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Background: Rapid technologic development and expansion of procedural expertise have led to widespread proliferation of catheter-based electrophysiology procedures. It is unclear whether these advances come at cost to patient safety., Objective: This meta-analysis aimed to assess complication rates after modern electrophysiology procedures during the lifetime of the procedures., Methods: A comprehensive search was performed to identify relevant data published before May 30, 2023. Studies were included if they met the following inclusion criteria: prospective trials or registries, including comprehensive complications data; and patients undergoing atrial fibrillation ablation, ventricular tachyarrhythmia ablation, leadless cardiac pacemaker implantation, and percutaneous left atrial appendage occlusion. Pooled incidences of procedure-related complications were individually assessed by random effects models to account for heterogeneity. Temporal trends in complications were investigated by clustering trials by publication year (2000-2018 vs 2019-2023)., Results: A total of 174 studies (43,914 patients) met criteria for analysis: 126 studies of atrial fibrillation ablation (n = 24,057), 25 studies of ventricular tachyarrhythmia ablation (n = 1781), 21 studies of leadless cardiac pacemaker (n = 8896), and 18 studies of left atrial appendage occlusion (n = 9180). The pooled incidences of serious procedure-related complications (3.49% [2000-2018] vs 3.05% [2019-2023]; P < .001), procedure-related stroke (0.46% vs 0.28%; P = .002), pericardial effusion requiring intervention (1.02% vs 0.83%; P = .037), and procedure-related death (0.15% vs 0.06%; P = .003) significantly decreased over time. However, there was no significant difference in the incidence of vascular complications over time (1.86% vs 1.88%; P = .888)., Conclusion: Despite an increase in cardiac electrophysiology procedures, procedural safety has improved over time., Competing Interests: Disclosures Dr Reddy reports no disclosures related to this manuscript; but unrelated to this manuscript, he serves as a consultant for and has equity in Ablacon, Acutus Medical, Affera-Medtronic, Apama Medical–Boston Scientific, Anumana, APN Health, Aquaheart, Atacor, Autonomix, Axon Therapies, Backbeat, BioSig, CardiaCare, CardioNXT/AFTx, Circa Scientific, CoRISMA, Corvia Medical, Dinova-Hangzhou DiNovA EP Technology, East End Medical, EPD-Philips, EP Frontiers, Epix Therapeutics–Medtronic, EpiEP, Eximo, Farapulse–Boston Scientific, Field Medical, Focused Therapeutics, HRT, Intershunt, Javelin, Kardium, Keystone Heart, Laminar Medical, LuxMed, Medlumics, Middlepeak, Neutrace, Nuvera–Biosense Webster, Oracle Health, Restore Medical, Sirona Medical, SoundCath, Valcare; unrelated to this work, has served as a consultant for Abbott, Adagio Medical, AtriAN, Biosense-Webster, BioTel Heart, Biotronik, Boston Scientific, Cairdac, Cardiofocus, Cardionomic, CoreMap, Fire1, Gore & Associates, Impulse Dynamics, Medtronic, Novartis, Philips, Pulse Biosciences; and has equity in DRS Vascular, Manual Surgical Sciences, Newpace, Nyra Medical, Surecor, and Vizaramed. Dr Koruth has received grant support and stock options from Affera-Medtronic; unrelated to this manuscript, he has also served as a consultant to and has received grant support from Cardiofocus; has served as a consultant for Abbott, Boston Scientific, Biosense Webster, and Medtronic; and has received grant support from Pulse Bioscience. All other authors report no conflicts., (Copyright © 2024 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: During pulsed field ablation (PFA), electrode-tissue proximity optimizes lesion quality. A novel "single-shot" map-and-ablate spherical multielectrode PFA array catheter that is able to verify electrode-tissue contact was recently studied in a first-in-human trial of atrial fibrillation (AF)., Objective: The aim of this study was to report lesion durability data, safety, and 12-month effectiveness outcomes., Methods: The spherical PFA catheter, an all-in-one mapping and ablation system, was used to render anatomy and to deliver biphasic pulses (ungated 1.7 kV pulses; ∼40 seconds/application). Ablation sites included pulmonary veins (PVs) and, in selected patients, posterior wall and mitral isthmus. Follow-up was invasive remapping at ∼3 months, electrocardiograms, Holter monitoring at 6 and 12 months, and symptomatic and scheduled transtelephonic monitoring. The primary and secondary efficacy end points were acute PV isolation (PVI), PVI durability, and atrial arrhythmia recurrence., Results: In the 48-patient AF cohort (paroxysmal, 48%; persistent, 52%), lesion sets included PVI (n = 48; 1.2 applications/PV), posterior wall (n = 20; 3.6 applications/posterior wall), and mitral isthmus (n = 11; 2.9 applications/mitral isthmus). Lesions were acutely successful for all 187 of 187 PVs (100%), 20 of 20 posterior walls (100%), and 10 of 11 mitral isthmuses (91%). Pulse delivery time, left atrial catheter dwell time, and procedure time were 61.5 ± 32.8 seconds, 53.9 ± 26.5 minutes, and 87.8 ± 29.8 minutes, respectively. Remapping (43/48 patients [89.5%]) revealed that 158 of 169 PVs (93.5%) were durably isolated. The only complication was a drug-responsive pericarditis. The 1-year Kaplan-Meier estimates of freedom from atrial arrhythmia were 84.2% (paroxysmal AF) and 80.0% (persistent AF)., Conclusion: The single-shot spherical array PFA catheter can safely achieve durable lesions, translating into good clinical efficacy., Competing Interests: Disclosures Vivek Reddy reports receiving consulting fees (and equity) from Kardium Inc; and unrelated to this manuscript, he also serves as a consultant for and has equity in Ablacon, Acutus Medical, Affera-Medtronic, Anumana, Apama Medical–Boston Scientific, APN Health, Aquaheart, Atacor, Autonomix, Axon Therapies, Backbeat, BioSig, CardiaCare, Cardiofocus, CardioNXT/AFTx, Circa Scientific, CoRISMA, Corvia Medical, Dinova-Hangzhou DiNovA EP Technology, East End Medical, EPD-Philips, EP Frontiers, Epix Therapeutics–Medtronic, EpiEP, Eximo, Farapulse–Boston Scientific, Field Medical, Focused Therapeutics, HRT, Intershunt, Javelin, Keystone Heart, Laminar Medical, LuxMed, Medlumics, Middlepeak, Neutrace, Nuvera–Biosense Webster, Oracle Health, Restore Medical, Sirona Medical, SoundCath, Valcare; unrelated to this work, he has served as a consultant for Abbott, Adagio Medical, Append Medical, AtriAN, Biosense Webster, BioTel Heart, Biotronik, Boston Scientific, Cairdac, Cardionomic, CoreMap, Fire1, Gore & Associates, Impulse Dynamics, Medtronic, Novartis, Novo Nordisk, Philips, Pulse Biosciences; and unrelated to this work, he has equity in Atraverse, DRS Vascular, Manual Surgical Sciences, Newpace, Nyra Medical, Soundcath, Surecor, and Vizaramed. Petr Neuzil: grant support from Kardium Inc. Jacob Koruth: grant support and stock options from Kardium/Affera-Medtronic/Pulse Biosciences and Field Medical; consultant/grant support from Cardiofocus; consultant for Biosense Webster, Abbott, Boston Scientific and Medtronic. Mohit Turagam: consultant for Biosense Webster, Boston Scientific, Alta Thera; speaking honorarium: Sanofi, Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: Endocardial catheter-based pulsed field ablation (PFA) of the ventricular myocardium is promising. However, little is known about PFA's ability to target intracavitary structures, epicardium, and ways to achieve transmural lesions across thick ventricular tissue., Methods: A lattice-tip catheter was used to deliver biphasic monopolar PFA to swine ventricles under general anesthesia, with electroanatomical mapping, fluoroscopy and intracardiac echocardiography guidance. We conducted experiments to assess the feasibility and safety of repetitive monopolar PFA applications to ablate (1) intracavitary papillary muscles and moderator bands, (2) epicardial targets, and (3) bipolar PFA for midmyocardial targets in the interventricular septum and left ventricular free wall., Results: (1) Papillary muscles (n=13) were successfully ablated and then evaluated at 2, 7, and 21 days. Nine lesions with stable contact measured 18.3±2.4 mm long, 15.3±1.5 mm wide, and 5.8±1.0 mm deep at 2 days. Chronic lesions demonstrated preserved chordae without mitral regurgitation. Two targeted moderator bands were transmurally ablated without structural disruption. (2) Transatrial saline/carbon dioxide assisted epicardial access was obtained successfully and epicardial monopolar lesions had a mean length, width, and depth of 30.4±4.2, 23.5±4.1, and 9.1±1.9 mm, respectively. (3) Bipolar PFA lesions were delivered across the septum (n=11) and the left ventricular free wall (n=7). Twelve completed bipolar lesions had a mean length, width, and depth of 29.6±5.5, 21.0±7.3, and 14.3±4.7 mm, respectively. Chronically, these lesions demonstrated uniform fibrotic changes without tissue disruption. Bipolar lesions were significantly deeper than the monopolar epicardial lesions., Conclusions: This in vivo evaluation demonstrates that PFA can successfully ablate intracavitary structures and create deep epicardial lesions and transmural left ventricular lesions., Competing Interests: Disclosures Drs Koruth and Reddy have served as a consultant to and received grant support and equity from Affera-Medtronic. A comprehensive list of all financial disclosures (unrelated to this article) is included in the Supplemental Material. Dr Nies has received a scholarship from the German Research Foundation (Deutsche Forschungsgemeinschaft). The other authors report no conflicts.

