VF) is a rare event, and critical factors favouring the pathological phenotype remain often elusive. This study explores how concomitant triggering conditions may impact on VF onset in a symptomatic proband carrying the S805L/SCN5A BrS mutation.
Methods and results: Clinical, in-vitro, numerical, and structural analyses were performed. A 67-year-old male was resuscitated after cardiac arrest, and clinical analysis upon hospitalisation revealed severe hypokalaemia (2.5 mEq/L). The ECG showed a coved type-I BrS pattern and the SCN5A mutation (S805L) was identified. Patch-clamp studies carried out in a heterologous expression system (HEK293 cells) revealed that WT/S805L channels exhibit two different phenotypes (normal and LOF); the main parameter controlling this distribution is the cell membrane potential. A protected/normal behaviour was observed at -80 mV; conversely, LOF occurred at more negative potentials (-100/-120 mV). Further analyses in isolated outflow tract ventricular cardiomyocytes showed that hypokalaemia (and bradycardia) induced diastolic potential hyperpolarisation, thus favouring the Na+ current LOF. Computational and molecular modelling confirmed our findings and revealed the structural determinant of this alteration.
Conclusion: WT/S805L Na+ channels exhibit either a LOF or a wild-type-like behaviour depending on the membrane potential. Since hypokalaemia and slow pacing rate induce cell hyperpolarisation and the associated LOF, they represent concurrent elements creating the scenario responsible for the VF and cardiac arrest. These results may represent an interpretative paradigm applicable to other BrS mutations.
{"title":"Hypokalaemia and bradycardia unmask the loss-of-function phenotype of a Brugada Syndrome SCN5A mutation.","authors":"Anthony Frosio, Procolo Marchese, Giorgia Bertoli, David Molla, Martina Arici, Chiara Bartolucci, Chiara Piantoni, Giulia Guidi, Claudia Bazzini, Patrizia Benzoni, Raffaella Milanesi, Antonio Fortunato, Pierfrancesco Grossi, Luigi Pianese, Yi Wang, Riccardo Cappato, Marco Nardini, Stefano Severi, Annalisa Bucchi, Marcella Rocchetti, Mirko Baruscotti","doi":"10.1093/europace/euaf160","DOIUrl":"10.1093/europace/euaf160","url":null,"abstract":"<p><strong>Aims: </strong>Loss-of-function (LOF) mutations of the cardiac Na+ channel (SCN5A) are causatively associated with the Brugada Syndrome (BrS). However, the onset of Ventricular Fibrillation (VF) is a rare event, and critical factors favouring the pathological phenotype remain often elusive. This study explores how concomitant triggering conditions may impact on VF onset in a symptomatic proband carrying the S805L/SCN5A BrS mutation.</p><p><strong>Methods and results: </strong>Clinical, in-vitro, numerical, and structural analyses were performed. A 67-year-old male was resuscitated after cardiac arrest, and clinical analysis upon hospitalisation revealed severe hypokalaemia (2.5 mEq/L). The ECG showed a coved type-I BrS pattern and the SCN5A mutation (S805L) was identified. Patch-clamp studies carried out in a heterologous expression system (HEK293 cells) revealed that WT/S805L channels exhibit two different phenotypes (normal and LOF); the main parameter controlling this distribution is the cell membrane potential. A protected/normal behaviour was observed at -80 mV; conversely, LOF occurred at more negative potentials (-100/-120 mV). Further analyses in isolated outflow tract ventricular cardiomyocytes showed that hypokalaemia (and bradycardia) induced diastolic potential hyperpolarisation, thus favouring the Na+ current LOF. Computational and molecular modelling confirmed our findings and revealed the structural determinant of this alteration.</p><p><strong>Conclusion: </strong>WT/S805L Na+ channels exhibit either a LOF or a wild-type-like behaviour depending on the membrane potential. Since hypokalaemia and slow pacing rate induce cell hyperpolarisation and the associated LOF, they represent concurrent elements creating the scenario responsible for the VF and cardiac arrest. These results may represent an interpretative paradigm applicable to other BrS mutations.</p>","PeriodicalId":11981,"journal":{"name":"Europace","volume":" ","pages":""},"PeriodicalIF":7.4,"publicationDate":"2026-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12886553/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144759545","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-02-03DOI: 10.1093/europace/euaf323
Lucía Osoro, Elena Arbelo, Nikola Kozhuharov, Runa Landen, Martin Martinek, Christophe Leclerq, Laurent Fauchier, Jean-Claude De Haro, Serge Boveda, Philipp Sommer, Michiel Rienstra, Piotr Symanski, Michal Farkowski, Anastasia Egorova, Francisco Moscoso Costa, Diana Tint, Stefan Simovic, Krasimir Dzhinsov, Francisco Leyva, Giuseppe Boriani, Josep Figueras, Zenichi Ihara, Jose Luis Merino, Haran Burri, Helmut Pürerfellner, Rubén Casado-Arroyo
Aims: Procurement of cardiac implantable electronic devices (CIEDs) across the European Union is shaped by diverse healthcare systems, reimbursement mechanisms and levels of clinician involvement. Despite a shared legal framework, limited comparative data are available on how procurement is implemented across countries.
