Pub Date : 2024-11-26DOI: 10.1007/s10840-024-01945-1
Ashish Kumar, Mariam Shariff, Jose Carlos Pachon, Juan C Zerpa Acosta, Christopher V DeSimone, John Stulak, Malini Madhavan, Abhishek J Deshmukh, Gurukripa N Kowlgi
{"title":"A comparative meta-analysis of addition of ganglionic plexus ablation versus no ganglionic plexus ablation to pulmonary vein isolation for atrial fibrillation.","authors":"Ashish Kumar, Mariam Shariff, Jose Carlos Pachon, Juan C Zerpa Acosta, Christopher V DeSimone, John Stulak, Malini Madhavan, Abhishek J Deshmukh, Gurukripa N Kowlgi","doi":"10.1007/s10840-024-01945-1","DOIUrl":"https://doi.org/10.1007/s10840-024-01945-1","url":null,"abstract":"","PeriodicalId":16202,"journal":{"name":"Journal of Interventional Cardiac Electrophysiology","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2024-11-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142716151","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-25DOI: 10.1007/s10840-024-01940-6
Andrea Natale, Sanghamitra Mohanty, Cindy Chen, Yuan Zhao, Alicia K Campbell, Brahim Bookhart, Veronica Ashton
Background: Atrial fibrillation (AF) and obstructive sleep apnea (OSA) are often comorbid and associated with increased risk of cardiovascular events such as stroke. We evaluated the effectiveness, safety, healthcare resource utilization, and costs of rivaroxaban versus warfarin in patients with nonvalvular AF (NVAF) and comorbid OSA.
Methods: We used the IQVIA PharMetrics® Plus adjudicated claims database to evaluate patients with NVAF, OSA, and moderate-to-severe stroke risk who initiated rivaroxaban or warfarin between November 2011 and December 2022. We adjusted for potential confounders with propensity score overlap weighting. Primary endpoints were evaluated based on intent-to-treat (ITT) and on-treatment follow-up to compare stroke or systemic embolism risk, major bleeding risk, all-cause healthcare resource utilization (inpatient hospitalizations, emergency department visits, outpatient visits, and pharmacy fills), and costs (per patient per year [PPPY]) by treatment cohort.
Results: In total, 14,765 patients were included (9133 received rivaroxaban; 5632 received warfarin). Rivaroxaban significantly reduced stroke or systemic embolism versus warfarin by 26% (ITT-hazard ratio, 0.74 [95% CI 0.60-0.91]; P = 0.004) and 30% (on-treatment-hazard ratio, 0.70 [95% CI 0.55-0.89]; P = 0.004). Major bleeding was not significantly different between rivaroxaban and warfarin in either analysis. All-cause healthcare resource utilization was significantly reduced with rivaroxaban versus warfarin, leading to significantly reduced PPPY costs.
Conclusions: Among patients with NVAF and OSA, rivaroxaban was associated with a significant reduction in stroke or systemic embolism risk versus warfarin with no difference in major bleeding. Rivaroxaban significantly reduced healthcare resource utilization and costs compared with warfarin, providing support for the use of rivaroxaban in this population.
