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Characteristics of electrograms depend on the electrode design and distance to the electric source. Our aim was to assess the impact of electrode design and distance from the myocardial electric source on the unipolar and bipolar electrograms to deduce a far-field cut-off. We retrospectively analyzed left atrial electroanatomical maps of 25 patients acquired using an ablation catheter with a 4.5 mm tip-, mini- and 2 mm ring electrodes. The unipolar and bipolar electrograms were characterized based on peak-to-peak amplitude, signal duration, maximal slope, and relative power of the high frequency spectrum above 50 Hz (HF_rel). The unipolar electrograms of ring electrodes showed an increased amplitude (140%), slope (150%) and HF_rel (16% vs. 11%) compared to the tip- and mini-electrodes. The median amplitude, slope, and HF_rel for the ring electrodes followed a power-law decay with distance with a steep decline up to 4 mm. This near-field cut-off can be identified based on a HF_rel above 10% in unipolar electrograms. In conclusion, we observed a higher unipolar amplitude for small ring-electrodes compared to larger tip-electrodes. The rapid decay of the amplitude, slope, and HF_rel up to a distance of 4 mm is suggestive for near-field cut-off identified based on HF_rel above 50 Hz.Clinical Trial Registration: NCT04095559., (© 2024. The Author(s).)

Aims: Advanced ablation strategies are needed to treat ventricular tachycardia (VT) and premature ventricular complexes (PVC) refractory to standard unipolar radiofrequency ablation (Uni-RFA). Bipolar radiofrequency catheter ablation (Bi-RFA) has emerged as a treatment option for refractory VT and PVC. Multicentre registry data on the use of Bi-RFA in the setting of refractory VT and PVC are lacking. The aim of this Bi-RFA registry is to determine its real-world safety, feasibility, and efficacy in patients with refractory VT/PVC., Methods and Results: Consecutive patients undergoing Bi-RFA at 16 European centres for recurring VT/PVC after at least one standard Uni-RFA were included. Second ablation catheter was used instead of a dispersive patch and was positioned at the opposite site of the ablation target. Between March 2021 and August 2024, 91 patients underwent 94 Bi-RFA procedures (74 males, age 62 ± 13, and prior Uni-RFA range 1-8). Indications were recurrence of PVC (n = 56), VT (n = 20), electrical storm (n = 13), or PVC-triggered ventricular fibrillation (n = 2). Procedural time was 160 ± 73 min, Bi-RFA time 426 ± 286 s, and mean Uni-RFA time 819 ± 697 s. Elimination of clinical VT/PVC was achieved in 67 (74%) patients and suppression of VT/PVC in a further 10 (11%) patients. In the remaining 14 patients (15%), no effect on VT/PVC was observed. Three major complications occurred: coronary artery occlusion, atrioventricular block, and arteriovenous fistula. Follow-up lasted 7 ± 8 months. Nineteen patients (61%) remained VT free. ≥80% PVC burden reduction was achieved in 45 (78%)., Conclusion: These real-world registry data indicate that Bi-RFA appears safe, is feasible, and is effective in the majority of patients with VT/PVC., Competing Interests: Conflict of interest: P.F. reports patents related to high-voltage and bipolar ablation and has equity in CorSystem. J.K. reports personal fees from Biosense Webster, Boston Scientific, GE Healthcare, Medtronic, and St. Jude Medical (Abbott) for participation in scientific advisory boards and has received speaker honoraria from Biosense Webster, Biotronik, Boston Scientific, Medtronic, ProMed CS, St. Jude Medical (Abbott), and Viatris. All remaining authors have declared no conflicts of interest., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Background: The role of catheter ablation in elderly patients with atrial fibrillation (AF) is unclear. Pulsed field ablation (PFA) demonstrates a favorable clinical profile, however, data on elderly patients are lacking., Aims: We aimed to assess the safety and efficacy of PFA in the elderly, using data from the EU-PORIA registry., Methods: Periprocedural complications and long-term safety and efficacy outcomes of AF ablation using the pentaspline PFA catheter (Farapulse™) were compared between patients older than 80 years old and their younger counterparts, across seven European centers., Results: Among the 1233 patients in the registry, 88 (7.1 %) were older than 80 years. Elderly patients were more often females (51.1 % vs 37.8 %, p = 0.01) with a lower median BMI (26.0, IQR:23.5-29.2 vs 26.9, IQR:24.4-30.4 kg/m 2 , p = 0.02), a higher median CHA 2 DS 2 -VASc score (4, IQR:3-5 vs 2, IQR:1-3, p < 0.001) and a higher incidence of hypertension (73.9 % vs 52.7 %, p < 0.001). In both groups, most patients had paroxysmal AF (58.0 % vs 60.3 %, p = 0.65). Ablation in the elderly was more frequently performed with minimally interrupted anticoagulation (87.5 % vs 59.7 %, p < 0.001). Despite comparable rates of overall complications (5.7 % vs 3.5 %, p = 0.29), elderly patients had a higher incidence of stroke (2.3 % vs 0.3 %, p = 0.04). At 12 months, major adverse clinical events (4.5 % vs. 2.1 %, p = 0.12) and arrhythmia-free survival (70 % vs 74 %, p = 0.69) were comparable in both groups. None of the recurrence-free elderly patients were on antiarrhythmic drugs at the end of follow-up., Conclusion: In this real-world cohort, the efficacy of PFA for AF was similar in elderly and younger patients. Despite comparable complication rates, a higher incidence of stroke was observed in the elderly., Competing Interests: Declaration of competing interest R.M.: none. V.S.: none. B.S. is a consultant for and has received honoraria as well as research funding from Abbott, Medtronic, Boston Scientific, and Biosense Webster. S.B. has received honoraria from Medtronic and Biosense Webster. K.R.J.C. is a consultant for and has received honoraria as well as research funding from Abbott, Medtronic, Boston Scientific, and Biosense Webster. T.R. has received research grants from the Goldschmidt-Jacobson Foundation, the Swiss National Science Foundation, the Swiss Heart Foundation, and the sitem insel support fund, all for work outside the submitted study. He has received speaker/consulting honoraria or travel support from Abbott/SJM, Bayer, Biosense-Webster, Biotronik, Boston-Scientific, Daiichi Sankyo, Farapulse, Medtronic, and Pfizer-BMS, all for work outside the submitted study. He has received support for his institution's fellowship program from Abbott/SJM, Biosense-Webster, Biotronik, Boston-Scientific, and Medtronic for work outside the submitted study. T.K.: none. K.N. is a consultant for Biosense Webster, Boston Scientific, Field Medical, and LifeTech Scientific. N.R.: consultant for Boston Scientific. J.H.: speakers fees from Boston Scientific and Biosense Webster. M.H.R.: none. P.v.d.V.: none. Y.B. has received research grants from Medtronic and Atricure. He has received speaker/consulting honoraria from Abbott/SJM and Boston-Scientific, all for work outside the submitted study. S.J.: none. B.A.M.: none. S.B. is consultant for Medtronic, Boston Scientific, Microport, and Zoll., (Copyright © 2024 Elsevier B.V. All rights reserved.)

Background: Dexmedetomidine and propofol are common sedatives in intensive care units and for interventional procedures. Both may compromise sinus node function and atrioventricular conduction. The objective of this prospective, randomized study is to compare the effect of dexmedetomidine with propofol on sinus node function and atrioventricular conduction., Methods: In a tertiary care center in Switzerland we included from September 2019 to October 2020 160 patients (65 ± 11 years old; 32% female) undergoing first ablation for atrial fibrillation by cryoballoon ablation or by radiofrequency ablation. Patients were randomly assigned to deep sedation with dexmedetomidine (DEX group) versus propofol (PRO group). A standard electrophysiological study was performed after pulmonary vein isolation with the patients still deeply sedated and hemodynamically stable., Results: Eighty patients each were randomized to the DEX and PRO group. DEX group patients had higher baseline sinus cycle length (1022 vs. 1138 ms; p = 0.003) and longer sinus node recovery time (SNRT400; 1597 vs. 1412 ms; p = 0.042). However, both corrected SNRT and normalized SNRT did not differ. DEX group patients had longer PR interval (207 vs. 186 ms; p = 0.002) and AH interval (111 vs. 95 ms, p = 0.008), longer Wenckebach cycle length of the atrioventricular node (512 vs. 456 ms; p = 0.005), and longer atrioventricular node effective refractory period (390 vs. 344 ms; p = 0.009). QRS width and HV interval were not different. An arrhythmia, mainly atrial fibrillation, was induced in 33 patients during the electrophysiological study, without differences among groups (20% vs. 15%, p = 0.533)., Conclusions: Dexmedetomidine has a more pronounced slowing effect on sinus rate and suprahissian AV conduction than propofol, but not on infrahissian AV conduction and ventricular repolarization. These differences need to be taken into account when using these sedatives., Trial Registration: ClinicalTrials.gov number NCT03844841, 19/02/2019., (© 2024. The Author(s).)

