Daniel R Musikantow, Vivek Y Reddy, Ivo Skalsky, Tamaz Shaburishvili, Martin van Zyl, Barry O'Brien, Ken Coffey, John Reilly, Petr Neuzil, Samuel Asirvatham, Joris R de Groot
{"title":"心脏手术中脉冲场电穿孔（NEURAL AF）靶向消融心外膜神经节丛。","authors":"Daniel R Musikantow, Vivek Y Reddy, Ivo Skalsky, Tamaz Shaburishvili, Martin van Zyl, Barry O'Brien, Ken Coffey, John Reilly, Petr Neuzil, Samuel Asirvatham, Joris R de Groot","doi":"10.1007/s10840-023-01615-8","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Modulation of the cardiac autonomic nervous system (ANS) is a promising adjuvant therapy in the treatment of atrial fibrillation (AF). In pre-clinical models, pulsed field (PF) energy has the advantage of selectively ablating the epicardial ganglionated plexi (GP) that govern the ANS. This study aims to demonstrate the feasibility and safety of epicardial ablation of the GPs with PF during cardiac surgery with a primary efficacy outcome of prolongation of the atrial effective refractory period (AERP).</p><p><strong>Methods: </strong>In a single-arm, prospective analysis, patients with or without a history of AF underwent epicardial GP ablation with PF during coronary artery bypass grafting (CABG). AERP was determined immediately pre- and post- GP ablation to assess cardiac ANS function. Holter monitors were performed to determine rhythm status and heart rate variability (HRV) at baseline and at 1-month post-procedure.</p><p><strong>Results: </strong>Of 24 patients, 23 (96%) received the full ablation protocol. No device-related adverse effects were noted. GP ablation resulted in a 20.7 ± 19.9% extension in AERP (P < 0.001). Post-operative AF was observed in 7 (29%) patients. Holter monitoring demonstrated an increase in mean heart rate (74.0 ± 8.7 vs. 80.6 ± 12.3, P = 0.01). There were no significant changes in HRV. There were no study-related complications.</p><p><strong>Conclusions: </strong>This study demonstrates the safety and feasibility of epicardial ablation of the GP using PF to modulate the ANS during cardiac surgery. Large, randomized analyses are necessary to determine whether epicardial PF ablation can offer a meaningful impact on the cardiac ANS and reduce AF.</p><p><strong>Trial registration: </strong>Clinical trial registration: NCT04775264.</p>","PeriodicalId":16202,"journal":{"name":"Journal of Interventional Cardiac Electrophysiology","volume":" ","pages":"467-474"},"PeriodicalIF":2.6000,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12043773/pdf/","citationCount":"0","resultStr":"{\"title\":\"Targeted ablation of epicardial ganglionated plexi during cardiac surgery with pulsed field electroporation (NEURAL AF).\",\"authors\":\"Daniel R Musikantow, Vivek Y Reddy, Ivo Skalsky, Tamaz Shaburishvili, Martin van Zyl, Barry O'Brien, Ken Coffey, John Reilly, Petr Neuzil, Samuel Asirvatham, Joris R de Groot\",\"doi\":\"10.1007/s10840-023-01615-8\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Modulation of the cardiac autonomic nervous system (ANS) is a promising adjuvant therapy in the treatment of atrial fibrillation (AF). In pre-clinical models, pulsed field (PF) energy has the advantage of selectively ablating the epicardial ganglionated plexi (GP) that govern the ANS. This study aims to demonstrate the feasibility and safety of epicardial ablation of the GPs with PF during cardiac surgery with a primary efficacy outcome of prolongation of the atrial effective refractory period (AERP).</p><p><strong>Methods: </strong>In a single-arm, prospective analysis, patients with or without a history of AF underwent epicardial GP ablation with PF during coronary artery bypass grafting (CABG). AERP was determined immediately pre- and post- GP ablation to assess cardiac ANS function. Holter monitors were performed to determine rhythm status and heart rate variability (HRV) at baseline and at 1-month post-procedure.</p><p><strong>Results: </strong>Of 24 patients, 23 (96%) received the full ablation protocol. No device-related adverse effects were noted. GP ablation resulted in a 20.7 ± 19.9% extension in AERP (P < 0.001). Post-operative AF was observed in 7 (29%) patients. Holter monitoring demonstrated an increase in mean heart rate (74.0 ± 8.7 vs. 80.6 ± 12.3, P = 0.01). There were no significant changes in HRV. There were no study-related complications.</p><p><strong>Conclusions: </strong>This study demonstrates the safety and feasibility of epicardial ablation of the GP using PF to modulate the ANS during cardiac surgery. Large, randomized analyses are necessary to determine whether epicardial PF ablation can offer a meaningful impact on the cardiac ANS and reduce AF.