背景:心房颤动(AF)和阻塞性睡眠呼吸暂停(OSA)通常合并存在,并与中风等心血管事件的风险增加有关。我们评估了利伐沙班与华法林在非瓣膜性房颤(NVAF)和合并 OSA 患者中的有效性、安全性、医疗资源利用率和成本:我们使用 IQVIA PharMetrics® Plus 裁判索赔数据库对 2011 年 11 月至 2022 年 12 月期间开始使用利伐沙班或华法林的 NVAF、OSA 和中重度卒中风险患者进行了评估。我们采用倾向得分重叠加权法调整了潜在的混杂因素。主要终点根据意向治疗(ITT)和治疗随访进行评估,比较不同治疗队列的卒中或全身性栓塞风险、大出血风险、全因医疗资源利用率(住院、急诊就诊、门诊就诊和药房配药)和成本(每位患者每年 [PPPY]):共纳入 14765 名患者(9133 人接受利伐沙班治疗;5632 人接受华法林治疗)。利伐沙班与华法林相比,中风或全身性栓塞明显减少了26%(ITT-危险比,0.74 [95% CI 0.60-0.91];P = 0.004)和30%(治疗中-危险比,0.70 [95% CI 0.55-0.89];P = 0.004)。在这两项分析中,利伐沙班与华法林的大出血差异均不大。利伐沙班与华法林相比,全因医疗资源利用率明显降低,从而显著降低了PPPY成本:结论:在 NVAF 和 OSA 患者中,利伐沙班与华法林相比可显著降低中风或全身性栓塞风险,但在大出血方面没有差异。与华法林相比,利伐沙班大大降低了医疗资源的利用率和成本,为在这一人群中使用利伐沙班提供了支持。
{"title":"Clinical and economic outcomes with rivaroxaban versus warfarin in patients with nonvalvular atrial fibrillation and obstructive sleep apnea: retrospective analysis of US healthcare claims.","authors":"Andrea Natale, Sanghamitra Mohanty, Cindy Chen, Yuan Zhao, Alicia K Campbell, Brahim Bookhart, Veronica Ashton","doi":"10.1007/s10840-024-01940-6","DOIUrl":"https://doi.org/10.1007/s10840-024-01940-6","url":null,"abstract":"<p><strong>Background: </strong>Atrial fibrillation (AF) and obstructive sleep apnea (OSA) are often comorbid and associated with increased risk of cardiovascular events such as stroke. We evaluated the effectiveness, safety, healthcare resource utilization, and costs of rivaroxaban versus warfarin in patients with nonvalvular AF (NVAF) and comorbid OSA.</p><p><strong>Methods: </strong>We used the IQVIA PharMetrics<sup>®</sup> Plus adjudicated claims database to evaluate patients with NVAF, OSA, and moderate-to-severe stroke risk who initiated rivaroxaban or warfarin between November 2011 and December 2022. We adjusted for potential confounders with propensity score overlap weighting. Primary endpoints were evaluated based on intent-to-treat (ITT) and on-treatment follow-up to compare stroke or systemic embolism risk, major bleeding risk, all-cause healthcare resource utilization (inpatient hospitalizations, emergency department visits, outpatient visits, and pharmacy fills), and costs (per patient per year [PPPY]) by treatment cohort.</p><p><strong>Results: </strong>In total, 14,765 patients were included (9133 received rivaroxaban; 5632 received warfarin). Rivaroxaban significantly reduced stroke or systemic embolism versus warfarin by 26% (ITT-hazard ratio, 0.74 [95% CI 0.60-0.91]; P = 0.004) and 30% (on-treatment-hazard ratio, 0.70 [95% CI 0.55-0.89]; P = 0.004). Major bleeding was not significantly different between rivaroxaban and warfarin in either analysis. All-cause healthcare resource utilization was significantly reduced with rivaroxaban versus warfarin, leading to significantly reduced PPPY costs.</p><p><strong>Conclusions: </strong>Among patients with NVAF and OSA, rivaroxaban was associated with a significant reduction in stroke or systemic embolism risk versus warfarin with no difference in major bleeding. Rivaroxaban significantly reduced healthcare resource utilization and costs compared with warfarin, providing support for the use of rivaroxaban in this population.</p>","PeriodicalId":16202,"journal":{"name":"Journal of Interventional Cardiac Electrophysiology","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2024-11-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142710222","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-22DOI: 10.1007/s10840-024-01951-3
Ryan P O'Hara, Justin D Opfermann, Bryan Gonzalez, Bradley C Clark, Charles I Berul, Rohan N Kumthekar
{"title":"A novel, minimally invasive technology for intrapericardial injections via direct visualization.","authors":"Ryan P O'Hara, Justin D Opfermann, Bryan Gonzalez, Bradley C Clark, Charles I Berul, Rohan N Kumthekar","doi":"10.1007/s10840-024-01951-3","DOIUrl":"https://doi.org/10.1007/s10840-024-01951-3","url":null,"abstract":"","PeriodicalId":16202,"journal":{"name":"Journal of Interventional Cardiac Electrophysiology","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2024-11-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142687142","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-21DOI: 10.1007/s10840-024-01949-x
Alex Scripcariu, Serge Boveda, Robin Richard-Vitton, Stephane Combes, Jean Paul Albenque, Nicolas Combes, Quentin Voglimacci-Stephanopoli
We present two cases of patients with inaccessible femoral veins referred for ablation of paroxysmal atrial fibrillation (AF) who underwent Jugular access pulmonary vein isolation (PVI) with the pentaspline pulsed field ablation system. To our knowledge, there is only one other case reported of usage of this system via a superior approach by Mol et al. (Journal of Interventional Cardiac Electrophysiology (2023) 66:835-836).