Aims: Atrial fibrillation (AF) ablation and left atrial appendage occlusion (LAAO) are increasingly performed as individual procedures. Pulsed field ablation (PFA) has significantly reduced procedure duration and may be advantageous for the combined approach., Methods and Results: We have launched a programme for simultaneous AF ablation using PFA and LAAO for patients qualifying for both treatments and excluding those with a complex anatomy. We compare procedure duration and fluoroscopy time against individual procedures (either AF ablation or LAAO alone), all performed by the same operators and using consistent technologies. We performed the combined procedure in 10 patients (50% males; median age 70 years) and excluded 2 patients (17%) because of a complex left atrial appendage anatomy. No death, stroke, or major bleeding events, including pericardial effusion, occurred. For single-procedure comparison, 207 AF ablation procedures and 61 LAAO procedures were available. The total median procedure duration was 79 min (range 60-125) for the combined procedure, 71 min (25-241) for individual AF ablation (51 min without and 78 min with 3-dimensional electroanatomic mapping), and 47 min (15-162) for individual LAAO. The respective fluoroscopy times were 21 (15-26), 15 (5-44), and 10 (3-50) min. For the combined procedure, femoral vein access to last PFA application lasted 49 min (34-93) and LAAO added 20 min (15-37)., Conclusion: Simultaneous PFA-based AF ablation and LAAO in carefully selected patients is feasible and safe and can be executed within a short overall procedure duration., Competing Interests: Conflict of interest: T.R.: research grants from the Swiss National Science Foundation, the Swiss Heart Foundation, the sitem-insel support fund, Biotronik, Boston Scientific, and Medtronic, all for work outside the submitted study. He has received speaker/consulting honoraria or travel support from Abbott/SJM, Biosense Webster, Biotronik, Boston Scientific, and Medtronic. He has received support for his institution’s fellowship programme from Abbott/SJM, Biosense Webster, Biotronik, Boston Scientific, and Medtronic. C.G. has received funding from the Swiss National Science Foundation, InnoSuisse, the Center for Artificial Intelligence in Medicine, the University of Bern, the GAMBIT foundation, the Novartis Foundation for Medical Biological Research, and the Swiss Heart Foundation, outside of the submitted work. C.G. serves as Editor-in-Chief of The International Journal of Cardiovascular Imaging, Springer. T.K. has received research grants from the Swiss Heart Foundation for work outside the submitted study. R.G. has received speaker fees/honoraria from Boston Scientific. L.Rä. has received research grants for his institution from Abbott, Boston Scientific, Heartflow, Infraredx, Sanofi, and the Swiss National Science Foundation, and Regeneron and speaker/consultation fees from Abbott, Amgen, Biotronik, Canon, Gentuitity, Novo Nordisc, Medtronic, Occlutech, and Sanofi. L.Ro. has received research grants from Medtronic, the Swiss National Foundation, the Swiss Heart Foundation, the Immanuel and Ilse Straub Foundation, and the sitem-insel Support Fund, all for work outside the submitted study. He has received speaker fees/honoraria from Biosense Webster, Boston Scientific, Abbott, and Medtronic. All remaining authors have declared no conflicts of interest., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Background: Single-shot devices are increasingly used for pulmonary vein isolation (PVI) in atrial fibrillation (AF). The Arctic Front cryoballoon is the most frequently used single-shot technology. A recently developed novel pulsed field ablation (PFA) device (FARAPULSE) has been introduced with the aim to improve procedural safety and efficacy., Objective: This study will compare the novel FARAPULSE PFA device and the Arctic Front cryoballoon for first PVI in patients with symptomatic paroxysmal AF., Methods: SINGLE SHOT CHAMPION is a multicenter, randomized controlled trial with blinded endpoint adjudication by an independent clinical events committee. Overall, 210 patients with paroxysmal AF undergoing their PVI are randomized 1:1 between PFA and cryoballoon ablation. Continuous rhythm monitoring with an implantable cardiac monitor is performed in all patients., Results: The primary endpoint is time to first recurrence of any atrial tachyarrhythmia (AF and/or organized atrial tachyarrhythmia) lasting ≥120 seconds and identified by the implantable cardiac monitor within 91 and 365 days postablation. The composite procedural safety endpoint includes cardiac tamponade requiring drainage, persistent phrenic nerve palsy, vascular complications requiring intervention, stroke/transient ischemic attack, atrioesophageal fistula, and death occurring during or up to 30 days after the procedure. Key secondary endpoints include (1) increase in high-sensitivity troponin on day 1 postablation, (2) analysis of postablation 3-dimensional electroanatomic mapping (first 25 patients per study group), (3) AF burden, and (4) quality-of-life changes., Conclusion: SINGLE SHOT CHAMPION will evaluate the efficacy and safety of PVI using the novel FARAPULSE PFA for patients with symptomatic paroxysmal AF., (© 2024 Heart Rhythm Society. Published by Elsevier Inc.)

