Pub Date : 2026-01-05DOI: 10.1016/j.hrthm.2025.12.041
Antonio Frontera, Alessia Chiara Latini, Philipp Krisai, Vincenzo Battaglia, Lisa Amalie Gottlieb, Kostantinos Vlachos, Lorenzo Gigli, Fabrizio Guarracini, Matteo Baroni, Alberto Preda, Marisa Varrenti, Sara Vargiu, Marco Paolucci, Roberto Menè, Marco Carbonaro, Giulia Colombo, Bianca J J M Brundel, Ingrid Elisabeth Christophersen, Cristina Giannattasio, Natasja M S De Groot, Patrizio Mazzone
Atrial electrical remodeling spans molecular, electrical, and structural alterations that shorten refractoriness, facilitate reentry, and ultimately create the atrial substrate underlying atrial fibrillation (AF). These changes include ion channel dysfunction, calcium-handling abnormalities, oxidative injury, and deranged proteostasis that are tightly intertwined with atrial fibrosis and cardiomyopathy. High-density mapping and advanced imaging now allow in vivo staging of this substrate: left atrial low-voltage areas and functional conduction phenomena identify regions of fibrosis and conduction slowing that are associated with postablation recurrence, although the benefit of low-voltage area-targeted substrate ablation remains uncertain. Building on this pathophysiological framework, this review integrates experimental and clinical evidence to guide decision making in AF therapy, emphasizing early rhythm-control strategies and careful substrate characterization in sinus rhythm. Pulmonary vein (PV) isolation is presented as the cornerstone of ablation, whereas adjunctive substrate-oriented strategies, including low-voltage modification, hybrid surgical-catheter approaches, and vein of Marshall-based techniques, are discussed as investigational options for selected high-risk patients. Finally, the review contrasts PV- and non-PV-dependent forms of AF and appraises emerging artificial intelligence-guided electrogram interpretation within a mechanism-driven framework for personalized management of atrial electrical remodeling.
{"title":"From bench to bedside: The clinical relevance of atrial electrical remodeling in atrial fibrillation therapy.","authors":"Antonio Frontera, Alessia Chiara Latini, Philipp Krisai, Vincenzo Battaglia, Lisa Amalie Gottlieb, Kostantinos Vlachos, Lorenzo Gigli, Fabrizio Guarracini, Matteo Baroni, Alberto Preda, Marisa Varrenti, Sara Vargiu, Marco Paolucci, Roberto Menè, Marco Carbonaro, Giulia Colombo, Bianca J J M Brundel, Ingrid Elisabeth Christophersen, Cristina Giannattasio, Natasja M S De Groot, Patrizio Mazzone","doi":"10.1016/j.hrthm.2025.12.041","DOIUrl":"10.1016/j.hrthm.2025.12.041","url":null,"abstract":"<p><p>Atrial electrical remodeling spans molecular, electrical, and structural alterations that shorten refractoriness, facilitate reentry, and ultimately create the atrial substrate underlying atrial fibrillation (AF). These changes include ion channel dysfunction, calcium-handling abnormalities, oxidative injury, and deranged proteostasis that are tightly intertwined with atrial fibrosis and cardiomyopathy. High-density mapping and advanced imaging now allow in vivo staging of this substrate: left atrial low-voltage areas and functional conduction phenomena identify regions of fibrosis and conduction slowing that are associated with postablation recurrence, although the benefit of low-voltage area-targeted substrate ablation remains uncertain. Building on this pathophysiological framework, this review integrates experimental and clinical evidence to guide decision making in AF therapy, emphasizing early rhythm-control strategies and careful substrate characterization in sinus rhythm. Pulmonary vein (PV) isolation is presented as the cornerstone of ablation, whereas adjunctive substrate-oriented strategies, including low-voltage modification, hybrid surgical-catheter approaches, and vein of Marshall-based techniques, are discussed as investigational options for selected high-risk patients. Finally, the review contrasts PV- and non-PV-dependent forms of AF and appraises emerging artificial intelligence-guided electrogram interpretation within a mechanism-driven framework for personalized management of atrial electrical remodeling.</p>","PeriodicalId":12886,"journal":{"name":"Heart rhythm","volume":" ","pages":""},"PeriodicalIF":5.7,"publicationDate":"2026-01-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145917324","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-05DOI: 10.1016/j.hrthm.2025.12.038
Andrea Igoren Guaricci, Andrea Faggiano, Karim Wahbi, Roberto Barriales-Villa, Maria Cristina Carella, Stefano Carugo, Alex Hørby Christensen, Cinzia Forleo, Elisa Gherbesi, Kristina H Haugaa, Marco Merlo, José M Larrañaga-Moreira, Saima Mushtaq, Valeria Novelli, Giovanni Peretto, Nicoletta Resta, Christine Rootwelt-Norberg, Rabah Ben Yaou, Marco Matteo Ciccone, Gianfranco Sinagra, Gianluca Pontone
Background: Variants in the LMNA gene, responsible for laminopathies, are associated with severe cardiovascular outcomes, including arrhythmias and heart failure (HF). However, the differential prognostic impact of missense vs nonmissense variants remains unclear.