{"title":"Pulsed-field ablation of atrial fibrillation using the Farapulse system through the jugular vein: a case series of two patients.","authors":"Alex Scripcariu, Serge Boveda, Robin Richard-Vitton, Stephane Combes, Jean Paul Albenque, Nicolas Combes, Quentin Voglimacci-Stephanopoli","doi":"10.1007/s10840-024-01949-x","DOIUrl":"https://doi.org/10.1007/s10840-024-01949-x","url":null,"abstract":"<p><p>We present two cases of patients with inaccessible femoral veins referred for ablation of paroxysmal atrial fibrillation (AF) who underwent Jugular access pulmonary vein isolation (PVI) with the pentaspline pulsed field ablation system. To our knowledge, there is only one other case reported of usage of this system via a superior approach by Mol et al. (Journal of Interventional Cardiac Electrophysiology (2023) 66:835-836).</p>","PeriodicalId":16202,"journal":{"name":"Journal of Interventional Cardiac Electrophysiology","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2024-11-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142687143","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background: Patients undergoing cardiovascular implantable electronic device (CIED) implantation are often on direct oral anticoagulation (DOAC). However, the evidence on whether to continue or temporarily discontinue DOAC therapy during the perioperative period in these patients is unclear.
Methods: We conducted a comprehensive literature review using PubMed, Embase, and Cochrane databases through July 2024. We included studies comparing uninterrupted versus interrupted perioperative DOAC therapy in patients undergoing CIED procedure- primary implants, pulse generator replacement, and device upgrades. Primary outcomes were clinically significant device-pocket hematoma and thromboembolic events. Secondary outcomes included any device-pocket hematoma, all-cause mortality, major bleeding, and any bleeding.
Results: A total of 1,607 patients from 8 studies were included. The mean age was 73.2 years, with atrial fibrillation as the indication for DOAC therapy in most patients. The mean CHA2DS2-VASc was 3.4. Among the included studies, 2 were randomized control trials (RCTs), while the others were observational cohort studies, including one that was propensity score matched. Our meta-analysis found both strategies to be similar in terms of clinically significant pocket hematoma (RR 1.70; 95%CI 0.84-3.45; p = 0.14; I2 = 0%), thromboembolic complications (RR 0.35; 95%CI 0.04-3.32; p = 0.36; I2 = 19%), any pocket hematoma, all-cause mortality and any bleeding with a higher risk of major bleeding with uninterrupted anticoagulation.
Conclusion: This meta-analysis shows that uninterrupted DOAC therapy is comparable to interrupted therapy for CIED procedures, with a potential increase in major bleeding risk but low overall complication rates. Further research is needed to confirm the best approach of periprocedural anticoagulation in these patients.
