Aims: Advanced atrial fibrillation (AF) is currently a dilemma for electrophysiologists when choosing a minimally invasive treatment strategy. Previous studies have demonstrated the outcome of either catheter ablation or thoracoscopic surgical ablation (SA) is unsatisfactory in these patients. Whether hybrid ablation (HA) could improve outcomes in these patients is unknown. The purpose of this study was to evaluate the clinical efficacy of HA for the treatment of advanced AF.
Methods and results: A randomized controlled trial was designed to enrol patients with persistent AF (PerAF) and enlarged left atrium or long-standing persistent AF (LSPAF) who were randomized to HA or thoracoscopic SA at a 1:1 ratio. The primary endpoint was freedom from any recurrence of AF off antiarrhythmic drugs (AADs) 12 months after operation. The primary endpoint was monitored by 7-day electrocardiogram monitoring devices. One hundred patients were enrolled. The mean age was 58.5 ± 7.6 years, and the mean left atrial diameter (LAD) was 50.1 ± 6.1 mm. At 12 months, freedom from AF off AADs was recorded in 71.4% (35/49) of patients in HA group and 45.8% (22/48) in SA group [odds ratio 2.955, 95% confidence interval (1.275-6.848), P = 0.014]. HA significantly reduced patients' AF burden (30.2% in SA group and 14.8% in HA group, P = 0.048) and the LAD (mean differences: -5.53 ± 4.97 mm in HA group and -3.27 ± 5.20 mm in SA group, P = 0.037) at 12 months after operation.
Conclusion: In patients with PerAF and enlarged left atrium or LSPAF, HA achieved better freedom from AF after 1 year of follow-up compared with thoracoscopic SA.
{"title":"Comparing simultaneous hybrid ablation with stand-alone thoracoscopic surgical ablation for the treatment of non-paroxysmal atrial fibrillation: a prospective randomized controlled trial.","authors":"Zhe Zheng, Yan Yao, Haojie Li, Chunyu Yu, Lihui Zheng, Ligang Ding, Lingmin Wu, Sipeng Chen, Hengqiang Lin, Ying Meng","doi":"10.1093/europace/euae226","DOIUrl":"10.1093/europace/euae226","url":null,"abstract":"<p><strong>Aims: </strong>Advanced atrial fibrillation (AF) is currently a dilemma for electrophysiologists when choosing a minimally invasive treatment strategy. Previous studies have demonstrated the outcome of either catheter ablation or thoracoscopic surgical ablation (SA) is unsatisfactory in these patients. Whether hybrid ablation (HA) could improve outcomes in these patients is unknown. The purpose of this study was to evaluate the clinical efficacy of HA for the treatment of advanced AF.</p><p><strong>Methods and results: </strong>A randomized controlled trial was designed to enrol patients with persistent AF (PerAF) and enlarged left atrium or long-standing persistent AF (LSPAF) who were randomized to HA or thoracoscopic SA at a 1:1 ratio. The primary endpoint was freedom from any recurrence of AF off antiarrhythmic drugs (AADs) 12 months after operation. The primary endpoint was monitored by 7-day electrocardiogram monitoring devices. One hundred patients were enrolled. The mean age was 58.5 ± 7.6 years, and the mean left atrial diameter (LAD) was 50.1 ± 6.1 mm. At 12 months, freedom from AF off AADs was recorded in 71.4% (35/49) of patients in HA group and 45.8% (22/48) in SA group [odds ratio 2.955, 95% confidence interval (1.275-6.848), P = 0.014]. HA significantly reduced patients' AF burden (30.2% in SA group and 14.8% in HA group, P = 0.048) and the LAD (mean differences: -5.53 ± 4.97 mm in HA group and -3.27 ± 5.20 mm in SA group, P = 0.037) at 12 months after operation.</p><p><strong>Conclusion: </strong>In patients with PerAF and enlarged left atrium or LSPAF, HA achieved better freedom from AF after 1 year of follow-up compared with thoracoscopic SA.</p>","PeriodicalId":11981,"journal":{"name":"Europace","volume":" ","pages":""},"PeriodicalIF":7.9,"publicationDate":"2024-08-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11411208/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142125205","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 : 2024-08-30DOI: 10.1093/europace/euae204
Andreas Goette, Domenico Corradi, Dobromir Dobrev, Luis Aguinaga, Jose-Angel Cabrera, Sumeet S Chugh, Joris R de Groot, Laurie Soulat-Dufour, Guilherme Fenelon, Stephane N Hatem, Jose Jalife, Yenn-Jiang Lin, Gregory Y H Lip, Gregory M Marcus, Katherine T Murray, Hui-Nam Pak, Ulrich Schotten, Naohiko Takahashi, Takanori Yamaguchi, William A Zoghbi, Stanley Nattel, Lluis Mont, Joseph G Akar, Nazem Akoum, Till Althoff, Juan Carlos Diaz, Jean-Baptiste Guichard, Amir Jadidi, Jonathan Kalman, Han Lim, Ricardo Alkmim Teixeira
Aims: The concept of "atrial cardiomyopathy" (AtCM) had been percolating through the literature since its first mention in 1972. Since then, publications using the term were sporadic until the decision was made to convene an expert working group with representation from four multinational arrhythmia organizations to prepare a consensus document on atrial cardiomyopathy in 2016 (EHRA/HRS/APHRS/SOLAECE expert consensus on atrial cardiomyopathies: definition, characterization, and clinical implication). Subsequently, publications on AtCM have increased progressively.