Aims: Pulsed field ablation (PFA) has significant advantages over conventional thermal ablation of atrial fibrillation (AF). This first-in-human, single-arm trial to treat paroxysmal AF (PAF) assessed the efficiency, safety, pulmonary vein isolation (PVI) durability and one-year clinical effectiveness of an 8 Fr, large-lattice, conformable single-shot PFA catheter together with a dedicated electroanatomical mapping system., Methods and Results: After rendering the PV anatomy, the PFA catheter delivered monopolar, biphasic pulse trains (5-6 s per application; ∼4 applications per PV). Three waveforms were tested: PULSE1, PULSE2, and PULSE3. Follow-up included ECGs, Holters at 6 and 12 months, and symptomatic and scheduled transtelephonic monitoring. The primary and secondary efficacy endpoints were acute PVI and post-blanking atrial arrhythmia recurrence, respectively. Invasive remapping was conducted ∼75 days post-ablation. At three centres, PVI was performed by five operators in 85 patients using PULSE1 (n = 30), PULSE2 (n = 20), and PULSE3 (n = 35). Acute PVI was achieved in 100% of PVs using 3.9 ± 1.4 PFA applications per PV. Overall procedure, transpired ablation, PFA catheter dwell and fluoroscopy times were 56.5 ± 21.6, 10.0 ± 6.0, 19.1 ± 9.3, and 5.7 ± 3.9 min, respectively. No pre-defined primary safety events occurred. Upon remapping, PVI durability was 90% and 99% on a per-vein basis for the total and PULSE3 cohort, respectively. The Kaplan-Meier estimate of one-year freedom from atrial arrhythmias was 81.8% (95% CI 70.2-89.2%) for the total, and 100% (95% CI 80.6-100%) for the PULSE3 cohort., Conclusion: Pulmonary vein isolation (PVI) utilizing a conformable single-shot PFA catheter to treat PAF was efficient, safe, and effective, with durable lesions demonstrated upon remapping., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Competing Interests: Funding Support and Author Disclosures Dr Nies has received a scholarship from the German Research Foundation (Deutsche Forschungsgemeinschaft). Dr Koruth has served as a consultant for, and has received grant support from Cardiofocus; has served as a consultant for Abbott, Boston Scientific, Biosense Webster, and Medtronic; has received grant support and stock options from Affera-Medtronic; has received grant support from Pulse Bioscience. Dr Reddy has served as a consultant to, and received equity from Affera-Medtronic; unrelated to this manuscript, he also serves as a consultant for and has equity in Ablacon, Acutus Medical, Apama Medical-Boston Scientific, Anumana, APN Health, Aquaheart, Atacor, Autonomix, Axon Therapies, Backbeat, BioSig, CardiaCare, CardioNXT / AFTx, Circa Scientific, CoRISMA, Corvia Medical, Dinova-Hangzhou DiNovA EP Technology, East End Medical, EPD-Philips, EP Frontiers, Epix Therapeutics-Medtronic, EpiEP, Eximo, Farapulse-Boston Scientific, Field Medical, Focused Therapeutics, HRT, Intershunt, Javelin, Kardium, Keystone Heart, LuxMed, Medlumics, Middlepeak, Neutrace, Nuvera-Biosense Webster, Oracle Health, Restore Medical, Sirona Medical, SoundCath, Valcare; unrelated to this work, has served as a consultant for Abbott, AtriAN, Biosense-Webster, BioTel Heart, Biotronik, Boston Scientific, Cairdac, Cardiofocus, Cardionomic, CoreMap, Fire1, Gore & Associates, Impulse Dynamics, Medtronic, Novartis, Philips, Pulse Biosciences; and has equity in DRS Vascular, Manual Surgical Sciences, Newpace, Nyra Medical, Surecor, and Vizaramed. All other authors reported that they have no relationships relevant to the contents of this paper to disclose.

Importance: In treating atrial fibrillation, pulsed field ablation (PFA) is a novel energy modality with comparable efficacy to conventional thermal ablation, such as radiofrequency ablation (RFA), but with the benefit of some preferentiality to myocardial tissue ablation. Studies have demonstrated important safety advantages, including the absence of esophageal injury or pulmonary vein stenosis and only rare phrenic nerve injury. However, there is emerging evidence of coronary artery vasospasm provoked by PFA., Objective: To compare the incidence and severity of left circumflex arterial vasospasm between PFA and RFA during adjacent ablation along the mitral isthmus., Design, Setting, and Participants: This prospective cohort study enrolled consecutive adult patients receiving first-ever PFA or RFA of the mitral isthmus during catheter ablation of atrial fibrillation in 2022 with acute follow-up at a single referral European center., Exposure: A posterolateral mitral isthmus line was created using either a multielectrode pentaspline PFA catheter (endocardial ablation) or a saline-irrigated RFA catheter. Simultaneous diagnostic coronary angiography was performed before, during, and after catheter ablation. Nitroglycerin was planned for spasm persisting beyond 20 minutes or for significant electrocardiographic changes., Main Outcomes and Measures: The frequency and severity of left circumflex arterial vasospasm was assessed and monitored, as were time to remission and any need for nitroglycerin administration., Results: Of 26 included patients, 19 (73%) were male, and the mean (SD) age was 65.5 (9.3) years. Patients underwent either PFA (n = 17) or RFA (n = 9) along the mitral isthmus. Coronary spasm was observed in 7 of 17 patients (41.2%) undergoing PFA: in 7 of 9 (77.8%) when the mitral isthmus ablation line was situated superiorly and in 0 of 8 when situated inferiorly. Conversely, coronary spasm did not occur in any of the 9 patients undergoing RFA. Of 5 patients in whom crossover PFA was performed after RFA failed to achieve conduction block, coronary spasm occurred in 3 (60%). Most instances of spasm (9 of 10 [90%]) were subclinical, with 2 (20%) requiring nitroglycerin administration. The median (range) time to resolution of spasm was 5 (5-25) minutes., Conclusion and Relevance: When creating a mitral isthmus ablation line during catheter ablation of atrial fibrillation, adjacent left circumflex arterial vasospasm frequently occurred with PFA and not RFA but was typically subclinical.

Background: During electrophysiological mapping of tachycardias, putative target sites are often only truly confirmed to be vital after observing the effect of ablation. This lack of mapping specificity potentiates inadvertent ablation of innocent cardiac tissue not relevant to the arrhythmia. But if myocardial excitability could be transiently suppressed at critical regions, their suitability as targets could be conclusively determined before delivering tissue-destructive ablation lesions. We studied whether reversible pulsed electric fields (PF REV ) could transiently suppress electrical conduction, thereby providing a means to dissect tachycardia circuits in vivo., Methods: PF REV energy was delivered from a 9-mm lattice-tip catheter to the atria of 12 swine and 9 patients, followed by serial electrogram assessments. The effects on electrical conduction were explored in 5 additional animals by applying PF REV to the atrioventricular node: 17 low-dose (PF REV-LOW ) and 10 high-dose (PF REV-HIGH ) applications. Finally, in 3 patients manifesting spontaneous tachycardias, PF REV was applied at putative critical sites., Results: In animals, the immediate post-PF REV electrogram amplitudes diminished by 74%, followed by 78% recovery by 5 minutes. Similarly, in patients, a 69.9% amplitude reduction was followed by 84% recovery by 3 minutes. Histology revealed only minimal to no focal, superficial fibrosis. PF REV-LOW at the atrioventricular node resulted in transient PR prolongation and transient AV block in 59% and 6%, while PF REV-HIGH caused transient PR prolongation and transient AV block in 30% and 50%, respectively. The 3 tachycardia patients had atypical atrial flutters (n=2) and atrioventricular nodal reentrant tachycardia. PF REV at putative critical sites reproducibly terminated the tachycardias; ablation rendered the tachycardias noninducible and without recurrence during 1-year follow-up., Conclusions: Reversible electroporation pulses can be applied to myocardial tissue to transiently block electrical conduction. This technique of pulsed field mapping may represent a novel electrophysiological tool to help identify the critical isthmus of tachycardia circuits., Competing Interests: Disclosures Dr Reddy: Affera-Medtronic: consultant, equity (stock); other disclosures not related to this article are detailed in the Supplemental Material. Dr Koruth: Affera-Medtronic: grant support, stock, consultant. Dr Neuzil: Affera-Medtronic: grant support.