{"title":"Perioperative direct oral anticoagulant management during cardiac implantable electronic device surgery: an updated systematic review and meta-analysis.","authors":"Chidubem Ezenna, Vinicius Pereira, Mohammed Abozenah, Ancy Jenil Franco, Oghenetejiri Gbegbaje, Ayesha Zaidi, Mrinal Murali Krishna, Meghna Joseph, Prasana Ramesh, Fadi Chalhoub","doi":"10.1007/s10840-024-01947-z","DOIUrl":"https://doi.org/10.1007/s10840-024-01947-z","url":null,"abstract":"<p><strong>Background: </strong>Patients undergoing cardiovascular implantable electronic device (CIED) implantation are often on direct oral anticoagulation (DOAC). However, the evidence on whether to continue or temporarily discontinue DOAC therapy during the perioperative period in these patients is unclear.</p><p><strong>Methods: </strong>We conducted a comprehensive literature review using PubMed, Embase, and Cochrane databases through July 2024. We included studies comparing uninterrupted versus interrupted perioperative DOAC therapy in patients undergoing CIED procedure- primary implants, pulse generator replacement, and device upgrades. Primary outcomes were clinically significant device-pocket hematoma and thromboembolic events. Secondary outcomes included any device-pocket hematoma, all-cause mortality, major bleeding, and any bleeding.</p><p><strong>Results: </strong>A total of 1,607 patients from 8 studies were included. The mean age was 73.2 years, with atrial fibrillation as the indication for DOAC therapy in most patients. The mean CHA2DS2-VASc was 3.4. Among the included studies, 2 were randomized control trials (RCTs), while the others were observational cohort studies, including one that was propensity score matched. Our meta-analysis found both strategies to be similar in terms of clinically significant pocket hematoma (RR 1.70; 95%CI 0.84-3.45; p = 0.14; I<sup>2</sup> = 0%), thromboembolic complications (RR 0.35; 95%CI 0.04-3.32; p = 0.36; I<sup>2</sup> = 19%), any pocket hematoma, all-cause mortality and any bleeding with a higher risk of major bleeding with uninterrupted anticoagulation.</p><p><strong>Conclusion: </strong>This meta-analysis shows that uninterrupted DOAC therapy is comparable to interrupted therapy for CIED procedures, with a potential increase in major bleeding risk but low overall complication rates. Further research is needed to confirm the best approach of periprocedural anticoagulation in these patients.</p>","PeriodicalId":16202,"journal":{"name":"Journal of Interventional Cardiac Electrophysiology","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2024-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142639211","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-14DOI: 10.1007/s10840-024-01942-4
Ulises Rojel Martinez, José Llorente, Nestor López Cabanillas, Luis Ignacio Mondragon, Mauricio Ibrahim Scanavacca, Juan Carlos Zerpa Acosta, William Fernando Bautista Vargas, María Eugenia Santillan, Dulce María García Frias, Armando Perez Silva, Leonardo Onetto, Alexander Dal Forno, Hermes Leonel Morales Molina, Mauricio Abello, Enrique Monjes, Richard Soto Becerra, Alberto Alfie, Juan Carlos Diaz Martinez, Diego Andres Rodríguez Guerrero, Manuel Felipe Patete Ayala, Januário de Pardo Mêo Neto, Silvano Diangelo, Jefferson Jaber, Luis Alberto Wayar Caballero, Edgardo Alfredo Rodriguez Salazar, Gustavo Tortajada, Carina Hardy, Fernando Vidal Bett, Hael Lizandro Fernandez Prado, Elibet Chavez Gonzalez, Luis Fernando Pava, José Enrique Vives Rodríguez, Mauricio Contreras, Lenin Rene Bulnes Garcia, Eric Karabut, Ramón Antonio Requena Dugun, Roberto Keegan
Background: Patient's clinical characteristics, technical resources, center and operator volume, and operator experience and training are known variables impacting outcomes. Although international standards have been agreed to maximize the benefits of this therapy, regional and global differences still exist. Latin American information has not been updated in the last 10 years. This study aimed to analyze current information on operators, centers, and CA in Latin America.