Methods and results: The present consensus document elaborates the 2016 AtCM document further to implement a simple AtCM staging system (AtCM stages 1-3) by integrating biomarkers, atrial geometry, and electrophysiological changes. However, the proposed AtCM staging needs clinical validation. Importantly, it is clearly stated that the presence of AtCM might serve as a substrate for the development of atrial fibrillation (AF) and AF may accelerates AtCM substantially, but AtCM per se needs to be viewed as a separate entity.
Conclusion: Thus, the present document serves as a clinical consensus statement of the European Heart Rhythm Association (EHRA) of the ESC, the Heart Rhythm Society (HRS), the Asian Pacific Heart Rhythm Society (APHRS), and the Latin American Heart Rhythm Society (LAHRS) to contribute to the evolution of the AtCM concept.
{"title":"Atrial cardiomyopathy revisited-evolution of a concept: a clinical consensus statement of the European Heart Rhythm Association (EHRA) of the ESC, the Heart Rhythm Society (HRS), the Asian Pacific Heart Rhythm Society (APHRS), and the Latin American Heart Rhythm Society (LAHRS).","authors":"Andreas Goette, Domenico Corradi, Dobromir Dobrev, Luis Aguinaga, Jose-Angel Cabrera, Sumeet S Chugh, Joris R de Groot, Laurie Soulat-Dufour, Guilherme Fenelon, Stephane N Hatem, Jose Jalife, Yenn-Jiang Lin, Gregory Y H Lip, Gregory M Marcus, Katherine T Murray, Hui-Nam Pak, Ulrich Schotten, Naohiko Takahashi, Takanori Yamaguchi, William A Zoghbi, Stanley Nattel, Lluis Mont, Joseph G Akar, Nazem Akoum, Till Althoff, Juan Carlos Diaz, Jean-Baptiste Guichard, Amir Jadidi, Jonathan Kalman, Han Lim, Ricardo Alkmim Teixeira","doi":"10.1093/europace/euae204","DOIUrl":"10.1093/europace/euae204","url":null,"abstract":"<p><strong>Aims: </strong>The concept of \"atrial cardiomyopathy\" (AtCM) had been percolating through the literature since its first mention in 1972. Since then, publications using the term were sporadic until the decision was made to convene an expert working group with representation from four multinational arrhythmia organizations to prepare a consensus document on atrial cardiomyopathy in 2016 (EHRA/HRS/APHRS/SOLAECE expert consensus on atrial cardiomyopathies: definition, characterization, and clinical implication). Subsequently, publications on AtCM have increased progressively.</p><p><strong>Methods and results: </strong>The present consensus document elaborates the 2016 AtCM document further to implement a simple AtCM staging system (AtCM stages 1-3) by integrating biomarkers, atrial geometry, and electrophysiological changes. However, the proposed AtCM staging needs clinical validation. Importantly, it is clearly stated that the presence of AtCM might serve as a substrate for the development of atrial fibrillation (AF) and AF may accelerates AtCM substantially, but AtCM per se needs to be viewed as a separate entity.</p><p><strong>Conclusion: </strong>Thus, the present document serves as a clinical consensus statement of the European Heart Rhythm Association (EHRA) of the ESC, the Heart Rhythm Society (HRS), the Asian Pacific Heart Rhythm Society (APHRS), and the Latin American Heart Rhythm Society (LAHRS) to contribute to the evolution of the AtCM concept.</p>","PeriodicalId":11981,"journal":{"name":"Europace","volume":" ","pages":""},"PeriodicalIF":7.9,"publicationDate":"2024-08-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11431804/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141792246","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 : 2024-08-30DOI: 10.1093/europace/euae231
Christopher R Zörner, Jacob Tønnesen, Lise Da Riis-Vestergaard, Charlotte Middelfart, Regitze Hein, Peter Vibe Rasmussen, Martin H Ruwald, Gunnar Gislason, Morten Lock Hansen
Aims: Atrial fibrillation (AF) is a common arrhythmia associated with reduced quality of life that can lead to serious complications such as stroke and heart failure. Ablation is a safe and effective treatment for AF but is not offered equally to all patients. The aim of this study is to identify demographic groups more or less likely to undergo AF ablation.