Background: We previously reported feasibility of irrigated needle ablation (INA) with a retractable 27-G end-hole needle catheter to treat nonendocardial ventricular arrhythmia substrate, an important cause of ablation failure., Objectives: The purpose of this study was to report outcomes and complications in our entire INA-treated population., Methods: Patients with recurrent sustained monomorphic ventricular tachycardia (VT) or high-density premature ventricular contractions (PVCs) despite radiofrequency ablation were prospectively enrolled at 4 centers. Endpoints included a 70% decrease in VT frequency or PVC burden decrease to <5,000/24 h at 6 months., Results: INA was performed in 111 patients (median: 2 failed prior ablations, 71% nonischemic heart disease, and left ventricular ejection fraction 36% ± 14%). INA acutely abolished targeted PVCs in 33 of 37 patients (89%), and PVCs were reduced to <5,000/day in 29 patients (78%). During 6-month follow-up, freedom from hospitalization was observed in 50 of 72 patients with VT (69%), and improvement or abolition of VT occurred in 47%. All patients received multiple INA applications, with more in the VT group than in the PVC group (median: 12 [IQR: 7-19] vs 7 [5-15]; P < 0.01). After INA, additional endocardial standard radiofrequency ablation was required in 23% of patients. Adverse events included 4 pericardial effusions (3.5%), 3 cases of (anticipated) atrioventricular block (2.6%), and 3 heart failure exacerbations (2.6%). During 6-month follow-up, 5 deaths occurred; none were procedure-related., Conclusions: INA achieves improved arrhythmia control in 78% of patients with PVCs and avoids hospitalization in 69% of patients with VT refractory to standard ablation at 6-month follow-up. Procedural risks are acceptable. (Intramural Needle Ablation for Ablation of Recurrent Ventricular Tachycardia, NCT01791543; Intramural Needle Ablation for the Treatment of Refractory Ventricular Arrhythmias, NCT03204981)., Competing Interests: Funding Support and Author Disclosures Dr Kurata has received a scholarship from the Japanese Heart Rhythm Society. Dr Hasegawa has received support from the International Rotary Fellowship of Healthcare Professionals. Dr Tedrow has received honoraria from Biosense Webster, Boston Scientific, and Abbott; and consulting fees from Thermedical Inc. Dr Dukkipati has received a research grant from Biosense Webster; and reports equity in Manual Surgical Sciences and Farapulse, which was acquired by Boston Scientific. Dr Richardson has received speaker honoraria from Medtronic; research funding from Medtronic and Abbott; and served as a consultant for Philips and Biosense Webster. Dr Kanagasundram has received speaker honoraria from Biosense Webster. Dr Koruth has received research grants from Affera, Farapulse, Cardiofocus, and Biosense Webster; consulting fees from Abbott, Farapulse, and Cardiofocus; and has equity in Affera. Dr John has received speaker honoraria from Abbott and Medtronic. Dr Sapp is a coholder of a patent for irrigated needle ablation with rights assigned to Brigham and Women’s Hospital; has received research grants from Biosense Webster and Abbott; and (modest) speaker or consulting honoraria from Medtronic, Abbott, Biosense Webster, and Varian. Dr Reddy has reported consulting fees and equity from Abalcon, Acutus Medical, Affera, Apama Medical, Aquaheart, Atacor, Autonomix, Backbeat, BioSig, Circa Scientific, Corvia Medical, Dinova-Hangzhou Nuomao Medtech Co, Ltd, East End Medical, EPD, Epix Therapeutics, EpiEP, Eximo, Fire1, Javelin, Kardium, Keystone Heart, LuxCath, Medlumics, Middlepeak, Nuvera, Sirona Medical, and Valcare; equity in Manual Surgical Sciences, Newpace, Surecor, Vizaramed, and Farapulse, which was acquired by Boston Scientific; and has received consulting fees from Abbott, Axon, Biosense Webster, Biotronic, Boston Scientific, Cardiofocus, Cardionomic, CardioNXT/AFTx, EBR, Impulse Dynamics, Medtronic, Philips, Pulse Biosciences, Stimda, and Thermedical. Dr Stevenson is a coholder of a patent for irrigated needle ablation with rights assigned to Brigham and Women’s Hospital; and has received speaking honoraria from Abbott, Boston Scientific, Biotronik, Biosense Webster, and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Because of its safety, "single-shot" pulsed field ablation (PFA) catheters have been developed for pulmonary vein isolation (PVI). However, most atrial fibrillation (AF) ablation procedures are performed with focal catheters to permit flexibility of lesion sets beyond PVI., Objectives: This study sought to determine the safety and efficacy of a focal ablation catheter able to toggle between radiofrequency ablation (RFA) or PFA to treat paroxysmal or persistent AF., Methods: In a first-in-human study, a focal 9-mm lattice tip catheter was used for PFA posteriorly and either irrigated RFA (RF/PF) or PFA (PF/PF) anteriorly. Protocol-driven remapping was at ∼3 months postablation. The remapping data prompted PFA waveform evolution: PULSE1 (n = 76), PULSE2 (n = 47), and the optimized PULSE3 (n = 55)., Results: The study included 178 patients (paroxysmal/persistent AF = 70/108). Linear lesions, either PFA or RFA, included 78 mitral, 121 cavotricuspid isthmus, and 130 left atrial roof lines. All lesion sets (100%) were acutely successful. Invasive remapping of 122 patients revealed improvement of PVI durability with waveform evolution: PULSE1: 51%; PULSE2: 87%; and PULSE3: 97%. After 348 ± 652 days of follow-up, the 1-year Kaplan-Meier estimates for freedom from atrial arrhythmias were 78.3% ± 5.0% and 77.9% ± 4.1% for paroxysmal and persistent AF, respectively, and 84.8% ± 4.9% for the subset of persistent AF patients receiving the PULSE3 waveform. There was 1 primary adverse event-inflammatory pericardial effusion not requiring intervention., Conclusions: AF ablation with a focal RF/PF catheter allows efficient procedures, chronic lesion durability, and good freedom from atrial arrhythmias-for both paroxysmal and persistent AF. (Safety and Performance Assessment of the Sphere-9 Catheter and the Affera Mapping and RF/PF Ablation System to Treat Atrial Fibrillation; NCT04141007 and NCT04194307)., Competing Interests: Funding Support and Author Disclosures This study was funded by a research grant from Affera Inc. Drs Reddy and Anter have received research grants from Affera, Inc. Drs Reddy, Anter, Koruth, and Jais hold stock options in Affera, Inc. Dr Reddy has served as a consultant to Kardium Inc (including Equity); is a consultant to Abbott, Ablacon, Acutus Medical, Affera-Medtronic, Apama Medical-Boston Scientific, APN Health, Aquaheart, Atacor, AtiAN, Autonomix, Axon Therapies, Backbeat, BioSig, Biosense-Webster, BioTel Heart, Biotronik, Boston Scientific, Cairdac, CardiaCare, Cardiofocus, Cardionomic, CardioNXT / AFTx, Circa Scientific, CoreMap, CoRISMA, Corvia Medical, Dinova-Hangzhou DiNovA EP Technology, East End Medical, EBR, EPD-Philips, EP Frontiers, Epix Therapeutics, EpiEP, Eximo, Farapulse-Boston Scientific, Fire1, Focused Therapeutics, Gore & Associates, HRT, Impulse Dynamics, Intershunt, Javelin, Keystone Heart, LuxMed, Medlumics, Medtronic, Middlepeak, Neutrace, Nuvera-Biosense Webster, Oracle Health, Philips, Pulse Biosciences, Restore Medical, Sirona Medical, SoundCath, and Valcare; and has equity from Ablacon, Acutus Medical, Affera-Medtronic, Apama Medical-Boston Scientific, APN Health, Aquaheart, Atacor, Autonomix, Axon Therapies, Backbeat, BioSig, CardiaCare, CardioNXT / AFTx, Circa Scientific, CoRISMA, Corvia Medical, Dinova-Hangzhou DiNovA EP Technology, East End Medical, EPD-Philips, EP Frontiers, Epix Therapeutics, EpiEP, Eximo, Farapulse-Boston Scientific, Focused Therapeutics, HRT, Intershunt, Javelin, Keystone Heart, LuxMed, Manual Surgical Sciences, Medlumics, Middlepeak, Neutrace, Newpace, Nuvera-Biosense Webster, Nyra Medical, Oracle Health, Restore Medical, Sirona Medical, SoundCath, Surecor, Valcare, and Vizaramed. Dr Peichl has received speaker honoraria from Abbott, Biosense Webster, Biotronik, Medtronic, MSD, Pfizer, and ProMed sro. Dr Anter has received research grants from Biosense Webster and Boston Scientific; and stock options from Itamar Medical. Dr Natale has received speaker honoraria from Boston Scientific, Biosense Webster, St. Jude Medical, Biotronik, and Medtronic; and is a consultant for Biosense Webster, Baylis Medical, Boston Scientific, Bristol-Myers Squibb, Biotronik, St. Jude Medical, and Medtronic. Dr Kautzner has received personal fees from Bayer, Biosense Webster, Boehringer Ingelheim, Medtronic, Merck Sharp & Dohme, Merit Medical, and St. Jude Medical (Abbott) for participation in scientific advisory boards; and has received speaker honoraria from Bayer, Biosense Webster, Biotronik, Boehringer Ingelheim, Boston Scientific, Daiichi Sankyo, Medtronic, Merck Sharp & Dohme, Mylan, Pfizer, ProMed sro, and St. Jude Medical (Abbott). All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Preclinical studies have revealed that pulsed field ablation (PFA) lesion dimensions increase with repetitive applications at a similar electric field., Objectives: This study investigated whether pulmonary vein isolation (PVI) durability varies with single vs repetitive pulsed field (PF) applications., Methods: Atrial fibrillation patients underwent PVI using a spherical multielectrode array PFA catheter delivered with a 19-F deflectable sheath under intracardiac echocardiographic guidance. Esophagogastroduodenoscopy and brain magnetic resonance imaging were performed within 1 to 3 days, and invasive remapping at ∼2 to 3 months., Results: The patient cohort (n = 21; age 63 ± 11 years; 67% women) underwent PVI in either of 2 groups: group 1 (n = 11)-single PF application/PV; and group 2 (n = 10)-3 PF applications/PV. In both groups, PVI was acutely successful in all (100%) patients. Despite significantly longer pulse delivery times (75.2 ± 7.4 s/patient vs 24.5 ± 5.5 s/patient) the procedure times (73.2 ± 13.7 minutes vs 93.7 ± 18.5 minutes) were shorter with group 2 vs group 1. There was no stroke/transient ischemic attack, pericardial effusion, phrenic nerve injury, or esophageal complications. Esophagogastroduodenoscopy was normal in both groups of patients (n = 9). Screening brain magnetic resonance imaging revealed asymptomatic cerebral lesions (diffusion weighted imaging+/fluid attenuated inversion recovery-) in 3 of 16 (18.7%) patients. PV remapping revealed durable PVI in 62.5% PVs in group 1 (n = 10), compared with all 100% PVs in group 2 (n = 9); this translates to all PVs being durably isolated in 30% vs 100% (P < 0.05) of patients in groups 1 and 2, respectively., Conclusions: In his first-in-human trial, the "single-shot" spherical array PFA catheter was shown to safely isolate PVs. Repetitive PF application is key for lesion consolidation to maximize PVI durability., Competing Interests: Funding Support and Author Disclosures Drs Neuzil and Koruth have received grant support from Kardium Inc. Dr Reinders is an employee of and holds stock in Kardium Inc. Dr Reddy has served as a consultant to Kardium Inc (including Equity); is a consultant to Abbott, Ablacon, Acutus Medical, Affera-Medtronic, Apama Medical-Boston Scientific, APN Health, Aquaheart, Atacor, AtiAN, Autonomix, Axon Therapies, Backbeat, BioSig, Biosense-Webster, BioTel Heart, Biotronik, Boston Scientific, Cairdac, CardiaCare, Cardiofocus, Cardionomic, CardioNXT / AFTx, Circa Scientific, CoreMap, CoRISMA, Corvia Medical, Dinova-Hangzhou DiNovA EP Technology, East End Medical, EBR, EPD-Philips, EP Frontiers, Epix Therapeutics, EpiEP, Eximo, Farapulse-Boston Scientific, Fire1, Focused Therapeutics, Gore & Associates, HRT, Impulse Dynamics, Intershunt, Javelin, Keystone Heart, LuxMed, Medlumics, Medtronic, Middlepeak, Neutrace, Nuvera-Biosense Webster, Oracle Health, Philips, Pulse Biosciences, Restore Medical, Sirona Medical, SoundCath, and Valcare; and has equity from Ablacon, Acutus Medical, Affera-Medtronic, Apama Medical-Boston Scientific, APN Health, Aquaheart, Atacor, Autonomix, Axon Therapies, Backbeat, BioSig, CardiaCare, CardioNXT / AFTx, Circa Scientific, CoRISMA, Corvia Medical, Dinova-Hangzhou DiNovA EP Technology, East End Medical, EPD-Philips, EP Frontiers, Epix Therapeutics, EpiEP, Eximo, Farapulse-Boston Scientific, Focused Therapeutics, HRT, Intershunt, Javelin, Keystone Heart, LuxMed, Manual Surgical Sciences, Medlumics, Middlepeak, Neutrace, Newpace, Nuvera-Biosense Webster, Nyra Medical, Oracle Health, Restore Medical, Sirona Medical, SoundCath, Surecor, Valcare, and Vizaramed. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: During atrial fibrillation ablations using thermal energy, the treatment effect is attributed to not just pulmonary vein isolation (PVI), but also to modulation of the autonomic nervous system by ablation of cardiac ganglionated plexi (GP)., Objectives: This study sought to assess the impact of pulsed field ablation (PFA) on the GP in patients undergoing PVI., Methods: In the retrospective phase, heart rate was assessed pre- versus post-PVI using PFA, cryoballoon ablation, or radiofrequency ablation. In the prospective phase, a pentaspline PFA catheter was used in a protocol: 1) pre-PFA, high-frequency stimulation (HFS) identified GP sites by vagal effects; 2) PVI was performed assessing for repetitive vagal effects over each set of PF applications; 3) mapping defined PVI extent to identify those GP in the ablation zone; and 4) repeat HFS at GP sites to assess for persistence of vagal effects., Results: Between baseline and 3 months, heart rates in the retrospective radiofrequency ablation (n = 40), cryoballoon (n = 40), and PFA (n = 40) cohorts increased by 8.9 ± 11.4, 11.1 ± 9.4, and -0.1 ± 9.2 beats/min, respectively (P= 0.01 PFA vs radiofrequency ablation; P= 0.01 PFA vs cryoballoon ablation). In the prospective phase, pre-PFA HFS in 20 additional patients identified 65 GP sites. During PFA, vagal effects were noted in 45% of first PF applications, persisting through all applications in 83%. HFS post-PFA reproduced vagal effects in 29 of 38 sites (76%) in low-voltage tissue., Conclusions: PFA has minimal effect on GP. Unlike with thermal ablation, the mechanism by which PFA treats atrial fibrillation is mediated solely by durable PVI., Competing Interests: Funding Support and Author Disclosures Dr Neuzil has received grant support from, and has served as a consultant to Farapulse Inc. Dr Dukkipati has equity in Farapulse Inc. Dr Reddy has served as a consultant to and owns equity in Farapulse Inc, Ableton, Acutus Medical, Affera, Apama Medical–Boston Scientific, APN Health, Aquaheart, Atacor, Autonomix, Axon Therapies, Backbeat, BioSig, CardiaCare, CardioNXT/AFTx, Circa Scientific, CoRISMA, Corvia Medical, Dinova-Hangzhou DiNOVA EP Technology, East End Medical, EPD-Philips, EP Frontiers, EPIX Therapeutics, EpiEP, Eximo, HRT, Intershunt, Javelin, Kardium, Keystone heart, LuxMed, Medlumics, Middlepeak, Neutrace, Nuvera-Biosense Weber, Oracle Health, Restore Medical, Sirona Medical, and Valcare, is a consultant to Abbott, AtiAN, Biosense-Webster, BioTel Heart, Biotronik, Boston Scientific, Cardiofocus, Cardionomic, CoreMap, EBR, Fire1, W. L. Gore and Associates, Impulse Dynamics, Medtronic, Philips, and Pulse Biosciences, and holds equity in Manual Surgical Sciences, Newpace, Surecor, and Vizaramed. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023. Published by Elsevier Inc.)