Objective: The primary end point of this systematic review and meta-analysis was to compare the cardiovascular outcome defined as combined malignant ventricular arrhythmias (MVAs) and HF among patients with missense vs nonmissense variants in the LMNA gene. Secondary outcomes included a comparison of MVAs and HF-related events analyzed separately.
Methods: A systematic search of PubMed, Ovid MEDLINE, and Cochrane Library was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Meta-analyses were performed using fixed or random effects models, depending on heterogeneity. PROSPERO identifier: CRD42024584721.
Results: 12 studies comprising 1818 participants were included. Of these, 969 had missense variants, and 849 had nonmissense variants. The nonmissense group showed a significantly higher rate of cardiovascular events (30.5% vs 21.3%; odds ratio [OR] 2.22; P < .001). MVAs were more frequent in nonmissense carriers (25.5% vs 18.9%; OR 2.37; P < .001). Although limited by the small number of studies (n = 5) and single-study bias, the incidence of HF-related severe events seemed similar between the groups (18.2% vs 23.9%; OR 0.956; P = .801).
Conclusion: Nonmissense LMNA variants are associated with worse cardiovascular outcomes, particularly arrhythmic events, whereas HF-related events seem comparable between nonmissense and missense variants.
背景:导致板层病的LMNA基因变异与严重的心血管结局相关,包括心律失常和心力衰竭(HF)。然而,错义变异与非错义变异对预后的不同影响仍不清楚。目的:本系统综述和荟萃分析的主要终点是比较LMNA基因错义与非错义变异患者合并恶性室性心律失常(MVA)和HF的心血管结局。次要结局包括分别分析MVA和hf相关事件的比较。方法:根据PRISMA指南系统检索PubMed、OVID-MEDLINE和Cochrane Library。根据异质性,采用固定或随机效应模型进行meta分析。普洛斯彼罗标识符:CRD42024584721。结果:纳入了12项研究,包括1818名参与者。其中,969个有错义变异,849个有非错义变异。非错义组心血管事件发生率明显高于对照组(30.5% vs. 21.3%, OR: 2.22, p < 0.001)。恶性室性心律失常在非错义携带者中更为常见(25.5% vs. 18.9%, OR: 2.37, p < 0.001)。虽然受到研究数量较少(n=5)和单研究偏倚的限制,两组之间hf相关严重事件的发生率相似(18.2% vs. 23.9%, OR: 0.956, p = 0.801)结论:非错义LMNA变异与更差的心血管结局相关,尤其是心律失常事件,而非错义和错义变异之间hf相关事件具有可变性。
{"title":"Cardiovascular prognostic impact of missense vs nonmissense lamin A/C variants: A systematic review and meta-analysis.","authors":"Andrea Igoren Guaricci, Andrea Faggiano, Karim Wahbi, Roberto Barriales-Villa, Maria Cristina Carella, Stefano Carugo, Alex Hørby Christensen, Cinzia Forleo, Elisa Gherbesi, Kristina H Haugaa, Marco Merlo, José M Larrañaga-Moreira, Saima Mushtaq, Valeria Novelli, Giovanni Peretto, Nicoletta Resta, Christine Rootwelt-Norberg, Rabah Ben Yaou, Marco Matteo Ciccone, Gianfranco Sinagra, Gianluca Pontone","doi":"10.1016/j.hrthm.2025.12.038","DOIUrl":"10.1016/j.hrthm.2025.12.038","url":null,"abstract":"<p><strong>Background: </strong>Variants in the LMNA gene, responsible for laminopathies, are associated with severe cardiovascular outcomes, including arrhythmias and heart failure (HF). However, the differential prognostic impact of missense vs nonmissense variants remains unclear.</p><p><strong>Objective: </strong>The primary end point of this systematic review and meta-analysis was to compare the cardiovascular outcome defined as combined malignant ventricular arrhythmias (MVAs) and HF among patients with missense vs nonmissense variants in the LMNA gene. Secondary outcomes included a comparison of MVAs and HF-related events analyzed separately.