Methods and results: All patients with newly diagnosed AF between 2010 and 2018 were identified in the Danish nationwide registries. The association between gender, age, level of education and attachment to the job market, and the likelihood of receiving AF ablation was investigated using multivariable Cox proportional hazard analysis. Cumulative incidence was calculated using the Aalen-Johansen estimator. A total of 176 248 patients were included. Men were more likely to receive ablation than women (7% vs. 3%). Patients aged 25-44 and 45-64 were most likely to receive ablation, while only 0.7% of patients aged 80 or above received ablation. The rate of ablation significantly decreased with decreasing level of education. Full-time employed patients were most likely to receive ablation, followed by self-employed, unemployed, on sick leave, undergoing education, and early retired patients. Retired patients were the least likely to receive ablation (3%).
Conclusion: This study found that women, older patients, patients with lower levels of education, and patients on social benefits are less likely to receive AF ablation. These findings suggest that there are significant social and economic disparities in AF ablation treatment in Denmark.
{"title":"Disparities in the access to atrial fibrillation ablation in Denmark: who gets ablated, who neglected?","authors":"Christopher R Zörner, Jacob Tønnesen, Lise Da Riis-Vestergaard, Charlotte Middelfart, Regitze Hein, Peter Vibe Rasmussen, Martin H Ruwald, Gunnar Gislason, Morten Lock Hansen","doi":"10.1093/europace/euae231","DOIUrl":"10.1093/europace/euae231","url":null,"abstract":"<p><strong>Aims: </strong>Atrial fibrillation (AF) is a common arrhythmia associated with reduced quality of life that can lead to serious complications such as stroke and heart failure. Ablation is a safe and effective treatment for AF but is not offered equally to all patients. The aim of this study is to identify demographic groups more or less likely to undergo AF ablation.</p><p><strong>Methods and results: </strong>All patients with newly diagnosed AF between 2010 and 2018 were identified in the Danish nationwide registries. The association between gender, age, level of education and attachment to the job market, and the likelihood of receiving AF ablation was investigated using multivariable Cox proportional hazard analysis. Cumulative incidence was calculated using the Aalen-Johansen estimator. A total of 176 248 patients were included. Men were more likely to receive ablation than women (7% vs. 3%). Patients aged 25-44 and 45-64 were most likely to receive ablation, while only 0.7% of patients aged 80 or above received ablation. The rate of ablation significantly decreased with decreasing level of education. Full-time employed patients were most likely to receive ablation, followed by self-employed, unemployed, on sick leave, undergoing education, and early retired patients. Retired patients were the least likely to receive ablation (3%).</p><p><strong>Conclusion: </strong>This study found that women, older patients, patients with lower levels of education, and patients on social benefits are less likely to receive AF ablation. These findings suggest that there are significant social and economic disparities in AF ablation treatment in Denmark.</p>","PeriodicalId":11981,"journal":{"name":"Europace","volume":" ","pages":""},"PeriodicalIF":7.9,"publicationDate":"2024-08-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11411207/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142125206","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 : 2024-08-30DOI: 10.1093/europace/euae202
Frederic Franceschi, Linda Koutbi, Baptiste Maille
{"title":"Phrenic nerve palsy and pulsed field ablation procedures for atrial fibrillation.","authors":"Frederic Franceschi, Linda Koutbi, Baptiste Maille","doi":"10.1093/europace/euae202","DOIUrl":"10.1093/europace/euae202","url":null,"abstract":"","PeriodicalId":11981,"journal":{"name":"Europace","volume":" ","pages":""},"PeriodicalIF":7.9,"publicationDate":"2024-08-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11393493/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141906229","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 : 2024-08-30DOI: 10.1093/europace/euae213
Rafal Gardas, Danuta Loboda, Jolanta Biernat, Tomasz Soral, Piotr Kulesza, Sylwia Gladysz-Wanha, Michal Joniec, Mateusz Sajdok, Kamil Zub, Krzysztof S Golba
Aims: The application of conduction system pacing (CSP) in clinical practice is growing, and the need for lead extraction will also increase. The data on outcomes and safety of CSP lead extraction are limited. The aim of this study was to assess procedural outcomes and safety of CSP lead removal.