Background: Atrial fibrillation (AF) and heart failure (HF) coexist, increasing morbidity and mortality. Studies have demonstrated improved outcomes following AF ablation in HF patients with reduced ejection fraction (EF)., Objective: This study sought to assess the outcomes of pulsed field ablation (PFA) in HF., Methods: MANIFEST-PF (Multi-National Survey on the Methods, Efficacy, and Safety on the Post-Approval Clinical Use of Pulsed Field Ablation) is a multicenter, patient-level registry of consecutive patients undergoing PFA for paroxysmal AF or persistent AF (PerAF). In this substudy, patients were stratified as no history of HF (no-HF), HF with preserved EF (HFpEF) (left ventricular EF of ≥50%) or HF with reduced/mildly reduced EF (HFmr/rEF) (left ventricular EF of <50%). The primary effectiveness and safety endpoints were freedom from documented atrial arrhythmias lasting ≥30 seconds and major adverse events, respectively., Results: Of the 1,381 patients, 85% (n = 1,174) were no-HF, 6.2% (n = 87) were HFpEF, and 8.6% (n = 120) were HFmr/rEF. No-HF patients had less PerAF than patients with HF (P < 0.001), with no difference between HF subtypes (P = >0.99). The 1-year freedom from atrial arrhythmia was significantly higher in no-HF patients than in those with HFpEF or HFmr/rEF (79.9%, 71.3%, and 67.5%, respectively; P < 0.001) but similar between patients with HFmr/rEF and HFpEF (P = 0.26). However, there was no significant difference in freedom from atrial arrhythmia among patients with no-HF vs HFpEF vs HFmr/rEF for those with paroxysmal AF (82.8%, 82.4%, and 71.7%, respectively; P = 0.09) and PerAF (73.3%, 64.2%, and 64.9%, respectively; P = 0.14). Major adverse event rates were similar between the no-HF, HFpEF, and HFmr/rEF groups (1.9%, 0%, and 2.5%, respectively)., Conclusions: PFA appears to be potentially safe and effective in AF patients with HF. Freedom from atrial arrhythmia post-PFA was higher in patients without a history of HF, with no significant difference between HF subtypes., Competing Interests: Funding Support and Author Disclosures Boston Scientific provided a grant to help fund data collection but was not otherwise involved with study design or analysis and did not have access to this manuscript before submission. Dr Turagam has received consulting fees from Biosense Webster, Boston Scientific Inc, and AltaThera and speaker honoraria from Sanofi and Medtronic. Dr Neuzil has received a grant from the Ministry of Health, Czech Republic, Development of Research Organizations (DRO), Na Homolka Hospital (NHH) (0023884). Dr Schmidt has received speaker fees and research grants from Boston Scientific/Farapulse, Medtronic, Biosense Webster, and Abbott. Dr Reichlin has received research grants from the Swiss National Science Foundation, the Swiss Heart Foundation, and the sitem insel support fund; speaker/consulting honoraria or travel support from Abbott/SJM, Bayer, Biosense Webster, Biotronik, Boston Scientific, Daiichi Sankyo, Medtronic, and Pfizer-BMS; and support for his institution’s fellowship program from Abbott/SJM, Biosense Webster, Biotronik, Boston Journal Pre-proof 21 Scientific, and Medtronic. Dr Neven has received speaker fees from Farapulse, Inc. Dr Metzner has received a research grant and fees from Farapulse. Dr Hansen has received speaker fees and grant support from Biosense Webster and Medtronic. Dr Blaauw has received research grants from Medtronic and Atricure and consulting fees from Abbott, Biosense Webster, Boston Scientific. Dr Sommer has served as a member of the Advisory Board for Abbott, Biosense Webster, Boston Scientific, and Medtronic. He has received modest honoraria from Medtronic. Dr Anic has received consultant fees from Farapulse Inc, Boston Scientific Inc, Galaxy Medical Inc, and Biosense Webster and has performed contracted research for Farapulse Inc, Boston Scientific Inc, Galaxy Medical Inc, and Biosense Webster. Dr Anselme has received consulting fees from Boston Scientific, Medtronic, and Microport CRM. Dr Boveda has received consulting fees from Medtronic, Boston Scientific, Microport, Zoll, and BMS. Dr Deneke has received speaker honoraria from Galaxy Medical, Abbott, and Biotronik, has been a consultant to Farapulse, and has served on a Clinical Events Committee for Boston Scientific. Dr Willems has received grants and personal fees from Abbott, Boston Scientific, and Medtronic and personal fees from Boehringer Ingelheim, Brystol Myers Squibb, Bayer Vital, Accutus, Daiichi, and Farapulse Inc. Dr Tilz has received consulting fees from Boston Scientific, Abbott Medical, Biotronik, and Biosense Webster and speaker honoraria from Boston Scientific, Abbott Medical, Biotronik, and Biosense Webster. Dr Scherr has received an educational grant from Farapulse Inc and is a consultant for Boston Scientific Inc. Dr Wakili has received investigator-initiated funding for research projects (initiated by him) from Bristol Myers Squibb, Pfizer, and Boston Scientific and speaking honoraria from Boston Scientific, Biotronik, and Medtronic. Dr Steven has received speaker fees from Pfizer, Bayer, Abbott, Johnson & Johnson, and Medtronic; grants from Abbott, Johnson & Johnson, and Boston Scientific; and consulting fees from Boston Scientific and Johnson & Johnson. Dr Kautzner has received personal fees from Bayer, Biosense Webster, Boehringer Ingelheim, Medtronic, and Abbott for participation in Scientific Advisory Boards and speaker honoraria from Bayer, Biosense Webster, Biotronik, Boehringer Ingelheim, CathVision, Medtronic, Mylan, Pfizer, ProMed, and Abbott. Dr Jais has received partial funding from L'institut Des Maladies Du Rythme Cardiaque, LIRYC ANR-10-IAHU-04, equity from Farapulse, and consulting fees and a grant from Boston Scientific. Dr Chun has received speaker fees and research grants from Boston Scientific/Farapulse, Medtronic, Biosense Webster, and Abbott. Dr Roten has received research grants from Medtronic, the Swiss National Foundation, the Swiss Heart Foundation, the Immanuel and Ilse Straub Foundation, and the Sitem Insel Support Fund and speaker fees/honoraria from Biosense Webster, Boston Scientific, Abbott, and Medtronic. Dr Lemoine has received a research grant from Farapulse. Dr Rollin has received a research grant from Farapulse. Dr Gunawardene has received grants from Farapulse Inc and Abbott. Dr Heeger has received travel grants and research grants from Boston Scientific, Lifetech, Biosense Webster, and Cardiofocus and speaker honoraria from Boston Scientific, Lifetech. Biosense Webster, Bayer, and Cardiofocus and he has served as a consultant for Medtronic, Journal Pre-proof 22 Lifetech, Boston Scientific, Biosense Webster, and Cardiofocus. Dr Manninger has received speaker fees from Bayer, Biosense Webster, Biotronik, Amomed, AOP Orphan, Boston Scientific, Daiichi Sankyo, and BMS/Pfizer and research grants from Biosense Webster and Abbott. Dr Sultan has received lecture and consulting honoraria from Medtronic, Abbott, and Bayer. Dr Derval has received receiving consulting fees from Boston Scientific. Dr Reddy has received consulting fees (and equity—now divested) from Farapulse Inc; has served as a consultant for Boston Scientific Inc; unrelated to this manuscript, has also served 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, 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, and Valcare; unrelated to this work, has served as a consultant for Abbott, Adagio Medical, Append Medical, AtriAN, Biosense Webster, BioTel Heart, Biotronik, Cairdac, Cardionomic, CoreMap, Fire1, Gore & Associates, Impulse Dynamics, Medtronic, Novartis, Novo Nordisk, Philips, Pulse Biosciences; and unrelated to this work, has equity in Atraverse, DRS Vascular, Manual Surgical Sciences, Newpace, Nyra Medical, Soundcath, Surecor, and Vizaramed. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Pulmonary vein isolation (PVI) alone is insufficient to treat many patients with persistent atrial fibrillation (PersAF). Adjunctive left atrial posterior wall (LAPW) ablation with thermal technologies has revealed lack of efficacy, perhaps limited by the difficulty in achieving lesion durability amid concerns of esophageal injury., Objectives: This study aims to compare the safety and effectiveness of PVI + LAPW ablation vs PVI in patients with PersAF using pulsed-field ablation (PFA)., Methods: In a retrospective analysis of the MANIFEST-PF (Multi-National Survey on the Methods, Efficacy, and Safety on the Post-approval Clinical Use of Pulsed Field Ablation) registry, we studied consecutive PersAF patients undergoing post-approval treatment with a pentaspline PFA catheter. The primary effectiveness outcome was freedom from any atrial arrhythmia of ≥30 seconds. Safety outcomes included the composite of acute and chronic major adverse events., Results: Of the 547 patients with PersAF who underwent PFA, 131 (24%) received adjunctive LAPW ablation. Compared to PVI-alone, patients receiving adjunctive LAPW ablation were younger (65 vs 67 years of age, P = 0.08), had a lower CHA 2 DS 2 -VASc score (2.3 ± 1.6 vs 2.6 ± 1.6, P = 0.08), and were more likely to receive electroanatomical mapping (48.1% vs 39.0%, P = 0.07) and intracardiac echocardiography imaging (46.1% vs 17.1%, P < 0.001). The 1-year Kaplan-Meier estimate for freedom from atrial arrhythmias was not statistically different between groups in the full (PVI + LAPW: 66.4%; 95% CI: 57.6%-74.4% vs PVI: 73.1%; 95% CI: 68.5%-77.2%; P = 0.68) and propensity-matched cohorts (PVI + LAPW: 71.7% vs PVI: 68.5%; P = 0.34). There was also no significant difference in major adverse events between the groups (2.2% vs 1.4%, respectively, P = 0.51)., Conclusions: In patients with PersAF undergoing PFA, as compared to PVI-alone, adjunctive LAPW ablation did not improve freedom from atrial arrhythmia at 12 months., Competing Interests: Funding Support and Author Disclosures Boston Scientific provided a grant to help fund data collection but was not otherwise involved with study design or analysis nor did they have access to this manuscript before submission. Dr Turagam has received consulting fees from Biosense Webster; and has received speaker honorarium from Sanofi and Medtronic. Dr Neuzil has received grants from the Ministry of Health, Czech Republic, DRO (NHH, 00023884). Dr Schmidt has received speaker fees and research grants from Boston Scientific/Farapulse, Medtronic, Biosense Webster, and Abbott. Dr Reichlin has received grants from the Swiss National Science Foundation, the Swiss Heart Foundation, and the sitem insel support fund; has received speaker/consulting honoraria or travel support from Abbott/SJM, Bayer, Biosense Webster, Biotronik, Boston Scientific, Daiichi Sankyo, Medtronic, and Pfizer-BMS; and has received support for his institution’s fellowship program from Abbott/SJM, Biosense Webster, Biotronik, Boston Scientific, and Medtronic. Dr Metzner has received grants and fees from Farapulse. Dr Hansen has received speaker fees and grant support from Biosense Webster and Medtronic. Dr Blaauw has received grants from Medtronic and Atricure; and has received consulting fees from Abbott, Biosense Webster, and Boston Scientific. Dr Sommer has been a member of the advisory boards for Abbott, Biosense Webster, Boston Scientific, and Medtronic. Dr Anic has received consultant fees from Farapulse Inc, Boston Scientific Inc, Galaxy Medical Inc, Biosense Webster; and has performed contracted research for Farapulse Inc, Boston Scientific Inc, Galaxy Medical Inc, and Biosense Webster. Dr Anselme has received consulting fees from Boston Scientific, Medtronic, and Microport CRM. Dr Boveda has received consulting fees from Medtronic, Boston Scientific, Microport, Zoll, and BMS. Dr Deneke has received speaker honoraria from Galaxy Medical, Abbott, and Biotronik; has received consulting fees from Farapulse; and has served on a Clinical Events Committee for Boston Scientific. Dr Willems has received grants and personal fees from Abbott, Boston Scientific, and Medtronic; and has received personal fees from Boehringer Ingelheim, Brystol Myers Squibb, Bayer Vital, Accutus, Daiichi, and Farapulse Inc. Dr Tilz reports receiving consulting fees from Boston Scientific, Abbott Medical, Biotronik, Biosense Webster and speaker honorarium from Boston Scientific, Abbott Medical, Biotronik, Biosense Webster. Dr Scherr has received an educational grant from Farapulse Inc; and is a consultant For Boston Scientific Inc. Dr Wakili has received consulting fees and travel expenses from Boston Scientific and Biotronik; has received investigator-initiated funding for research projects (initiated by him) from Bristol-Myers Squibb, Pfizer, and Boston Scientific; and has received speaking honoraria from Boston Scientific, Biotronik, and Medtronic. Dr Scherr has received speaking fees from Pfizer, Bayer, Abbott, Johnson & Johnson, and Medtronic; has received grants from Abbott, Johnson & Johnson, and Boston Scientific; and has received consulting fees from Boston Scientific and Johnson & Johnson. Dr Kautzner has received personal fees from Bayer, Biosense Webster, Boehringer Ingelheim, Medtronic, and Abbott for participation in scientific advisory boards; and has received speaker honoraria from Bayer, Biosense Webster, Biotronik, Boehringer Ingelheim, CathVision, Medtronic, Mylan, Pfizer, ProMed, and Abbott. Dr Jais has received partial funding from IHU LIRYC ANR-10-IAHU-04; has received equity from Farapulse; and has received consulting fees and grants from Boston Scientific. Dr Chun has received speaker fees and research grants from Boston Scientific/Farapulse, Medtronic, Biosense Webster, and Abbott. Dr Roten has received speaker honoraria from Abbott/SJM; has received consulting honoraria from Medtronic; and has received research funding to the institution from Medtronic. Dr Lemoine has received grants from Farapulse. Dr Rollin has received grants from Farapulse. Dr Nentwich has received speaker fees from Farapulse, Inc. Dr Gunawardine has received grants from Farapulse Inc and Abbott. Dr Heeger has received travel grants and research grants from Boston Scientific, Lifetech, Biosense Webster, and Cardiofocus; has received speaker honoraria from Boston Scientific, Lifetech, Biosense Webster, Bayer, and Cardiofocus; and has received consulting fees from Medtronic, Lifetech, Boston Scientific, Biosense Webster, and Cardiofocus. Dr Manninger has received speaker fees from Bayer, Biosense Webster, Biotronik, Amomed, AOP Orphan, Boston Scientific, Daiichi Sankyo, and BMS/Pfizer; and has received grants from Biosense Webster and Abbott. Dr Sultan has received lecture and consulting honoraria from Medtronic, Abbott, and Bayer. Dr Derval has received consulting fees from Boston Scientific. Dr Reddy has received consulting fees (and equity – now divested) from Farapulse Inc; has received consulting fees from Boston Scientific Inc; and, unrelated to this manuscript, has served 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, Field Medical, Focused Therapeutics, HRT, Intershunt, Javelin, Kardium, Keystone Heart, Laminar, LuxMed, Medlumics, Middlepeak, Neutrace, Nuvera-Biosense Webster, Oracle Health, Restore Medical, Sirona Medical, SoundCath, Valcare; also unrelated to this work, he has received consulting fees from AtriAN, Biosense-Webster, BioTel Heart, Biotronik, Cairdac, Cardiofocus, Cardionomic, CoreMap, Fire1, Gore & Associates, Impulse Dynamics, Medtronic, Novartis, Philips, and Pulse Biosciences; and he has equity in Manual Surgical Sciences, Newpace, Nyra Medical, Surecor, and Vizaramed. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Pulsed-field ablation (PFA) has shown promising data in terms of safety and procedural efficiency for pulmonary vein isolation (PVI), with similar long-term outcomes compared to radiofrequency ablation (RFA) and cryoballoon ablation (CBA) in patient with paroxysmal atrial fibrillation (AF) OBJECTIVE: To compare the procedural and long-term outcomes of patients with persistent AF undergoing PVI using PFA, CBA, or RFA., Methods: Consecutive patients with persistent AF undergoing a first PVI with PFA, CBA, or RFA were included. Patients underwent 7d-Holter-ECG at 3, 6, and 12 months post-ablation. The primary outcome was recurrence of any atrial arrhythmia after a 90-day blanking period. Safety outcomes included the composite of in-hospital major adverse events., Results: A total of 533 patients with persistent AF underwent PVI using PFA (n=214), CBA (n=190), or RFA (n=129). Procedures with PFA guided by fluoroscopy were shorter compared to CBA (median 60 min, IQR 53-80 vs. 84 min, IQR 68-101, p=<0.001), and procedures with PFA in combination with 3D-electroanatomical mapping were shorter compared to RFA (median 101 min, IQR 85-126 vs. 171 min, IQR 141-204, p<0.001). Acute safety events occurred in 2.3%, 2.6% and 0.8% in the PFA, CBA and RFA group (p=0.545). The 1-year confounder-adjusted estimate for freedom from atrial arrhythmias was 62.1% for CBA, 55.3% for PFA and 48.3% for RFA (CBA vs. PFA p=0.79, CBA vs. RFA p=0.009; PFA vs. RFA p=0.010)., Conclusion: In patients with persistent AF undergoing a first PVI, 1-year confounder-adjusted outcomes are better with PFA and CBA compared to RFA., (Copyright © 2024. Published by Elsevier Inc.)