</p><p><strong>Methods: </strong>A systematic search of PubMed, Ovid MEDLINE, and Cochrane Library was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Meta-analyses were performed using fixed or random effects models, depending on heterogeneity. PROSPERO identifier: CRD42024584721.</p><p><strong>Results: </strong>12 studies comprising 1818 participants were included. Of these, 969 had missense variants, and 849 had nonmissense variants. The nonmissense group showed a significantly higher rate of cardiovascular events (30.5% vs 21.3%; odds ratio [OR] 2.22; P < .001). MVAs were more frequent in nonmissense carriers (25.5% vs 18.9%; OR 2.37; P < .001). Although limited by the small number of studies (n = 5) and single-study bias, the incidence of HF-related severe events seemed similar between the groups (18.2% vs 23.9%; OR 0.956; P = .801).</p><p><strong>Conclusion: </strong>Nonmissense LMNA variants are associated with worse cardiovascular outcomes, particularly arrhythmic events, whereas HF-related events seem comparable between nonmissense and missense variants.</p>","PeriodicalId":12886,"journal":{"name":"Heart rhythm","volume":" ","pages":""},"PeriodicalIF":5.7,"publicationDate":"2026-01-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145917295","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-01DOI: 10.1016/j.hrthm.2025.02.028
Guojie Ye MD , Yingyue Zhang PhD , Le Peng PhD , Zhenze Yu MD , Yunhe Bai MD , Meishan Wu MD , Dan Lu PhD , Chunhua Ding PhD
Background
The association of thyroid hormone sensitivity with heart rate remains unclear.
Objective
This study aims to elucidate the relationship between impaired thyroid hormone sensitivity and lower heart rate in the euthyroid population.
Methods
A total of 550 participants were included. Heart rate and serum biochemicals were measured. Thyroid hormone sensitivity indices were calculated using the thyrotropin index (TSHI), thyrotropin thyroxine resistance index (TT4RI), thyroid feedback quantile–based index (TFQI), Chinese-referenced parametric TFQI (PTFQI), and the ratio of free triiodothyronine to free thyroxine (FT3/FT4 ratio). Logistic regression analyses were applied to explore the relationship between thyroid hormone sensitivity indices and heart rate.
Results
TSHI, TT4RI, TFQI, and PTFQI were higher, and FT3/FT4 ratio was lower in participants with heart rate ≤ 60 beats/min (P < .001 for all). Participants with increased TSHI, TT4RI, TFQI, and PTFQI and reduced FT3/FT4 ratio had lower heart rate (≤60 beats/min) (P for trend < .001 for all). Odds ratios (95% confidence intervals) for TSHI, TT4RI, TFQI, PTFQI, and FT3/FT4 ratio in the highest quartile were 2.090 (1.092–4.000), 2.240 (1.151–4.361), 2.014 (1.043–3.887), 2.163 (1.123–4.166), and 0.498, (0.249–0.996), respectively, as compared with the lowest quartile after adjusting for sex, age, body mass index, smoking, drinking, hypertension, diabetes, coronary artery disease, glycated hemoglobin, total cholesterol, low-density lipoprotein cholesterol, and triglycerides.