Background: Pulsed field ablation (PFA) has recently been shown to penetrate ischemic scar, but details on its efficacy, risk of arrhythmias, and imaging insights are lacking. In a porcine model of myocardial scar, we studied the ability of ventricular PFA to penetrate scarred tissue, induce ventricular arrhythmias, and assess the influence of QRS gating during pulse delivery., Methods: Of a total of 6 swine, 5 underwent coronary occlusion and 1 underwent radiofrequency ablation to create infarct scar and iatrogenic scar models, respectively. Two additional swine served as healthy controls. An 8 Fr focal PFA catheter was used to deliver bipolar, biphasic PFA (2.0 kV) lesions guided by electroanatomical mapping, fluoroscopy, and intracardiac echocardiography over both scarred and healthy myocardium. Swine underwent magnetic resonance imaging 2-7 days post-PFA., Results: PFA successfully penetrated scar without significant difference in lesion depth between lesion at the infarct border (5.9±1.0 mm, n=41) and healthy myocardium (5.7±1.3 mm, n=26; P =0.53). PFA penetration of both infarct and iatrogenic radiofrequency abalation scar was observed in all examined sections. Sustained ventricular arrhythmias requiring defibrillation occurred in 4 of 187 (2.1%) ungated applications, whereas no ventricular arrhythmias occurred during gated PFA applications (0 of 64 [0%]). Dark-blood late-gadolinium-enhanced sequences allowed for improved endocardial border detection as well as lesion boundaries compared with conventional bright-blood late-gadolinium-enhanced sequences., Conclusions: PFA penetrates infarct and iatrogenic scar successfully to create deep lesions. Gated delivery eliminates the occurrence of ventricular arrhythmias observed with ungated porcine PFA. Optimized magnetic resonance imaging sequences can be helpful in detecting lesion boundaries.

Background: Our understanding of catheter-based pulsed field ablation (PFA) of the ventricular myocardium is limited. We conducted a series of exploratory evaluations of ventricular PFA in swine ventricles., Methods: A focal lattice-tip catheter was used to deliver proprietary biphasic monopolar PFA applications to swine ventricles under general anesthesia, with guidance from electroanatomical mapping, fluoroscopy, and intracardiac echocardiography. We conducted experiments to assess the impact of (1) delivery repetition (2×, 3×, or 4×) at each location, (2) epicardial PFA delivery, and (3) confluent areas of shallow healed endocardial scar created by prior PFA (4 weeks earlier) on subsequent endocardial PFA. Additional assessments included PFA optimized for the ventricle, lesion visualization by intracardiac echocardiography imaging, and immunohistochemical insights., Results: Experiment no. 1: lesions (n=49) were larger with delivery repetition of either 4× or 3× versus 2×: length 17.6±3.9 or 14.2±2.0 versus 12.7±2.0 mm ( P <0.01, P =0.22), width 13.4±1.8 or 10.6±1.3 versus 10.5±1.1 mm ( P <0.01, P =1.00), and depth 6.1±2.1 or 5.1±1.3 versus 4.2±1.0 mm ( P <0.01, P =0.21). Experiment no. 2: epicardial lesions (n=18) were reliably created and comparable to endocardial lesions: length 24.6±9.7 mm (n=5), width 15.6±4.6 mm, and depth 4.5±3.7 mm. Experiment no. 3: PFA (n=16) was able to penetrate to a depth of 4.8 (interquartile range, 4.5-5.4) mm in healthy myocardium versus 5.6 (interquartile range, 3.6-6.6) mm in adjacent healed endocardial scar ( P =0.79), suggesting that superficial scar does not significantly impair PFA. Finally, we demonstrate, PFA optimized for the ventricle yielded adequate lesion dimensions, can result in myocardial activation, can be visualized by intracardiac echocardiography, and have unique immunohistochemical characteristics., Conclusions: This in vivo evaluation offers insights into the behavior of endocardial or epicardial PFA delivered using the lattice-tip catheter to normal or scarred porcine ventricular myocardium, thereby setting the stage for future clinical studies.

Background: Frequent premature ventricular contractions (PVCs) are often amenable to catheter ablation. However, a deep intramural focus may lead to failure due to inability of standard ablation techniques to penetrate the focus. We sought to assess the efficacy and safety of infusion needle ablation (INA) for PVCs that are refractory to standard radiofrequency ablation., Methods: Under 2 Food and Drug Administration approved protocols, INA was evaluated in patients with frequent PVCs that were refractory to standard ablation. Initial targets for ablation were selected by standard mapping techniques. INA was performed with a deflectable catheter equipped with an extendable/retractable needle at the tip that can be extended up to 12 mm into the myocardium and is capable of pacing and recording. After contrast injection for location assessment, radiofrequency ablation was performed with the needle tip using a temperature-controlled mode (maximum temperature 60 °C) with saline infusion from the needle. The primary end point was a decrease in PVC burden to <5000/24 hours at 6 months. The primary safety end point was incidence of procedure- or device-related serious adverse events., Results: At 4 centers, 35 patients (age 55.3±16.9 years, 74.2% male) underwent INA. The baseline median PVC burden was 25.4% (interquartile range, 18.4%-33.9%) and mean left ventricular ejection fraction was 37.7±12.3%. Delivering 10.3±8.0 INA lesions/patient (91% had adjunctive standard radiofrequency ablation also) resulted in acute PVC elimination in 71.4%. After a mean follow-up of 156±109 days, the primary efficacy end point was met in 73.3%. The median PVC burden decreased to 0.8% (interquartile range, 0.1%-6.0%; P <0.001). The primary safety end point occurred in 14.3% consisting of 1 (2.9%) heart block, 1 (2.9%) femoral artery dissection, and 3 (8.6%) pericardial effusions (all treated percutaneously)., Conclusions: INA is effective for the elimination of frequent PVCs that are refractory to conventional ablation and is associated with an acceptable safety profile., Registration: URL: https://www., Clinicaltrials: gov; Unique identifier: NCT01791543 and NCT03204981.