Background: Pulsed-field ablation (PFA) is a novel nonthermal ablation technology. Its potential value for repeat procedures after unsuccessful thermal ablation for atrial fibrillation has not been assessed., Objective: The purpose of this study was to summarize our initial experience with patients undergoing repeat procedures using PFA., Methods: Consecutive patients with arrhythmia recurrences after a prior thermal ablation undergoing a repeat procedure using a multipolar PFA catheter from May 2021 and December 2022 were included. After 3-dimensional electroanatomic mapping, reconnected pulmonary veins (PVs) were reisolated and veins with only ostial isolation wither ablated to widen antral PV isolation. Posterior wall ablation was performed if all PVs were durably isolated or in case of low-voltage areas on the posterior wall at the discretion of the operator. Patients underwent follow-up with 7-day Holter electrocardiography after 3, 6, and 12 months., Results: A total of 186 patients undergoing a repeat procedure using PFA were included. The median number of previous ablations was 1 (range 1-6). The prior ablation modality was radiofrequency in 129 patients (69.4%), cryoballoon in 51 (27.4%), and epicardial ablation in 6 (3.2%). At the beginning of the procedure, 258 of 744 PVs (35%) showed reconnections. Additional antral ablations were applied in 236 of 486 still isolated veins (49%). Posterior wall ablation was added in 125 patients (67%). Major complications occurred in 1 patient (transient ischemic attack 0.5%). Freedom from arrhythmia recurrence in Kaplan-Meier-analysis was 78% after 6 months and 54% after 12 months., Conclusion: PFA is a versatile and safe option for repeat procedures after failed prior thermal ablation., (© 2024 Heart Rhythm Society. Published by Elsevier Inc.)

Background: Pulsed-field ablation (PFA) is a novel nonthermal ablation technology with high procedural safety and efficiency for pulmonary vein isolation (PVI). Premarket data showed high PVI durability during mandatory remapping studies. Data on lesion durability in real-world patients with clinically indicated redo procedures are scarce., Objectives: This study sought to report PVI durability rates in patients undergoing a clinically indicated redo procedure after an index PVI using PFA., Methods: Patients from 7 European centers undergoing an index PVI using PFA were included the EU-PORIA (European Real-world Outcomes With Pulsed Field Ablation in Patients With Symptomatic Atrial Fibrillation) registry. In patients with subsequent left atrial redo procedures due to arrhythmia recurrence, 3-dimensional electroanatomical maps were acquired. PVI durability was assessed on a per-vein and per-patient level, and sites of reconnections and predictors of lesion durability were identified., Results: Of 1,184 patients (62% paroxysmal atrial fibrillation) undergoing an index PVI using PFA, 272 (23%) had an arrhythmia recurrence. Of these, 144 (53%) underwent a left atrial redo procedure a median of 7 (Q1-Q3: 5-10) months after the first ablation. Three-dimensional electroanatomical maps identified 404 of 567 pulmonary veins (71%) with durable isolation. In 54 patients (38%), all pulmonary veins were durably isolated. Prior operator experience with cryoballoon ablation was associated with a higher PVI durability compared to operators with only point-by-point radiofrequency experience (76% vs 60%; P < 0.001). Neither the operators' cumulative experience in atrial fibrillation ablation (≤5 vs >5 years) nor the size of the PFA device used (31 mm vs 35 mm) had an impact on subsequent lesion durability (both P > 0.50)., Conclusions: In 144 patients with arrhythmia recurrence after PFA PVI, durable isolation was observed in 71% of the pulmonary veins during the redo procedure, and 38% of all patients showed durable isolation of all veins., Competing Interests: Funding Support and Author Disclosures The EU-PORIA registry was supported by a research grant from Boston Scientific. Dr Bordignon has received honoraria from Medtronic and Biosense Webster. Dr Neven has served as a consultant for Biosense Webster, Boston Scientific, Field Medical, and LifeTech Scientific. Dr Blaauw has received research grants from Medtronic and Atricure; has received speaker/consulting fees from Abbott/St Jude Medical and Boston-Scientific, all for work outside the submitted study. Dr Hansen has received speaker fees from Boston Scientific and Biosense Webster. Dr Füting has received an educational grant from Boston Scientific. Dr Roten has received research grants from Medtronic and speaker/consulting fees from Abbott and Medtronic. Dr Reinsch has served as a consultant for Boston Scientific. Dr Boveda has served as a consultant for Medtronic, Boston Scientific, Microport, and Zoll. Drs Albrecht and Schneider are salaried employees of Boston Scientific. Dr Chun has served as a consultant for and has received honoraria as well as research funding from Abbott, Medtronic, Boston Scientific, and Biosense Webster. Dr Schmidt has served as a consultant for and has received honoraria as well as research funding from Abbott, Medtronic, Boston Scientific, and Biosense Webster. Dr Reichlin has received research grants from the Goldschmidt-Jacobson Foundation, the Swiss National Science Foundation, the Swiss Heart Foundation and the sitem insel support fund, all for work outside the submitted study; has received speaker/consulting fees or travel support from Abbott/St Jude Medical, Biosense Webster, Biotronik, Boston Scientific, and Medtronic; and has received support for his institution’s fellowship program from Abbott/St Jude Medical, Biosense Webster, Biotronik, Boston Scientific, and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: A novel multipolar pulsed-field ablation (PFA) catheter has recently been introduced for pulmonary vein isolation (PVI). Pre-market data showed high rates for PVI-durability during mandatory remapping studies., Objective: To present post-market data in patients with recurrent arrhythmias., Methods: Consecutive patients undergoing a redo procedure after an index PFA PVI using a bipolar-biphasic PFA system were included. 3-D electro-anatomical maps (3D-EAM) on redo procedure were compared to the 3D-EAM acquired after ablation during the index procedure. PVI durability was assessed on a per-vein and per-patient level and the sites of reconnections were identified. Furthermore, lesion extent around veins with durable isolation was compared to study lesion regression., Results: Of 341 patients treated with a PFA PVI, 29 (8.5%) underwent a left atrial redo ablation due to arrhythmia recurrence. At the end of the index procedure, 110/112 veins (98%, four common ostia) were isolated. On redo procedures performed a median of 6 months after the first ablation, 3D-EAM identified 69/110 (63%) PVs with durable isolation. In 6 (21%) patients, all PVs were durably isolated. Reconnections were more often found on the right-sided veins and on the anterior aspects of the upper veins. Only minor lesion regression was observed between the index and redo procedure (a median of 3 mm (0 - 9.5) on the posterior wall)., Conclusion: In patients with arrhythmia recurrence after PFA PVI using a first-generation PFA device, durable isolation was observed in 63% of the veins and 21% of the patients showed durable isolation of all previously isolated veins., (© 2024. The Author(s).)

Background: Pulsed-field ablation (PFA) has shown favourable data in terms of safety and procedural efficiency for pulmonary vein isolation (PVI). We sought to compare procedural and 1-year follow-up data of patients with paroxysmal atrial fibrillation (AF) undergoing PVI using PFA, cryoballoon ablation (CBA) and radiofrequency ablation (RFA)., Methods: Consecutive patients with paroxysmal AF undergoing a first PVI with PFA at our institution were included. For comparison, patients with paroxysmal AF undergoing a first PVI with CBA and RFA were selected using a 1:2:2 propensity score matching. The PFA group followed the standard 32-applications lesion-set protocol, the CBA group a time-to-effect plus 2-min strategy, and the RFA group the CLOSE protocol. Patients were followed with 7d-Holter ECGs 3, 6, and 12 months after ablation. The primary endpoint was recurrence of atrial tachyarrhythmia (ATa) following a blanking period of 3 months., Results: A total of 200 patients were included (PFA n = 40; CBA n = 80; RFA n = 80). Median procedure times were shortest with CBA (75 min) followed by PFA (94 min) and RFA (182 min; p < 0.001). Fluoroscopy dose was lowest with RFA (1.6Gycm 2 ) followed by PFA (5.0Gycm 2 ) and CBA (5.7Gycm 2 ; p < 0.001). After a 1-year follow-up, freedom from ATa recurrence was 85.0% with PFA, 66.2% with CBA and 73.8% with RFA (p = 0.12 PFA vs. CBA; p = 0.27 PFA vs. RFA)., Conclusion: In a propensity score matched analysis of patients with paroxysmal AF, freedom from any ATa 1 year after PVI using PFA was favourable and at least as good as for PVI with CBA or RFA., (© 2023. The Author(s).)

