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Aims: Contact force (CF)-sensing radiofrequency (RF) catheters with an ablation index have shown reproducible outcomes for the treatment of atrial fibrillation (AF) in large multicentre studies. A dual-energy (DE) focal CF catheter to deliver RF and unipolar/biphasic pulsed field ablation (PFA), integrated with a three-dimensional (3D) mapping system, can provide operators with additional flexibility. The SmartfIRE study assessed the safety and efficacy of this novel technology for the treatment of drug-refractory, symptomatic paroxysmal AF. Results at 3 months post-ablation are presented here., Methods and Results: Pulmonary vein isolation (PVI) was performed using a DE focal, irrigated CF-sensing catheter with the recommendation of PFA at posterior/inferior and RF ablation at the anterior/ridge/carina segments. Irrespective of energy, a tag size of 3 mm; an inter-tag distance ≤6 mm; a target index of 550 for anterior, roof, ridge, and carina; and a target index of 400 for posterior and inferior were recommended. Cavotricuspid isthmus ablation was permitted in patients with documented typical atrial flutter. The primary effectiveness endpoint was acute procedural success. The primary safety endpoint was the rate of primary adverse events (PAEs) within 7 days of the procedure. A prespecified patient subset underwent oesophageal endoscopy (EE; 72 h post-procedure), neurological assessment (NA; pre-procedure and discharge), and cardiac computed tomography (CT)/magnetic resonance angiogram (MRA) imaging (pre-procedure and 3 months post-procedure) for additional safety evaluation, and a mandatory remapping procedure (Day 75 ± 15) for PVI durability assessment. Of 149 patients enrolled between February and June 2023, 140 had the study catheter inserted (safety analysis set) and 137 had ablation energy delivered (per-protocol analysis set). The median (Q1/Q3) total procedure and fluoroscopy times were 108.0 (91.0/126.0) and 4.2 (2.3/7.7) min (n = 137). The acute procedural success rate was 100%. First-pass isolation was achieved in 89.1% of patients and 96.8% of veins. Cavotricuspid isthmus ablations were successfully performed in 12 patients [pulsed field (PF) only: 6, RF only: 5, and RF/PF: 1]. The PAE rate was 4.4% [6/137 patients; 2 pulmonary vein (PV) stenoses, 2 cardiac tamponades/perforations, 1 stroke, and 1 pericarditis]. No coronary artery spasm was reported. No oesophageal lesion was seen in the EE subset (0/31, 0%). In the NA subset (n = 30), microemboli lesions were identified in 2 patients (2/30, 6.7%), both of which were resolved at follow-up; only 1 was symptomatic (silent cerebral lesion, 3.3%). In the CT/MRA subset (n = 30), severe PV narrowing (of >70%) was detected in 2 patients (2/30, 6.7%; vein level 2/128, 1.6%), of whom 1 underwent dilatation and stenting and 1 was asymptomatic; both were associated with high index values and a small inter-tag distance. In the PV durability subset (n = 30), 100/115 treated PVs (87%) were durably isolated and 18/30 patients (60.0%) had all PVs durably isolated., Conclusion: A DE focal CF catheter with 3D mapping integration showed a 100% acute success rate with an acceptable safety profile in the treatment of paroxysmal AF. Prespecified 3-month remapping showed notable PVI durability., Clinical Trial Registration: ClinicalTrials.gov Identifier: NCT05752487., Competing Interests: Conflict of interest: M.D. has served on the speakers bureau and as a consultant and has received research support from Biosense Webster, Inc. T.D.P. has received consulting fees and honoraria for lectures and presentations from Biosense Webster, Inc. and Adagio Medical (all payments were directed to institution). J.H. reports speakers fees and consultant honoraria from Biosense Webster, Inc. and Boston Scientific. T.P. reports support for attending a meeting and travel from Biosense Webster, Inc. J.V. reports research grants from Abbott, Biotronik, Boston Scientific, CardioFocus, and Medtronic; speakers fees from Abbott and CardioFocus; and serving on an advisory board for Boston Scientific. G.S. reports personal fees from Abbott, Bayer, Boston Scientific, Johnson & Johnson Medical, and LUMA Vision not related to the present study and fees from Johnson & Johnson Medical in relation to the present study. M.B.K. reports speakers fees from Biosense Webster, Inc. H.P. reports consultancy and honoraria as a speaker for Abbott, Biosense Webster, Inc., Boston Scientific, and Medtronic. P.L. has received consulting fees and a travel grant from Biosense Webster, Inc. outside the presented work. 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: 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: We previously presented the safety and early efficacy of the inspIRE study (Study for Treatment of Paroxysmal Atrial Fibrillation [PAF] by Pulsed-field Ablation [PFA] System With Irreversible Electroporation [IRE]). With the study's conclusion, we report the outcomes of the full pivotal study cohort, with an additional analysis of predictors of success., Methods: InspIRE was a prospective, multicenter, single-arm clinical trial of drug-refractory paroxysmal atrial fibrillation. Pulmonary vein isolation was performed with a variable-loop circular catheter integrated with a 3-dimensional mapping system. Follow-up with 24-hour Holter was at 3, 6, and 12 months, as well as remote rhythm monitoring: weekly from 3 to 5 months, monthly from 6 to 12 months, and for symptoms. The primary effectiveness end point (PEE) was acute pulmonary vein isolation plus freedom from any atrial arrhythmia at 12 months. Additional subanalyses report predictors of PEE success., Results: The patient cohort included 186 patients: aged 59±10 years, female 30%, and CHA 2 DS 2 -VASc 1.3±1.2. The previously reported primary adverse event rate was 0%. One serious procedure-related adverse event, urinary retention, was reported. The PEE was achieved in 75.6% (95% CI, 69.5%-81.8%). The clinical success of freedom from symptomatic recurrence was 81.7% (95% CI, 76.1%-87.2%). Simulating a monitoring method used in standard real-world practice (without protocol-driven remote rhythm monitoring), this translates to a freedom from all and symptomatic recurrence of 85.8% (95% CI, 80.8%-90.9%) or 94.0% (95% CI, 90.6%-97.5%), respectively. Multivariate analyses revealed that left ventricular ejection fraction ≥60% (adjusted odds ratio, 0.30) and patients receiving ≥48 PFA applications (adjusted odds ratio, 0.28) were independent predictors of PEE success. Moreover, PEE success was 79.2% in patients who received ≥12 PFA applications per vein compared with 57.1% in patients receiving fewer PFA applications., Conclusions: The inspIRE study confirms the safety and effectiveness of pulmonary vein isolation using the novel 3-dimensional mapping integrated circular loop catheter. An optimal number of PFA applications (≥48 total or ≥12 per vein) resulted in an improved 1-year success rate of ≈80%., Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04524364., Competing Interests: Disclosures Dr De Potter has received consulting fees and honoraria for lectures and presentations from Biosense Webster and Adagio Medical (all payments were directed to the institution). Dr Grimaldi has an unrelated patent agreement with Biosense Webster, Inc. Dr Duytschaever has served on the speakers’ bureau and as a consultant for Biosense Webster, Inc, and has received research support from Biosense Webster, Inc. Dr Anic has received consulting fees and has contracted research with Farapulse, Boston Scientific, Galaxy Medical, and Biosense Webster, Inc. Dr Vijgen has received grant support from Biosense Webster, Inc. Dr Neuzil has received grant support from Biosense Webster, Inc. Dr Van Herendael has received support from Biosense Webster, Inc, for congress-related activities. Dr Verma has received grants from Biosense Webster, Inc, Medtronic, Bayer, and Biotronik; has received consulting fees from Biosense Webster, Inc, Medtronic, Adagio Medical, Galaxy Medical, Ablacon, and Thermedical; and has received honoraria for lectures from Biosense Webster, Inc, and Medtronic. Dr Skanes has served on the speakers’ bureau for Biosense Webster, Inc, and has received research support from Biosense Webster, Inc. Dr Scherr has received grant support from Biosense Webster, Inc. Dr Pürerfellner has received consulting fees from Biosense Webster, Inc, Abbott, Boston Scientific, Biotronik, and Medtronic, and has received payment or honoraria for lectures or presentations from Biosense Webster, Inc, Abbott, Boston Scientific, Biotronik, and Medtronic. Dr Jais has received research grants from Biosense Webster, Inc; has received speaker fees from Biosense Webster, Inc; is a shareholder of Farapulse/Affera; and has received speaker fees and research grants from Boston Scientific, Medtronic, and Abbott. Dr Reddy is a consultant for Biosense Webster, Inc; and 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, 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, 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. Johnson & Johnson MedTech has an agreement with the Yale Open Data Access Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant-level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the Yale Open Data Access Project site at http://yoda.yale.edu. The other authors report no conflicts.

