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Competing Interests: Disclosures Dr Turagam has served as a consultant for Biosense Webster and Boston Scientific. Dr Nair has served as a consultant for Boston Scientific and Johnson & Johnson. Dr Doshi has served as a consultant for Boston Scientific and Abbott Vascular. Dr Valderrabano has served as a consultant for Biosense Webster and Abbott. Dr Natale has served as a consultant for Abbott, Biosense Webster, and Boston Scientific. Dr Halperin has served as a consultant for Abbott and Bayer HealthCare. Dr Mansour has received consulting fees from Biosense Webster and Boston Scientific. Dr Reddy has served as an unpaid consultant for Boston Scientific, Biosense Webster, and Abbott. Dr Reddy has served as a consultant to Boston Scientific and Abbott; and unrelated to this manuscript, he has served as a consultant for and has equity in Ablacon, Acutus Medical, Affera-Medtronic, Anumana, Apama Medical-Boston Scientific, APN Health, Append Medical, Aquaheart, Atacor, Autonomix, Axon Therapies, Backbeat, BioSig, CardiaCare, Cardiofocus, CardioNXT/AFTx, Circa Scientific, CoRISMA, Corvia Medical, Dinova-Hangzhou DiNovA EP Technology, East End Medical, EP Frontiers, Farapulse-Boston Scientific, Field Medical, Focused Therapeutics, HRT, Intershunt, Javelin, Kardium, Laminar Medical, LuxMed, Medlumics, Neutrace, Nuvera-Biosense Webster, Oracle Health, Pulse Biosciences, Restore Medical, Sirona Medical, SoundCath; and unrelated to this work, has served as a consultant for Adagio Medical, AtriAN, Biosense-Webster, BioTel Heart, Biotronik, Cairdac, Cardionomic, CoreMap, Fire1, Gore & Associates, Impulse Dynamics, Medtronic, Novartis, Novo Nordisk, Philips; and has equity in Atraverse, 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.

Competing Interests: Disclosures The authors have no conflicts to disclose.

Introduction: Cardiac implantable electronic device (CIED) functions are susceptible to electromagnetic interference (EMI) from electromagnetic fields (EMF). Data on EMI risks from new-generation electronic appliances (EA) are limited., Objective: We performed a systematic literature review on the mechanisms of EMI, current evidence, and recently published trials evaluating the effect of EMF on CIEDs from electric vehicles (EV), smartphone, and smartwatch technology and summarize its safety data., Methods: Electronic databases, including PubMed and EMBASE, were searched for in vivo studies evaluating EMF strength and incidence between CIEDs and commercial EVs, new-generation smartphones, and new-generation smartwatches., Results: A total of ten studies (three on EVs, five on smartphones, one on smartphones, one on smartphones and smartwatches) were included in our systematic review. There was no report of EMI incidence associated with EVs or smartwatches. Magnet-containing smartphones (iPhone 12) can cause EMI when placed directly over CIEDs - thereby triggering the magnet mode; otherwise, no report of EMI was observed with other positions or smartphone models., Conclusion: Current evidence suggests CIED recipients are safe from general interaction with EVs/HEVs, smartphones, and smartwatches. Strictly, results may only be applied to commercial brands or models tested in the published studies. There is limited data on EMI risk from EVs wireless charging and smartphones with MagSafe technology., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background: The safety and efficacy of CA for AF and left-sided atrial arrhythmias (AA) in patients with left atrial appendage occlusion (LAAO) devices are lacking., Methods: This is a single-center retrospective registry that included all patients with prior LAAO who underwent catheter ablation for AF or left-sided atrial arrhythmia from January 2020-January 2023. The primary outcomes were procedure-related complications, device-related complications, AA recurrence, and stroke., Results: A total of 30 patients with prior LAAO were included in the analysis (mean age 75.1 ± 7.1 years old, 50% male, mean CHA 2 DS 2 -VASc score 4 ± 1.6, 46.7% paroxysmal AF, 73.3% had prior AF ablation, mean time to ablation 475 ± 365 days). 93.3% (n = 28) and 6.6% (n = 2) patients had ablation for AF (46.7% paroxysmal, 36.7% persistent, 10% long-standing persistent) and left-sided atrial tachycardia, respectively. 16.7% (n = 5) patients underwent ablation along the left atrial appendage ostium, and 3.3% (n = 1) underwent Vein of Marshall alcohol ablation. There were 3 (10%) peri-procedural complications (1 access hematoma and two pericardial effusions requiring intervention-none related to left atrial appendage ostium or alcohol ablation). During the mean follow-up of 440 ± 379 days, 40% (n = 12) patients had AA recurrence (91.6% AF, 8.3% atrial tachycardia), of which five patients needed repeat ablation, and two patients were readmitted for heart failure. There was no stroke or any device-related complications, including new peri-device leaks or device-related thrombosis in patients who had follow-up imaging studies (n = 11, 36.7%)., Conclusion: Catheter ablation for AF (including VoM alcohol ablation) in patients with prior LAAO devices is feasible and safe with favorable outcomes., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

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

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.)

