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

Pulsed field ablation (PFA) is an emerging technology for the treatment of atrial fibrillation (AF), for which pre-clinical and early-stage clinical data are suggestive of some degree of preferentiality to myocardial tissue ablation without damage to adjacent structures. Here in the MANIFEST-17K study we assessed the safety of PFA by studying the post-approval use of this treatment modality. Of the 116 centers performing post-approval PFA with a pentaspline catheter, data were received from 106 centers (91.4% participation) regarding 17,642 patients undergoing PFA (mean age 64, 34.7% female, 57.8% paroxysmal AF and 35.2% persistent AF). No esophageal complications, pulmonary vein stenosis or persistent phrenic palsy was reported (transient palsy was reported in 0.06% of patients; 11 of 17,642). Major complications, reported for ~1% of patients (173 of 17,642), were pericardial tamponade (0.36%; 63 of 17,642) and vascular events (0.30%; 53 of 17,642). Stroke was rare (0.12%; 22 of 17,642) and death was even rarer (0.03%; 5 of 17,642). Unexpected complications of PFA were coronary arterial spasm in 0.14% of patients (25 of 17,642) and hemolysis-related acute renal failure necessitating hemodialysis in 0.03% of patients (5 of 17,642). Taken together, these data indicate that PFA demonstrates a favorable safety profile by avoiding much of the collateral damage seen with conventional thermal ablation. PFA has the potential to be transformative for the management of patients with AF., (© 2024. The Author(s).)

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: Strokes after left atrial appendage closure (LAAC) prophylaxis are generally less severe than those after warfarin prophylaxis-thought to be secondary to more hemorrhagic strokes with warfarin. Hemorrhagic strokes are similarly infrequent with direct oral anticoagulant (DOAC) prophylaxis, so the primary subtype after either LAAC or DOAC prophylaxis is ischemic stroke (IS)., Objectives: The purpose of this study was to compare the severity of IS using the modified Rankin Scale in atrial fibrillation patients receiving prophylaxis with DOACs vs LAAC., Methods: A retrospective analysis was performed of consecutive patients undergoing LAAC at 8 centers who developed an IS (IS LAAC ) compared with contemporaneous consecutive patients who developed IS during treatment with DOACs (IS DOAC ). The primary outcome was disabling/fatal stroke (modified Rankin Scale 3-5) at discharge and 3 months later., Results: Compared with IS DOAC patients (n = 322), IS LAAC patients (n = 125) were older (age 77.2 ± 13.4 years vs 73.1 ± 11.9 years; P = 0.002), with higher HAS-BLED scores (3.0 vs 2.0; P = 0.004) and more frequent prior bleeding events (54.4% vs 23.6%; P < 0.001), but similar CHA 2 DS 2 -VASc scores (5.0 vs 5.0; P = 0.28). Strokes were less frequently disabling/fatal with IS LAAC than IS DOAC at both hospital discharge (38.3% vs 70.3%; P < 0.001) and 3 months later (33.3% vs 56.2%; P < 0.001). Differences in stroke severity persisted after propensity score matching. By multivariate regression analysis, IS LAAC was independently associated with fewer disabling/fatal strokes at discharge (OR: 0.22; 95% CI: 0.13-0.39; P < 0.001) and 3 months (OR: 0.25; 95% CI: 0.12-0.50; P < 0.001), and fewer deaths at 3 months (OR: 0.28; 95% CI: 0.12-0.64; P < 0.001)., Conclusions: Ischemic strokes in patients with atrial fibrillation are less often disabling or fatal with LAAC than DOAC prophylaxis., Competing Interests: Funding Support and Author Disclosures Dr Turagam has served as a consultant for Biosense Webster and Sanofi. Dr Nair has served as a consultant for and receives honoraria for speaking engagements from Boston Scientific, Johnson and Johnson, and Medtronic. Dr Doshi has served as a consultant to Boston Scientific, Biosense Webster, and Abbott Vascular. Dr Valderrabano has received scientific research support from and served as a consultant to Circa; has received research support from and served as a consultant to Biosense Webster; and has served as a consultant to Abbott. Dr Dukkipati has received payment for Farapulse acquisition from Boston Scientific; and has equity in Manual Surgical Sciences. Dr Natale has served as a consultant for Abbott, Baylis, Biosense Webster, Biotronik, Boston Scientific, and Medtronic. Dr Reddy has served as an unpaid consultant to Boston Scientific; unrelated to this paper, he 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, 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, AtriAN, Biosense Webster, BioTel Heart, Biotronik, Cairdac, Cardiofocus, Cardionomic, CoreMap, Fire1, Gore and Associates, Impulse Dynamics, Medtronic, Novartis, Philips, and Pulse Biosciences; and has equity in DRS Vascular, 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.)

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: Dual occlusive closure mechanism (disc and lobe type), Amulet device (Abbott; a second-generation device that has replaced Amplatzer Cardiac Plug) was approved by the Food and Drug Administration (FDA) in August 2021 for percutaneous left atrial appendage occlusion (LAAO). However, real-world safety data on the delivery system (Amplatzer Cardiac Plug and Amplatzer Amulet device) are lacking., Objective: We sought to assess the type of adverse events associated with the Amplatzer LAAO delivery system using the FDA Manufacturer and User Facility Device Experience (MAUDE) database., Methods: A MAUDE database search was conducted on March 31, 2023, for reports received between February 2013 and March 2023 to capture all adverse events., Results: A total of 59 adverse events were reported, of which 58 were sheath-related events, and one was a wire-related event. The most commonly encountered issue was air embolism (19%, 11 events), followed by sheath thrombosis (13.8%, eight events, two of which were also associated with device thrombosis), kinked sheath (10.3%, six events), and sheath deformation (8.6%, five events). Patient-related adverse events included pericardial effusion requiring pericardiocentesis (22.4%, 13 events), vascular complications (20.7%, 12 events), and device dislodgement (5.2%, three events)., Conclusion: LAAO-related adverse events are increasingly being reported using the Amplatzer LAAO delivery sheath. It is anticipated that improvements in device technology, the advent of steerable sheaths, and operator experience will minimize these complications., (© 2023 Wiley Periodicals LLC.)

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.