Background: In patients with persistent atrial fibrillation (PersAF), catheter ablation aiming for pulmonary vein isolation (PVI) is associated with moderate clinical effectiveness. We investigated the benefit of continuing previously ineffective class 1C or 3 antiarrhythmic drug therapy (ADT) in the setting of a standardized PVI-only ablation strategy., Methods: In this multicenter, randomized controlled study, patients with PersAF (≥7 days and <12 months) despite ADT were prospectively randomized 1:1 to PVI with ADT continued versus discontinued beyond the blanking period (ADT ON versus ADT OFF). Standardized catheter ablation was performed aiming for durable isolation with stable, contiguous, and optimized radio frequency applications encircling the pulmonary veins (CLOSE protocol). Clinical visits and 1-to-7-day Holter were performed at 3, 6, and 12 months. The primary end point was any documented atrial tachyarrhythmia lasting >30 seconds beyond 3 months. Prospectively defined secondary end points included repeat ablations, unscheduled arrhythmia-related visits, and quality of life among groups., Results: Of 200 PersAF patients, 98 were assigned to ADT OFF and 102 to ADT ON. The longest atrial fibrillation episode qualifying for PersAF was 28 (10-90) versus 30 (11-90) days. Clinical characteristics and procedural characteristics were similar. Recurrence of atrial tachyarrhythmia was comparable in both groups (20% OFF versus 21.2% ON). No differences were observed in repeat ablations and unscheduled arrhythmia-related visits. Marked improvement in quality of life was observed in both groups., Conclusions: In patients with PersAF, there is no benefit in continuing previously ineffective ADT beyond the blanking period after catheter ablation. The high success rate of PVI-only might be explained by the high rate of durable isolation after optimized PVI and the early stage of PersAF (POWDER-AF2)., Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03437356., Competing Interests: Disclosures None.

Background: Pulsed field ablation (PFA) is a novel ablation technology recently adopted in the treatment of atrial fibrillation (AF). Currently, little is known about the durability of PFA ablation lesions., Methods: We investigated patients who underwent redo-ablation due to recurrent AF/atrial-flutter or tachycardia (AFL/AT) following PVI with PFA. We report electrophysiological findings and ablation strategy during redo-ablation., Results: Of 447 patients undergoing index PVI with PFA, 14 patients (age: 61.9±10.8 years; 7 (50.0%) males; left atrial volume index (n=10): 39.4±14.6 mL/m 2 ) were referred for redo-ablation. Initial indication was paroxysmal-AF in 7 patients, persistent-AF in 6 and long-standing-persistent-AF in one patient. Mean time-to-recurrence was 4.9±1.9 months. Three patients received additional posterior-wall-isolation during index PFA. Twelve (85.7%) patients suffered AF recurrence and 5/12 had concomitant AFL. In the remaining 2 patients, one had a (box-dependent) AFL, and one had an atypical AT. No patients had all PVs reconnected. Reconnection in zero, one, two or three PVs was found in 35.7%, 21.4%, 14.3%, and 28.6% of patients, respectively. All 7 patients with zero or one reconnection with AF recurrence received additional/repeat posterior-wall-isolation during re-ablation, while in the others, PVs were re-isolated. Patients with only AFL/AT had no reconnection of PVs, and the substrate was successfully ablated., Conclusions: Durable PVI (all PV's isolated) was observed in over one-third of patients at re-do. The predominant recurrent arrhythmia following PVI-only was AF. Concomitant (35.7%) or isolated (14.3%) AFL/AT recurrence was observed in 50% of patients., (© 2023. 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.