Introduction: The QDOT MICRO TM Ablation Catheter is a next-generation ablation catheter that allows for high-power ablation up to 90 watts., Methods: We aimed to assess AE associated with the QDOT MICRO TM catheter using the MAUDE database. A MAUDE database search was conducted on May 25, 2024, to capture all AEs (since FDA approval) associated with this ablation catheter., Results: A total of 302 AEs from November 23, 2022, to April 30, 2024, were reported including 148 (49%) catheter-related issues and 154 (51%) clinical complications. Among the catheter-related issues, physical catheter damage (74.3%, n = 110) was most common, followed by communication or display issue (10.8%, n = 16), irrigation issue (9.5%, n = 14), signal issue or artifact (3.4%, n = 5), and inaccurate temperature measurement (2.0%, n = 3). Regarding clinical complications, the most common AE was pericardial effusion (43.5%, n = 67), followed by char formation (11.7%, n = 18), catheter thrombosis (7.1%, n = 11), stroke (7.1%, n = 11), pericarditis (7.1%, n = 11), esophageal complications (6.5%, n = 10), phrenic nerve palsy (3.9%, n = 6), cardiac arrest (3.9%, n = 6), significant AV block (3.9%, n = 6), pulmonary vein stenosis (3.2%, n = 5), coronary artery spasm (1.3%, n = 2), and pulmonary embolism (0.6%, n = 1). There were 11 deaths (five related to esophageal complications, five related to cardiac arrest, and one related to pericardial effusion with cardiac tamponade)., Conclusion: As high-power ablation strategy with novel ablation catheters is becoming more widely utilized, operators must be aware of potential catheter-related issues and clinical complications that may arise. More data are needed to further evaluate risks of these complications to improve the catheter's safety and efficacy., (© 2024 Wiley Periodicals LLC.)

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).)

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

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

Background: Atrial fibrillation (AF) and heart failure (HF) coexist, increasing morbidity and mortality. Studies have demonstrated improved outcomes following AF ablation in HF patients with reduced ejection fraction (EF)., Objective: To assess the outcomes of pulsed-field ablation (PFA) in HF., Methods: MANIFEST-PF is a multicenter patient-level registry of consecutive patients undergoing PFA for paroxysmal (PAF) or persistent AF (PerAF). In this sub-study, patients were stratified as: no history of HF (no-HF), HF with preserved EF (HF P EF; LVEF≥50%) or HF with reduced/mildly-reduced EF (HF MR/R EF; LVEF<50%). The primary effectiveness and safety endpoints were freedom from documented atrial arrhythmias lasting ≥30s and major adverse events (MAEs), respectively., Results: Of the 1,381 patients, 85% (n=1,174) were no-HF, 6.2% (n=87) were HF P EF, and 8.6% (n=120) were HF MR/R EF. No-HF patients had less PerAF than patients with HF (p<0.001), with no difference between HF subtypes (p=1.00). The 1-year freedom from atrial arrhythmia was significantly higher in no-HF than with HF P EF or HF MR/R EF (79.9%, 71.3%, 67.5%, p<0.001), but similar between HF MR/R EF and HF P EF (p=0.26). However, there was no significant difference in freedom from atrial arrhythmia among patients with no-HF vs HF P EF vs HF MR/R EF for those with PAF (82.8%/82.4%/71.7%, p=0.09) and PerAF (73.3%, 64.2%, and 64.9%, p=0.14.MAE rates were similar between the no-HF, HF P EF and HF MR/R EF groups (1.9%, 0%, and 2.5%, respectively)., Conclusion: PFA appears to be potentially safe and effective in AF patients with HF. Freedom from atrial arrhythmia post-PFA was higher in patients without a history of HF, with no significant difference between HF subtypes., (Copyright © 2024. Published by Elsevier Inc.)

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.