Objectives: This study sought to examine the effect of the return electrode's surface area on bipolar RFA lesion size., Background: Bipolar radiofrequency ablation (RFA) is typically performed between 2 3.5-mm tip catheters serving as active and return electrodes. We hypothesized that increasing the surface area of the return electrode would increase lesion dimensions by reducing the circuit impedance, thus increasing the current into a larger tissue volume enclosed between the electrodes., Methods: In step 1, ex vivo bipolar RFA was performed between 3.5-mm and custom-made return electrodes with increasing surface areas (20, 80, 180 mm 2 ). In step 2, ex vivo bipolar RFA was performed between 3.5-mm and 3.5-mm or 8-mm electrode catheters positioned perpendicular or parallel to the tissue. In step 3, in vivo bipolar RFA was performed between 3.5-mm and either 3.5-mm or 8-mm parallel electrode at the: 1) left ventricular summit; 2) interventricular septum; and 3) healed anterior infarction., Results: In step 1, increasing the surface area of the return electrode resulted in lower circuit impedance (R = -0.65; P < 0.001), higher current (R = +0.80; P < 0.001), and larger lesion volume (R = +0.88; P < 0.001). In step 2, an 8-mm return electrode parallel to tissue produced larger and deeper lesions compared with a 3.5-mm return electrode (P = 0.014 and P = 0.02). Similarly, in step 3, compared with a 3.5-mm, bipolar RFA with an 8-mm return electrode produced larger (volume: 1,525 ± 871 mm 3 vs 306 ± 310 mm 3 , respectively; P < 0.001) and more transmural lesions (88% vs 0%; P < 0.001)., Conclusions: Bipolar RFA using an 8-mm return electrode positioned parallel to the tissue produces larger lesions in comparison with a 3.5-mm return electrode., Competing Interests: Funding Support and Author Disclosures Mr Bubar is an employee of Biosense Webster. Dr Tarakji receives consultation fees from AliveCor, Medtronic, Janssen, and Pfizer. Dr Anter has received research grants and speaking honoraria from Biosense Webster, Boston Scientific, Affera Inc, and Itamar Medical; and holds stock options in Affera Inc. Dr Koruth has received research grants from Affera Inc, Farapulse, Cardiofocus, Biosense, Acutus, Kardium; has equity in Affera Inc; and serves as a consultant to Farapulse and Abbott. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aims: We studied the extent/area of electrical pulmonary vein isolation (PVI) after either pulsed field ablation (PFA) using a pentaspline catheter or thermal ablation technologies., Methods and Results: In a clinical trial (NCT03714178), paroxysmal atrial fibrillation (PAF) patients underwent PVI with a multi-electrode pentaspline PFA catheter using a biphasic waveform, and after 75 days, detailed voltage maps were created during protocol-specified remapping studies. Comparative voltage mapping data were retrospectively collected from consecutive PAF patients who (i) underwent PVI using thermal energy, (ii) underwent reablation for recurrence, and (iii) had durably isolated PVs. The left and right PV antral isolation areas and non-ablated posterior wall were quantified. There were 20 patients with durable PVI in the PFA cohort, and 39 in the thermal ablation cohort [29 radiofrequency ablation (RFA), 6 cryoballoon, and 4 visually guided laser balloon]. Pulsed field ablation patients were younger with shorter follow-up. Left atrial diameter and ventricular systolic function were preserved in both cohorts. There was no significant difference between the PFA and thermal ablation cohorts in either the left- and right-sided PV isolation areas, or the non-ablated posterior wall area. The right superior PV isolation area was smaller with PFA than RFA, but this disappeared after propensity score matching. Notch-like normal voltage areas were seen at the posterior aspect of the carina in the balloon sub-cohort, but not the PFA or RFA cohorts., Conclusion: Catheter-based PVI with the pentaspline PFA catheter creates chronic PV antral isolation areas as encompassing as thermal energy ablation., (© The Author(s) 2021. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Importance: Early rhythm control of atrial fibrillation (AF) with either antiarrhythmic drugs (AADs) or catheter ablation has been reported to improve cardiovascular outcomes compared with usual care; however, the optimal therapeutic modality to achieve early rhythm control is unclear., Objective: To assess the safety and efficacy of AF ablation as first-line therapy when compared with AADs in patients with paroxysmal AF., Data Sources: PubMed/MEDLINE, Scopus, Google Scholar, and various major scientific conference sessions from January 1, 2000, through November 23, 2020., Study Selection: Randomized clinical trials (RCTs) published in English that had at least 12 months of follow-up and compared clinical outcomes of ablation vs AADs as first-line therapy in adults with AF. The quality of individual studies was assessed using the Cochrane risk of bias tool. Six RCTs met inclusion criteria, including 1212 patients., Data Extraction and Synthesis: Two investigators independently extracted data. Reporting was performed in compliance with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analysis) guidelines. Analysis was performed using a random-effects model with the Mantel-Haenszel method, and results are presented as 95% CIs., Main Outcomes and Measures: Main outcomes were safety and efficacy of AF ablation as first-line therapy when compared with AADs. Trials were evaluated as having low risk of selection and attrition biases, high risk of performance bias, and with unclear risk for detection biases due to unblinding and open-label designs., Results: A total of 6 RCTs involving 1212 patients with AF were included (609 were randomized to AF ablation and 603 to drug therapy; mean [SD] age, 56 [11] years). Compared with AADs, catheter ablation use was associated with reductions in recurrent atrial arrhythmia (32.3% vs 53%; risk ratio [RR], 0.62; 95% CI, 0.51-0.74; P < .001; I2 = 40%), with a number needed to treat with ablation to prevent 1 arrhythmia of 5. Use of ablation was also associated with reduced symptomatic atrial arrhythmia (11.8% vs 26.4%; RR, 0.44; 95% CI, 0.27-0.72; P = .001; I2 = 54%) and hospitalization (5.6% vs 18.7%; RR, 0.32; 95% CI, 0.19-0.53; P < .001) with no significant difference in serious adverse events between the groups (4.2% vs 2.8%; RR, 1.52; 95% CI, 0.81-2.85; P = .19)., Conclusions and Relevance: In this meta-analysis of randomized clinical trials including first-line therapy of patients with paroxysmal AF, catheter ablation compared with antiarrhythmic drugs was associated with reductions in recurrence of atrial arrhythmias and hospitalizations, with no difference in major adverse events.

Background: The tissue specificity of pulsed field ablation (PFA) makes it an attractive energy source for pulmonary vein (PV) isolation (PVI). However, beyond each PFA lesion's zone of irreversible electroporation and cell death, there may be a surrounding zone of reversible electroporation and cell injury that could potentially normalize with time., Objective: The purpose of this study was to assess whether the level of electrical PVI that is observed acutely after PFA regresses over time., Methods: In a clinical trial, patients with paroxysmal atrial fibrillation underwent PVI using a biphasic PFA waveform delivered through a dedicated, variably deployable multielectrode basket/flower catheter. Detailed voltage maps were created using a multispline diagnostic catheter immediately after PFA and again ∼3 months later in a prospective, protocol-specified reassessment procedure. We analyzed 20 patients who underwent PFA with durable PVI and available maps from both time points. To compare the ablated zones, the left- and right-sided PV antral isolation areas and nonablated posterior wall area were quantified and the distances between left and right PV low-voltage edges were measured., Results: A comparison of voltage maps immediately after PFA and at a median of 84 days (interquartile range 69-90 days) later revealed that there was no significant difference in either the left- and right-sided PV antral isolation areas or nonablated posterior wall area. The distances between low-voltage edges on the posterior wall were also not significantly different between the 2 time points., Conclusion: This study demonstrates that the level of PV antral isolation after PFA with a multielectrode PFA catheter persists without regression., (Copyright © 2021 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: Same-day discharge (SDD) after atrial fibrillation (AF) ablation is increasingly being considered. This study examined the barriers and financial impact associated with SDD in a contemporary cohort of patients undergoing elective AF ablation., Methods: A single center retrospective review was conducted of the 249 first case-of-the-day outpatient AF ablations performed in 2019 to evaluate the proportion of patients that could have undergone SDD. Barriers to SDD were defined as any intervention that prevented SDD by 8 p.m. The financial impact of SDD was based on savings from avoidance of the overnight hospital stay and revenue related to management of chest pain facilitated by a vacant hospital bed., Results: SDD could have occurred in 157 patients (63%) without change in management and in up to 200 patients (80%) if avoidable barriers were addressed. Barriers to SDD included non-clinical logistical issues (43%), prolonged post-procedure recovery (42%) and minor procedural complications (15%). On multivariate analysis, factors associated with barriers to SDD included increasing age (P = .01), left ventricular ejection fraction ≤ 35% (P = .04), and severely dilated left atrium (P = .04). The financial gain from SDD would have ranged from $1,110,096 (assuming discharge of 63% of eligible patients) to $1,480,128 (assuming 80% discharge) over the course of a year., Conclusions: Up to 80% of patients undergoing outpatient AF ablation were amenable to SDD if avoidable delays in care had been anticipated. Based on reduced hospital operating expenses and increased revenue from management of individuals with chest pain, this would translate to a financial savings of ∼$1.5 million., (© 2021 Wiley Periodicals LLC.)

Background: Pulmonary vein (PV) stenosis is an important potential complication of PV isolation using thermal modalities such as radiofrequency ablation (RFA). Pulsed field ablation (PFA) is an alternative energy that causes nonthermal myocardial cell death., Objective: The purpose of this study was to compare the effect of PFA vs RFA on the incidence and severity of PV narrowing or stenosis., Methods: Data were analyzed from 4 paroxysmal atrial fibrillation ablation trials using either PFA or RFA; because of absent CT scans or poor computed tomography scan quality, 73 of 153 patients (47.7%) were excluded. Baseline and 3-month cardiac computed tomography scans were reconstructed into 3-dimensional images, and the long and short axes of the PV ostia were quantitatively and qualitatively assessed in a randomized blinded manner by 2 physicians., Results: A total of 299 PVs from 80 patients after either PFA (n = 37) or RFA (n = 43) were enrolled. PV ostial diameters decreased significantly less with PFA than with RFA (% change; long axis: 0.9% ± 8.5% vs -11.9% ± 16.3%; P < .001 and short axis: 3.4% ± 12.7% vs -12.9% ± 18.5%; P < .001). After a combined quantitative/qualitative analysis, mild (30%-49%), moderate (50%-69%), or severe (70%-100%) PV narrowing was observed, respectively, in 9.0% (15 of 166), 1.8% (3 of 166), and 1.2% (2 of 166) of PVs in the RFA cohort but in none of the PVs after PFA (P < .001). Overall, PV narrowing/stenosis was present in 0% and 0% vs 12.0% and 32.5% of PVs and patients who underwent PFA and RFA, respectively., Conclusion: This study indicates that unlike after RFA, the incidence and severity of PV narrowing/stenosis after PV isolation is virtually eliminated with PFA., (Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.)