Background: Very high-power, short-duration (90-W/4-second) ablation for pulmonary vein isolation (PVI) may reduce procedural times. However, shorter applications with higher power may impact lesion quality., Objectives: In this multicenter, randomized controlled trial, the authors compared procedural efficiency, efficacy, and safety of PVI using 90-W/4-second ablation to 35/50-W ablation., Methods: Patients with paroxysmal or persistent atrial fibrillation undergoing first-time PVI were randomized to pulmonary vein encirclement with contiguous applications using very high-power, short-duration applications (90 W over 4 seconds) or 35/50-W applications (titrated up to ablation index >550 anteriorly and >400 posteriorly). Prospective endpoints were procedural efficiency (procedure time and first-pass isolation), safety (including esophageal endoscopic evaluation), and 6-month effectiveness using repetitive Holter monitoring., Results: A total of 180 patients were randomized, 90 to the 90-W group (mean age: 64.2 ± 8.9 years) and 90 to the 35/50-W group (mean age: 62.3 ± 10.8 years). Procedural time was shorter in the 90-W group vs the 35/50-W group (70 [IQR: 60-80] minutes vs 75 [IQR: 65-88.3] minutes; P = 0.009). A nonsignificant trend towards lower rates of first-pass isolation was seen in the 90-W group (83.9% vs 90%; P = 0.0852). No major complications were observed in both groups with esophageal injury occurring in 1 patient per group. At 6 months, 17% of patients in the 90-W group vs 15% in the 35/50-W group experienced recurrent arrhythmia (P = 0.681)., Conclusions: Contiguous ablation using very high-power, short-duration applications results in a significant but modest reduction in procedure time with similar safety and 6-month efficacy vs a conventional approach. A hybrid approach combining both ablation modalities might be the most optimal strategy. (POWER PLUS [Very High Power Ablation in Patients With Atrial Fibrillation Schedule for a First Pulmonary Vein Isolation]; NCT04784013)., Competing Interests: Funding Support and Author Disclosures Dr Kobza has served as a consultant for Biosense-Webster, Biotronik, and Medtronic, not related to this work. Drs Duytschaever and Scherr have received speaker fees from Biosense Webster, not related to this work. Dr Manninger has received research grants from Biosense Webster, not related to this work., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: The inspIRE study (Study for Treatment of Paroxysmal Atrial Fibrillation [PAF] by Pulsed Field Ablation [PFA] System With Irreversible Electroporation [IRE]) evaluated safety and effectiveness of a fully integrated biphasic pulsed field ablation (PFA) system with a variable-loop circular catheter for the treatment of drug-refractory paroxysmal atrial fibrillation., Methods: Subjects underwent pulmonary vein (PV) isolation with the PFA system, using at least 12 applications per vein; adenosine/isoproterenol was administered to confirm entrance block. Wave I assessed initial safety, including for esophageal lesions, silent cerebral lesions, and PV stenosis. Wave II (pivotal phase) tested (1) primary safety, incidence of early-onset primary adverse events, and (2) primary effectiveness, confirmed PV isolation with freedom from documented atrial arrhythmia at 12 months. The study design specified an interim analysis to determine early success once 30 subjects reached the 12-month follow-up and all subjects reached 3-month follow-up., Results: Across 13 centers in Europe/Canada, 226 subjects were enrolled, met criteria for safety and effectiveness evaluations, and received PFA (Wave I, 40; Wave II, 186). Wave I demonstrated no esophageal thermal lesions or PV stenosis. Among 39 subjects with cerebral magnetic resonance imaging, silent cerebral lesions were detected in 4 of the first 6 subjects, after which workflow enhancements, including a 10-second pause between PFA applications, were implemented; subsequently, only 4 of 33 subjects had silent cerebral lesions. In the Wave II phase, no primary adverse events were reported. Upon declaring early success, 83 subjects reached 12-month follow-up. With 100% entrance block, PV isolation without acute reconnection was achieved in 97.1% of targeted veins. For Wave II, the primary effectiveness end point per Kaplan-Meier at the time of interim analysis was 70.9%; 12-month freedom from symptomatic atrial fibrillation/atrial flutter/atrial tachycardia recurrence and repeat ablation was 78.9% and 92.3%, respectively. Total procedure and transpired PFA times were 70.1±27.7 and 26.7±14.0 minutes, respectively., Conclusions: The inspIRE trial confirmed the safety and effectiveness of the novel mapping-integrated PFA system., Registration: URL: https://www., Clinicaltrials: gov; unique identifier: NCT04524364.