Methods and results: Forty-seven patients from the EXTRACT Registry with the indication for CSP lead removal were enrolled in the study conducted at the Department of Electrocardiology in Katowice, Poland. Extraction technique, outcomes, safety, and complication were evaluated. Forty-three (91.5%) leads were successfully removed, and 41 (87.2%) were removed with traction only. The dwelling time of 28 extracted leads was longer than 1 year, and the oldest extracted lead was implanted for 89 months. Seven (14.9%) leads were removed from the left bundle branch (LBB) area and 36 from the His bundle (HB). Transient complete atrioventricular block occurred during the procedure in two patients. In 27 out of 31 attempts (87.1%), new CSP leads were implanted: nine (33.3%) HB pacing leads and 18 (66.7%) LBB area pacing leads.
Conclusion: The CSP lead extraction is safe and feasible with a low complication rate and high rate of CSP lead reimplantation.
{"title":"Extraction of lumenless pacing leads from the His bundle and left bundle branch area: outcomes of the high-volume centre.","authors":"Rafal Gardas, Danuta Loboda, Jolanta Biernat, Tomasz Soral, Piotr Kulesza, Sylwia Gladysz-Wanha, Michal Joniec, Mateusz Sajdok, Kamil Zub, Krzysztof S Golba","doi":"10.1093/europace/euae213","DOIUrl":"10.1093/europace/euae213","url":null,"abstract":"<p><strong>Aims: </strong>The application of conduction system pacing (CSP) in clinical practice is growing, and the need for lead extraction will also increase. The data on outcomes and safety of CSP lead extraction are limited. The aim of this study was to assess procedural outcomes and safety of CSP lead removal.</p><p><strong>Methods and results: </strong>Forty-seven patients from the EXTRACT Registry with the indication for CSP lead removal were enrolled in the study conducted at the Department of Electrocardiology in Katowice, Poland. Extraction technique, outcomes, safety, and complication were evaluated. Forty-three (91.5%) leads were successfully removed, and 41 (87.2%) were removed with traction only. The dwelling time of 28 extracted leads was longer than 1 year, and the oldest extracted lead was implanted for 89 months. Seven (14.9%) leads were removed from the left bundle branch (LBB) area and 36 from the His bundle (HB). Transient complete atrioventricular block occurred during the procedure in two patients. In 27 out of 31 attempts (87.1%), new CSP leads were implanted: nine (33.3%) HB pacing leads and 18 (66.7%) LBB area pacing leads.</p><p><strong>Conclusion: </strong>The CSP lead extraction is safe and feasible with a low complication rate and high rate of CSP lead reimplantation.</p>","PeriodicalId":11981,"journal":{"name":"Europace","volume":" ","pages":""},"PeriodicalIF":7.9,"publicationDate":"2024-08-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11363868/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141975404","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 : 2024-08-30DOI: 10.1093/europace/euae220
Luigi Di Biase, Jacopo Marazzato, Tara Gomez, Eric Byun, Fengwei Zou, Vito Grupposo, Sanghamitra Mohanty, Vincenzo Mirco La Fazia, Giuseppe Ammirati, Aung Lin, Domingo Ynoa Garcia, Domenico Della Rocca, Amin Al Ahamad, Marco Schiavone, Alessio Gasperetti, Michael Freilich, Juan Cedeno Serna, Giovanni Forleo, Xu Liu, Dhanunjaya Lakkireddy, Claudio Tondo, Andrea Natale, Xiao-Dong Zhang
Aims: Pulsed-field ablation (PFA) is a novel, myocardial-selective, non-thermal ablation modality used to target cardiac arrhythmias. Although prompt electrogram (EGM) signal disappearance is observed immediately after PFA application in the pulmonary veins, whether this finding results in adequate transmural lesions is unknown. The aim of this study is to check whether application repetition and catheter-tissue contact impact lesion formation during PFA.
Methods and results: A circular loop PFA catheter was used to deliver repeated energy applications with various levels of contact force. A benchtop vegetal potato model and a beating heart ventricular myocardial model were utilized to evaluate the impact of application repetition, contact force, and catheter repositioning on contiguity and lesion depth. Lesion development occurred over 18 h in the vegetal model and over 6 h in the porcine model. Lesion formation was found to be dependent on application repetition and contact. In porcine ventricles, single and multiple stacked applications led to a lesion depth of 3.5 ± 0.7 and 4.4 ± 1.3 mm, respectively (P = 0.002). Furthermore, the greater the catheter-tissue contact, the more contiguous and deeper the lesions in the vegetal model (1.0 ± 0.9 mm with no contact vs. 5.4 ± 1.4 mm with 30 g of force; P = 0.0001).