Conclusion
Impaired sensitivity to thyroid hormones was associated with lower heart rate in euthyroid participants. Future large-scale studies are needed to confirm our findings.
{"title":"Impaired sensitivity to thyroid hormones is associated with lower heart rate in the euthyroid population","authors":"Guojie Ye MD , Yingyue Zhang PhD , Le Peng PhD , Zhenze Yu MD , Yunhe Bai MD , Meishan Wu MD , Dan Lu PhD , Chunhua Ding PhD","doi":"10.1016/j.hrthm.2025.02.028","DOIUrl":"10.1016/j.hrthm.2025.02.028","url":null,"abstract":"<div><h3>Background</h3><div>The association of thyroid hormone sensitivity with heart rate remains unclear.</div></div><div><h3>Objective</h3><div><span>This study aims to elucidate the relationship between impaired thyroid hormone sensitivity and lower heart rate in the </span>euthyroid population.</div></div><div><h3>Methods</h3><div><span>A total of 550 participants were included. Heart rate and serum biochemicals were measured. Thyroid hormone sensitivity indices were calculated using the thyrotropin<span> index (TSHI), thyrotropin </span></span>thyroxine<span> resistance index (TT4RI), thyroid feedback quantile–based index (TFQI), Chinese-referenced parametric TFQI (PTFQI), and the ratio of free triiodothyronine<span><span> to free thyroxine (FT3/FT4 ratio). </span>Logistic regression analyses were applied to explore the relationship between thyroid hormone sensitivity indices and heart rate.</span></span></div></div><div><h3>Results</h3><div>TSHI, TT4RI, TFQI, and PTFQI were higher, and FT3/FT4 ratio was lower in participants with heart rate ≤ 60 beats/min (<em>P</em><span> < .001 for all). Participants with increased TSHI, TT4RI, TFQI, and PTFQI and reduced FT3/FT4 ratio had lower heart rate (≤60 beats/min) (</span><em>P</em><span> for trend < .001 for all). Odds ratios (95% confidence intervals) for TSHI, TT4RI, TFQI, PTFQI, and FT3/FT4 ratio in the highest quartile were 2.090 (1.092–4.000), 2.240 (1.151–4.361), 2.014 (1.043–3.887), 2.163 (1.123–4.166), and 0.498, (0.249–0.996), respectively, as compared with the lowest quartile after adjusting for sex, age, body mass index<span><span>, smoking, drinking, hypertension, diabetes, coronary artery disease, </span>glycated hemoglobin<span><span>, total cholesterol, low-density lipoprotein cholesterol, and </span>triglycerides.</span></span></span></div></div><div><h3>Conclusion</h3><div>Impaired sensitivity to thyroid hormones was associated with lower heart rate in euthyroid participants. Future large-scale studies are needed to confirm our findings.</div></div>","PeriodicalId":12886,"journal":{"name":"Heart rhythm","volume":"23 1","pages":"Pages 203-211"},"PeriodicalIF":5.7,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143476370","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-01DOI: 10.1016/j.hrthm.2025.07.001
Florent I.P. Farnir MD , Sevasti-Maria Chaldoupi MD, PhD , Ben Hermans PhD , Arne Johannessen MD, DMSc , Martin Aar Haugdal MSc , Martin H. Ruwald MD , Tasnim Mohaissen PhD , Arnela Saljic PhD , Kezia Jerltorp DVM , Sarah Dalgas Nissen DVM, PhD , Julie Norup Hertel DVM , Frédéric Farnir PhD , Thomas Jespersen PhD , Ulrich Schotten MD, PhD , Justin G.L.M. Luermans MD, PhD , Kevin Vernooy MD, PhD , Jim Hansen MD, DMSc , Dominik Linz MD, PhD
Background
Pulsed-field ablation for the treatment of cavotricuspid isthmus (CTI)–dependent atrial flutter has been associated with coronary spasms (CS) and atrioventricular conduction disorders (CD).