Background: Leadless pacemaker (LP) offers an innovative approach for treating bradyarrhythmia, thus avoiding pacemaker pocket and lead-related complications. The Food and Drug Administration (FDA) has recently approved the Aveir™ leadless pacing system (screw-in type LP)., Methods: We queried the FDA MAUDE database to study the safety profile and assess the types of complications with this relatively novel device technology. A MAUDE database search was conducted on January 20, 2023, for reports received post-FDA approval to capture all adverse events., Results: A total of 98 medical device report were reported for Aveir™ LP. After excluding duplicate, programmer-related, or introducer-sheath-related entries (n = 34), 64 entries were included. The most commonly encountered problem was high threshold/noncapture (28.1%, 18 events), followed by stretched helix (17.2%, 11 events) and device dislodgement (15.6%, ten events-5 intraprocedural, while 5 in the postoperative Day 1). Other reported events included high impedance (14.1%, nine events), sensing issues (12.5%, eight events), bent/broken helix (7.8%, five events), premature separation (4.7%, three events), interrogation problem (3.1%, two events), low impedance (3.1%, two events), premature battery depletion (1.6%, one event) and inadvertent MRI mode switch (1.6%, one event) and miscellaneous (15.6%, n = 10). There were eight serious patient injury events-pericardial effusion requiring pericardiocentesis (7.8%, five events) due to cardiac perforation that resulted in two deaths (3.1%) followed by sustained ventricular arrhythmias (4.6%, n = 3)., Conclusion: In our study assessing the real-world safety profile of the Aveir™ LP, serious adverse events have been reported-life-threatening ventricular arrhythmias, pericardial effusion, device explantation/reimplantation, and death., (© 2023 Wiley Periodicals LLC.)

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

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.)

Background: There has been increasing interest in physiologic pacing techniques that directly activate the specialized conduction system. We aimed to assess outcomes of conduction system pacing (CSP) in patients with prosthetic heart valves., Methods: This systematic review was performed according to PRISMA guidelines. Freeman-Tukey double arcsine transformation with the random-effect model was used to summarize the data. Outcomes studied were 1) implant success (defined as ability to recruit the His-Purkinje system or the distal Purkinje system); (2) lead parameters at implant and follow-up; and (3) procedure-related complications., Results: This systematic review of 7 studies included 267 unique patients in whom CSP was attempted with either HBP or LBBAP for pacing indications after a prosthetic valve. HBP was attempted in 38% (n = 108), while LBBAP in 62% (n = 175) patients. The overall success rate of CSP was 87%, while in patients post-TAVR, the overall success rate was 83.2%. In the subgroup analysis, LBBAP had a significant higher overall success rate compared to HBP (94.3% vs. 76.5%, p interaction  = 0.02) and post-TAVR patients (94.3 vs. 66.9%, p interaction  < 0.01), respectively. The LBBAP thresholds were significantly lower compared to HBP both at implant (0.67 ± 0.4 @ 0.44 ms vs. 1.35 ± 1 @ 0.85 ms, p interaction  < 0.01) and at a mean follow-up of 12.4 ± 8 months (0.73 ± 0.1 @ 0.44 ms vs. 1.39 ± 1 @ 0.85 ms, p interaction  < 0.01), respectively., Conclusion: CSP is safe and feasible in patients with a prosthetic valve, with a significantly higher success rate and superior lead parameters with LBBAP than HBP, especially in patients post-TAVR., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background: We compared the efficacy and safety of cardioneuroablation (CNA) vs. permanent pacing (PM) for recurrent cardioinhibitory vasovagal syncope (CI-VVS)., Methods: One hundred sixty-two patients (CNA = 61, PM = 101), age 36 + 11 years) with syncope frequency of 6.7 ± 3.9/year were included in this multicenter study. All patients with CNA were provided by a single center, while patients with PM were provided by 4 other centers. In the CNA arm, an electroanatomic mapping guided approach was used to detect and ablate ganglionated plexus sites. Dual chamber rate drop response (RDR) or close loop stimulation (CLS) transvenous and leadless pacemakers were implanted using standard technique. The primary endpoint was freedom from syncope., Results: Of 101 patients in the PM group, 39 received dual-chamber pacemaker implants with the CLS algorithm, 38 received dual-chamber pacemakers with the RDR algorithm, and 24 received a leadless pacemaker. At 1-year follow-up, 97% and 89% in the CNA and PM group met the primary endpoint (adjusted HR = 0.27, 95% CI 0.06-1.24, p = 0.09). No significant differences in adverse events were noted between groups. There was no significant association between age (HR:1.01, 95% CI 0.96-1.06, p = 0.655), sex (HR:1.15, 95% CI 0.38-3.51, p = 0.809), and syncope frequency in the past year (HR:1.10, 95% CI 0.97-1.25, p = 0.122) and the primary outcome in univariable analyses., Conclusions: After adjustment for patient characteristics, the medium-term syncope recurrence risk of CI-VVS patients who underwent CNA was similar to that of a population of patients undergoing pacemaker implantation with a similar safety profile., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Competing Interests: Conflicts of interest: The authors have provided declaration of interest information for all relationships that might be perceived as real or potential sources of conflicts of interest. The full disclosures can be viewed in the Supplementary material online for this article, available online at [URL].