Introduction: Pulmonary vein isolation (PVI) using standard radiofrequency (RF) catheters is limited by incomplete contiguity and prolonged procedural times. A novel, 9-mm lattice-tip irrigated RF catheter can create wide lesions rapidly in swine atria., Methods: In five swine, temperature limited (75°C) irrigated RF for 5 seconds/ablation was selected, to isolate seven pulmonary veins (PVs; five right superior and two inferior commons) and create five right atrial lines. After 4 weeks, repeat mapping and additional ablation to create atrial isthmus lesions were performed. The chronic lesions were submitted for histology. This was compared with right superior PVI data using standard 3.5-mm irrigated tip ablation in six swine., Results: All targeted PVs (seven of seven, 100%) were acutely isolated. Durable isolation was observed in all six of six PVs treated with 5-second applications, but not in one PV inadvertently treated with 4-second applications. For the durably isolated PVs, the mean lesion count/PV and total RF time/PV was 16.3 ± 5.2 applications and 81.3 ± 25.9 seconds for the right superior and 14.5 ± 0.7 applications and 71.1 ± 5.5 seconds for the inferior common PV. Right atrial linear ablation was performed with a lesion count of 12 ± 2.3 applications and RF times of 59.5 ± 12.5 seconds. Cavotricuspid and mitral isthmus linear ablations were transmural along their entire length. All 53 of 53 (100%) sections were transmural on histology., Conclusion: Rapid and durable PVI and linear atrial ablation is feasible with this novel 9-mm lattice-tip catheter., (© 2020 Wiley Periodicals, Inc.)

Background: The tissue selectivity of pulsed field ablation (PFA) provides safety advantages over radiofrequency ablation in treating atrial fibrillation. One-shot PFA catheters have been shown capable of performing pulmonary vein isolation, but not flexible lesion sets such as linear lesions. A novel lattice-tip ablation catheter with a compressible 9-mm nitinol tip is able to deliver either focal radiofrequency ablation or PFA lesions, each in 2 to 5 s., Methods: In a 3-center, single-arm, first-in-human trial, the 7.5F lattice catheter was used with a custom mapping system to treat paroxysmal or persistent atrial fibrillation. Toggling between energy sources, point-by-point pulmonary vein encirclement was performed using biphasic PFA posteriorly and either temperature-controlled irrigated radiofrequency ablation or PFA anteriorly (RF/PF or PF/PF, respectively). Linear lesions were created using either PFA or radiofrequency ablation., Results: The 76-patient cohort included 55 paroxysmal and 21 persistent atrial fibrillation patients undergoing either RF/PF (40 patients) or PF/PF (36 patients) ablation. The pulmonary vein isolation therapy duration time (transpiring from first to last lesion) was 22.6±8.3 min/patient, with a mean of 50.1 RF/PF lesions/patient. Linear lesions included 14 mitral (4 RF/2 RF+PF/8 PF), 34 left atrium roof (12 RF/22 PF), and 44 cavotricuspid isthmus (36 RF/8 PF) lines, with therapy duration times of 5.1±3.5, 1.8±2.3, and 2.4±2.1 min/patient, respectively. All lesion sets were acutely successful, using 4.7±3.5 minutes of fluoroscopy. There were no device-related complications, including no strokes. Postprocedure esophagogastroduodenoscopy revealed minor mucosal thermal injury in 2 of 36 RF/PF and 0 of 24 PF/PF patients. Postprocedure brain magnetic resonance imaging revealed diffusion-weighted imaging+/fluid-attenuated inversion recovery- and diffusion-weighted imaging+/fluid-attenuated inversion recovery+ asymptomatic lesions in 5 and 3 of 51 patients, respectively., Conclusions: A novel lattice-tip catheter could safely and rapidly ablate atrial fibrillation using either a combined RF/PF approach (capitalizing on the safety of PFA and the years of experience with radiofrequency energy) or an entirely PF approach. Registration: URL: https://www.clinicaltrials.gov; Unique identifiers: NCT04141007 and NCT04194307.

Background: A novel ablation and mapping system can toggle between delivering biphasic pulsed field (PF) and radiofrequency energy from a 9-mm lattice-tip catheter. We assessed the preclinical feasibility and safety of (1) focal PF-based thoracic vein isolation and linear ablation, (2) combined PF and radiofrequency focal ablation, and (3) PF delivered directly atop the esophagus., Methods: Two cohorts of 6 swine were treated with pulsed fields at low dose (PF LD ) and high dose (PF HD ) and followed for 4 and 2 weeks, respectively, to isolate 25 thoracic veins and create 5 right atrial (PF LD ), 6 mitral (PF HD ), and 6 roof lines (radiofrequency+PF HD ). Baseline and follow-up voltage mapping, venous potentials, ostial diameters, and phrenic nerve viability were assessed. PF HD and radiofrequency lesions were delivered in 4 and 1 swine from the inferior vena cava onto a forcefully deviated esophagus. All tissues were submitted for histopathology., Results: Hundred percent of thoracic veins (25 of 25) were successfully isolated with 12.4±3.6 applications/vein with mean PF times of <90 seconds/vein. Durable isolation improved from 61.5% PF LD to 100% with PF HD ( P =0.04), and all linear lesions were successfully completed without incurring venous stenoses or phrenic injury. PF HD sections had higher transmurality rates than PF LD (98.3% versus 88.1%; P =0.03) despite greater mean thickness (2.5 versus 1.3 mm; P <0.001). PF lesions demonstrated homogenous fibrosis without epicardial fat, nerve, or vessel involvement. In comparison, radiofrequency+PF HD sections revealed similar transmurality but expectedly more necrosis, inflammation, and epicardial fat, nerve, and vessel involvement. Significant ablation-related esophageal necrosis, inflammation, and fibrosis were seen in all radiofrequency sections, as compared with no PF sections., Conclusions: The lattice-tip catheter can deliver focal PF to durably isolate veins and create linear lesions with excellent transmurality and without complications. The PF lesions did not damage the phrenic nerve, vessels, and the esophagus.

Catheter ablation of atrial fibrillation necessitates ablation on the posterior left atrium. The anterior esophagus touches the posterior left atrium, although its course is highly variable. The proximity of the left atrium to the esophagus confers risk of injury with radiofrequency and cryoablation owing to the heat transfer that occurs with thermal ablation. Early detection of esophageal temperature changes with probes may decrease the extent of damage to the esophagus, but evidence is mixed. Avoiding ablation on the esophagus with esophageal deviation and modifying ablation approaches may decrease the risk of injury., Competing Interests: Disclosure Dr V.Y. Reddy: Manual Surgical Sciences and Circa Scientific. Drs R. Bhardwaj and J.S. Koruth have nothing to disclose., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Aims: Pulsed field ablation (PFA) is a novel, non-thermal modality that selectively ablates myocardium with ultra-short electrical impulses while sparing collateral tissues. In a proof-of-concept study, the safety and feasibility of ventricular PFA were assessed using a prototype steerable, endocardial catheter., Methods and Results: Under general anaesthesia, the left and right ventricles of four healthy swine were ablated using the 12-Fr deflectable PFA catheter and a deflectable sheath guided by electroanatomic mapping. Using the study catheter, electrograms were recorded for each site and pre-ablation and post-ablation pacing thresholds (at 2.0 ms pulse width) were recorded in two of four animals. After euthanasia at 35.5 days, the hearts were submitted for histology. The PFA applications (n = 39) resulted in significant electrogram reduction without ventricular arrhythmias. In ablation sites where it was measured, the pacing thresholds increased by >16.8 mA in the right ventricle (3 sites) and >16.1 mA in the left ventricle (7 sites), with non-capture at maximum amplitude (20 mA) observable in 8 of 10 sites. Gross measurements, available for 28 of 30 ablation sites, revealed average lesion dimensions to be 6.5 ± 1.7 mm deep by 22.6 ± 4.1 mm wide, with a maximum depth and width of 9.4 mm and 28.6 mm, respectively. In the PFA lesions, fibrous tissue homogeneously replaced myocytes with a narrow zone of surrounding myocytolysis and no overlying thrombus. When present, nerve fascicles and vasculature were preserved within surrounding fibrosis., Conclusion: We demonstrate that endocardial PFA can be focally delivered using this prototype catheter to create homogeneous, myocardium-specific lesions., (© The Author(s) 2019. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Background: Pulsed field ablation (PFA) can be myocardium selective, potentially sparing the esophagus during left atrial ablation. In an in vivo porcine esophageal injury model, we compared the effects of newer biphasic PFA with radiofrequency ablation (RFA)., Methods: In 10 animals, under general anesthesia, the lower esophagus was deflected toward the inferior vena cava using an esophageal deviation balloon, and ablation was performed from within the inferior vena cava at areas of esophageal contact. Four discrete esophageal sites were targeted in each animal: 6 animals received 8 PFA applications/site (2 kV, multispline catheter), and 4 animals received 6 clusters of irrigated RFA applications (30 W×30 seconds, 3.5 mm catheter). All animals were survived to 25 days, sacrificed, and the esophagus submitted for pathological examination, including 10 discrete histological sections/esophagus., Results: The animals weight increased by 13.7±6.2% and 6.8±6.3% ( P =0.343) in the PFA and RFA cohorts, respectively. No PFA animals (0 of 6, 0%) developed abnormal in-life observations, but 1 of 4 RFA animals (25%) developed fever and dyspnea. On necropsy, no PFA animals (0 of 6, 0%) demonstrated esophageal lesions. In contrast, esophageal injury occurred in all RFA animals (4 of 4, 100%; P =0.005): a mean of 1.5 mucosal lesions/animal (length, -21.8±8.9 mm; width, -4.9±1.4 mm) were observed, including one esophago-pulmonary fistula and deep esophageal ulcers in the other animals. Histological examination demonstrated tissue necrosis surrounded by acute and chronic inflammation and fibrosis. The necrotic RFA lesions involved multiple esophageal tissue layers with evidence of arteriolar medial thickening and fibrosis of periesophageal nerves. Abscess formation and full-thickness esophageal wall disruptions were seen in areas of perforation/fistula., Conclusions: In this novel porcine model of esophageal injury, biphasic PFA induced no chronic histopathologic esophageal changes, while RFA demonstrated a spectrum of esophageal lesions including fistula and deep esophageal ulcers and abscesses.