Objectives
The purpose of this study was to evaluate the feasibility of CTI ablation using a monopolar focal pulsed-field ablation (F-PFA) catheter and to assess the risk of CS and CD during and after the procedure.
Methods
We prospectively enrolled patients with atrial flutter treated with an F-PFA system (CardioFocus, Marlborough, MA) or by focal radiofrequency ablation (RFA) using contact force–sensing catheters integrated into electroanatomic mapping systems. Intravenous nitroglycerin was administered prior to F-PFA. Feasibility and safety with a focus on CS or CD were assessed. In a subgroup of patients, the course of the right coronary artery and the His position were determined.
Results
In total, 82 patients underwent CTI ablation with F-PFA (mean age 66 ± 8 years; 15 (18%) being female; CHA2DS2-VA score 1.6 ± 1.3) and 27 patients underwent CTI ablation with RFA (mean age 63 ± 9 years; 4 (23%) being female; CHA2DS2-VA score 2 ± 1.3). For F-PFA, the rate of first-pass block was higher (93% vs 55%) and the median (interquartile range) procedure times were shorter (7 [5–11] minutes vs 17 [15–19] minutes) than for RFA. In the F-PFA group, 4 patients (5%) had transient ST-segment elevation and 2 patients (2%) had transient complete atrioventricular block during ablation. There was a small but significant prolongation of the PQ interval after CTI ablation in the F-PFA group.
Conclusion
CTI ablation using F-PFA is feasible, but operators should be aware of rare but critical CD and CS during the procedure, even when preventive measures such as nitroglycerin administration are used.
{"title":"Ablation of cavotricuspid isthmus–dependent atrial flutter using a focal monopolar pulsed-field ablation catheter: Feasibility, periprocedural coronary spasms and conduction disorders","authors":"Florent I.P. Farnir MD , Sevasti-Maria Chaldoupi MD, PhD , Ben Hermans PhD , Arne Johannessen MD, DMSc , Martin Aar Haugdal MSc , Martin H. Ruwald MD , Tasnim Mohaissen PhD , Arnela Saljic PhD , Kezia Jerltorp DVM , Sarah Dalgas Nissen DVM, PhD , Julie Norup Hertel DVM , Frédéric Farnir PhD , Thomas Jespersen PhD , Ulrich Schotten MD, PhD , Justin G.L.M. Luermans MD, PhD , Kevin Vernooy MD, PhD , Jim Hansen MD, DMSc , Dominik Linz MD, PhD","doi":"10.1016/j.hrthm.2025.07.001","DOIUrl":"10.1016/j.hrthm.2025.07.001","url":null,"abstract":"<div><h3>Background</h3><div>Pulsed-field ablation for the treatment of cavotricuspid isthmus (CTI)–dependent atrial flutter has been associated with coronary spasms (CS) and atrioventricular conduction disorders (CD).</div></div><div><h3>Objectives</h3><div>The purpose of this study was to evaluate the feasibility of CTI ablation using a monopolar focal pulsed-field ablation (F-PFA) catheter and to assess the risk of CS and CD during and after the procedure.</div></div><div><h3>Methods</h3><div>We prospectively enrolled patients with atrial flutter treated with an F-PFA system (CardioFocus, Marlborough, MA) or by focal radiofrequency ablation (RFA) using contact force–sensing catheters integrated into electroanatomic mapping systems. Intravenous nitroglycerin was administered prior to F-PFA. Feasibility and safety with a focus on CS or CD were assessed. In a subgroup of patients, the course of the right coronary artery and the His position were determined.