Introduction: Multiple randomized controlled trials have demonstrated sodium-glucose cotransporter-2 inhibitors (SGLT2i) decrease the composite endpoint of cardiovascular death or heart failure hospitalizations in all heart failure patients. It is uncertain whether SGLT2i impacts the risk of sudden cardiac death in patients with heart failure., Methods: A comprehensive search was performed to identify relevant data published before August 28, 2022. Trials were included if: (1) all patients had clinical heart failure (2) SGLT2i and placebo were compared (3) all patients received conventional medical therapy and (4) reported outcomes of interest (sudden cardiac death [SCD], ventricular arrhythmias, atrial arrhythmias)., Results: SCD was reported in seven of the eleven trials meeting selection criteria: 10 796 patients received SGLT2i and 10 796 received placebo. SGLT2i therapy was associated with a significant reduction in the risk of SCD (risk ratios [RR]: 0.68; 95% confidence intervals [CI]: 0.48-0.95; p = .03; I 2  = 0%). Absent dedicated rhythm monitoring, there were no significant differences in the incidence of sustained ventricular arrhythmias not associated with SCD (RR: 1.03; 95% CI: 0.83-1.29; p = .77; I 2  = 0%) or atrial arrhythmias (RR: 0.91; 95% CI: 0.77-1.09; p = .31; I 2  = 29%) between patients receiving an SGLT2i versus placebo., Conclusion: SGLT2i therapy is associated with a reduced risk of SCD in patients with heart failure receiving contemporary medical therapy. Prospective trials are needed to determine the long-term impact of SGLT2i therapy on atrial and ventricular arrhythmias., (© 2023 Wiley Periodicals LLC.)

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

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.)

Objectives: This is a first report of the safety and 1-year outcomes of left atrial appendage closure (LAAC) using a novel foam-based conformable device, guided by intracardiac echocardiography (ICE)., Background: Limitations of current transcatheter LAAC devices include the need for precise coaxial delivery into the left atrial appendage (LAA), potential for traumatic implantation, incomplete LAA seal, and device-related thrombus., Methods: The device (Conformal Left Atrial Appendage Seal, Conformal Medical Inc) is a self-expanding occluder consisting of a cylindrical nitinol endoskeleton with low-profile anchor barbs around the midpoint, covered with a porous foam cup. In a prospective single-center series, under conscious sedation, the device was delivered under fluoroscopic and ICE guidance. After positioning, a transesophageal echocardiography probe was placed to confirm ICE findings before device release. After closure, dual antiplatelet therapy was administered for 6 months. Follow-up imaging was planned for 45 days and 6 and 12 months., Results: A total of 15 patients (age 71.3 ± 10.8 years, 33% men, CHA 2 DS 2 -VASc 4.1 ± 1.7, HAS-BLED 3.4 ± 1.4) underwent LAAC, 100% successfully. There were no procedure/device-related complications requiring intervention. Asymptomatic pericardial effusion occurred in 2 patients. The 45-day, 6-month, and 12-month follow-up imaging in 11, 9, and 13 patients, respectively, revealed adequate LAA seal (leak ≤5 mm) in all patients; device-related thrombus was detected in 1 patient at 6 months. Over 1-year follow-up, there were no ischemic strokes and 1 minor bleed. Nonprocedure-/device-related death occurred in 2 patients., Conclusions: This first report indicates that LAAC with the conformable implant guided by ICE imaging is feasible with encouraging 1-year clinical outcomes. (The Conformal Prague Study; NCT04193826)., Competing Interests: Funding Support and Author Disclosures Conformal Medical, Inc, provided funding for this study. Dr Neuzil has received grants from Conformal Medical Inc and Biosense Webster Inc. Dr Dukkipati has received a grant from Biosense Webster. Dr Reddy has served as an unpaid consultant to Conformal Medical Inc and Biosense Webster Inc; has served as a consultant for and has equity in Ablacon, Acutus Medical, Affera, Apama Medical, Aquaheart, Atacor, Autonomix, Backbeat, BioSig, Circa Scientific, Corvia Medical, Dinova-Hangzhou Nuomao Medtech Co, Ltd, East End Medical, EPD, Epix Therapeutics, EpiEP, Eximo, Fire1, Javelin, Kardium, Keystone Heart, LuxCath, Medlumics, Middlepeak, Nuvera, Sirona Medical, and Valcare unrelated to this work; has served as a consultant for Abbott, Axon, Biotronik, Cardiofocus, Cardionomic, CardioNXT/AFTx, EBR, Impulse Dynamics, Medtronic, Philips, Pulse Biosciences, Stimda, and Thermedical unrelated to this work; and has equity in Manual Surgical Sciences, Newpace, Surecor, and Vizaramed unrelated to this work. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022. Published by Elsevier Inc.)

Background: Perioperative anticoagulation management with uninterrupted or minimally interrupted anticoagulation during atrial fibrillation (AF) ablation is thought to be critical to minimize thromboembolic complications. Protamine is often administered to neutralize the effects of heparin and expedite vascular hemostasis post-procedure., Objective: We performed a systematic review and meta-analysis to determine the effectiveness of protamine to expedite vascular hemostasis and ambulation in patients undergoing AF ablation., Methods: Electronic searches on PubMed, The Cochrane Library, EMBASE, EBSCO, Web of Science, and CINAHL databases from the inception through August 7, 2021, were performed. The primary outcomes included-time to hemostasis (minutes) and time to ambulation (minutes). The secondary outcomes included - any vascular complications (excluding minor hematoma), minor hematoma, or cerebrovascular accidents (CVA)., Results: A total of 5 eligible studies (3 retrospective cohort studies and two randomized trials) consisting of 1012 patients (515 patients received protamine group and 497 patients did not receive protamine group) were included in the meta-analysis. There was a significant reduction in time to ambulation [weighted mean difference (WMD) -176.6 minutes, 95% Confidence interval (CI) -266.9 to -86.3; p < 0.01] and time to hemostasis (WMD -13.72 minutes, 95% CI -22 to -5.4, p < 0.01) in the protamine group compared to the contrary. At a follow-up up to 3 months, there was no statistical difference between the two groups with regards to vascular complications (2.9% vs. 7.4%; Risk ratio (RR) 0.46 95% CI 0.17 to 1.24; p = 0.12), minor hematoma (2.1% vs. 5.8%; RR 0.43, 95% CI 0.16 to 1.2; p = 0.11) or CVA (0 vs. 0.3%; RR 0.62, 95% CI 0.08 to 4.98; p = 0.65)., Conclusion: Protamine administration was associated with reduced time to ambulation (176 minutes reduction) and time to hemostasis (13 minutes reduction) without an increase in any adverse events., Competing Interests: The authors declare no conflict of interest., (© 2022 The Author(s). Published by IMR Press.)