Aims: Cryoballoon (CB)-based pulmonary vein isolation (PVI) is an effective treatment for atrial fibrillation (AF). The most frequent complication during CB-based PVI is right-sided phrenic nerve injury (PNI) which is leading to premature abortion of the freeze cycle. Here, we analysed reconnection rates after CB-based PVI and PNI in a large-scale population during repeat procedures., Methods and Results: In the YETI registry, a total of 17 356 patients underwent CB-based PVI in 33 centres, and 731 (4.2%) patients experienced PNI. A total of 111/731 (15.2%) patients received a repeat procedure for treatment of recurrent AF. In 94/111 (84.7%) patients data on repeat procedures were available. A total of 89/94 (94.7%) index pulmonary veins (PVs) have been isolated during the initial PVI. During repeat procedures, 22 (24.7%) of initially isolated index PVs showed reconnection. The use of a double stop technique did non influence the PV reconnection rate (P = 0.464). The time to PNI was 140.5 ± 45.1 s in patients with persistent PVI and 133.5 ± 53.8 s in patients with reconnection (P = 0.559). No differences were noted between the two populations in terms of CB temperature at the time of PNI (P = 0.362). The only parameter associated with isolation durability was CB temperature after 30 s of freezing. The PV reconnection did not influence the time to AF recurrence., Conclusion: In patients with cryoballon application abortion due to PNI, a high rate of persistent PVI rate was found at repeat procedures. Our data may help to identify the optimal dosing protocol in CB-based PVI procedures., Clinical Trial Registration: https://clinicaltrials.gov/ct2/show/NCT03645577?term=YETI&cntry=DE&draw=2&rank=1 ClinicalTrials.gov Identifier: NCT03645577., Competing Interests: Conflict of interest: C.H.H. received travel grants and research grants from Medtronic, Boston Scientific, Biosense Webster and Cardiofocus and is a proctor and lecturer of Medtronic, Boston Scientific, Cardiofocus and Biosense Webster. K.H.K. received travel grants and research grants from Biosense Webster, Stereotaxis, Prorhythm, Medtronic, Edwards, Cryocath, and is a consultant to St. Jude Medical, Biosense Webster, Prorhythm, and Stereotaxis. He received speaker's honoraria from Medtronic. R.R.T. received travel grants from St. Jude Medical, Biosense Webster, Daiichi Sankyo, SentreHeart and Speaker’s Bureau Honoraria from Biosense Webster, Biotronik, Boston scientific, Pfizer, Topera, Bristol-Myers Squibb, Bayer, Sanofi Aventis, and research grants by Cardiofocus, Boston Scientific and Lifetech. K.A. is a proctor and lecturer for Medtronic, Biosense Webster, and Abbott. A.M. received speaker's honoraria and travel grants from Medtronic, Biosense Webster and Cardiofocus. F.S. received honoraria for lectures from Medtronic, Philips EPD Solutions, and Bristol-Myers-Squibb, outside the submitted work; and educational support from Pfizer. S.C. received travel grants and speaker’s honoraria from Medtronic, Biosense Webster and Abbott, and is a proctor of Medtronic. E.J.P. received consultant fees from Medtronic, Biotronik, Abbott, Boston Scientific. E.W. is a consultant to Medtronic. All other authors have no relevant disclosures., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Aims: Pulsed field ablation (PFA) is a novel atrial fibrillation (AF) ablation modality that has demonstrated preferential tissue ablation, including no oesophageal damage, in first-in-human clinical trials. In the MANIFEST-PF survey, we investigated the 'real world' performance of the only approved PFA catheter, including acute effectiveness and safety-in particular, rare oesophageal effects and other unforeseen PFA-related complications., Methods and Results: This retrospective survey included all 24 clinical centres using the pentaspline PFA catheter after regulatory approval. Institution-level data were obtained on patient characteristics, procedure parameters, acute efficacy, and adverse events. With an average of 73 patients treated per centre (range 7-291), full cohort included 1758 patients: mean age 61.6 years (range 19-92), female 34%, first-time ablation 94%, paroxysmal/persistent AF 58/35%. Most procedures employed deep sedation without intubation (82.1%), and 15.1% were discharged same day. Pulmonary vein isolation (PVI) was successful in 99.9% (range 98.9-100%). Procedure time was 65 min (38-215). There were no oesophageal complications or phrenic nerve injuries persisting past hospital discharge. Major complications (1.6%) were pericardial tamponade (0.97%) and stroke (0.4%); one stroke resulted in death (0.06%). Minor complications (3.9%) were primarily vascular (3.3%), but also included transient phrenic nerve paresis (0.46%), and TIA (0.11%). Rare complications included coronary artery spasm, haemoptysis, and dry cough persistent for 6 weeks (0.06% each)., Conclusion: In a large cohort of unselected patients, PFA was efficacious for PVI, and expressed a safety profile consistent with preferential tissue ablation. However, the frequency of 'generic' catheter complications (tamponade, stroke) underscores the need for improvement., Competing Interests: Conflict of interest: V.Y.R. reports receiving consulting fees and equity (stock) from Farapulse Inc. and is a consultant for Boston Scientific Inc.; he also has additional disclosures unrelated to this manuscript that are listed in the Supplementary material online. B.S. reports receiving speaker’s fees and research grants from Boston Scientific/Farapulse, Medtronic, Biosense Webster, and Abbott. T.R. 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. L.R. reports receiving speaker honoraria from Abbott/SJM and consulting honoraria from Medtronic. K.N. reports speaker’s Fees from Farapulse, Inc. A.M. reports research grant and fees from Farapulse. A.R. reports receiving research grant from Farapulse. J.H. reports receiving speaker fees and grant support from Biosense Webster and Medtronic. Y.B.: reports receiving Research grant from Medtronic and Atricure and consulting fees from Abbott, Biosense Webster, Boston Scientific. P.S. reports member of the advisory board for Abbott, Biosense Webster, Boston Scientific, and Medtronic. C.S. reports receiving modest honoraria from Medtronic. A.A. 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., Biosense Webster. F.A. reports receiving consulting fees from Boston Scientific, Medtronic and Microport CRM. S.B. reports receiving consulting fees for Medtronic, Boston Scientific, Microport, Zoll, and BMS. T.D. 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. S.W. reports receiving grants and personal fees from Abbott, Boston Scientific, Medtronic, and personal fees from Boehringer Ingelheim, Brystol Myers Squibb, Bayer Vital, Accutus, Daiichi, Farapulse Inc. M.G. reports grant from Farapulse Inc. and Abbott. R.T. reports receiving consulting fees from Boston Scientific, Abbot Medical, Biotronik, and speakers honorarium from Boston Scientific, Abbot Medical, Biotronik, Biosense Webster. B.K. reports receiving Travel and Congress Sponsoring from Biotronik, Abbott, Impulse Dynamics, DGK AG EP, EHRA, Pfizer; she also received fellowship sponsoring from Johnson & Johnson, Boston Scientific and Lecture Honorary from Biotronik, Impulse Dynamics, C.T.I. GmbH, Doctrina Med. D.S. reports receiving an educational grant from Farapulse Inc., and is a consultant For Boston Scientific Inc. R.W. 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. D.S. reports receiving speaking fees from Pfizer, Bayer, Abbott, Johnson & Johnson, and Medtronic; grant from Abbott, Johnson & Johnson, and Boston Scientific; and consulting fees from Boston Scientific and Johnson & Johnson. A.S. reports receiving lecture and consulting honoraria from Medtronic, Abbott, and Bayer. J.K. 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. P.J. reports receiving equity from Farapulse and consulting fees and grant from Boston Scientific. N.D. reports receiving consulting fees from Boston scientific. J.C. reports receiving speaker’s fees and research grants from Boston Scientific/Farapulse, Medtronic, Biosense Webster, and Abbott. P.N. reports receiving grant from the Ministry of Health, Czech Republic, DRO (NHH, 00023884). All the remaining authors have declared no conflict of interest., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Background: Cryoballoon-based pulmonary vein isolation (PVI) has emerged as an effective treatment for atrial fibrillation. The most frequent complication during cryoballoon-based PVI is phrenic nerve injury (PNI). However, data on PNI are scarce., Methods: The YETI registry is a retrospective, multicenter, and multinational registry evaluating the incidence, characteristics, prognostic factors for PNI recovery and follow-up data of patients with PNI during cryoballoon-based PVI. Experienced electrophysiological centers were invited to participate. All patients with PNI during CB2 or third (CB3) and fourth-generation cryoballoon (CB4)-based PVI were eligible., Results: A total of 17 356 patients underwent cryoballoon-based PVI in 33 centers from 10 countries. A total of 731 (4.2%) patients experienced PNI. The mean time to PNI was 127.7±50.4 seconds, and the mean temperature at the time of PNI was -49±8°C. At the end of the procedure, PNI recovered in 394/731 patients (53.9%). Recovery of PNI at 12 months of follow-up was found in 97.0% of patients (682/703, with 28 patients lost to follow-up). A total of 16/703 (2.3%) reported symptomatic PNI. Only 0.06% of the overall population showed symptomatic and permanent PNI. Prognostic factors improving PNI recovery are immediate stop at PNI by double-stop technique and utilization of a bonus-freeze protocol. Age, cryoballoon temperature at PNI, and compound motor action potential amplitude loss >30% were identified as factors decreasing PNI recovery. Based on these parameters, a score was calculated. The YETI score has a numerical value that will directly represent the probability of a specific patient of recovering from PNI within 12 months., Conclusions: The incidence of PNI during cryoballoon-based PVI was 4.2%. Overall 97% of PNI recovered within 12 months. Symptomatic and permanent PNI is exceedingly rare in patients after cryoballoon-based PVI. The YETI score estimates the prognosis after iatrogenic cryoballoon-derived PNI. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03645577. Graphic Abstract: A graphic abstract is available for this article.