Conclusion: Pulsed-field ablation delivered via a circular catheter showed that both repetition and catheter contact led independently to deeper lesion formation. These findings indicate that endpoints for effective PFA are related more to PFA biophysics than to mere EGM attenuation.
{"title":"Application repetition and electrode-tissue contact result in deeper lesions using a pulsed-field ablation circular variable loop catheter.","authors":"Luigi Di Biase, Jacopo Marazzato, Tara Gomez, Eric Byun, Fengwei Zou, Vito Grupposo, Sanghamitra Mohanty, Vincenzo Mirco La Fazia, Giuseppe Ammirati, Aung Lin, Domingo Ynoa Garcia, Domenico Della Rocca, Amin Al Ahamad, Marco Schiavone, Alessio Gasperetti, Michael Freilich, Juan Cedeno Serna, Giovanni Forleo, Xu Liu, Dhanunjaya Lakkireddy, Claudio Tondo, Andrea Natale, Xiao-Dong Zhang","doi":"10.1093/europace/euae220","DOIUrl":"10.1093/europace/euae220","url":null,"abstract":"<p><strong>Aims: </strong>Pulsed-field ablation (PFA) is a novel, myocardial-selective, non-thermal ablation modality used to target cardiac arrhythmias. Although prompt electrogram (EGM) signal disappearance is observed immediately after PFA application in the pulmonary veins, whether this finding results in adequate transmural lesions is unknown. The aim of this study is to check whether application repetition and catheter-tissue contact impact lesion formation during PFA.</p><p><strong>Methods and results: </strong>A circular loop PFA catheter was used to deliver repeated energy applications with various levels of contact force. A benchtop vegetal potato model and a beating heart ventricular myocardial model were utilized to evaluate the impact of application repetition, contact force, and catheter repositioning on contiguity and lesion depth. Lesion development occurred over 18 h in the vegetal model and over 6 h in the porcine model. Lesion formation was found to be dependent on application repetition and contact. In porcine ventricles, single and multiple stacked applications led to a lesion depth of 3.5 ± 0.7 and 4.4 ± 1.3 mm, respectively (P = 0.002). Furthermore, the greater the catheter-tissue contact, the more contiguous and deeper the lesions in the vegetal model (1.0 ± 0.9 mm with no contact vs. 5.4 ± 1.4 mm with 30 g of force; P = 0.0001).</p><p><strong>Conclusion: </strong>Pulsed-field ablation delivered via a circular catheter showed that both repetition and catheter contact led independently to deeper lesion formation. These findings indicate that endpoints for effective PFA are related more to PFA biophysics than to mere EGM attenuation.</p>","PeriodicalId":11981,"journal":{"name":"Europace","volume":" ","pages":""},"PeriodicalIF":7.9,"publicationDate":"2024-08-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11393494/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141987682","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 : 2024-08-30DOI: 10.1093/europace/euae225
Venkata Sagi, Francis Murgatroyd, Lucas V A Boersma, Jaimie Manlucu, Bradley P Knight, Christophe Leclercq, Anish Amin, Ulrika Maria Birgersdotter-Green, Joseph Yat Sun Chan, Henri Roukoz, Mauro Biffi, Haris Haqqani, Russell Denman, Christopher Wiggenhorn, Thomas R Holmes, Thomas Lulic, Paul Friedman, Ian Crozier
Aims: The extravascular implantable cardioverter-defibrillator (EV ICD) has been shown to be safe and effective for patients at risk of sudden cardiac death, but little is known about EV ICD lead removal in humans. This analysis aimed to characterize the EV ICD lead removal experience thus far.
Methods and results: This was a retrospective analysis of lead removals from the EV ICD Pilot, Pivotal, and Continued Access Studies. Patients with a successful EV ICD implant who underwent lead removal were included. The main objective was lead removal success. Ancillary objectives included characterizing technique used, procedure complications, and reimplantation status. An EV ICD system was successfully implanted in 347 patients across the 3 studies (25.9% female; 53.4 ± 13.3 years; left ventricular ejection fraction: 39.7 ± 15.9). Of these patients, 29 (8.4%) underwent lead removal with a mean lead dwell time of 12.6 ± 14.3 months (0.2-58.4). The main reason for lead removal was lead dislodgement (n = 9, 31.0%). Lead removal was successful in 27/29 (93.1%) cases [100% (19/19) success rate <1 year and 80% (8/10) success rate >1 year post-implant]. Simple traction was used in 22/26 (84.6%) and extraction tools in 4/26 (15.4%) successful cases where technique was known. No complications were reported for any of the removal procedures. All 11 EV ICD reimplant attempts were successful.
Conclusion: Complete removal of the EV ICD lead was successful in 93.1% of cases, and simple traction was sufficient in most instances. Based on these results, lead removal from the substernal space was safe and achievable up to 3 years post-implant.