Aims: During atrial fibrillation ablation, oesophageal heating typically prompts reduction or termination of radiofrequency energy delivery. We previously demonstrated oesophageal temperature rises are associated with posterior left atrial pulmonary vein reconnection (PVR) during redo procedures. In this study, we assessed whether mechanical oesophageal deviation (MED) during an index procedure minimizes posterior wall PVRs during redo procedures., Methods and Results: Patients in whom we performed a first-ever procedure followed by a clinically driven redo procedure were divided based on both the use of MED for oesophageal protection and the ablation catheter employed (force or non-force sensing) in the first procedure. The PVR sites were compared between MED using a force-sensing catheter (MEDForce), or no MED with a non-force (ControlNoForce) or force (ControlForce) sensing catheter. Despite similar clinical characteristics, the MEDForce redo procedure rate (9.2%, 26/282 patients) was significantly less than the ControlNoForce (17.2%, 126/734 patients; P = 0.002) and ControlForce (17.5%, 20/114 patients; P = 0.024) groups. During the redo procedure, the posterior PVR rate with MEDForce (2%, 1/50 PV pairs) was significantly less than with either ControlNoForce (17.7%, 44/249 PV pairs; P = 0.004) or ControlForce (22.5%, 9/40 PV pairs; P = 0.003), or aggregate Controls (18.3%, 53/289 PV pairs; P = 0.006). However, the anterior PVR rate with MEDForce (8%, 4/50 PV pairs) was not significantly different than Controls (aggregate Controls-3.5%, 10/289 PV pairs, P = 0.136; ControlNoForce-2.4%, 6/249 PV pairs, P = 0.067; ControlForce-10%, 4/40 PV pairs, P = 1.0)., Conclusion: Oesophageal deviation improves the durability of the posterior wall ablation lesion set during AF ablation., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2019. For permissions, please email: journals.permissions@oup.com.)

Background: Nodofascicular and nodoventricular (NFV) accessory pathways connect the atrioventricular node and the Purkinje system or ventricular myocardium, respectively. Concealed NFV pathways participate as the retrograde limb of supraventricular tachycardia (SVT). Manifest NFV pathways can comprise the anterograde limb of wide-complex SVT but are quite rare. The purpose of this report is to highlight the electrophysiological properties and sites of ablation for manifest NFV pathways., Methods: Eight patients underwent electrophysiology studies for wide-complex tachycardia (3), for narrow-complex tachycardia (1), and preexcitation (4)., Results: NFV was an integral part of the SVT circuit in 3 patients. Cases 1 to 2 were wide-complex tachycardia because of manifest NFV SVT. Case 3 was a bidirectional NFV that conducted retrograde during concealed NFV SVT and anterograde causing preexcitation during atrial pacing. NFV was a bystander during atrioventricular node re-entrant tachycardia, atrial fibrillation, atrial flutter, and orthodromic atrioventricular re-entrant tachycardia in 4 cases and caused only preexcitation in 1. Successful NFV ablation was achieved empirically in the slow pathway region in 1 case. In 5 cases, the ventricular insertion was mapped to the slow pathway region (2 cases) or septal right ventricle (3 cases). The NFV was not mapped in cases 5 and 7 because of its bystander role. QRS morphology of preexcitation predicted the right ventricle insertion sites in 4 of the 5 cases in which it was mapped. During follow-up, 1 patient noted recurrent palpitations but no documented SVT., Conclusions: Manifest NFV may be critical for wide-complex tachycardia/manifest NFV SVT, act as the retrograde limb for narrow-complex tachycardia/concealed NFV SVT, or cause bystander preexcitation. Ablation should initially target the slow pathway region, with mapping of the right ventricle insertion site if slow pathway ablation is not successful. The QRS morphology of maximal preexcitation may be helpful in predicting successful right ventricle ablation site.

Background: Catheter ablation of atrial fibrillation using thermal energies such as radiofrequency or cryothermy is associated with indiscriminate tissue destruction. During pulsed field ablation (PFA), subsecond electric fields create microscopic pores in cell membranes-a process called electroporation. Among cell types, cardiomyocytes have among the lowest thresholds to these fields, potentially permitting preferential myocardial ablation., Objectives: The purpose of these 2 trials was to determine whether PFA allows durable pulmonary vein (PV) isolation without damage to collateral structures., Methods: Two trials were conducted to assess the safety and effectiveness of catheter-based PFA in paroxysmal atrial fibrillation. Ablation was performed using proprietary bipolar PFA waveforms: either monophasic with general anesthesia and paralytics to minimize muscle contraction, or biphasic with sedation because there was minimal muscular stimulation. No esophageal protection strategy was used. Invasive electrophysiological mapping was repeated after 3 months to assess the durability of PV isolation., Results: In 81 patients, all PVs were acutely isolated by monophasic (n = 15) or biphasic (n = 66) PFA with ≤3 min elapsed delivery/patient, skin-to-skin procedure time of 92.2 ± 27.4 min, and fluoroscopy time of 13.1 ± 7.6 min. With successive waveform refinement, durability at 3 months improved from 18% to 100% of patients with all PVs isolated. Beyond 1 procedure-related pericardial tamponade, there were no additional primary adverse events over the 120-day median follow-up, including: stroke, phrenic nerve injury, PV stenosis, and esophageal injury. The 12-month Kaplan-Meier estimate of freedom from arrhythmia was 87.4 ± 5.6%., Conclusions: In first-in-human trials, PFA preferentially affected myocardial tissue, allowing facile ultra-rapid PV isolation with excellent durability and chronic safety. (IMPULSE: A Safety and Feasibility Study of the IOWA Approach Endocardial Ablation System to Treat Atrial Fibrillation; NCT03700385; and PEFCAT: A Safety and Feasibility Study of the FARAPULSE Endocardial Ablation System to Treat Paroxysmal Atrial Fibrillation; NCT03714178)., (Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.)

Catheter ablation for atrial fibrillation has improved in part due to advances in technology and techniques. Improved power delivery through contact force and irrigation and new balloon-based catheter systems for pulmonary vein isolation have resulted in greater success in paroxysmal atrial fibrillation. New tools are under development to facilitate understanding targets for ablation in persistent atrial fibrillation and create permanent ablation lesions safely and quickly., (Copyright © 2019 Elsevier Inc. All rights reserved.)

This article has been corrected. The original version (PDF) is appended to this article as a Supplement., Background: Atrial fibrillation (AF) and heart failure (HF) frequently coexist and are associated with increased morbidity and mortality risk., Purpose: To compare benefits and harms between catheter ablation and drug therapy in adult patients with AF and HF., Data Sources: ClinicalTrials.gov, PubMed, Web of Science (Clarivate Analytics), EBSCO Information Services, Cochrane Central Register of Controlled Trials, Google Scholar, and various scientific conference sessions from 1 January 2005 to 1 October 2018., Study Selection: Randomized controlled trials (RCTs) published in English that had at least 6 months of follow-up and compared clinical outcomes of catheter ablation versus drug therapy in adults with AF and HF., Data Extraction: 2 investigators independently extracted data and assessed study quality., Data Synthesis: 6 RCTs involving 775 patients met inclusion criteria. Compared with drug therapy, AF ablation reduced all-cause mortality (9.0% vs. 17.6%; risk ratio [RR], 0.52 [95% CI, 0.33 to 0.81]) and HF hospitalizations (16.4% vs. 27.6%; RR, 0.60 [CI, 0.39 to 0.93]). Ablation improved left ventricular ejection fraction (LVEF) (mean difference, 6.95% [CI, 3.0% to 10.9%]), 6-minute walk test distance (mean difference, 20.93 m [CI, 5.91 to 35.95 m]), peak oxygen consumption (Vo2max) (mean difference, 3.17 mL/kg per minute [CI, 1.26 to 5.07 mL/kg per minute]), and quality of life (mean difference in Minnesota Living with Heart Failure Questionnaire score, -9.02 points [CI, -19.75 to 1.71 points]). Serious adverse events were more common in the ablation groups, although differences between the ablation and drug therapy groups were not statistically significant (7.2% vs. 3.8%; RR, 1.68 [CI, 0.58 to 4.85])., Limitation: Results driven primarily by 1 clinical trial, possible patient selection bias in the ablation group, lack of patient-level data, open-label trial designs, and heterogeneous follow-up length among trials., Conclusion: Catheter ablation was superior to conventional drug therapy in improving all-cause mortality, HF hospitalizations, LVEF, 6-minute walk test distance, Vo2max, and quality of life, with no statistically significant increase in serious adverse events., Primary Funding Source: None.

Objectives: The goal of this study was to determine the safety and feasibility of a novel esophageal balloon retractor (DV8) for MED during PVI., Background: The authors previously showed that mechanical esophageal deviation (MED) is feasible using an off-the-shelf metal stylet to allow uninterrupted ablation along the posterior left atrium during pulmonary vein isolation (PVI). Although it is an attractive strategy to avoid esophageal thermal injury, this technique was hampered by both the propensity for oropharyngeal trauma from the stiff stylet and the limited lateral esophageal displacement., Methods: In 200 consecutive patients undergoing atrial fibrillation ablation, the DV8 balloon retractor was used for MED; contrast was instilled into the esophagus to accurately delineate the trailing esophageal edge. Deviation was performed to maximize the distance from the trailing esophageal edge to the closest point of the ablation line (MED Effective ) and correlated to occurrences of luminal esophageal temperature elevation., Results: In patients undergoing MED during a first-ever PVI of 304 vein pairs, the MED Effective during right and left PVI were 21.2 ± 8.7 mm and 15.5 ± 6.8 mm, respectively. Deviation of at least 5 mm of MED Effective was achievable in 97.7%. Luminal esophageal temperature increases universally occurred (100%) at MED Effective  <5 mm, less often (28%) at MED Effective 5 to 20 mm, and rarely (1.9%) at MED Effective >20 mm. There were no esophageal complications, but 2 patients experienced oropharyngeal bleeding due to trauma related to device placement., Conclusions: MED with the balloon retractor safely moved the esophagus away from the site of energy delivery during atrial fibrillation ablation., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