</p><p><strong>Trial registration: </strong>Clinical trial registration: NCT04775264.</p>\",\"PeriodicalId\":16202,\"journal\":{\"name\":\"Journal of Interventional Cardiac Electrophysiology\",\"volume\":\" \",\"pages\":\"467-474\"},\"PeriodicalIF\":2.6000,\"publicationDate\":\"2025-03-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12043773/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Interventional Cardiac Electrophysiology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s10840-023-01615-8\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2023/8/10 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q3\",\"JCRName\":\"CARDIAC & CARDIOVASCULAR SYSTEMS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Interventional Cardiac Electrophysiology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s10840-023-01615-8","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2023/8/10 0:00:00","PubModel":"Epub","JCR":"Q3","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
Targeted ablation of epicardial ganglionated plexi during cardiac surgery with pulsed field electroporation (NEURAL AF).
Background: Modulation of the cardiac autonomic nervous system (ANS) is a promising adjuvant therapy in the treatment of atrial fibrillation (AF). In pre-clinical models, pulsed field (PF) energy has the advantage of selectively ablating the epicardial ganglionated plexi (GP) that govern the ANS. This study aims to demonstrate the feasibility and safety of epicardial ablation of the GPs with PF during cardiac surgery with a primary efficacy outcome of prolongation of the atrial effective refractory period (AERP).
Methods: In a single-arm, prospective analysis, patients with or without a history of AF underwent epicardial GP ablation with PF during coronary artery bypass grafting (CABG). AERP was determined immediately pre- and post- GP ablation to assess cardiac ANS function. Holter monitors were performed to determine rhythm status and heart rate variability (HRV) at baseline and at 1-month post-procedure.
Results: Of 24 patients, 23 (96%) received the full ablation protocol. No device-related adverse effects were noted. GP ablation resulted in a 20.7 ± 19.9% extension in AERP (P < 0.001). Post-operative AF was observed in 7 (29%) patients. Holter monitoring demonstrated an increase in mean heart rate (74.0 ± 8.7 vs. 80.6 ± 12.3, P = 0.01). There were no significant changes in HRV. There were no study-related complications.
Conclusions: This study demonstrates the safety and feasibility of epicardial ablation of the GP using PF to modulate the ANS during cardiac surgery. Large, randomized analyses are necessary to determine whether epicardial PF ablation can offer a meaningful impact on the cardiac ANS and reduce AF.
期刊介绍：
The Journal of Interventional Cardiac Electrophysiology is an international publication devoted to fostering research in and development of interventional techniques and therapies for the management of cardiac arrhythmias. It is designed primarily to present original research studies and scholarly scientific reviews of basic and applied science and clinical research in this field. The Journal will adopt a multidisciplinary approach to link physical, experimental, and clinical sciences as applied to the development of and practice in interventional electrophysiology. The Journal will examine techniques ranging from molecular, chemical and pharmacologic therapies to device and ablation technology. Accordingly, original research in clinical, epidemiologic and basic science arenas will be considered for publication. Applied engineering or physical science studies pertaining to interventional electrophysiology will be encouraged. The Journal is committed to providing comprehensive and detailed treatment of major interventional therapies and innovative techniques in a structured and clinically relevant manner. It is directed at clinical practitioners and investigators in the rapidly growing field of interventional electrophysiology. The editorial staff and board reflect this bias and include noted international experts in this area with a wealth of expertise in basic and clinical investigation. Peer review of all submissions, conflict of interest guidelines and periodic editorial board review of all Journal policies have been established.
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