背景和目的:血管外植入式心律转复除颤器(EV ICD)已被证明对有心脏性猝死风险的患者安全有效,但人们对人体中 EV ICD 导联的移除知之甚少。本分析旨在描述迄今为止 EV ICD 导联移除经验的特点:这是一项对 EV ICD 试验研究、关键研究和持续访问研究中的导联移除情况进行的回顾性分析。研究纳入了成功植入 EV ICD 并进行了导联移除的患者。主要目标是移除导联的成功率。辅助目标包括描述所用技术、手术并发症和再植入情况:3项研究共为347名患者成功植入了EV ICD系统(25.9%为女性;53.4±13.3岁;LVEF:39.7±15.9)。在这些患者中,29 人(8.4%)进行了导联移除,平均导联停留时间为 12.6±14.3 个月(0.2-58.4)。移除导联的主要原因是导联脱落(9 人,31.0%)。27/29(93.1%)例成功拔除了引线[植入后1年成功率为100%(19/19)]。在 22/26 例(84.6%)中使用了简单牵引,在 4/26 例(15.4%)成功病例中使用了拔出工具,这些病例的技术都是已知的。所有移除手术均未报告并发症。所有 11 例 EV ICD 再植入尝试均获得成功:结论:93.1% 的病例成功地完全取出了 EV ICD 导联,在大多数情况下,简单的牵引就足够了。基于这些结果,从胸骨下间隙移除导联是安全的,并且可以在植入后 3 年内完成。
{"title":"Comprehensive analysis of substernal lead removal: experience from EV ICD Pilot, Pivotal, and Continued Access Studies.","authors":"Venkata Sagi, Francis Murgatroyd, Lucas V A Boersma, Jaimie Manlucu, Bradley P Knight, Christophe Leclercq, Anish Amin, Ulrika Maria Birgersdotter-Green, Joseph Yat Sun Chan, Henri Roukoz, Mauro Biffi, Haris Haqqani, Russell Denman, Christopher Wiggenhorn, Thomas R Holmes, Thomas Lulic, Paul Friedman, Ian Crozier","doi":"10.1093/europace/euae225","DOIUrl":"10.1093/europace/euae225","url":null,"abstract":"<p><strong>Aims: </strong>The extravascular implantable cardioverter-defibrillator (EV ICD) has been shown to be safe and effective for patients at risk of sudden cardiac death, but little is known about EV ICD lead removal in humans. This analysis aimed to characterize the EV ICD lead removal experience thus far.</p><p><strong>Methods and results: </strong>This was a retrospective analysis of lead removals from the EV ICD Pilot, Pivotal, and Continued Access Studies. Patients with a successful EV ICD implant who underwent lead removal were included. The main objective was lead removal success. Ancillary objectives included characterizing technique used, procedure complications, and reimplantation status. An EV ICD system was successfully implanted in 347 patients across the 3 studies (25.9% female; 53.4 ± 13.3 years; left ventricular ejection fraction: 39.7 ± 15.9). Of these patients, 29 (8.4%) underwent lead removal with a mean lead dwell time of 12.6 ± 14.3 months (0.2-58.4). The main reason for lead removal was lead dislodgement (n = 9, 31.0%). Lead removal was successful in 27/29 (93.1%) cases [100% (19/19) success rate <1 year and 80% (8/10) success rate >1 year post-implant]. Simple traction was used in 22/26 (84.6%) and extraction tools in 4/26 (15.4%) successful cases where technique was known. No complications were reported for any of the removal procedures. All 11 EV ICD reimplant attempts were successful.</p><p><strong>Conclusion: </strong>Complete removal of the EV ICD lead was successful in 93.1% of cases, and simple traction was sufficient in most instances. Based on these results, lead removal from the substernal space was safe and achievable up to 3 years post-implant.</p>","PeriodicalId":11981,"journal":{"name":"Europace","volume":" ","pages":""},"PeriodicalIF":7.9,"publicationDate":"2024-08-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11420630/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142105744","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 : 2024-08-23DOI: 10.1093/europace/euae214
Katja Zeppenfeld, Robert Rademaker, Amin Al-Ahmad, Corrado Carbucicchio, Christian De Chillou, Micaela Ebert, William G Stevenson, Gordon Ho, Josef Kautzner, Marek Sramko, Pier Lambiase, Michael Lloyd, Jose Luis Merino, Etienne Pruvot, John Sapp, Luis Schiappacasse, Paul C Zei
Stereotactic arrythmia radioablation (STAR) is a novel, non-invasive and promising treatment option for ventricular arrythmias (VA). It has been applied in highly selected patients mainly as bail-out procedure, when (multiple) catheter-ablations, together with anti-arrhythmic drugs, were unable to control the VAs. Despite the increasing clinical use there is still limited knowledge of the acute and long-term response of normal and diseased myocardium to STAR. Acute toxicity appeared to be reasonably low but potential late adverse effects may be underreported. Among published studies, the provided methodological information is often limited, and patient selection, target volume definition, methods for determination and transfer of target volume, and techniques for treatment planning and execution differ across studies, hampering pooling of data and comparison across studies. In addition, STAR requires close and new collaboration between clinical electrophysiologists and radiation oncologists, which is facilitated by shared knowledge in each collaborator's area of expertise and a common language. This clinical consensus statement provides uniform definition of cardiac target volumes. It aims to provide advice in patient selection for STAR including etiology specific aspects, and advice in optimal cardiac target volume identification based on available evidence. Safety concerns and the advice for acute and long-term monitoring including the importance of standardized reporting and follow-up are covered by this document. Areas of uncertainty are listed, which require high-quality, reliable pre-clinical and clinical evidence before expansion of STAR beyond clinical scenarios in which proven therapies are ineffective or unavailable.