Background: Periprocedural pulmonary vein isolation (PVI) anticoagulation requires balancing between bleeding and thromboembolic risk. Intraprocedural anticoagulation is monitored by activated clotting time (ACT) with target value >300 s, and there are no guidelines specifying an initial unfractionated heparin (UFH) dose., Methods: We aimed to assess differences in ACT values and UFH dosage during PVI in patients on different oral anticoagulants. We conducted an international, multi-center, registry-based study. Consecutive patients with atrial fibrillation (AF) undergoing PVI, on uninterrupted anticoagulation therapy, were analyzed. Before transseptal puncture, UFH bolus of 100 IU/kg was administered regardless of the anticoagulation drug., Results: Total of 873 patients were included (median age 61 years, IQR 53-66; female 30%). There were 248, 248, 189, 188 patients on warfarin, dabigatran, rivaroxaban, and apixaban, respectively. Mean initial ACT was 257 ± 50 s, mean overall ACT 295 ± 45 s and total UFH dose 158 ± 60 IU/kg. Patients who were receiving warfarin and dabigatran compared to patients receiving rivaroxaban and apixaban had: (i) significantly higher initial ACT values (262 ± 57 and 270 ± 48 vs. 248 ± 42 and 241 ± 44 s, p < .001), (ii) significantly higher ACT throughout PVI (309 ± 46 and 306 ± 44 vs. 282 ± 37 and 272 ± 42 s, p < .001), and (iii) needed lower UFH dose during PVI (140 ± 39 and 157 ± 71 vs. 171 ± 52 and 172 ± 70 IU/kg)., Conclusion: There are significant differences in ACT values and UFH dose during PVI in patients receiving different anticoagulants. Patients on warfarin and dabigatran had higher initial and overall ACT values and needed lower UFH dose to achieve adequate anticoagulation during PVI than patients on rivaroxaban and apixaban., (© 2021 The Authors. Clinical Cardiology published by Wiley Periodicals LLC.)