Objective: The objectives of this study are to examine CIED procurement strategies in 22 European countries where public tendering is mandatory and to explore how clinical, economic and structural factors influence procurement processes.
Methods and results: We conducted 23 structured interviews with cardiologists and one industry expert across 22 European countries. A thematic analysis was used to synthesize procurement models, clinical involvement and reimbursement structures. No formal outcome or cost-effectiveness analysis was performed. Procurement models varied widely, encompassing centralized, decentralized and hybrid systems. Clinician involvement ranged from leading device selection based on clinical criteria to being excluded from decision-making in systems driven primarily by price. Reimbursement pathways also differed, with procedure tariffs for single-chamber pacemakers ranging from €1059 to €14 889. A single region in Finland had implemented a pilot value-based procurement model linking payment to patient outcomes.
Conclusion: Cardiac implantable electronic device procurement across Europe is heterogeneous and predominantly cost driven, with limited integration of clinical outcomes or value-based principles. While not designed to evaluate cost-effectiveness directly, this study identifies procurement structures that may support or hinder value-based decision-making. Further research is needed to assess how procurement impacts clinical outcomes, innovation adoption and system sustainability.
{"title":"Public procurement of cardiac implantable electronic devices across Europe: are we purchasing value or cost-effectiveness?","authors":"Lucía Osoro, Elena Arbelo, Nikola Kozhuharov, Runa Landen, Martin Martinek, Christophe Leclerq, Laurent Fauchier, Jean-Claude De Haro, Serge Boveda, Philipp Sommer, Michiel Rienstra, Piotr Symanski, Michal Farkowski, Anastasia Egorova, Francisco Moscoso Costa, Diana Tint, Stefan Simovic, Krasimir Dzhinsov, Francisco Leyva, Giuseppe Boriani, Josep Figueras, Zenichi Ihara, Jose Luis Merino, Haran Burri, Helmut Pürerfellner, Rubén Casado-Arroyo","doi":"10.1093/europace/euaf323","DOIUrl":"10.1093/europace/euaf323","url":null,"abstract":"<p><strong>Aims: </strong>Procurement of cardiac implantable electronic devices (CIEDs) across the European Union is shaped by diverse healthcare systems, reimbursement mechanisms and levels of clinician involvement. Despite a shared legal framework, limited comparative data are available on how procurement is implemented across countries.</p><p><strong>Objective: </strong>The objectives of this study are to examine CIED procurement strategies in 22 European countries where public tendering is mandatory and to explore how clinical, economic and structural factors influence procurement processes.</p><p><strong>Methods and results: </strong>We conducted 23 structured interviews with cardiologists and one industry expert across 22 European countries. A thematic analysis was used to synthesize procurement models, clinical involvement and reimbursement structures. No formal outcome or cost-effectiveness analysis was performed. Procurement models varied widely, encompassing centralized, decentralized and hybrid systems. Clinician involvement ranged from leading device selection based on clinical criteria to being excluded from decision-making in systems driven primarily by price. Reimbursement pathways also differed, with procedure tariffs for single-chamber pacemakers ranging from €1059 to €14 889. A single region in Finland had implemented a pilot value-based procurement model linking payment to patient outcomes.</p><p><strong>Conclusion: </strong>Cardiac implantable electronic device procurement across Europe is heterogeneous and predominantly cost driven, with limited integration of clinical outcomes or value-based principles. While not designed to evaluate cost-effectiveness directly, this study identifies procurement structures that may support or hinder value-based decision-making. Further research is needed to assess how procurement impacts clinical outcomes, innovation adoption and system sustainability.</p>","PeriodicalId":11981,"journal":{"name":"Europace","volume":"28 2","pages":""},"PeriodicalIF":7.4,"publicationDate":"2026-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12916237/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146219069","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-02-03DOI: 10.1093/europace/euag018
Giuseppe Ciconte, Raffaele Salerno, Alessandro Fuga, Alessia Vuturo, Antonio Boccellino, Gabriele Negro, Roberto Rondine, Marco Ballarotto, Cristiano Ciaccio, Antonio Izzo, Davide Antonio Morciano, Arianna Garbelli, Luigi Giannelli, Vincenzo Maiolo, Zarko Calovic, Luigi Anastasia, Carlo Pappone
Aims: Obesity adversely affects atrial fibrillation (AF) outcomes and is associated with higher recurrence after catheter ablation. Glucagon-like peptide-1 receptor agonists (GLP-1RAs) promote weight loss and improve metabolic inflammation, but their role as adjuncts to ablation has not been completely defined. This study investigated the impact of semaglutide on post-ablation rhythm outcomes in obese patients with AF.