立体定向心律失常射频消融术(STAR)是治疗室性心律失常(VA)的一种新型、无创且前景广阔的治疗方法。在(多次)导管植入术和抗心律失常药物无法控制室性心律失常的情况下,它主要作为一种救助手术被应用于经过严格筛选的患者。尽管 STAR 的临床应用越来越多,但人们对正常和患病心肌对 STAR 的急性和长期反应的了解仍然有限。急性毒性似乎相当低,但潜在的后期不良反应可能报告不足。在已发表的研究中,所提供的方法学信息往往有限,而且不同研究在患者选择、靶体积定义、靶体积确定和转移方法以及治疗计划和执行技术等方面存在差异,妨碍了数据的汇集和不同研究间的比较。此外,STAR 还要求临床电生理学家和放射肿瘤学家之间开展新的密切合作,而合作双方在各自专业领域的知识共享和共同语言则有助于这种合作。本临床共识声明提供了心脏靶体积的统一定义。它旨在为 STAR 患者的选择提供建议,包括特定病因方面的建议,以及根据现有证据确定最佳心脏靶体积的建议。本文件涵盖了安全性问题以及急性和长期监测建议,包括标准化报告和随访的重要性。本文件列出了不确定的领域,这些领域需要高质量、可靠的临床前和临床证据,才能将 STAR 的应用范围扩大到已证实疗法无效或无法使用的临床情况之外。
{"title":"Patient selection, ventricular tachycardia substrate delineation and data transfer for stereotactic arrhythmia radioablation. A Clinical Consensus Statement of the European Heart Rhythm Association (EHRA) of the ESC and the Heart Rhythm Society (HRS).","authors":"Katja Zeppenfeld, Robert Rademaker, Amin Al-Ahmad, Corrado Carbucicchio, Christian De Chillou, Micaela Ebert, William G Stevenson, Gordon Ho, Josef Kautzner, Marek Sramko, Pier Lambiase, Michael Lloyd, Jose Luis Merino, Etienne Pruvot, John Sapp, Luis Schiappacasse, Paul C Zei","doi":"10.1093/europace/euae214","DOIUrl":"https://doi.org/10.1093/europace/euae214","url":null,"abstract":"<p><p>Stereotactic arrythmia radioablation (STAR) is a novel, non-invasive and promising treatment option for ventricular arrythmias (VA). It has been applied in highly selected patients mainly as bail-out procedure, when (multiple) catheter-ablations, together with anti-arrhythmic drugs, were unable to control the VAs. Despite the increasing clinical use there is still limited knowledge of the acute and long-term response of normal and diseased myocardium to STAR. Acute toxicity appeared to be reasonably low but potential late adverse effects may be underreported. Among published studies, the provided methodological information is often limited, and patient selection, target volume definition, methods for determination and transfer of target volume, and techniques for treatment planning and execution differ across studies, hampering pooling of data and comparison across studies. In addition, STAR requires close and new collaboration between clinical electrophysiologists and radiation oncologists, which is facilitated by shared knowledge in each collaborator's area of expertise and a common language. This clinical consensus statement provides uniform definition of cardiac target volumes. It aims to provide advice in patient selection for STAR including etiology specific aspects, and advice in optimal cardiac target volume identification based on available evidence. Safety concerns and the advice for acute and long-term monitoring including the importance of standardized reporting and follow-up are covered by this document. Areas of uncertainty are listed, which require high-quality, reliable pre-clinical and clinical evidence before expansion of STAR beyond clinical scenarios in which proven therapies are ineffective or unavailable.</p>","PeriodicalId":11981,"journal":{"name":"Europace","volume":" ","pages":""},"PeriodicalIF":7.9,"publicationDate":"2024-08-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142035552","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-08-03DOI: 10.1093/europace/euae199
Nadine Molitor, Shmaila Saleem-Talib, Hemanth Ramanna, Daniel Hofer, Alexander Breitenstein, Jan Steffel
Aims: Leadless pacemaker therapy was introduced to overcome lead- and pocket-related complications in conventional transvenous pacemaker systems. Implantation via the femoral vein, however, may not always be feasible. The aim of this study was to evaluate leadless pacemaker implantation using a jugular vein approach and compare it to the standard implantation via the femoral vein.