Background: The left atrial posterior wall is a potential ablation target in patients with recurrent atrial fibrillation despite durable pulmonary vein isolation or in patients with roof-dependent atrial tachycardia (AT). Pulsed-field ablation (PFA) offers efficient and safe posterior wall ablation (PWA), but available data is scarce., Methods: Consecutive patients undergoing PWA using PFA were included. PWA was performed using a pentaspline PFA catheter and verified by 3D-electroanatomic mapping. Follow-up was performed using 7-day Holter-ECGs 3, 6, and 12 months after ablation. Recurrence of any atrial arrhythmia lasting more than 30 seconds was defined as failure. Lesion durability was assessed during redo procedures., Results: PWA was performed in 215 patients (70% males, median age 70 [IQR 61-75] years, 67% redo procedures) and was successful in all patients (100%) by applying a median of 36 (IQR 32-44) PFA lesions. Severe adverse events were cardiac tamponade and vascular access complication in one patient each (0.9%). Median follow-up was 7.3 (IQR 5.0-11.8) months. One-year arrhythmia-free outcome in Kaplan-Meier analysis was 53%. A redo procedure was performed in 26 patients (12%) after a median of 6.9 (IQR 2.4-11) months and showed durable PWA in 22 patients (85%) with only minor lesion regression. Among 4 patients with posterior wall reconnection, 3 (75%) presented with roof-dependent AT., Conclusion: PWA with this pentaspline PFA catheter can be safely and efficiently performed with a high durability observed during redo procedures. The added value of durable PWA for the treatment of atrial fibrillation remains to be evaluated., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Importance: Previous studies evaluating the association of patient sex with clinical outcomes using conventional thermal ablative modalities for atrial fibrillation (AF) such as radiofrequency or cryoablation are controversial due to mixed results. Pulsed field ablation (PFA) is a novel AF ablation energy modality that has demonstrated preferential myocardial tissue ablation with a unique safety profile., Objective: To compare sex differences in patients undergoing PFA for AF in the Multinational Survey on the Methods, Efficacy, and Safety on the Postapproval Clinical Use of Pulsed Field Ablation (MANIFEST-PF) registry., Design, Setting, and Participants: This was a retrospective cohort study of MANIFEST-PF registry data, which included consecutive patients undergoing postregulatory approval treatment with PFA to treat AF between March 2021 and May 2022 with a median follow-up of 1 year. MANIFEST-PF is a multinational, retrospectively analyzed, prospectively enrolled patient-level registry including 24 European centers. The study included all consecutive registry patients (age ≥18 years) who underwent first-ever PFA for paroxysmal or persistent AF., Exposure: PFA was performed on patients with AF. All patients underwent pulmonary vein isolation and additional ablation, which was performed at the discretion of the operator., Main Outcomes and Measures: The primary effectiveness outcome was freedom from clinically documented atrial arrhythmia for 30 seconds or longer after a 3-month blanking period. The primary safety outcome was the composite of acute (<7 days postprocedure) and chronic (>7 days) major adverse events (MAEs)., Results: Of 1568 patients (mean [SD] age, 64.5 [11.5] years; 1015 male [64.7%]) with AF who underwent PFA, female patients, as compared with male patients, were older (mean [SD] age, 68 [10] years vs 62 [12] years; P < .001), had more paroxysmal AF (70.2% [388 of 553] vs 62.4% [633 of 1015]; P = .002) but had fewer comorbidities such as coronary disease (9% [38 of 553] vs 15.9% [129 of 1015]; P < .001), heart failure (10.5% [58 of 553] vs 16.6% [168 of 1015]; P = .001), and sleep apnea (4.7% [18 of 553] vs 11.7% [84 of 1015]; P < .001). Pulmonary vein isolation was performed in 99.8% of female (552 of 553) and 98.9% of male (1004 of 1015; P = .90) patients. Additional ablation was performed in 22.4% of female (124 of 553) and 23.1% of male (235 of 1015; P = .79) patients. The 1-year Kaplan-Meier estimate for freedom from atrial arrhythmia was similar in male and female patients (79.0%; 95% CI, 76.3%-81.5% vs 76.3%; 95% CI, 72.5%-79.8%; P = .28). There was also no significant difference in acute major AEs between groups (male, 1.5% [16 of 1015] vs female, 2.5% [14 of 553]; P = .19)., Conclusion and Relevance: Results of this cohort study suggest that after PFA for AF, there were no significant sex differences in clinical effectiveness or safety events.

Background: Superimposition of farfield (FF) and nearfield (NF) bipolar voltage electrograms (BVE) complicates the confirmation of pulmonary vein (PV) isolation after catheter ablation of atrial fibrillation. Our aim was to develop an automatic algorithm based on a single-beat analysis to discriminate PV NF from atrial FF BVE from a circular mapping catheter during the cryoballoon PV isolation., Methods: During freezing cycles in cryoablation PVI, local NF and distant FF signals were recorded, identified and labelled. BVEs were classified using four different machine learning algorithms based on four frequency domain (high-frequency power (P HF ), low-frequency power (P LF ), relative high power band, P HF ratio of neighbouring electrodes) and two time domain features (amplitude (V max ), slew rate). The algorithm-based classification was compared to the true identification gained during the PVI and to a classification by cardiac electrophysiologists., Results: We included 335 BVEs from 57 consecutive patients. Using a single feature, P HF with a cut-off at 150 Hz showed the best overall accuracy for classification (79.4%). By combining P HF with V max , overall accuracy was improved to 82.7% with a specificity of 89% and a sensitivity of 77%. The overall accuracy was highest for the right inferior PV (96.6%) and lowest for the left superior PV (76.9%). The algorithm showed comparable accuracy to the classification by the EP specialists., Conclusions: An automated farfield-nearfield discrimination based on two simple features from a single-beat BVE is feasible with a high specificity and comparable accuracy to the assessment by experienced cardiac electrophysiologists., (© 2023. The Author(s).)

Introduction: Single-shot devices are increasingly used for pulmonary vein isolation (PVI) in atrial fibrillation (AF). The Arctic Front cryoballoon (Medtronic) is the most frequently used single-shot technology. A recently developed novel cryoballoon has been introduced (PolarX, Boston Scientific) with the aim to address limitations of the Arctic Front system., Methods: COMPARE CRYO is a multicentre, randomized, controlled trial with blinded endpoint adjudication by an independent clinical events committee. A total of 200 patients with paroxysmal AF undergoing their first PVI are randomized 1:1 between PolarX cryoballoon ablation and Arctic Front cryoballoon ablation. Continuous monitoring during follow-up is performed using an implantable cardiac monitor (ICM) in all patients. The primary endpoint is time to first recurrence of any atrial tachyarrhythmia (AF, atrial flutter, and/or atrial tachycardia) ≥ 120 s between days 91 and 365 post ablation as detected on the (ICM). Procedural safety is assessed by a composite of cardiac tamponade, persistent phrenic nerve palsy >24 h, vascular complications requiring intervention, stroke/transient ischemic attack, atrioesophageal fistula or death occurring during or up to 30 days after the procedure. Key secondary endpoints include (Chung et al., 2020 (1)) procedure and fluoroscopy times, Wolf et al. (1991) (2) AF burden, Wang et al. (2003) (3) proportion of patients with recurrence in the blanking period, Benjamin et al. (1998) (4) proportion of patients undergoing repeat ablation, and (Chen et al., 2013 (5)) quality of life changes at 12 months compared to baseline., Conclusion: COMPARE CRYO will compare the efficacy and safety of the novel PolarX cryoballoon and the standard-of-practice Arctic Front cryoballoon for first PVI performed in patients with symptomatic paroxysmal AF., Trial Registration: (ClinicalTrials.gov ID: NCT04704986)., (Copyright © 2023. Published by Elsevier Inc.)