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

Competing Interests: The authors have no conflicts of interest to declare.

Objectives: The goal of this study is to determine the incidence, predictors, and outcomes of atrial fibrillation (AF) or atrial flutter (AFL) in patients hospitalized with coronavirus disease-2019 (COVID-19)., Background: COVID-19 results in increased inflammatory markers previously associated with atrial arrhythmias. However, little is known about their incidence or specificity in COVID-19 or their association with outcomes., Methods: This is a retrospective analysis of 3,970 patients admitted with polymerase chain reaction-positive COVID-19 between February 4 and April 22, 2020, with manual review performed of 1,110. The comparator arm included 1,420 patients with influenza hospitalized between January 1, 2017, and January 1, 2020., Results: Among 3,970 inpatients with COVID-19, the incidence of AF/AFL was 10% (n = 375) and in patients without a history of atrial arrhythmias it was 4% (n = 146). Patients with new-onset AF/AFL were older with increased inflammatory markers including interleukin 6 (93 vs. 68 pg/ml; p < 0.01), and more myocardial injury (troponin-I: 0.2 vs. 0.06 ng/ml; p < 0.01). AF and AFL were associated with increased mortality (46% vs. 26%; p < 0.01). Manual review captured a somewhat higher incidence of AF/AFL (13%, n = 140). Compared to inpatients with COVID-19, patients with influenza (n = 1,420) had similar rates of AF/AFL (12%, n = 163) but lower mortality. The presence of AF/AFL correlated with similarly increased mortality in both COVID-19 (relative risk: 1.77) and influenza (relative risk: 1.78)., Conclusions: AF/AFL occurs in a subset of patients hospitalized with either COVID-19 or influenza and is associated with inflammation and disease severity in both infections. The incidence and associated increase in mortality in both cohorts suggests that AF/AFL is not specific to COVID-19, but is rather a generalized response to the systemic inflammation of severe viral illnesses., Competing Interests: Funding Support and Author Disclosures Dr Koruth has received consulting fees from Abbott Laboratories, CardioFocus, Farapulse, and Vytron US, Inc. Dr Dukkipati has received grant support from Biosense Webster; and has equity with Farapulse and Manual Surgical Sciences, LLC. Dr Halperin has received consulting fees from Boehringer Ingelheim, Johnson & Johnson-Janssen Pharmaceuticals, and Medtronic. Dr Reddy is a consultant with Abbott, Ablacon, Acutus Medical, Affera, Apama Medical, Aquaheart, Atacor, Autonomix, Axon, Backbeat, BioSig, Biosense Webster, Biotronik, Boston Scientific, Cardiofocus, Cardionomic, CardioNXT/AFTx, Circa Scientific, Corvia Medical, Dinova-Hangzhou Nuomao Medtech Co., Ltd., East End Medical, EBR, EPD, Epix Therapeutics, EpiEP, Eximo, Fire1, Impulse Dynamics, Javelin, Kardium, Keystone Heart, LuxCath, Manual Surgical Sciences, Medlumics, Medtronic, Middlepeak, Newpace, Nuvera, Philips, Pulse Biosciences, Sirona Medical, Stimda, Surecor, Thermedical, and Valcare; and has equity in Ablacon, Acutus Medical, Affera, Apama, Aquaheart, Atacor, Autonomix, Backbeat, BioSig, Circa Scientific, Corvia Medical, Dinova-Hangzhou Nuomao Medtech Co., Ltd., East End Medical, EPD, Epix Therapeutics, EpiEP, Eximo, Fire 1, Javelin, Kardium, Keystone Heart, LuxCath, Manual Surgical Sciences, Medlumics, Middlepeak, Newpace, Nuvera, Sirona Medical, Surecor, Valcare, and Vizaramed. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Introduction: The LARIAT epicardial suture snaring device has been fraught with technical challenges and procedural complications. Over time, technique modification and improved operator experience have helped overcome many of these challenges. METHODS AND RESULTS: Studies reporting left atrial appendage epicardial closure over a 12-year period from 2009 to 2020 were evaluated. The primary efficacy outcome evaluated was left atrial appendage closure with residual flow ≤1 mm. Safety outcomes evaluated were periprocedural and long term complications after device placement. Nine studies consisting of 1430 patients were included in this analysis, of which 1386 (97%) underwent successful device placement. The mean age was 69.3 years, with a mean CHADS 2 -VASC score of 3.78. Primary efficacy end point was achieved in 95.8% patients immediately after device placement, and in 92.8% patients on long term follow-up. Early procedural complications consisted of pericardial effusion 5.6%, cardiac perforation 2.7%, pericarditis 2.6%, and need for open heart surgery 1.5%. Long term complications consisted of all-cause mortality 2.3%, stroke 1.5%, and left atrial appendage thrombus 2.3%. Reduced complications were noted using micropuncture needles (2.20% vs. 10.14%; p < .0001), a longer duration pericardial drainage, and use of anti-inflammatory medications (1.58% vs. 8.4%). Oral anticoagulation use decreased from 44.7% to 22.9% post device implantation, and to 8.5% on last clinical follow up., Conclusions: The LARIAT device is effective in epicardial closure of the left atrial appendage. Improvement in device techniques such as use of micropuncture needle, prophylactic colchicine, and maintenance of a pericardial drain have helped improve safety over time., (© 2021 Wiley Periodicals LLC.)