Methods: Observational, retrospective study collecting Latin American information on operators and centers participating in CA, and procedures performed in 2023, from January 1 to December 31.
Results: Electrophysiologists 178 (18 countries). Mean age 46,8 ± 9,2 (28-74) years. Male 86,5%. AFib, VT, and cardioneuroablation were performed by 80,2%, 70,9%, and 35,5% of operators respectively. Centers 175 (17 countries). Private 79,4% and academic 44,0%. Low volume (< 50/year) represented 36,6% and 38,3% performed ≥ 100 ablations/year. Procedures 7.595 (8.284 arrhythmias, 17 countries, 134 centers, 76 electrophysiologists). Patients mean age 51,5 ± 19,3 (1-95) years, male 55,3%, and 77,5% had a structurally normal heart. RF was the energy in 95,6% of procedures, cryoablation in 4,7%, and PFA in 0,2%. The most frequently treated arrhythmias were AFib (28,2%), AVNRT (20,9%), APs (15,8%), and PVC/NSVT (8,3%). Global success and complication rates were 93,6% and 3,0%, respectively and mortality 0,05%.
Conclusion: II LAHRS EP Registry brings new and interesting data related to EP in Latin America. Electrophysiologists showed acceptable levels of experience, skills, and qualification. Although centers revealed an under-ideal availability of infrastructure and technical resources, the results of CA were comparable to other registries worldwide.
背景:患者的临床特征、技术资源、中心和操作人员的数量以及操作人员的经验和培训都是影响治疗效果的已知变量。虽然国际标准已经达成一致,以最大限度地发挥这种疗法的优势,但地区和全球差异依然存在。拉丁美洲的信息在过去 10 年中没有更新过。本研究旨在分析拉丁美洲操作人员、中心和 CA 的当前信息:观察性、回顾性研究,收集拉丁美洲参与 CA 的操作人员和中心的信息,以及 2023 年 1 月 1 日至 12 月 31 日进行的手术:电生理学家 178 名(18 个国家)。平均年龄 46.8 ± 9.2 (28-74) 岁。男性占 86.5%。分别有 80.2%、70.9% 和 35.5% 的操作者进行了房颤、室上性心动过速和心脏神经消融术。中心 175 个(17 个国家)。私立中心占 79.4%,学术中心占 44.0%。手术量少(结论:II LAHRS EP 登记为拉丁美洲的 EP 带来了新的有趣数据。电生理学家的经验、技能和资质水平均可接受。尽管各中心显示基础设施和技术资源的可用性不够理想,但CA的结果与全球其他登记处的结果相当。
{"title":"The second Latin American catheter ablation registry (\"II LAHRS EP registry\").","authors":"Ulises Rojel Martinez, José Llorente, Nestor López Cabanillas, Luis Ignacio Mondragon, Mauricio Ibrahim Scanavacca, Juan Carlos Zerpa Acosta, William Fernando Bautista Vargas, María Eugenia Santillan, Dulce María García Frias, Armando Perez Silva, Leonardo Onetto, Alexander Dal Forno, Hermes Leonel Morales Molina, Mauricio Abello, Enrique Monjes, Richard Soto Becerra, Alberto Alfie, Juan Carlos Diaz Martinez, Diego Andres Rodríguez Guerrero, Manuel Felipe Patete Ayala, Januário de Pardo Mêo Neto, Silvano Diangelo, Jefferson Jaber, Luis Alberto Wayar Caballero, Edgardo Alfredo Rodriguez Salazar, Gustavo Tortajada, Carina Hardy, Fernando Vidal Bett, Hael Lizandro Fernandez Prado, Elibet Chavez Gonzalez, Luis Fernando Pava, José Enrique Vives Rodríguez, Mauricio Contreras, Lenin Rene Bulnes Garcia, Eric Karabut, Ramón Antonio Requena Dugun, Roberto Keegan","doi":"10.1007/s10840-024-01942-4","DOIUrl":"https://doi.org/10.1007/s10840-024-01942-4","url":null,"abstract":"<p><strong>Background: </strong>Patient's clinical characteristics, technical resources, center and operator volume, and operator experience and training are known variables impacting outcomes. Although international standards have been agreed to maximize the benefits of this therapy, regional and global differences still exist. Latin American information has not been updated in the last 10 years. This study aimed to analyze current information on operators, centers, and CA in Latin America.