</div></div><div><h3>Results</h3><div>In total, 82 patients underwent CTI ablation with F-PFA (mean age 66 ± 8 years; 15 (18%) being female; CHA<sub>2</sub>DS<sub>2</sub>-VA score 1.6 ± 1.3) and 27 patients underwent CTI ablation with RFA (mean age 63 ± 9 years; 4 (23%) being female; CHA<sub>2</sub>DS<sub>2</sub>-VA score 2 ± 1.3). For F-PFA, the rate of first-pass block was higher (93% vs 55%) and the median (interquartile range) procedure times were shorter (7 [5–11] minutes vs 17 [15–19] minutes) than for RFA. In the F-PFA group, 4 patients (5%) had transient ST-segment elevation and 2 patients (2%) had transient complete atrioventricular block during ablation. There was a small but significant prolongation of the PQ interval after CTI ablation in the F-PFA group.</div></div><div><h3>Conclusion</h3><div>CTI ablation using F-PFA is feasible, but operators should be aware of rare but critical CD and CS during the procedure, even when preventive measures such as nitroglycerin administration are used.</div></div>","PeriodicalId":12886,"journal":{"name":"Heart rhythm","volume":"23 1","pages":"Pages 105-113"},"PeriodicalIF":5.7,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144575357","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"High-risk transvenous lead extraction can be safely performed in the electrophysiology laboratory","authors":"Alphonsus Liew MBBS , Sandra Howell MBBS , Christopher Aldo Rinaldi MD, FHRS","doi":"10.1016/j.hrthm.2025.08.047","DOIUrl":"10.1016/j.hrthm.2025.08.047","url":null,"abstract":"","PeriodicalId":12886,"journal":{"name":"Heart rhythm","volume":"23 1","pages":"Pages e103-e104"},"PeriodicalIF":5.7,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145064747","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-01DOI: 10.1016/j.hrthm.2025.09.011
Robert D. Schaller DO, FHRS , Balaram Krishna Hanumanthu MD , Francis E. Marchlinski MD, FHRS , Marisa Cevasco MD , Michael Acker MD , Joshua M. Cooper MD, FHRS , Mouhannad M. Sadek MD, FHRS
{"title":"Response to the letter to the editor entitled “High-risk transvenous lead extraction can be safely performed in the electrophysiology laboratory”","authors":"Robert D. Schaller DO, FHRS , Balaram Krishna Hanumanthu MD , Francis E. Marchlinski MD, FHRS , Marisa Cevasco MD , Michael Acker MD , Joshua M. Cooper MD, FHRS , Mouhannad M. Sadek MD, FHRS","doi":"10.1016/j.hrthm.2025.09.011","DOIUrl":"10.1016/j.hrthm.2025.09.011","url":null,"abstract":"","PeriodicalId":12886,"journal":{"name":"Heart rhythm","volume":"23 1","pages":"Pages e104-e105"},"PeriodicalIF":5.7,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145064592","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-01DOI: 10.1016/j.hrthm.2025.02.012
Ian Crozier MB, CHB, FHRS , Francis Murgatroyd FRCP, FHRS , Anish Amin MD, FHRS , Nicolas Clementy MD, PhD , David Duncker MD, FHRS , Emily Kotschet MBBS , Christopher Wiggenhorn PhD , Lucas V.A. Boersma MD, PhD
Background
Premarket clinical trials have shown the extravascular implantable cardioverter-defibrillator (EV-ICD) system to provide effective therapy with a low complication rate, but its performance in the real world is unknown.
Objective
We report on the periprocedural safety and performance of the EV-ICD system from the postmarket Enlighten (EV-ICD Post-Approval Registry) Study.
Methods
Enlighten is an ongoing, global, prospective, postmarket registry study, enrolling patients guideline indicated for an ICD with a planned implantation of the Aurora EV-ICD system (Medtronic, Mounds View, MN). Procedure characteristics and outcomes, defibrillation testing details, system- or procedure-related major complications, electrical measurements, and pacing therapy programming through discharge were analyzed. A meta-analysis of premarket EV-ICD studies is included in the Supplemental Material for comparison with postmarket Enlighten Study data.