The thromboembolic complications of Atrial fibrillation (AF) remain a major problem in contemporary clinical practice. Despite advances and developments in anticoagulation strategies, therapy is complicated by the high risk of bleeding complications and need for meticulous medication compliance. Over the past few decades, the left atrial appendage has emerged as a promising therapeutic target to prevent thromboembolic events while mitigating bleeding complications and compliance issues. Emerging data indicates that it is a safe, effective and feasible alternative to systemic anticoagulation in patients with non-valvular AF. A number of devices have been developed for endocardial or epicardial based isolation of the left atrial appendage. Increasing experience has improved overall procedural safety and ease while simultaneously reducing device related complication rates. Furthermore, increasing recognition of the non-mechanical advantages of this procedure has led to further interest in its utility for further indications beyond the prevention of thromboembolic complications. In this review, we present a comprehensive overview of the evolution of left atrial appendage occlusion, commercially available devices and the role of this modality in the current management of AF. We also provide a brief outline of the landmark trials supporting this approach as well as the ongoing research and future prospects of left atrial appendage occlusion., (© 2021 Wiley Periodicals LLC.)

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

Background: Left atrial appendage closure (LAAC) has proven to be an effective alternative to long-term oral anticoagulation in the prevention of thromboembolic events in patients with atrial fibrillation. In a minority of patients, inadequate seal may result in persistent peridevice flow and inability of the appendage to fully thrombose, thereby representing a potential source for thromboembolism., Objective: The purpose of this study was to study the use of endovascular coiling of the appendage to address persistent peridevice leak in patients undergoing LAAC with the Watchman device., Methods: This is a retrospective single-center analysis involving patients who underwent placement of a LAAC device and returned for endovascular coiling to address persistent device leak between 2018 and 2020. Baseline characteristics, procedural outcomes, and follow-up echocardiograms were analyzed to demonstrate the feasibility and safety of this technique., Results: Patients (N = 20) were identified with a mean leak size of 3.8 ± 1.3 mm (range 2.5-7 mm), all of whom had a non-thrombosed appendage. Acute procedural success was achieved in 95% of patients. Complete or significant reduction in flow beyond the LAAC device was achieved in 61% and 33% of patients, respectively. The 1 procedure-related adverse event was a pericardial effusion before coil deployment, requiring percutaneous drainage., Conclusion: The clinical impact of residual peridevice leak post-Watchman implantation is a matter of continuing investigation. However, appendage coiling represents a new therapeutic tool to address this potential source for thromboembolism. Further studies should address the clinical impact of this technique, including the safety of discontinuing anticoagulation after successful coiling., (Copyright © 2021 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

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

Background: The next-generation Watchman FLX left atrial appendage closure (LAAC) device has: (1) an atraumatic closed distal end, (2) reduced height, (3) a recessed screw hub to decrease device-related thrombus (DRT), (4) two rows of J-shape anchors so redeployment is possible after full recapture, and (5) ability to treat a greater size range of LAA ostia., Objective: To report, for the first time, the feasibility and safety of intracardiac echocardiography (ICE)-guided Watchman FLX implantation., Methods: A single-center prospective registry of atrial fibrillation patients planned for LAAC with the FLX device underwent ICE-guided implantation with conscious sedation. Transesophageal echocardiography (TEE) imaging was done preprocedure (to assess LAA size and exclude thrombus) and at clinical follow-up at 6-12 weeks. Clinical outcomes were LAA closure success, complications, leak, or DRT on follow-up TEE and major safety events., Results: The study included 30 patients: age 75 ± 8 years, 53% men, CHA 2 DS 2 -VASc 4.6 ± 1.6, and HAS-BLED 3.4 ± 1.1. The primary indication was prior bleeding in 60% (72% GI bleeding). The LAA orifice width and length were 22.7 ± 3.1 and 25.7 ± 5.7 mm, respectively. Technical success was 100% (the first-choice device was used in 28 of 30). Procedure time was less than 30 min in 27 of 30 cases, with 36 ± 15 ml contrast used. The final device size was 29.2 ± 4.7 mm with 21.6 ± 4.5% compression. There were no procedure-related complications. Follow-up TEE at a median 47 days follow-up showed 100% device success with no DRT or peridevice leak ≥5 mm. Major safety events occurred in 6.6% (2/30)., Conclusion: The Watchman FLX device can be safely implanted with intraprocedural ICE imaging instead of TEE., (© 2021 Wiley Periodicals LLC.)