</p><p><strong>Methods: </strong>Observational, retrospective study collecting Latin American information on operators and centers participating in CA, and procedures performed in 2023, from January 1 to December 31.</p><p><strong>Results: </strong>Electrophysiologists 178 (18 countries). Mean age 46,8 ± 9,2 (28-74) years. Male 86,5%. AFib, VT, and cardioneuroablation were performed by 80,2%, 70,9%, and 35,5% of operators respectively. Centers 175 (17 countries). Private 79,4% and academic 44,0%. Low volume (< 50/year) represented 36,6% and 38,3% performed ≥ 100 ablations/year. Procedures 7.595 (8.284 arrhythmias, 17 countries, 134 centers, 76 electrophysiologists). Patients mean age 51,5 ± 19,3 (1-95) years, male 55,3%, and 77,5% had a structurally normal heart. RF was the energy in 95,6% of procedures, cryoablation in 4,7%, and PFA in 0,2%. The most frequently treated arrhythmias were AFib (28,2%), AVNRT (20,9%), APs (15,8%), and PVC/NSVT (8,3%). Global success and complication rates were 93,6% and 3,0%, respectively and mortality 0,05%.</p><p><strong>Conclusion: </strong>II LAHRS EP Registry brings new and interesting data related to EP in Latin America. Electrophysiologists showed acceptable levels of experience, skills, and qualification. Although centers revealed an under-ideal availability of infrastructure and technical resources, the results of CA were comparable to other registries worldwide.</p>","PeriodicalId":16202,"journal":{"name":"Journal of Interventional Cardiac Electrophysiology","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2024-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142622008","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-08DOI: 10.1007/s10840-024-01938-0
Ilaria My, Boris Schmidt, Laura Rottner, Shota Tohoku, Marc Lemoine, David Schaack, Fabian Moser, Lukas Urbanek, Julius Obergassel, Djemail Ismaili, Jun Hirokami, Paulus Kirchhof, Karin Plank, Bruno Reissmann, Feifan Ouyang, Andreas Rillig, Julian Chun, Andreas Metzner, Stefano Bordignon
Background: A novel irrigated radiofrequency balloon (RFB) for pulmonary vein isolation (PVI) integrated into a 3D mapping platform was recently launched.
Methods: Patients undergoing a first atrial fibrillation (AF) ablation at two German high-volume EP centers were included into the prospective AURORA registry. All patients underwent clinical follow-up (FU) at 90, 180, and 360 days following ablation including 48-h Holter ECGs.
Results: A total of 99 patients were enrolled (43/99 (43.4%) women, median age 67 years (interquartile range [IQR] 59-74), 43/99 (43.4%) persistent AF (Pers-AF), median left ventricular ejection fraction (LVEF) 60% (IQR 62-55)). Eighty-eight patients completed the follow-up. Acute PVI was achieved in 383/383 (100%) PV. Single-shot PVI was achieved in 211/383 (55.1%) PVs. Primary adverse events occurred in 3% of patients (1 postprocedural pharyngeal bleeding, 1 myocardial infarction, 1 non-cardiovascular death); no pericardial effusion, stroke, or phrenic nerve paralysis was observed. Median ablation and procedure times were 23 (IQR 18-32) and 67 (IQR 57-85) min, respectively. Median dose area product was 761 (IQR 509-1534) mGycm2. AF-free survival after a median FU of 361 (IQR 261-375) days was 78.4% for paroxysmal AF (PAF) and 75.4% for Pers-AF (p value = 0.828). Early recurrence of atrial tachyarrhythmia at the 90-day visit was the only independent predictor for AF recurrence at 1 year upon multiple regression analysis (hazard ratio [HR] 3.198; 95% confidence interval [95% CI] 1.036-10.32, p value = 0.0433).