Background: We describe our initial experience using a multipolar pulsed-field ablation catheter for the treatment of left atrial (LA) reentry tachycardia., Methods: We included all patients with LA reentry tachycardia treated with PFA at our institution between September 2021 and March 2022. The tachycardia mechanism was identified using 3D electro-anatomical mapping (3D-EAM). Subsequently, a roof line, anterior line, or mitral isthmus line was ablated as appropriate. Roof line ablation was always combined with LA posterior wall (LAPW) ablation. Positioning of the PFA catheter was guided by a 3D-EAM system and by fluoroscopy. Bidirectional block across lines was verified using standard criteria. Additional radiofrequency ablation (RFA) was used to achieve bidirectional block as necessary., Results: Among 22 patients (median age 70 (59-75) years; 9 females), we identified 27 LA reentry tachycardia: seven roof dependent macro-reentries, one posterior-wall micro-reentry, twelve peri-mitral macro-reentries, and seven anterior-wall micro-reentries. We ablated a total of 20 roof lines, 13 anterior lines, and 6 mitral isthmus lines. Additional RFA was necessary for two anterior lines (15%) and three mitral isthmus lines (50%). Bidirectional block was achieved across all roof lines, 92% of anterior lines, and 83% of mitral isthmus lines. We observed no acute procedural complications., Conclusion: Ablation of a roof line and of the LAPW is feasible, effective, and safe using this multipolar PFA catheter. However, the catheter is less suited for ablation of the mitral isthmus and the anterior line. A focal pulsed-field ablation catheter may be more effective for ablation of these lines. This study shows the feasibility to ablate linear lesions with a multipolar pulsed-field ablation catheter. 27 left atrial reentry tachycardia were treated in 22 patients., (© 2022. The Author(s).)

Background: Pulsed field ablation is a novel nonthermal cardiac ablation modality using ultra-rapid electrical pulses to cause cell death by a mechanism of irreversible electroporation. Unlike the traditional ablation energy sources, pulsed field ablation has demonstrated significant preferentiality to myocardial tissue ablation, and thus avoids certain thermally mediated complications. However, its safety and effectiveness remain unknown in usual clinical care., Methods: MANIFEST-PF (Multi-National Survey on the Methods, Efficacy, and Safety on the Post-Approval Clinical Use of Pulsed Field Ablation) is a retrospective, multinational, patient-level registry wherein patients at each center were prospectively included in their respective center registries. The registry included all patients undergoing postapproval treatment with a multielectrode 5-spline pulsed field ablation catheter to treat atrial fibrillation (AF) between March 1, 2021, and May 30, 2022. The primary effectiveness outcome was freedom from clinical documented atrial arrhythmia (AF/atrial flutter/atrial tachycardia) of ≥30 seconds on the basis of electrocardiographic data after a 3-month blanking period (on or off antiarrhythmic drugs). Safety outcomes included the composite of acute (<7 days postprocedure) and latent (>7 days) major adverse events., Results: At 24 European centers (77 operators) pulsed field ablation was performed in 1568 patients with AF: age 64.5±11.5 years, female 35%, paroxysmal/persistent AF 65%/32%, CHA 2 DS 2 -VASc 2.2±1.6, median left ventricular ejection fraction 60%, and left atrial diameter 42 mm. Pulmonary vein isolation was achieved in 99.2% of patients. After a median (interquartile range) follow-up of 367 (289-421) days, the 1-year Kaplan-Meier estimate for freedom from atrial arrhythmia was 78.1% (95% CI, 76.0%-80.0%); clinical effectiveness was more common in patients with paroxysmal AF versus persistent AF (81.6% versus 71.5%; P =0.001). Acute major adverse events occurred in 1.9% of patients., Conclusions: In this large observational registry of the postapproval clinical use of pulsed field technology to treat AF, catheter ablation using pulsed field energy was clinically effective in 78% of patients with AF., Competing Interests: Disclosures Dr Reddy reports receiving consulting fees (and equity—now divested) from Farapulse Inc. and is a consultant for Boston Scientific Inc; unrelated to this manuscript, Dr Reddy also 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, 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 AtriAN, Biosense-Webster, BioTel Heart, Biotronik, Cairdac, Cardiofocus, Cardionomic, CoreMap, Fire1, Gore & Associates, Impulse Dynamics, Medtronic, Novartis, Philips, Pulse Biosciences; and has equity in Manual Surgical Sciences, Newpace, Nyra Medical, Surecor, and Vizaramed. Dr Schmidt reports receiving speaker’s fees and research grants from Boston Scientific/Farapulse, Medtronic, Biosense Webster, and Abbott. Dr Reichlin reports research grants from the Swiss National Science Foundation, the Swiss Heart Foundation, and the sitem insel Support Fund. Speaker/consulting honoraria or travel support from Abbott/SJM, Bayer, Biosense Webster, Biotronik, Boston Scientific, Daiichi Sankyo, Medtronic, and Pfizer-BMS. Support for his institution’s fellowship programme from Abbott/SJM, Biosense Webster, Biotronik, Boston Scientific, and Medtronic. Dr Roten reports receiving speaker honoraria from Abbott/SJM, consulting honoraria from Medtronic, and research funding to the institution from Medtronic. Dr Neven reports speaker’s fees from Farapulse, Inc. Dr Metzner reports research grant and fees from Farapulse. Dr Rollin reports receiving research grant from Farapulse. Dr Lemoine reports receiving research grant from Farapulse. Dr Hansen reports receiving speaker fees and grant support from Biosense Webster, and Medtronic. Dr Blaauw reports receiving research grants from Medtronic and Atricure and consulting fees from Abbott, Biosense Webster, Boston Scientific. Dr Sommer reports member of the advisory board for Abbott, Biosense Webster, Boston Scientific, and Medtronic. Dr Anic reports receiving consultant fees from Farapulse Inc., Boston Scientific Inc., Galaxy Medical Inc., Biosense Webster, and performs contracted research for Farapulse Inc., Boston Scientific Inc., Galaxy Medical Inc., and Biosense Webster. Dr Anselme reports receiving consulting fees from Boston Scientific, Medtronic, and Microport CRM. Dr Boveda reports receiving consulting fees from Medtronic, Boston Scientific, Microport, Zoll, and BMS. Dr Deneke reports receiving speaker honoraria from Galaxy Medical, Abbott, and Biotronik, being a consultant to Farapulse, and serving on a Clinical Events Committee for Boston Scientific. Dr Willems reports receiving grants and personal fees from Abbott, Boston Scientific, Medtronic, and personal fees from Boehringer Ingelheim, Brystol Myers Squibb, Bayer Vital, Accutus, Daiichi, and Farapulse Inc. Dr Gunawardene reports grants from Farapulse Inc. and Abbott. Dr Tilz reports receiving consulting fees from Boston Scientific, Abbott Medical, Biotronik, Biosense Webster and speaker honorarium from Boston Scientific, Abbott Medical, Biotronik, and Biosense Webster. Dr Heeger received travel grants and research grants by Boston Scientific, Lifetech, Biosense Webster, and Cardiofocus and Speaker´s Honoraria from Boston Scientific, Lifetech. Biosense Webster, Bayer, and Cardiofocus. He is a consultant of Medtronic, Lifetech, Boston Scientific, Biosense Webster, and Cardiofocus. Dr Scheer reports receiving an educational grant from Farapulse Inc. and is a consultant for Boston Scientific Inc. Dr Wakili reports receiving consultant fees and travel expenses from Boston Scientific and Biotronik; investigator-initiated funding for research projects (initiated by him) from Bristol-Myers Squibb, Pfizer, and Boston Scientific; and speaking honoraria from Boston Scientific, Biotronik, and Medtronic. Dr Steven reports receiving speaking fees from Pfizer, Bayer, Abbott, Johnson & Johnson, and Medtronic; grants from Abbott, Johnson & Johnson, and Boston Scientific; and consulting fees from Boston Scientific and Johnson & Johnson. Dr Sultan reports receiving lecture and consulting honoraria from Medtronic, Abbott, and Bayer. Dr Kautzner reports personal fees from Bayer, Biosense Webster, Boehringer Ingelheim, Medtronic, and Abbott for participation in scientific advisory boards, and has received speaker honoraria from Bayer, Biosense Webster, Biotronik, Boehringer Ingelheim, CathVision, Medtronic, Mylan, Pfizer, ProMed, and Abbott. Dr Jais reports receiving equity from Farapulse and consulting fees and grant from Boston Scientific. Dr Derval reports receiving consulting fees from Boston scientific. Dr Chun reports receiving speaker’s fees and research grants from Boston Scientific/Farapulse, Medtronic, Biosense Webster, and Abbott. Dr Neuzil reports receiving grants from the Ministry of Health, Czech Republic, DRO (NHH, 00023884). Dr Manninger reports receiving speaker fees from Bayer, Biosense Webster, Biotronik, Amomed, AOP Orphan, Boston Scientific, Daiichi Sankyo, BMS/Pfizer and research grants from Biosense Webster and Abbott. All remaining authors have declared no conflict of interest.