Results
In total, 228 Enlighten patients underwent an Aurora EV-ICD implant attempt (49.4 ± 15.4 years old; 27.9% female; 43.5 ± 16.1 mean left ventricular ejection fraction). Tunneling and substernal lead placement were successful in 227 of 228 (99.6%) patients. After electrical testing, 221 (96.9%) patients remained implanted with the EV-ICD and proceeded to follow-up. Defibrillation testing, if performed, was successful in 191 of 193 (99.0%) patients. The rate of system- or procedure-related major complications at discharge was 3.9%. Electrical measurements were stable at discharge.
Conclusion
In a global, real-world cohort, the EV-ICD system demonstrated a high success rate for terminating induced ventricular arrhythmia episodes at implant and a low rate of periprocedural major complications at discharge, comparable with the premarket experience.
ClinicalTrials.gov ID
NCT06048731 (Enlighten Study: The EV-ICD Post-Approval Registry)
{"title":"Periprocedural outcomes from the postmarket study of the extravascular implantable cardioverter-defibrillator: Preliminary Enlighten study results and meta-analysis","authors":"Ian Crozier MB, CHB, FHRS , Francis Murgatroyd FRCP, FHRS , Anish Amin MD, FHRS , Nicolas Clementy MD, PhD , David Duncker MD, FHRS , Emily Kotschet MBBS , Christopher Wiggenhorn PhD , Lucas V.A. Boersma MD, PhD","doi":"10.1016/j.hrthm.2025.02.012","DOIUrl":"10.1016/j.hrthm.2025.02.012","url":null,"abstract":"<div><h3>Background</h3><div>Premarket clinical trials have shown the extravascular implantable cardioverter-defibrillator (EV-ICD) system to provide effective therapy with a low complication rate, but its performance in the real world is unknown.</div></div><div><h3>Objective</h3><div>We report on the periprocedural safety and performance of the EV-ICD system from the postmarket Enlighten (EV-ICD Post-Approval Registry) Study.</div></div><div><h3>Methods</h3><div>Enlighten is an ongoing, global, prospective, postmarket registry study, enrolling patients guideline indicated for an ICD with a planned implantation of the Aurora EV-ICD system (Medtronic, Mounds View, MN). Procedure characteristics and outcomes, defibrillation testing details, system- or procedure-related major complications, electrical measurements, and pacing therapy programming through discharge were analyzed. A meta-analysis of premarket EV-ICD studies is included in the Supplemental Material for comparison with postmarket Enlighten Study data.</div></div><div><h3>Results</h3><div>In total, 228 Enlighten patients underwent an Aurora EV-ICD implant attempt (49.4 ± 15.4 years old; 27.9% female; 43.5 ± 16.1 mean left ventricular ejection fraction). Tunneling and substernal lead placement were successful in 227 of 228 (99.6%) patients. After electrical testing, 221 (96.9%) patients remained implanted with the EV-ICD and proceeded to follow-up. Defibrillation testing, if performed, was successful in 191 of 193 (99.0%) patients. The rate of system- or procedure-related major complications at discharge was 3.9%. Electrical measurements were stable at discharge.</div></div><div><h3>Conclusion</h3><div>In a global, real-world cohort, the EV-ICD system demonstrated a high success rate for terminating induced ventricular arrhythmia episodes at implant and a low rate of periprocedural major complications at discharge, comparable with the premarket experience.</div></div><div><h3>ClinicalTrials.gov ID</h3><div><span><span>NCT06048731</span><svg><path></path></svg></span> (Enlighten Study: The EV-ICD Post-Approval Registry)</div></div>","PeriodicalId":12886,"journal":{"name":"Heart rhythm","volume":"23 1","pages":"Pages 180-185"},"PeriodicalIF":5.7,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143763671","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-01DOI: 10.1016/j.hrthm.2025.04.041
Parikshit S. Sharma MD, MPH, FACC, FHRS
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