Conclusion: RFB-based PVI is acutely successful, appears safe, and has comparable rhythm outcomes to other single-shot AF ablation tools. A recurrence of AF at 90 days predicts later AF recurrence.
{"title":"Radiofrequency balloon ablation: 1-year outcomes of the AURORA study.","authors":"Ilaria My, Boris Schmidt, Laura Rottner, Shota Tohoku, Marc Lemoine, David Schaack, Fabian Moser, Lukas Urbanek, Julius Obergassel, Djemail Ismaili, Jun Hirokami, Paulus Kirchhof, Karin Plank, Bruno Reissmann, Feifan Ouyang, Andreas Rillig, Julian Chun, Andreas Metzner, Stefano Bordignon","doi":"10.1007/s10840-024-01938-0","DOIUrl":"https://doi.org/10.1007/s10840-024-01938-0","url":null,"abstract":"<p><strong>Background: </strong>A novel irrigated radiofrequency balloon (RFB) for pulmonary vein isolation (PVI) integrated into a 3D mapping platform was recently launched.</p><p><strong>Methods: </strong>Patients undergoing a first atrial fibrillation (AF) ablation at two German high-volume EP centers were included into the prospective AURORA registry. All patients underwent clinical follow-up (FU) at 90, 180, and 360 days following ablation including 48-h Holter ECGs.</p><p><strong>Results: </strong>A total of 99 patients were enrolled (43/99 (43.4%) women, median age 67 years (interquartile range [IQR] 59-74), 43/99 (43.4%) persistent AF (Pers-AF), median left ventricular ejection fraction (LVEF) 60% (IQR 62-55)). Eighty-eight patients completed the follow-up. Acute PVI was achieved in 383/383 (100%) PV. Single-shot PVI was achieved in 211/383 (55.1%) PVs. Primary adverse events occurred in 3% of patients (1 postprocedural pharyngeal bleeding, 1 myocardial infarction, 1 non-cardiovascular death); no pericardial effusion, stroke, or phrenic nerve paralysis was observed. Median ablation and procedure times were 23 (IQR 18-32) and 67 (IQR 57-85) min, respectively. Median dose area product was 761 (IQR 509-1534) mGycm<sup>2</sup>. AF-free survival after a median FU of 361 (IQR 261-375) days was 78.4% for paroxysmal AF (PAF) and 75.4% for Pers-AF (p value = 0.828). Early recurrence of atrial tachyarrhythmia at the 90-day visit was the only independent predictor for AF recurrence at 1 year upon multiple regression analysis (hazard ratio [HR] 3.198; 95% confidence interval [95% CI] 1.036-10.32, p value = 0.0433).</p><p><strong>Conclusion: </strong>RFB-based PVI is acutely successful, appears safe, and has comparable rhythm outcomes to other single-shot AF ablation tools. A recurrence of AF at 90 days predicts later AF recurrence.</p>","PeriodicalId":16202,"journal":{"name":"Journal of Interventional Cardiac Electrophysiology","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2024-11-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142605147","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-01Epub Date: 2024-05-18DOI: 10.1007/s10840-024-01825-8
Vera Maslova, Thomas Demming, Robert Pantlik, Tamas Geczy, Peter Falk, Bjoern Andrew Remppis, Derk Frank, Evgeny Lian
Background: Data about necessity of performing transesophageal echocardiography (TOE) prior to every catheter ablation (CA) of atrial fibrillation (AF) is scarce. We aimed to evaluate the safety of an individualized risk-based approach to TOE with respect to thromboembolic cerebrovascular events (CVE) in patients undergoing CA for AF or left atrial tachycardia (AT).