Objectives: This study sought to determine the impact of adjunctive renal sympathetic denervation to catheter ablation in patients with atrial fibrillation (AF) and history of hypertension., Background: There are limited data regarding the impact of upstream adjunctive renal sympathetic denervation (RSDN) to pulmonary vein isolation (PVI) in patients with symptomatic atrial fibrillation (AF) and hypertension., Methods: The data for this study were obtained from 2 prospective randomized pilot studies, the HFIB (Adjunctive Renal Denervation to Modify Hypertension and Sympathetic tone as Upstream Therapy in the Treatment of Atrial Fibrillation)-1 (n = 30) and HFIB (Adjunctive Renal Denervation to Modify Hypertension and Sympathetic tone as Upstream Therapy in the Treatment of Atrial Fibrillation)-2 (n = 50) studies, and we performed a meta-analysis including all published studies comparing RSDN+PVI versus PVI alone up to January 25, 2020, in patients with AF and hypertension., Results: At 24 months, AF recurrence occurred in 53% and 38% in the PVI and PVI+RSDN groups (p = 0.43) in the HFIB-1 study, respectively, and 27% and 25% in the PVI and PVI+RSDN groups (p = 0.80) in the HFIB-2 study, respectively. When combined in a meta-analysis including 6 studies (n = 725), adjunctive RSDN significantly decreased the risk of AF recurrence (risk ratio [RR]: 0.68; 95% confidence interval [CI]: 0.55 to 0.83; p = 0.0002; I 2  = 0%) when compared with PVI. Six renal artery complications occurred in the HFIB-1 study and none occurred in the HFIB-2 study with RSDN. However, in the meta-analysis, there were no significant differences in overall complications between both groups (RR: 1.43; 95% CI: 0.63 to 3.22; p = 0.40; I 2  = 7%). When compared with baseline, RDSN significantly reduced the systolic blood pressure (-12.1 mm Hg; 95% CI: -20.9 to -3.3 mm Hg; p < 0.007; I 2  = 99%) and diastolic blood pressure (-5.60 mm Hg; 95% CI: -10.05 to -1.10 mm Hg; p = 0.01; I 2  = 98%) on follow-up., Conclusions: The pilot HFIB-1 and HFIB-2 studies did not demonstrate a benefit with RSDN as an adjunctive upstream therapy during PVI. However, in the meta-analysis, adjunctive RSDN to PVI appears to be safe, and improves clinical outcomes in AF patients with a history of hypertension., Competing Interests: Author Disclosures The HFIB-1 study was sponsored by Biosense Webster. The HFIB-2 study was sponsored by Boston Scientific. Dr. Cuoco has served as a consultant for St. Jude Medical and Boston Scientific. Dr. Mansour has received research grant support from Abbott, Biosense Webster, Johnson and Johnson, Boston Scientific, Medtronic, Pfizer, Boehringer Ingelheim, and Sentre Heart; has served as a consultant for Abbott, Biosense Webster, Jonhson and Johnson, Boston Scientific, Janssen, Medtronic, Philips, Novartis, and Sentre Heart; and owns equity interest in Affera, EPS Solutions, and NewPace Ltd. Dr. Lakkireddy has served as a steering committee member for the Amulet and Amaze IDE studies; and received consulting fees from Abbott. Dr. Michaud has served as a consultant for Biosense Webster, Boston Scientific, and Abbott; and has received honoraria from Biosense Webster, Boston Scientific, Biotronik, Medtronic, and Abbott. Dr. Dukkipati owns equity interest in Manual Surgical Sciences and Farapulse; and has received research grant support from Biosense Webster. Dr. Reddy has served as an unpaid consultant to and received grant support from Biosense Webster and Boston Scientific. Additional disclosures unrelated to this manuscript are listed in the Supplemental Appendix. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Purpose of Review: In patients with atrial fibrillation who are unable to take novel oral anticoagulants for stroke prophylaxis due to bleeding risk or other contraindications, left atrial appendage (LAA) occlusion and exclusion devices have shown benefit. In this review, we highlight the risks and benefits associated with LAA removal., Recent Findings: LAA, once considered a vestigial organ, has been shown to have physiological, anatomical, and arrhythmogenic properties. Device-related complications such as pericardial effusion, device embolization, device-related thrombus, while uncommon, are still present. With increased operator experience related to appendage occlusion, overall procedural complications have declined. Further refinements in device technology will help decrease complications. While benefits of appendage removal are plenty, procedural complications need to be weighed into the equation when making decisions regarding LAA occlusion.

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

Introduction: Transseptal puncture (TSP) is challenging in patients with prior percutaneous atrial septal defect (ASD) occluder. We aimed to perform a systematic review and meta-analysis of the safety and efficacy of catheter ablation for atrial fibrillation (AF) in patients with percutaneous ASD occluder., Methods: We searched PubMed, Medline, Embase, Ovid, and Cochrane for studies reporting results of AF ablation (freedom from AF, fluoroscopy/procedure time, and complications) in patients with percutaneous ASD occluders., Results: Three studies with a total of 64 patients met inclusion criteria. The success rate of TSP was 100%. All patients (but one) underwent TSP under fluoroscopic and intracardiac echocardiography guidance. Freedom from AF was achieved in 77.7% (95% confidence interval [CI]: 65.7-86.3) patients. In the subgroup analysis, comparing septal versus device puncture, no significant difference in recurrence of AF was observed (23.07% vs. 16.66%; risk ratio: 1.18; 95% CI: 0.35-4.00; p = .79, respectively). The total fluoroscopy time was not significantly different in patients with TSP via native septum or device (43.50 vs. 70.67 min; p = .44), total procedural time was significantly longer with TSP via the closure device (237.3 vs. 180 min; p = .004) compared with the native septum. There were no device dislodgement or residual interatrial shunt during the follow-up period., Conclusion: Catheter ablation for AF in patients with prior percutaneous ASD closure device is feasible and safe with favorable long-term outcomes., (© 2020 Wiley Periodicals LLC.)

Introduction: Novel oral anticoagulants (NOACs) are commonly used for thromboembolic risk reduction and treatment of pulmonary embolism and deep venous thrombosis. However, data regarding their efficacy and safety in comparison to warfarin for left atrial appendage thrombus is limited., Methods: A comprehensive literature search in PubMed, Google Scholar, and Cochrane Review from inception to 30 October 2019 was performed. Studies reporting clinical outcomes comparing warfarin vs NOACs were included. Two investigators independently extracted the data and individual quality assessment was performed. A meta-analysis was performed using random-effects model to calculate risk ratio (RR) and 95% confidence interval (CI). The analysis was performed using RevMan 5.3., Results: Four studies met inclusion criteria and a total of 322 patients were included of whom 141 were in the NOAC arm and 181 were in the warfarin arm. There was no significant difference in thrombus resolution between the two groups (RR, 1.00; 95% CI [0.77-1.29; P = .98]). There was no significant difference in major bleeding (RR, 1.30; 95% CI [0.14-12.21; P = .82]) or stroke (RR, 0.42; 95% CI [0.09-2.06; P = .29]) between the two groups., Conclusion: The results of our meta-analysis show that NOACs are as efficacious and safe as warfarin in the treatment of left atrial appendage thrombus in patients with non-valvular atrial fibrillation., (© 2020 Wiley Periodicals, Inc.)

Background: Electrophysiological procedures such as epicardial ventricular tachycardia ablation and Lariat left atrial appendage ligation that involve the epicardial space are typically associated with significant postoperative pain due to mechanical irritation and associated inflammation. There is an unmet need for an effective pain management strategy in this group of patients. We studied how this impacts patient comfort and duration of hospitalization and other associated comorbidities related to pericardial access., Methods: This is a multicenter retrospective study including 104 patients who underwent epicardial ventricular tachycardia ablation and Lariat left atrial appendage exclusion. We compared 53 patients who received postprocedural intrapericardial liposomal bupivacaine (LB)+oral colchicine (LB group) and 51 patients who received colchicine alone (non-LB group) between January 2015 and March 2018., Results: LB was associated with significant lowering of median pain scale at 6 hours (1.0 [0-2.0] versus 8.0 [6.0-8.0], P <0.001), 12 hours (1.0 [1.0-2.0] versus 6.0 [5.0-6.0], P <0.001), and up to 48 hours postprocedure. Incidence of acute severe pericarditis delayed pericardial effusion and gastrointestinal adverse effects were similar in both groups. Median length of stay was significantly lower in LB group (2.0 versus 3.0; adjusted linear coefficient -1 [CI -1.3 to -0.6], P <0.001). Subgroup analysis demonstrated similar favorable outcomes in both Lariat and epicardial ventricular tachycardia ablation groups., Conclusions: Addition of intrapericardial postprocedural LB to oral colchicine in patients undergoing epicardial access during ventricular tachycardia ablation or Lariat procedure is associated with significantly decreased numeric pain score up to 48 hours compared with colchicine alone. It is also associated with significantly shorter length of hospital stay without an increase in the risk of adverse events.