Methods and results: This single-centre, propensity-matched study included obese patients [body mass index (BMI) ≥ 30 kg/m²] undergoing first-time catheter ablation for paroxysmal AF (2019-2024). Patients who initiated semaglutide within 3 months before or 1 month after ablation were compared with matched controls who did not receive GLP-1RA therapy. All patients underwent continuous rhythm monitoring using implantable cardiac monitors. The primary endpoint was any atrial tachyarrhythmia recurrence beyond a 2-month blanking period. The final cohort included 181 semaglutide-treated patients and 181 controls with matched clinical and procedural characteristics. At 18-month follow-up, freedom from recurrence was 80.2% vs. 65.2%; semaglutide was associated with a significantly lower risk of recurrence (hazard ratio 0.52; 95% confidence interval 0.34-0.78; P = 0.002). Weight and BMI decreased significantly in the semaglutide group (-11.8 ± 3.8 kg; -4.0 ± 1.4 kg/m²) compared with controls (-1.9 ± 1.2 kg; -0.3 ± 0.8 kg/m²; both P < 0.001). A substantial proportion of treated patients achieved ≥10% weight reduction.
Conclusion: Glucagon-like peptide-1 receptor agonist therapy using semaglutide is associated with a reduced risk of AF recurrence in obese patients undergoing AF catheter ablation, indicating its potential as an adjunctive treatment. Further studies are needed to confirm these findings and elucidate the effects of GLP-1RA on AF recurrence.
{"title":"Semaglutide as adjunctive therapy to catheter ablation in obesity-related paroxysmal atrial fibrillation.","authors":"Giuseppe Ciconte, Raffaele Salerno, Alessandro Fuga, Alessia Vuturo, Antonio Boccellino, Gabriele Negro, Roberto Rondine, Marco Ballarotto, Cristiano Ciaccio, Antonio Izzo, Davide Antonio Morciano, Arianna Garbelli, Luigi Giannelli, Vincenzo Maiolo, Zarko Calovic, Luigi Anastasia, Carlo Pappone","doi":"10.1093/europace/euag018","DOIUrl":"10.1093/europace/euag018","url":null,"abstract":"<p><strong>Aims: </strong>Obesity adversely affects atrial fibrillation (AF) outcomes and is associated with higher recurrence after catheter ablation. Glucagon-like peptide-1 receptor agonists (GLP-1RAs) promote weight loss and improve metabolic inflammation, but their role as adjuncts to ablation has not been completely defined. This study investigated the impact of semaglutide on post-ablation rhythm outcomes in obese patients with AF.</p><p><strong>Methods and results: </strong>This single-centre, propensity-matched study included obese patients [body mass index (BMI) ≥ 30 kg/m²] undergoing first-time catheter ablation for paroxysmal AF (2019-2024). Patients who initiated semaglutide within 3 months before or 1 month after ablation were compared with matched controls who did not receive GLP-1RA therapy. All patients underwent continuous rhythm monitoring using implantable cardiac monitors. The primary endpoint was any atrial tachyarrhythmia recurrence beyond a 2-month blanking period. The final cohort included 181 semaglutide-treated patients and 181 controls with matched clinical and procedural characteristics. At 18-month follow-up, freedom from recurrence was 80.2% vs. 65.2%; semaglutide was associated with a significantly lower risk of recurrence (hazard ratio 0.52; 95% confidence interval 0.34-0.78; P = 0.002). Weight and BMI decreased significantly in the semaglutide group (-11.8 ± 3.8 kg; -4.0 ± 1.4 kg/m²) compared with controls (-1.9 ± 1.2 kg; -0.3 ± 0.8 kg/m²; both P < 0.001). A substantial proportion of treated patients achieved ≥10% weight reduction.</p><p><strong>Conclusion: </strong>Glucagon-like peptide-1 receptor agonist therapy using semaglutide is associated with a reduced risk of AF recurrence in obese patients undergoing AF catheter ablation, indicating its potential as an adjunctive treatment. Further studies are needed to confirm these findings and elucidate the effects of GLP-1RA on AF recurrence.</p>","PeriodicalId":11981,"journal":{"name":"Europace","volume":" ","pages":""},"PeriodicalIF":7.4,"publicationDate":"2026-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12910615/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146156601","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}