Aims: Pulsed field ablation (PFA) is a new, non-thermal ablation modality for pulmonary vein (PV) isolation in patients with atrial fibrillation (AF). The multi-centre EUropean Real World Outcomes with Pulsed Field AblatiOn in Patients with Symptomatic AtRIAl Fibrillation (EU-PORIA) registry sought to determine the safety, efficacy, and learning curve characteristics for the pentaspline, multi-electrode PFA catheter., Methods and Results: All-comer AF patients from seven high-volume centres were consecutively enrolled. Procedural and follow-up data were collected. Learning curve effects were analysed by operator ablation experience and primary ablation modality. In total, 1233 patients (61% male, mean age 66 ± 11years, 60% paroxysmal AF) were treated by 42 operators. In 169 patients (14%), additional lesions outside the PVs were performed, most commonly at the posterior wall (n = 127). Median procedure and fluoroscopy times were 58 (interquartile range: 40-87) and 14 (9-21) min, respectively, with no differences due to operator experience. Major complications occurred in 21/1233 procedures (1.7%) including pericardial tamponade (14; 1.1%) and transient ischaemic attack or stroke (n = 7; 0.6%), of which one was fatal. Prior cryoballoon users had less complication. At a median follow-up of 365 (323-386) days, the Kaplan-Meier estimate of arrhythmia-free survival was 74% (80% for paroxysmal and 66% for persistent AF). Freedom from arrhythmia was not influenced by operator experience. In 149 (12%) patients, a repeat procedure was performed due to AF recurrence and 418/584 (72%) PVs were durably isolated., Conclusion: The EU-PORIA registry demonstrates a high single-procedure success rate with an excellent safety profile and short procedure times in a real-world, all-comer AF patient population., Competing Interests: Conflict of interest: B.S. is a consultant for and has received honoraria as well as research funding from Abbott, Medtronic, Boston Scientific, and Biosense Webster. S.B. has received honoraria from Medtronic and Biosense Webster. K.R.J.C. is a consultant for and has received honoraria as well as research funding from Abbott, Medtronic, Boston Scientific, and Biosense Webster. S.B. is consultant for Medtronic, Boston Scientific, Microport, and Zoll. R.A.: none. R.M.: none. T.R. has received research grants from the Goldschmidt-Jacobson Foundation, the Swiss National Science Foundation, the Swiss Heart Foundation, and the sitem insel support fund, all for work outside the submitted study. He has received speaker/consulting honoraria or travel support from Abbott/SJM, Bayer, Biosense-Webster, Biotronik, Boston-Scientific, Daiichi Sankyo, Farapulse, Medtronic, and Pfizer-BMS, all for work outside the submitted study. He has received support for his institution’s fellowship program from Abbott/SJM, Biosense-Webster, Biotronik, Boston-Scientific, and Medtronic for work outside the submitted study. L.R. received research grants from Medtronic and speaker/consulting honoraria from Abbott and Medtronic. T.K.: none. K.N. is a consultant for Biosense Webster, Boston Scientific, Field Medical, and LifeTech Scientific. A.F.: educational grant from Boston Scientific. N.R.: consultant for Boston Scientific. J.H.: speakers fees from Boston Scientific and Biosense Webster. M.H.R.: none. A.O.: none. P.v.d.V.: none. Y.B. has received research grants from Medtronic and Atricure. He has received speaker/consulting honoraria from Abbott/SJM and Boston-Scientific, all for work outside the submitted study. B.A.M.: none. C.W.S. and E.M.A.: salaried employees of Boston Scientific., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Background: The implantation procedure of left ventricular (LV) leads and the management of cardiac resynchronization therapy (CRT) patients can be challenging. The IS-4 standard for CRT offers additional pacing vectors compared to bipolar leads (IS-1). IS-4 leads improve procedural outcome and may also result in lower adverse events during follow-up (FU) and improve clinical outcome in CRT patients. Further long-term FU data comparing the two lead designs are necessary., Methods: In this retrospective, single-center study we included adult patients implanted with a CRT-Defibrillator (CRT-D) or CRT-Pacemaker (CRT-P) with a quadripolar (IS-4 group) or bipolar (IS-1 group) LV lead and with available ≥3 years clinical FU. The combined primary endpoint was a combination of predefined, lead-related adverse events. Secondary endpoints were all single components of the primary endpoint., Results: Overall, 133 patients (IS-4 n = 66; IS-1 n = 67) with a mean FU of 4.03 ± 1.93 years were included. Lead-related adverse events were less frequent in patients with an IS-4 lead than with an IS-1 lead (n = 8, 12.1% vs. n = 23, 34.3%; p = .002). The secondary outcomes showed a lower rate of LV lead deactivation/explantation and LV lead dislodgement/dysfunction (4.5% vs. 22.4%; p = .003; 4.5% vs. 17.9%; p = .015, respectively) in the IS-4 patient group. Less patients suffered from unresolved phrenic nerve stimulation with an IS-4 lead (3.0% vs. 13.4%; p = .029). LV lead-related re-interventions were fewer in case of an IS-4 lead (6.1% vs. 17.9%; p = .036)., Conclusion: In this retrospective analysis, the IS-4 LV lead is associated with lower lead-related complication rates than the IS-1 lead at long-term FU., (© 2023 The Authors. Pacing and Clinical Electrophysiology published by Wiley Periodicals LLC.)

Aims: Pulsed field ablation (PFA) for pulmonary vein isolation (PVI) combines the benefits of high procedural efficacy and safety. Transseptal puncture (TSP) to obtain left atrial (LA) access during PVI remains an important source of complications during LA procedures. For PFA procedures, TSP is generally performed using a standard transseptal sheath that is then exchanged over the wire for a dedicated PFA sheath, which might be a potential source for air embolism. We aimed to prospectively evaluate the feasibility and safety of a simplified workflow using the PFA sheath (Faradrive, Boston Scientific) directly for TSP., Methods and Results: We prospectively enrolled 100 patients undergoing PVI using PFA at two centres. TSP was performed using the PFA sheath and a standard 98 cm transseptal needle under fluoroscopic guidance. TSP via the PFA sheath was successfully performed in all patients and no complications occurred. The median time from the first groin puncture to the completed LA access was 12 min (IQR 8-16 min)., Conclusion: An over-the-needle TSP directly with the PFA sheath proved feasible and safe in our study. This simplified workflow has the potential to reduce the risk of air embolism, to shorten procedure time, and to reduce cost., Competing Interests: Conflict of interest: L.R.: speaker/consulting honoraria from Abbott/SJM and Medtronic and research grant for investigator-initiated research from Medtronic. T.R.: research grants for investigator-initiated research from the Swiss National Science Foundation, the Swiss Heart Foundation, sitem-insel support fund, Biotronik, Boston Scientific, and Medtronic—all for work outside the submitted study. Speaker/consulting honoraria or travel support from Abbott/SJM, Astra Zeneca, Brahms, Bayer, Biosense Webster, Biotronik, Boston Scientific, Daiichi Sankyo, Farapulse, Medtronic, Pfizer-BMS, and Roche—all for work outside the submitted study. Support for his institution’s fellowship program from Abbott/SJM, Biosense-Webster, Biotronik, Boston Scientific, and Medtronic for work outside the submitted study. A.M.: owns stock from Boston Scientific. J.S.: the spouse of J.S. is an employee and stock owner of Boston Scientific. R.K. received institutional grant support from Abbott, Biotronik, Biosense Webster, Boston Scientific, and Medtronic. He received speaking fees, travel grants, and consultancy fees from Biosense Webster. B.B. received an EHRA grant from Abbott and a Biotronik International Fellowship. He received speaking fees, travel grants, and consultancy fees from Biosense Webster. All other authors report no conflicts of interest related to this paper., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)