Objectives: This study aimed to investigate the feasibility and safety of left atrial appendage occlusion (LAAO) procedures in patients with persistent left atrial appendage (LAA) thrombus., Background: The left atrial appendage (LAA) is the most common site of thrombus formation in patients with nonvalvular atrial fibrillation (AF). Oral anticoagulation (OAC) is used to prevent and treat AF-related thrombus. However, a significant proportion of patients may not be eligible for long-term OAC therapy. In many cases, OAC may fail to resolve the thrombus. Left atrial appendage occlusion (LAAO) may be a potential option in such cases. Major LAAO studies have excluded patients with LAA thrombus, and it is not known whether LAAO procedures in the presence of LAA thrombus is feasible and safe., Methods: This was a systematic review of patient-level data of all published cases of LAAO in the presence of LAA thrombus., Results: There was a total of 58 patients included in the study. Most of the patients had a distally located thrombus in the LAA. All cases underwent successful implantation of LAAO devices with some procedural modifications. Amulet was the most commonly used device (50%). A cerebral protection device was used in 17 (29%) patients, and procedural transesophageal echocardiography was used in most of the cases. One stroke (1.7%) and 2 (3.4%) device-related thromboses were noted during the mean follow-up of 3.4 ± 7 months., Conclusions: Percutaneous LAAO procedures appear to be feasible in patients with a distally located persistent LAA thrombus when performed by experienced operators with some technical modifications. Further studies are required to determine the long-term safety and efficacy of this approach., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study sought to evaluate the safety and feasibility of percutaneous retrieval of left atrial appendage closure (LAAC) devices with an endoscopic grasping tool., Background: Transcatheter LAAC is a mechanical stroke prevention strategy in patients with nonvalvular atrial fibrillation (AF) who are poor candidates for long-term oral anticoagulation. However, these LAAC devices can be inadvertently released into an unfavorable location, the device might migrate to a different (unfavorable) position within the left atrial appendage (LAA) or may embolize from the heart into the aorta. In such instances, it can be challenging to remove the LAAC device without open cardiac or vascular surgery., Methods: This study reports on a series of 4 cases in which an endoscopic grasping tool (Raptor) designed for gastrointestinal applications was used to percutaneously (non-surgically) remove LAAC devices that were either malpositioned or embolized., Results: LAAC devices were safely and non-surgically removed using the grasping device in all 4 cases (Amulet: 1, Watchman: 3). Devices were successfully retrieved from the left inferior pulmonary vein, descending aorta, aortic arch, and the edge of the LAA ostium. Time of device retrieval post-LAAC implantation ranged from 24 h to 1 year. Special precautionary measures, such as preemptive pericardial access, embolic protection devices, and intraprocedural imaging, were used in 2 cases., Conclusions: This case series demonstrated that the endoscopic grasping tool appeared to be safe and useful to percutaneously retrieve LAAC devices., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Catheter ablation for atrial fibrillation (AF) using point-by-point radiofrequency energy or single-application one-shot balloons is either technically challenging or have limited ability to accommodate variable patient anatomy to achieve acute and durable pulmonary vein (PV) isolation. A novel ablation system employs low intensity collimated ultrasound (LICU)-guided anatomic mapping and robotic ablation to isolate PVs. In this first-in-human, single-center, multioperator trial, VALUE trial (VytronUS Ablation System for Treatment of Paroxysmal Atrial Fibrillation; NCT03639597) in patients with paroxysmal atrial fibrillation, this LICU system was evaluated to determine its safety, effectiveness in PV isolation, and freedom from recurrent atrial arrhythmias., Methods: In the enrolled 52 patients with paroxysmal atrial fibrillation, ultrasound M-mode-based left atrial anatomies were successfully created, and ablation was performed under robotic control along an operator-defined lesion path. The LICU system software advanced over the course of the study: the last 13 patients were ablated with enhanced software., Results: Acute PV isolation was achieved in 98% of PVs-using LICU-only in 77.3% (153/198) of PVs and requiring touch-up with a standard radiofrequency ablation catheter in 22.7% (45/198) PVs. The touch-up rate decreased to 5.8% (3/52) in patients undergoing LICU-ablation with enhanced software. Freedom from atrial arrhythmia recurrence was 79.6% (39/49 patients) at 12 months or 92.3% (12/13 patients) with the enhanced software. Major adverse events occurred in 3 patients (5.8%): one had transient diaphragmatic paralysis, one vascular access complication, and one had transient ST-segment elevation from air-embolism, without sequelae., Conclusions: In this first-in-human study, low- intensity collimated ultrasound-guided anatomic mapping and robotic ablation allows PV isolation with good chronic safety; PV isolation success is improving with device enhancements. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03639597.