Objective: Pulmonary vein isolation (PVI) guided by a standardised CLOSE (contiguous optimised lesions) protocol has been shown to increase clinical success after catheter ablation for paroxysmal atrial fibrillation (PAF). This study analysed healthcare utilisation and quality of life (QOL) outcomes from a large multicentre prospective study, measured association between QOL and atrial fibrillation (AF) burden and identified factors associated with lack of QOL improvement., Methods: CLOSE-guided ablation was performed in 329 consecutive patients (age 61.4 years, 60.8% male) with drug-refractory PAF in 17 European centres. QOL was measured at baseline and 12 months post-ablation via Atrial Fibrillation Effect on QualiTy of Life Survey (AFEQT) and EuroQoL EQ-5D-5L questionnaires. All-cause and cardiovascular hospitalisations and cardioversions over 12 months pre-ablation and post-ablation were recorded. Rhythm monitoring included weekly and symptom-driven trans-telephonic monitoring, plus ECG and Holter monitoring at 3, 6 and 12 months. AF burden was defined as the percentage of postblanking tracings with an atrial tachyarrhythmia ≥30 s. Continuous measures across multiple time points were analysed using paired t-tests, and associations between various continuous measures were analysed using independent sample t-tests. Each statistical test used two-sided p values with a significance level of 0.05., Results: Both QOL instruments showed significant 12-month improvements across all domains: AFEQT score increased 25.1-37.5 points and 33.3%-50.8% fewer patients reporting any problem across EuroQoL EQ-5D-5L domains. Overall, AFEQT improvement was highly associated with AF burden (p=0.009 for <10% vs ≥10% burden, p<0.001 for <20% vs ≥20% burden). Cardiovascular hospitalisations were significantly decreased after ablation (42%, p=0.001). Patients without substantial improvement in AFEQT (55/301, 18.2%) had higher AFEQT and CHA 2 DS 2 -VASc scores at baseline, and higher AF burden following PVI., Conclusions: QOL improved and healthcare utilisation decreased significantly after ablation with a standardised CLOSE protocol. QOL improvement was significantly associated with impairment at baseline and AF burden after ablation., Trial Registration Number: NCT03062046., Competing Interests: Competing interests: Dr MD reports personal fees (consulting) from Biosense Webster, outside the submitted work; reports non-financial (travel) support for the submitted work. Dr RK reports grants from Biosense Webster, grants from Biotronik, grants from Abbott, grants from Medtronic, grants from Boston, grants from SIS Medical, outside the submitted work. Dr GS reports grants from Biosense Webster, during the conduct of the study; personal fees from Biosense Webster, personal fees from Abbott, outside the submitted work. Dr J-PA reports personal fees (consulting) from Biosense Webster and from Abbott outside the submitted work. Drs BB, TDP, SK, NS, DS, YS, PT, HVH, JV and MW have nothing to disclose., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.)

Aims: To evaluate the safety and effectiveness of pulmonary vein isolation in paroxysmal atrial fibrillation (PAF) using a standardized workflow aiming to enclose the veins with contiguous and optimized radiofrequency lesions., Methods and Results: This multicentre, prospective, non-randomized study was conducted at 17 European sites. Pulmonary vein isolation was guided by VISITAG SURPOINT (VS target ≥550 on the anterior wall; ≥400 on the posterior wall) and intertag distance (≤6 mm). Atrial arrhythmia recurrence was stringently monitored with weekly and symptom-driven transtelephonic monitoring on top of standard-of-care monitoring (24-h Holter and 12-lead electrocardiogram at 3, 6, and 12 months follow-up). Three hundred and forty participants with drug refractory PAF were enrolled. Acute effectiveness (first-pass isolation proof to a 30-min wait period and adenosine challenge) was 82.4% [95% confidence interval (CI) 77.4-86.7%]. At 12-month follow-up, the rate of freedom from any documented atrial arrhythmia was 78.3% (95% CI 73.8-82.8%), while freedom from atrial arrhythmia by standard-of-care monitoring was 89.4% (95% CI 78.8-87.0%). Freedom fromrepeat ablations by the Kaplan-Meier analysis was 90.4% during 12 months of follow-up. Of the 34 patients with repeat ablations, 14 (41.2%) demonstrated full isolation of all pulmonary vein circles. Primary adverse event (PAE) rate was 3.6% (95% CI 1.9-6.3%)., Conclusions: The VISTAX trial demonstrated that a standardized PAF ablation workflow aiming for contiguous lesions leads to low rates of PAEs, high acute first-pass isolation rates, and 12-month freedom from arrhythmias approaching 80%. Further research is needed to improve the reproducibility of the outcomes across a wider range of centres.Clinical trial registration: ClinicalTrials.gov, number NCT03062046, https://clinicaltrials.gov/ct2/show/NCT03062046., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2020. For permissions, please email: journals.permissions@oup.com.)

Aims: The ESC EORP EHRA Atrial Fibrillation (AF) Ablation Long-Term registry was designed to assess management and outcomes of AF catheter ablation procedures in Europe. To investigate the current ablation approaches and their outcomes for patients with paroxymal AF (PAF) and non-PAF in Europe., Methods and Results: Data from index ablations were collected in 27 European countries at 104 centres in a prospective fashion. Pre-procedural, procedural, and 1-year follow-up data were captured on a web-based electronic case record form. Data on the ablation procedure were available for 3446 patients. Of these, 2513 patients and 933 patients underwent pulmonary vein isolation (PVI) or PVI plus (PVIplus) additional ablation, respectively. The ablation strategy was limited to PVI in 81% and 56% of patients in the PAF and non-PAF group, respectively (P < 0.001). In the non-PAF group, left atrial linear ablation and ablation of complex fragmented atrial electrograms were more commonly performed. Arrhythmias recurrence after PVI was 29% and 39% in the PAF and non-PAF group, respectively (P < 0.001) and 42% after PVIplus in both groups. Atrial fibrillation related hospital admissions were more common in the PVIplus group (20% vs. 14%). A very low procedural complication rate was observed. No relevant differences were observed with regard to repeat ablation (PVI 9% and PVIplus 11%)., Conclusion: In patients with PAF and non-PAF, the ablation strategies of PVI and PVIplus led to similar arrhythmia-free survival rates after 1 year. A considerable hospital readmission rate was noted., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2019. For permissions, please email: journals.permissions@oup.com.)

Catheter ablation is an established treatment option for patients with atrial fibrillation (AF). In paroxysmal AF ablation, pulmonary vein isolation alone is a well-defined procedural endpoint, leading to success rates of up to 80% with multiple procedures over 5 years of follow-up. The success rate in persistent AF ablation is significantly more limited. This is partly due to the rudimentary understanding of the substrate maintaining persistent AF. Three main pathophysiological concepts for this arrhythmia exist: the multiple wavelet hypothesis, the concept of focal triggers, mainly located in the pulmonary veins and the rotor hypothesis. However, the targets and endpoints of persistent AF ablation are ill-defined and there is no consensus on the optimal ablation strategy in these patients. Based on these concepts, several ablation approaches for persistent AF have emerged: pulmonary vein isolation, the stepwise approach (i.e. pulmonary vein isolation, ablation of fractionated electrograms and linear ablation), magnetic resonance imaging (MRI) and rotor-based approaches. Currently, persistent AF ablation is a second-line therapy option to restore and maintain sinus rhythm. Several factors, such as the presence of structural heart disease, duration of persistent AF and dilatation and possibly also the degree of fibrosis of the left atrium should influence the decision to perform persistent AF ablation.