In contrast to ventricular tachycardia (VT) that occurs in the setting of a structurally normal heart, VT that occurs in patients with structural heart disease carries an elevated risk for sudden cardiac death (SCD), and implantable cardioverter-defibrillators (ICDs) are the mainstay of therapy. In these individuals, catheter ablation may be used as adjunctive therapy to treat or prevent repetitive ICD therapies when antiarrhythmic drugs are ineffective or not desired. However, certain patients with frequent premature ventricular contractions (PVCs) or VT and tachycardiomyopathy should be considered for ablation before ICD implantation because left ventricular function may improve, consequently decreasing the risk of SCD and obviating the need for an ICD. The goal of this paper is to review the pathophysiology, mechanism, and management of VT in the setting of structural heart disease and discuss the evolving role of catheter ablation in decreasing ventricular arrhythmia recurrence., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Catheter ablation of ventricular tachycardia (VT) is being increasingly performed; yet, there is often confusion regarding indications, outcomes, and how to identify those patient populations most likely to benefit. The management strategy differs between those with structural heart disease and those without. For the former, an implantable cardioverter-defibrillator (ICD) is typically required due to an elevated risk for sudden cardiac death, and catheter ablation can be used as adjunctive therapy to treat or prevent repetitive ICD therapies. In contrast, VT or premature ventricular contractions in the setting of a structurally normal heart carries a low risk for sudden cardiac death; accordingly, there is typically no indication for an ICD. In these patients, catheter ablation is considered for symptom management or to treat tachycardiomyopathy and is potentially curative. Here, the authors discuss the pathophysiology, mechanism, and management of VT that occurs in the setting of a structurally normal heart and the role of catheter ablation., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study sought to compare a novel lesion dimension estimation approach to actual measurements of lesion dimensions on necropsy in porcine atria and ventricles., Background: An irrigated-tip, force-sensing radiofrequency catheter with 6 temperature (tip-tissue interface) sensors allows for assessment of lesion dimensions based on estimated tissue temperature. Lesion dimension assessment has not been attempted previously in atrial tissue., Methods: Ablations were performed using this catheter in all chambers. Irrigated radiofrequency was delivered using 20 to 50 W for durations that ranged from 15 to 90 s with contact force ranging from 5 to 45 g to replicate a wide spectrum of clinical conditions. All swine were then sacrificed and lesions were identified and photographed. Three independent observers made offline measurements, which were then averaged to obtain lesion width and depth for comparison with estimated dimensions based on interface tissue temperature., Results: In 9 swine, 54 atrial and 61 ventricular lesions were assessed. In the atria, the mean difference between the measured and estimated depth and width was 0.9 ± 0.74 mm and 1.2 ± 0.9 mm, respectively. Eighty percent of all lesions had a difference of ≤1.7 mm for depth and ≤1.74 mm for width. In the ventricle, the mean difference between the measured and estimated depth and width was 0.75 ± 0.6 mm and 1.66 ± 1.1 mm, respectively. Eighty percent of all lesions had a difference of ≤1.1 mm ventricular depth and ≤2.6 mm for width., Conclusions: Estimation of lesion dimensions can be achieved with clinically relevant accuracy using unique temperature signatures. These data have important implications for understanding the adequacy of lesion overlap and assessment of transmurality., (Copyright © 2017. Published by Elsevier Inc.)

Objectives: This study sought to determine the extent of lateral esophageal displacement required during mechanical esophageal deviation (MED) and to eliminate luminal esophageal temperature elevation (LET Elev ) during pulmonary vein (PV) isolation., Background: MED is a conceptually attractive strategy of minimizing esophageal injury while allowing uninterrupted energy delivery along the posterior left atrium during PV isolation., Methods: MED was performed using a malleable metal stylet within a plastic tube placed within the esophagus. Barium was instilled to characterize the trailing esophageal edge. For each MED attempt, the MED Effective , defined as the distance from the trailing esophageal edge-to-ablation line, was correlated to occurrences of LET Elev ., Results: In 114 consecutive patients/221 PV pairs undergoing MED (age 62.1 ± 11 years, 75% men, 62%/38% paroxysmal/persistent AF), esophageal stretching invariably occurred such that the esophageal edge trailed behind the plastic tube. MED Effective distances of 0 mm to 10 mm, 10 mm to 15 mm, 15 mm to 20 mm or >20 mm were achieved in 60 (27.1%), 64 (29%), 48 (21.7%), and 49 (22.2%) attempts, respectively. Overall, LET elevation >38°C occurred in 81 of 221 (36.7%) PV pairs. The incidence of LET Elev among the 4 groups was 73.3%, 35.9%, 25%, and 4.1%, respectively. MED Effective distances were 9.1 ± 6.5 mm and 18 ± 7.6 mm in patients with and without LET Elev , respectively (p < 0.0001). Three patients (2.6%) experienced clinically significant MED-related trauma, albeit only with a stiffer stylet., Conclusions: Mechanical esophageal deviation >20 mm from the PV ablation line prevents significant esophageal heating during PV isolation, but this level of displacement was difficult to safely achieve with this off-the-shelf mechanical stylet approach., (Copyright © 2017. Published by Elsevier Inc.)

Background: Saline irrigation improved the safety of radiofrequency (RF) ablation, but the thermal feedback for energy titration is absent., Objectives: To allow temperature-controlled irrigated ablation, a novel irrigated RF catheter was designed with a diamond-embedded tip (for rapid cooling) and 6 surface thermocouples to reflect tissue temperature. High-resolution electrograms (EGMs) from the split-tip electrode allowed rapid lesion assessment. The authors evaluated the preclinical and clinical performance of this catheter for pulmonary vein (PV) isolation., Methods: Using the DiamondTemp (DT) catheter, pigs (n = 6) underwent discrete atrial ablation in a temperature control mode (60°C/50 W) until there was ∼80% EGM amplitude reduction. In a single-center clinical feasibility study, 35 patients underwent PV isolation with the DT catheter (study group); patients were planned for PV remapping after 3 months, regardless of symptomatology. A control group included 35 patients who underwent PV isolation with a standard force-sensing catheter., Results: Porcine lesion histology revealed transmurality in 51 of 55 lesions (92.7%). In patients, all PVs were successfully isolated; no char or thrombus formation was observed. Compared with the control group, the study cohort had shorter mean RF application duration (26.3 ± 5.2 min vs. 89.2 ± 27.2 min; p < 0.001), shorter mean fluoroscopic time (11.2 ± 8.5 min vs. 19.5 ± 6.8 min; p < 0.001), and lower acute dormant PV reconduction (0 of 35 vs. 5 of 35; p = 0.024). At 3 months, 23 patients underwent remapping: 39 of 46 PV pairs (84.8%) remained durably isolated in 17 of these patients (73.9%)., Conclusions: This first-in-human series demonstrated that temperature-controlled irrigated ablation produced rapid, efficient, and durable PV isolation. (ACT DiamondTemp Temperature-Controlled and Contact Sensing RF Ablation Clinical Trial for Atrial Fibrillation [TRAC-AF]; NCT02821351)., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Although percutaneous left ventricular assist devices (pLVADs) facilitate mapping and ablation of hemodynamically unstable ventricular tachycardia (VT), there is limited data whether clinical outcomes are improved. We sought to retrospectively compare the outcomes of patients undergoing scar-related VT ablation with and without pLVAD support., Methods and Results: The study population comprised 194 patients (109 pLVAD and 85 non-pLVAD). The pLVAD group more often had dilated cardiomyopathy (33% versus 13%; P =0.001), New York Heart Association heart failure class ≥III (51% versus 25%; P <0.001), lower left ventricular ejection fractions (26±10% versus 39±16%; P <0.001), and electrical storm (49% versus 34%; P =0.04). Procedure times (422±112 versus 330±92 minutes; P <0.001), postablation VT inducibility (20% versus 7%; P =0.02), and length of subsequent hospitalization (median 6 versus 4 days; P =0.001) were all higher in the pLVAD group. During median follow-up of 215 days, the primary end point (recurrent VT, heart transplantation, or death) occurred in 36% of the pLVAD versus 26% of the non-pLVAD groups ( P =0.14). After propensity matching for differences between groups, no differences were seen between groups for both acute procedural outcomes and the primary end point., Conclusions: In this large single-center scar-related VT ablation experience, despite the worse clinical status of the patients selected for pLVAD support, clinical outcomes were better than expected and were similar to healthier patients not receiving hemodynamic support. Patients with dilated cardiomyopathy presenting with electrical storm, advanced heart failure, and severe left ventricular dysfunction most frequently received hemodynamic support during VT ablation., (© 2017 American Heart Association, Inc.)

Introduction: Standard unipolar radiofrequency ablation (RFA) is typically successful in eliminating premature ventricular contractions (PVCs) originating from the ventricular outflow tract region. In a minority of cases, this approach may be ineffective. We report 4 cases where bipolar RFA was attempted after failed unipolar RFA., Methods: From a total of 73 consecutive PVC ablations, 4 patients underwent bipolar RFA after failed unipolar ablation. Three-dimensional electroanatomic activation mapping of the right and left ventricular outflow (RVOT and LVOT), coronary sinus, and aortic root was performed., Results: Mean age was 53 ± 22 years, 3 male. The mean 24-hour PVC burden in these patients was 33,107 ± 8,712. In 3 of 4 patients, the RVOT activation was earlier than the left side. The earliest activation on the left was in the right coronary cusp in 2 patients and left coronary cusp in 2. Unipolar RFA delivered sequentially at the site of earliest RVOT and then earliest aortic cusp sites failed to eradicate the PVCs in all 4 patients. Subsequently, bipolar RFA was applied between irrigated catheters placed at the earliest RVOT and aortic root sites. This approach eliminated PVCs in 3 of 4 (75%) cases. At a median follow-up of 4 months, those with successful bipolar RFA had no recurrence of clinical PVCs., Conclusions: This report demonstrates the potential utility of bipolar RFA in patients with outflow tract PVCs that fail unipolar RFA., (© 2014 Wiley Periodicals, Inc.)

Background: The disparity between catheter and tissue temperatures during irrigated RF ablation frustrates one's ability to predict steam pops. Microwave radiometry allows for "volumetric" temperature assessment-i.e., within a circumscribed volume around the catheter tip-permitting, direct assessment of temperature during ablation. The aim of this study was to examine (i) the ability of microwave radiometry to predict steam pops, and (ii) compare this to traditional parameters such as power, catheter temperature, and impedance., Methods and Results: Irrigated RF ablation was performed in 8 sheep using the Tempasure ablation catheter in all chambers. Power, impedance, catheter tip, and volumetric temperature were continually monitored. Ablation was terminated after a pop or at 60 seconds. A pop was defined as an audible or visualized pop (intracardiac echocardiography). Predictors of pops were determined by univariate and multivariate GEE logistic regression modeling. A total of 48 pops occurred during 143 lesions applied at 20-50 W. There was no association between the chamber of the heart and the occurrence of pops. The rate of rise of volumetric temperature (greater than 1.5 °C/s) was the single best predictor of pops (OR: 88.8 [95% CI: 12-604], P < 0.0007). Pops only occurred above a maximum volumetric temperature threshold of 89 °C., Conclusions: During irrigated RF ablation, steam pop occurrence can be predicted by both, the rate of rise and the maximum volumetric temperature measured by microwave radiometry., (© 2013 Wiley Periodicals, Inc.)