Background: Percutaneous left atrial appendage closure (pLAAC) emerged as an option for stroke prevention in patients with atrial fibrillation ineligible for long-term anticoagulation. Real-world data on pLAAC's in-hospital and 30-day readmission measures are limited., Objective: We sought to report the nationwide incidence of the above outcomes using 2016 claims data., Methods: We used the National Inpatient Sample for in-hospital outcomes and Nationwide Readmissions Database for readmissions. We identified hospitalizations with a primary diagnosis of atrial fibrillation and pLAAC procedure by using International Classification of Diseases, Tenth Revision codes and compared the outcomes mentioned above between the endocardial and epicardial cohorts. Statistical analyses were performed using R 3.3.2., Results: Among 5480 pLAAC procedures (endocardial: 5145; epicardial: 335), the in-hospital mortality was 0.3%. Endocardial left atrial appendage closure (LAAC) had lower complications (8.5% vs 25.4%; P < .001) and shorter length of stay median [interquartile range] 1 [1-1] day vs 2 [1-3] days; P < .001) but higher hospitalization cost (24.13 [18.45-30.17] × 1000 dollars vs 21.21 [14.03-27.86] × 1000 dollars; P = .016). The most common complications include pericardial (endocardial vs epicardial: 3% vs 10.4%; P < .001) and renal failure (1.4% vs 6.0%; P = .004). Epicardial LAAC had higher 30-day unplanned readmissions (19.5% vs 8.3%; P = .001), with the most common reason being pericarditis and/or effusion (33.9%)., Conclusion: Endocardial LAAC had lower complications and 30-day readmissions but higher hospitalization cost. Although epicardial LAAC showed higher complications, given recent improvements in its technique, and postprocedural care demonstrated a significant reduction in pericardial complications, more contemporary data comparing these outcomes are needed., (Copyright © 2019 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: Left atrial appendage closure (LAAC) with LARIAT has emerged as one of the alternatives to oral anticoagulation (OAC) in patients with nonvalvular atrial fibrillation (AF). Our aim was to study long-term outcomes in patients undergoing LARIAT procedure., Methods: We analyzed patients screened for LARIAT device in four centers between December 2009 and June 2012. Out of these, patients who didn't undergo LAAC with the LARIAT device due to unfavorable LAA morphology and other preprocedural contraindications were included in control group. We analyzed thromboembolism, bleeding events, and mortality between LAA and control group., Results: About 153 patients were screened. Out of these, 108 (70.6%) patients underwent LARIAT placement (LAA arm) and 45 (29.4%) excluded patients were included in control arm. There were no differences in CHADS 2 and CHA 2 DS 2 -VASc score. Mean HAS-BLED score was significantly higher in the LARIAT group (3.5 ± 1.06 vs 3.09 ± 1.22, P = .04). Mean follow-up time (in years) was 6.56 ± 0.84 in LAA and 6.5 ± 1.26 in control arm. During follow-up period, the LARIAT group was associated with significantly less thromboembolic events (1.9% vs 24%, P < .001), bleeding events (9.2% vs 24.4%, P = .03), and mortality (5.6% vs 20%, P = .01) as compared with the control group., Conclusions: Long-term data from routine clinical practice from our study suggests that LAA exclusion with LARIAT device is an effective treatment in management of nonvalvular AF patients with high risk of stroke, bleeding, and mortality. Further randomized trials, such as aMAZE, will provide more insight in this expanding field., (© 2019 Wiley Periodicals, Inc.)

Background: Direct current cardioversion (DCCV) is a common rhythm control strategy in patients with symptomatic atrial fibrillation or flutter. There is no long-term data regarding the safety of DCCV in patients with endocardial left atrial appendage occlusion (LAAO) devices., Objectives: The purpose of this study was to assess the feasibility and safety of DCCV in patients with an LAAO device., Methods: This multicenter retrospective study included 148 patients with an LAAO device who underwent DCCV for symptomatic atrial fibrillation or atrial flutter., Results: The average age of the included patients was 72 ± 7 years and 59% were men. All patients (100%) had a transesophageal echocardiogram prior to DCCV. Device-related thrombus was seen in 2.7%. They were all successfully treated with oral anticoagulation (OAC) and were able to undergo DCCV after 6 to 8 weeks. DCCV restored sinus rhythm in all patients. None of the patients had DCCV-related thromboembolic complications. A total of 22% of patients were newly started on OAC after DCCV. There was no difference in DCCV-related complications between patients treated with or without OAC post-DCCV. Patients receiving OAC post-DCCV were found to undergo cardioversion at an earlier time after implantation (3.6 months [interquartile range (IQR): 0.7 to 8.6 months] vs. 8.6 months [IQR: 2.5 to 13.3 months]; p = 0.003). Three transient ischemic attacks, unrelated to DCCV, were found during follow-up. During a median follow-up of 12.8 months (IQR: 11.8 to 14.2 months), no device or left atrial thrombosis, device dislodgement, or a new device leak were observed. One patient died during follow-up due to noncardiac cause., Conclusions: DCCV is feasible in high-risk AF patients with an LAAO device without the need for oral anticoagulation if pre-procedural transesophageal echocardiography shows good device position, absence of device-related thrombus, and peridevice leak of ≤5 mm. The preliminary results are encouraging, but further large studies are warranted to establish safety., (Copyright © 2019. Published by Elsevier Inc.)