Background: This study aimed to determine 5-year efficacy of catheter ablation for persistent atrial fibrillation (AF) using AF termination as a procedural end point., Methods and Results: One hundred fifty patients (57±10 years) underwent persistent AF ablation using a stepwise ablation approach (pulmonary vein isolation, electrogram-guided, and linear ablation) with the desired procedural end point being AF termination. Repeat ablation was performed for recurrent AF or atrial tachycardia. AF was terminated by ablation in 120 patients (80%). Arrhythmia-free survival rates after a single procedure were 35.3%±3.9%, 28.0%±3.7%, and 16.8%±3.2% at 1, 2, and 5 years, respectively. Arrhythmia-free survival rates after the last procedure (mean 2.1±1.0 procedures) were 89.7%±2.5%, 79.8%±3.4%, and 62.9%±4.5%, at 1, 2, and 5 years, respectively. During a median follow-up of 58 (interquartile range, 43-73) months after the last ablation procedure, 97 of 150 (64.7%) patients remained in sinus rhythm without antiarrhythmic drugs. Another 14 (9.3%) patients maintained sinus rhythm after reinitiation of antiarrhythmic drugs, and an additional 15 (10.0%) patients regressed to paroxysmal recurrences only. Failure to terminate AF during the index procedure (hazard ratio 3.831; 95% confidence interval, 2.070-7.143; P<0.001), left atrial diameter≥50 mm (hazard ratio 2.083; 95% confidence interval, 1.078-4.016; P=0.03), continuous AF duration≥18 months (hazard ratio 1.984; 95% confidence interval, 1.024-3.846; P<0.04), and structural heart disease (hazard ratio 1.874; 95% confidence interval, 1.037-3.388; P=0.04) predicted arrhythmia recurrence., Conclusions: In patients with persistent AF, an ablation strategy aiming at AF termination is associated with freedom from arrhythmia recurrence in the majority of patients over a 5-year follow-up period. Procedural AF nontermination and specific baseline factors predict long-term outcome after ablation., (© 2014 American Heart Association, Inc.)

Background: Rapid pulmonary vein (PV) activity has been shown to maintain paroxysmal atrial fibrillation (AF). We evaluated in persistent AF the cycle length (CL) gradient between PVs and the left atrium (LA) in an attempt to identify the subset of patients where PVs play an important role., Methods and Results: Ninety-seven consecutive patients undergoing first ablation for persistent AF were studied. For each PV, the CL of the fastest activation was assessed over 1 minute (PVfast) using Lasso recordings. The PV to LA CL gradient was quantified by the ratio of PVfast to LA appendage (LAA) AF CL. Stepwise ablation terminated AF in 73 patients (75%). In the AF termination group, the PVfast CL was much shorter than the LAA CL resulting in lower PVfast/LAA ratios compared with the nontermination group (71±10% versus 92±7%; P<0.001). Within the termination group, PVfast/LAA ratios were notably lower if AF terminated after PV isolation or limited adjunctive substrate ablation compared with patients who required moderate or extensive ablation (63±6% versus 75±8%; P<0.001). PVfast/LAA ratio <69% predicted AF termination after PV isolation or limited substrate ablation with 74% positive predictive value and 95% negative predictive value. After a mean follow-up of 29±17 months, freedom from arrhythmia recurrence off-antiarrhythmic drugs was achieved in most patients with PVfast/LAA ratios <69% as opposed to the remaining population (80% versus 43%; P<0.001)., Conclusions: The PV to LA CL gradient may identify the subset of patients in whom persistent AF is likely to terminate after PV isolation or limited substrate ablation and better long-term outcomes are achieved., (© 2014 American Heart Association, Inc.)

Atrial fibrillation (AF) ablation has evolved to the treatment of choice for patients with drug-resistant and symptomatic AF. Pulmonary vein isolation at the ostial or antral level usually is sufficient for treatment of true paroxysmal AF. For persistent AF ablation, drivers and perpetuators outside of the pulmonary veins are responsible for AF maintenance and have to be targeted to achieve satisfying arrhythmia-free success rate. Both complex fractionated atrial electrogram (CFAE) ablation and linear ablation are added to pulmonary vein isolation for persistent AF ablation. Nevertheless, ablation failure and necessity of repeat ablations are still frequent, especially after persistent AF ablation. Pulmonary vein reconduction is the main reason for arrhythmia recurrence after paroxysmal and to a lesser extent after persistent AF ablation. Failure of persistent AF ablation mostly is a consequence of inadequate trigger ablation, substrate modification or incompletely ablated or reconducting linear lesions. In this review we will discuss these points responsible for AF recurrence after ablation and review current possibilities on how to overcome these limitations.

This is a case of atrial tachycardia 2 years after pulmonary transplantation. After excluding right atrial involvement, tachycardia origin was located in a scar region medial to the anastomosis of the left inferior pulmonary donor vein. Tachycardia mechanism was microreentry. Noninvasive electrocardiographic mapping performed before the ablation procedure matched with results of invasive Carto mapping and predicted both tachycardia mechanism and origin. We discuss arrhythmia mechanism found after pulmonary transplantation and benefit of noninvasive electrocardiographic mapping for procedure planning., (© 2012 Wiley Periodicals, Inc.)