Methods and results: The records of the first consecutive 100 patients undergoing Micra™ leadless pacemaker implantation via the right internal jugular vein from two centres were included in this study. Peri-procedural safety and efficacy of the jugular approach were compared to the first 100 patients using a femoral implantation approach at the University Hospital Zurich. One hundred patients underwent successful implantation of a leadless pacemaker via the internal jugular vein (mean age, 81.18 ± 8.29, 60% males). Mean procedure time was 35.63 ± 10.29 min with a mean fluoroscopy time of 4.66 ± 5.16 min. The device was positioned at the inferior septum in 25 patients, at the high septum in 24 patients, and mid-septum in 51 patients. The mean pacing threshold was 0.56 ± 0.35 V at 0.24 ms pulse width with a sensed amplitude of 10.0 ± 4.4 mV. At follow-up, electrical parameters remained stable in all patients. Compared with femoral implantation, patients undergoing the jugular approach were of similar age and had similar comorbidities. Mean procedure (48.9 ± 21.0 min) and fluoroscopy times (7.7 ± 7.8 min, both P < 0.01) were shorter compared to the femoral approach. Electrical parameters were similar between the two approaches. There were only two complications during jugular veinous implantations (1 pericardial effusion and 1 dislocation), compared to 16 complications using the femoral approach (1 pericardial effusion, 2 femoral artery injuries, and 13 major groin haematomas).
Conclusion: The jugular approach may represent a safe and efficient alternative to femoral implantation of the Micra leadless pacemaker.
{"title":"Leadless pacemaker implantation via the internal jugular vein.","authors":"Nadine Molitor, Shmaila Saleem-Talib, Hemanth Ramanna, Daniel Hofer, Alexander Breitenstein, Jan Steffel","doi":"10.1093/europace/euae199","DOIUrl":"10.1093/europace/euae199","url":null,"abstract":"<p><strong>Aims: </strong>Leadless pacemaker therapy was introduced to overcome lead- and pocket-related complications in conventional transvenous pacemaker systems. Implantation via the femoral vein, however, may not always be feasible. The aim of this study was to evaluate leadless pacemaker implantation using a jugular vein approach and compare it to the standard implantation via the femoral vein.</p><p><strong>Methods and results: </strong>The records of the first consecutive 100 patients undergoing Micra™ leadless pacemaker implantation via the right internal jugular vein from two centres were included in this study. Peri-procedural safety and efficacy of the jugular approach were compared to the first 100 patients using a femoral implantation approach at the University Hospital Zurich. One hundred patients underwent successful implantation of a leadless pacemaker via the internal jugular vein (mean age, 81.18 ± 8.29, 60% males). Mean procedure time was 35.63 ± 10.29 min with a mean fluoroscopy time of 4.66 ± 5.16 min. The device was positioned at the inferior septum in 25 patients, at the high septum in 24 patients, and mid-septum in 51 patients. The mean pacing threshold was 0.56 ± 0.35 V at 0.24 ms pulse width with a sensed amplitude of 10.0 ± 4.4 mV. At follow-up, electrical parameters remained stable in all patients. Compared with femoral implantation, patients undergoing the jugular approach were of similar age and had similar comorbidities. Mean procedure (48.9 ± 21.0 min) and fluoroscopy times (7.7 ± 7.8 min, both P < 0.01) were shorter compared to the femoral approach. Electrical parameters were similar between the two approaches. There were only two complications during jugular veinous implantations (1 pericardial effusion and 1 dislocation), compared to 16 complications using the femoral approach (1 pericardial effusion, 2 femoral artery injuries, and 13 major groin haematomas).</p><p><strong>Conclusion: </strong>The jugular approach may represent a safe and efficient alternative to femoral implantation of the Micra leadless pacemaker.</p>","PeriodicalId":11981,"journal":{"name":"Europace","volume":" ","pages":""},"PeriodicalIF":7.9,"publicationDate":"2024-08-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11304476/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141757987","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}