Objectives: The purpose of this study was to evaluate the differences in transient thermal response (TTR) among various types of commercial esophageal temperature probes (ETPs) in the United States in an experimental model., Background: There is little information regarding the variation in TTR among various commercial ETPs that are approved for atrial fibrillation ablation., Methods: We compared various thermodynamic characteristics including, mean thermal time constant (τ), time to rise 1°C (T 1°C ), time to peak temperature (T peak ), and decay time among 22 different ETPs. Each probe was submerged in a constant-temperature water bath maintained at 37 ± 0.5°C and then quickly (<0.5 s) submerged into another water bath at 45 ± 0.5°C. The experiments were repeated 3 times with each probe. TTR properties were compared on the basis of probe size, design, and number of sensors., Results: The τ was significantly higher with the larger 24- and 18-F ETPs compared with the smaller 9-F ETPs. Compared with the 18-F probe, T 1°C (11.9 s vs. 5 s), T peak (40.3 s vs. 14.4 s), and T decay (92.4 s vs. 32.4 s) was shorter with the 9-F ETPs. Solid-shaft ETPs had shorter τ (8.6 s vs. 20.5 s), T 1°C (4.4 s vs. 10.1 s) and T peak (13.5 s vs. 32.5 s) compared with acoustascopes. Multisensor ETPs had shorter τs (3.9 s vs. 9.1 s), T 1°C (2.3 s vs. 5 s), and T peak (6.2 s vs. 14.4 s) compared with single-sensor ETPs., Conclusions: There is a significant variation in TTR among the various commercially available ETPs. The use of certain ETPs might result in underestimation of luminal esophageal temperature, which can potentially lead to adverse events., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Atrial arrhythmias (AA), including atrial fibrillation (AF), have been reported in patients after cavotricuspid isthmus (CTI) ablation for typical atrial flutter (AFL). Several studies have examined the effect of performing concomitant pulmonary vein isolation (PVI) with CTI on recurrent AA. These studies were analyzed to determine the overall effect of this approach on recurrent AA., Methods: PubMed and Google Scholar were searched for randomized trials comparing the incidence of AA after CTI versus CTI + PVI until June 2018. Only patients without prior history of AF were included in the recurrent AA analysis. All patients were included in the analyses of other clinical outcomes., Results: Four randomized control trials were included in the meta-analysis. In the recurrent AA analysis, a total of 314 patients were randomized in the studies (n = 158 CTI, n = 156 CTI + PVI). Freedom from AA at 1 year was significantly higher in the CTI + PVI group versus CTI alone (odds ratio [OR] 0.25 [0.14, 0.44] 95% confidence interval [CI], P < 0.00001). A total of 550 patients (n = 336 CTI, n = 214 CTI + PVI) were included in analyses for procedure time, fluoroscopy time, and complications rates. Procedure time and fluoroscopy time were significantly longer in the CTI + PVI group (mean difference [MD]: 103.31 min [94.40, 112.23] 95% CI, P < 0.00001) and (MD: 16.47 min [14.89, 18.05] 95% CI, P < 0.00001), respectively. Total complications were statistically similar between groups., Conclusion: This meta-analysis shows addition of a prophylactic PVI during CTI ablation significantly reduces recurrent AA at 1 year without significantly increasing major complications., (© 2019 Wiley Periodicals, Inc.)

Background: Currently, there is limited data regarding the impact of adjunctive renal sympathetic denervation (RSDN) with pulmonary vein isolation (PVI) in hypertensive patients with atrial fibrillation (AF)., Methods: A comprehensive literature search for studies comparing RSDN + PVI vs PVI alone for AF and history of hypertension until 1 January 2019 was performed. The results were expressed as risk ratio (RR) for the categorical variables and mean difference (MD) for the continuous variables with 95% confidence intervals (CIs)., Results: A total of six eligible (four randomized and two prospective nonrandomized) studies consisting of 432 patients (306 paroxysmal AF and 126 persistent AF) were included (RSDN + PVI group: 186 patients and PVI group: 246 patients). Follow-up is more than or equal to 1 year. Compared with PVI, RSDN + PVI significantly decreased the risk of AF recurrence (RR = 0.58, 95% confidence interval [CI] = 0.47-0.72, P < 0.00001) on follow-up. Fluoroscopy (MD = +5.53 minutes, 95% CI = 0.76-10.31, P = 0.02) and procedure time (MD = +34.85 minutes, 95% CI = 23.55-46.16, P < 0.00001) was significantly longer with the PVI + RSDN group compared with PVI alone. There were no significant differences in complications between both groups. Test of heterogeneity was low for all clinical outcomes (I 2  = 0%)., Conclusion: Our meta-analysis demonstrates that RSDN as an adjunct to PVI appears to be safe and improves clinical outcomes in both paroxysmal and persistent AF and history of hypertension., (© 2019 Wiley Periodicals, Inc.)

Introduction: Percutaneous left atrial appendage closure (LAAC) is typically performed utilizing transesophageal echocardiography (TEE) and fluoroscopy. Intracardiac echocardiography (ICE) can be a suitable alternative to guide implantation. Given the limited data, we performed a meta-analysis of all studies that compared ICE vs TEE for percutaneous LAAC., Methods: A comprehensive literature search was performed in PubMed, Embase, Scopus, Google Scholar, and major scientific conference sessions for published abstracts and manuscripts until 1 August 2018. Studies reporting clinical outcomes comparing TEE vs ICE for endocardial LAAC in human subjects aged greater than or equal to 18 years were included. Two investigators independently extracted the data and individual quality assessment was performed. The analysis was performed using Cochrane Collaboration software, RevMan 5.3., Results: Five eligible studies consisting of 1157 patients (ICE-391 patients and TEE-766 patients) were included. Four studies were retrospective and one was prospective, nonrandomized. Two studies included Watchman, two included the Amplatzer Cardiac Plug/Amulet device, and one included both devices. There was no significant difference in CHA2DS2VASC or HAS-BLED scores between both groups. There was no significant difference in acute procedural success between ICE vs TEE (risk ratio, 1.01; 95% CI, 0.99-1.04; P = 0.24). There was no significant difference in fluoroscopy time (mean difference [MD], 1.84 minutes; 95% CI, 0.59-4.27; P = 0.14) and total procedure time (MD, -5.06 minutes; 95% CI, -24.6-14.4; P = 0.61) between both groups. There was also no significant difference in complications including pericardial tamponade, device embolization, and stroke between both groups., Conclusion: In our meta-analysis, ICE was as effective as TEE during percutaneous LAAC., (© 2018 Wiley Periodicals, Inc.)

Background: Persistent left superior vena cava (PLSVC) is one of the most frequently reported congenital anomalies and may be an important source of trigger of atrial fibrillation (AF)., Methods: This was a multicenter retrospective experience including 28 patients with PLSVC who were referred for catheter ablation for drug-refractory symptomatic AF. Pulmonary vein and PLSVC isolation were performed (3.5-mm open irrigated tip ablation catheter at maximum power of 20 W, maximum temperature 43 °C with flow rate of 17 ml/min). Clinical outcomes such as complications and long-term freedom from AF were measured., Results: The mean age of the population was 61 ± 8 years, 21% were females, and AF duration was 60 ± 33 months. Sixty-one percent paroxysmal AF (17/28), 25% (7/28) persistent AF, and 14% (4/28) had long-standing persistent AF. There were no major complications that required any intervention. PLSVC isolation was achieved in 96% (27/28). Freedom from AF at 1 year without antiarrhythmic drugs was seen in 75% (21/28) of patients., Conclusions: In PLSVC patients with AF, segmental isolation of PLSVC appears to be feasible and safe and can translate into favorable clinical outcomes.