Purpose: Esophageal injury is a potential complication with radiofrequency ablation in the posterior wall of the left atrium (LA). The "box isolation" method isolates the posterior LA wall including the pulmonary veins without ablation on the posterior LA wall. This study compares the acute and long-term efficacy of the box isolation method with conventional circumferential pulmonary vein isolation (PVI) for catheter ablation of AF., Methods: Twenty-nine patients (age 60 ± 9 years, 62% male, 79% paroxysmal) with drug refractory AF underwent catheter ablation. Sixteen of the 29 patients (55%) underwent box isolation. Recurrence of AF was detected by checking the daily recorded rhythm strip on a portable home ECG monitor, irrespective of the symptoms. Mean follow-up duration was 10 ± 2 months., Results: Complete isolation of the posterior LA using box isolation lesions was achieved in three of 16 (19%) patients. The other 13 patients underwent creation of additional lesions until all PVs were isolated. Of the 16 patients who underwent box isolation, four patients (25%) had complete success, six patients (38%) had improvement, and the remaining six patients (37%) had failure. Of the 13 patients who underwent the standard PV isolation, two patients (15%) had complete success, eight patients (62%) had improvement, and the remaining three patients (23%) had failure (p = 0.44)., Conclusion: In this pilot study, the efficacy of box isolation is similar to the circumferential PVI for catheter ablation of AF. Few patients achieved PVI with box method alone. Based on these results, we do not recommend the box isolation strategy.

Atrial fibrillation (AF) is the most common cardiac arrhythmia, and is responsible for the highest number of rhythm-related disorders and cardioembolic strokes worldwide. Intracardiac signal analysis during the onset of paroxysmal AF led to the discovery of pulmonary vein as a triggering source of AF, which has led to the development of pulmonary vein ablation--an established curative therapy for drug-resistant AF. Complex, multicomponent and rapid electrical activity widely involving the atrial substrate characterizes persistent/permanent AF. Widespread nature of the problem and complexity of signals in persistent AF reduce the success rate of ablation therapy. Although signal processing applied to extraction of relevant features from these complex electrograms has helped to improve the efficacy of ablation therapy in persistent/permanent AF, improved understanding of complex signals should help to identify sources of AF and further increase the success rate of ablation therapy.

Introduction: Preprocedural factors may be helpful in selecting patients with atrial fibrillation (AF) for treatment with catheter ablation and in making an assumption regarding their prognosis. The aims of this study were to investigate whether left atrial (LA) volume and pulmonary venous (PV) anatomy, evaluated by computed tomography (CT) prior to ablation, will predict AF recurrence following catheter ablation., Methods and Results: We included 146 patients (mean age 57 +/- 11 years, 83% male) with symptomatic AF (55% paroxysmal, 18% persistent, 27% long-standing persistent). All patients underwent CT scanning prior to catheter ablation to evaluate LA volume and PV anatomy. Circumferential PV isolation was performed guided by Cartomerge electroanatomical mapping. The outcome was defined as complete success, improvement, or failure. After a mean follow-up of 19 +/-7 months, complete success was achieved in 59 patients (40%), and 38 patients (26%) demonstrated improvement. LA volume was found to be an independent predictor of AF recurrence with an adjusted OR of 1.14 for every 10-mL increase in volume (95% CI 1.00-1.29, P = 0.047). PV variations were equally distributed among the different outcomes of the ablation procedure, and therefore univariate analysis did not identify PV anatomy as a predictor of outcome., Conclusion: LA volume is an independent predictor of AF recurrence after catheter ablation. Additionally, PV anatomy did not have any effect on the outcome. These findings suggest that an assessment of LA volume may be incorporated into the preprocedural evaluation of patients being considered for AF ablation.

Each of the main approaches to catheter ablation of atrial fibrillation (AF, segmental and circumferential) is associated with limited efficacy in patients with permanent AF. The objective is to report outcomes of circumferential ablation with pulmonary vein (PV) isolation, determined using a circular mapping catheter, in patients with permanent AF and determine relations between the duration of permanent AF and efficacy. The patient population was composed of 41 consecutive patients (34 men; age 58 +/- 11 years) with permanent AF who underwent radiofrequency catheter ablation through circumferential ablation with PV isolation. They were in permanent AF for 2.3 +/- 3.6 years, and 3.4 +/- 2.2 cardioversion procedures and 1.9 +/- 0.8 class I/III antiarrhythmic drugs had failed. After a follow-up of 11 +/- 2 months, the single-procedure success rate was 36% (n = 15) with an additional 12% (n = 5) showing improvement. With repeat procedures in 19%, the success rate was 54% (n = 22) with an additional 12% (n = 5) showing improvement. All patients who underwent repeat ablations had recovered PV conduction. Single-procedure success was higher in patients who were in permanent AF for < or =1 year compared with those in permanent AF for >1 year (50% vs 20%, respectively, p = 0.05). A major complication occurred in 4 patients (8%), including 3 patients with vascular complications and 1 with stroke. In conclusion, study results suggest that circumferential ablation with PV isolation has moderate efficacy in patients with permanent AF. Efficacy is limited in those in continuous AF for >12 months.

Background: Although it is well recognized that recovery of pulmonary vein (PV) conduction is common among patients who fail atrial fibrillation (AF) ablation, little is known about the precise time course of recurrence., Objective: To determine the incidence and time course of early recurrence of conduction after PV isolation during AF ablation., Methods: The patient population was composed of 14 consecutive patients (9 men [64%]; age 56 +/- 7 years) with AF who underwent radiofrequency catheter ablation via circumferential ablation with PV isolation, determined by a circular mapping catheter. After successful isolation of the PVs, repeat circular electrode recordings from each PV were obtained at 30 and 60 minutes., Results: After complete isolation of all PVs, early PV recurrence was observed in 13 (93%) patients and 26 veins (50%). Seventeen veins (33%) showed a first recurrence at 30 minutes, while nine veins (17%) showed a first recurrence at 60 minutes., Conclusion: The results reveal an extremely high rate of early recurrence of PV conduction following AF ablation. It is particularly notable that about one-fifth of the veins remained isolated at 30 minutes, but subsequently developed recurrence between 30 and 60 minutes. Of the veins that showed early recurrence, one-third developed a first recurrence at 60 minutes. These findings suggest that AF ablation procedures should incorporate a 60-minute waiting period after initial isolation in order to detect early recurrence of conduction.