Methods: We performed a retrospective clinical study based on our institutional registry database. Patients undergoing CA for AF or left-sided AT following initial AF ablation at two participating centers were enrolled. Prior to the procedure, patients were scheduled for TOE only if they had a history of thromboembolic stroke, left atrial appendage (LAA) thrombus, or inappropriate anticoagulation regimen in the previous 3 to 4 weeks. The incidence of periprocedural cerebrovascular thromboembolic events was assessed.
Results: We analyzed 1155 patients (median age 70 years, 54.8% male, 48.1% had persistent AF/AT). In 261 patients, a TOE was performed; in 2 patients (0.7%), an LAA thrombus was detected, which led to cancellation of the catheter ablation; in 894 patients, the TOE was omitted. Of the 1153 (0.35%) patients who underwent ablation, 4 (0.35%) experienced a CVE (one TIA and three strokes). The rate of CVE in our study does not exceed that reported in most multicenter trials. The low event rates limited statistical analysis of possible risk factors for CVE. In all 4 patients with CVE, post-CVE imaging showed the absence of LAA thrombus.
Conclusions: An individualized selective approach to TOE before catheter ablation of AF or left AT showed a very low risk of overt intraprocedural thromboembolic events for the population in our study. A further randomized controlled study is needed to determine whether TOE prior to catheter ablation without ICE could be omitted in patients with uninterrupted OAC without previous thromboembolic events or a history of left atrial thrombus.
{"title":"Omitting transesophageal echocardiography before catheter ablation of atrial fibrillation.","authors":"Vera Maslova, Thomas Demming, Robert Pantlik, Tamas Geczy, Peter Falk, Bjoern Andrew Remppis, Derk Frank, Evgeny Lian","doi":"10.1007/s10840-024-01825-8","DOIUrl":"10.1007/s10840-024-01825-8","url":null,"abstract":"<p><strong>Background: </strong>Data about necessity of performing transesophageal echocardiography (TOE) prior to every catheter ablation (CA) of atrial fibrillation (AF) is scarce. We aimed to evaluate the safety of an individualized risk-based approach to TOE with respect to thromboembolic cerebrovascular events (CVE) in patients undergoing CA for AF or left atrial tachycardia (AT).</p><p><strong>Methods: </strong>We performed a retrospective clinical study based on our institutional registry database. Patients undergoing CA for AF or left-sided AT following initial AF ablation at two participating centers were enrolled. Prior to the procedure, patients were scheduled for TOE only if they had a history of thromboembolic stroke, left atrial appendage (LAA) thrombus, or inappropriate anticoagulation regimen in the previous 3 to 4 weeks. The incidence of periprocedural cerebrovascular thromboembolic events was assessed.</p><p><strong>Results: </strong>We analyzed 1155 patients (median age 70 years, 54.8% male, 48.1% had persistent AF/AT). In 261 patients, a TOE was performed; in 2 patients (0.7%), an LAA thrombus was detected, which led to cancellation of the catheter ablation; in 894 patients, the TOE was omitted. Of the 1153 (0.35%) patients who underwent ablation, 4 (0.35%) experienced a CVE (one TIA and three strokes). The rate of CVE in our study does not exceed that reported in most multicenter trials. The low event rates limited statistical analysis of possible risk factors for CVE. In all 4 patients with CVE, post-CVE imaging showed the absence of LAA thrombus.</p><p><strong>Conclusions: </strong>An individualized selective approach to TOE before catheter ablation of AF or left AT showed a very low risk of overt intraprocedural thromboembolic events for the population in our study. A further randomized controlled study is needed to determine whether TOE prior to catheter ablation without ICE could be omitted in patients with uninterrupted OAC without previous thromboembolic events or a history of left atrial thrombus.</p>","PeriodicalId":16202,"journal":{"name":"Journal of Interventional Cardiac Electrophysiology","volume":" ","pages":"1781-1791"},"PeriodicalIF":2.1,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11607098/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140957809","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}