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

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.)

Competing Interests: Funding Support and Author Disclosures Dr Doshi has received a grant from Boston Scientific. Dr Dukkipati has received a grant from Biosense Webster; and holds equity in Farapulse and Manual Surgical Sciences. Dr Neuzil has received grants from Biosense Webster and Boston Scientific. Dr Reddy is a consultant to Abbott, Ablacon, Acutus Medical, Affera, Apama Medical, APN Health, Aquaheart, Atacor, AtiAN, Autonomix, Axon Therapies, Backbeat, BioSig, Biosense Webster, BioTel Heart, Biotronik, Boston Scientific, Cardiac Implants, CardiaCare, Cardiofocus, Cardionomic, CardioNXT/AFTx, Circa Scientific, CoreMap, CoRISMA, Corvia Medical, Dinova-Hangzhou Nuomao Medtech, East End Medical, EBR, EPD, Epix Therapeutics, EpiEP, Eximo, Farapulse, Fire1, Gore & Associates, HRT, Impulse Dynamics, Intershunt, Javelin, Kardium, Keystone Heart, LuxCath, Medlumics, Medtronic, Middlepeak, Neutrace, Nuvera, Philips, Pulse Biosciences, Restore Medical, Sirona Medical, and Valcare; and holds equity in Ablacon, Acutus Medical, Affera, Apama Medical, APN Health, Aquaheart, Atacor, Autonomix, Backbeat, BioSig, Cardiac Implants, CardiaCare, Circa Scientific, CoRISMA, Corvia Medical, Dinova-Hangzhou Nuomao Medtech, East End Medical), EPD, Epix Therapeutics, EpiEP, Eximo, Farapulse, Fire1, HRT, Intershunt, Javelin, Kardium, Keystone Heart, LuxCath, Manual Surgical Sciences, Medlumics, Middlepeak, Neutrace, Newpace, Nuvera, Restore Medical, Sirona Medical, Surecor, Valcare, and Vizaramed (Equity). All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Background: Thromboembolic (TE) events are among the most common and devastating adverse events in patients with continuous-flow left ventricular assist device (cf-LVAD). Given the high burden of AF among cf-LVAD patients, we sought to evaluate the effect of concomitant surgical LAAO in patients receiving cf-LVAD., Methods: A systematic search using electronic databases was performed using the keywords: "left atrial appendage occlusion" and "left ventricular assist device." Statistical analysis was performed using metapackage for R version 4.0 and Rstudio version 1.2. Mantel-Haenszel risk ratio (RR) random-effects model was used to summarize data between two groups. The primary outcomes included: (a) stroke; (b) LVAD pump thrombosis; (c) all-cause mortality RESULTS: Three studies with a total of 305 patients (LAAO = 68 and No-LAAO = 237) were included in the analysis. HeartMate II (39%) and Heartware (27.5%) were the two most common cf-LVADs utilized, while only 5% received HeartMate III. At a mean follow up of 1.47 years, LAAO group had a lower risk of stroke (8.8% vs. 15.2%, RR 0.64; 95% CI 0.28-1.49), LVAD pump thrombosis (1.5% vs. 3.8%, RR 0.28; 95% CI 0.05-1.55) and all-cause mortality (5.9% vs. 20.2%, RR 0.69; 95% CI 0.19-2.52) when compared with no-LAAO group, but the difference did not reach statistical significance., Conclusion: Concomitant surgical LAAO at the time of cf-LVAD implantation demonstrated a trend toward positive outcomes and was not associated with adverse outcomes during the follow-up period, though the results were not statistically significant., (© 2022 Wiley Periodicals LLC.)

Background: Recent data suggest that epicardial left atrial appendage closure (LAAC) is associated with several short-term neurohormonal effects. However, the long-term effects are currently unknown., Objective: To investigate the effects of percutaneous epicardial left atial appendage (LAA) exclusion using LARIAT on neurohormonal profiles at long-term follow-up., Methods: In a prospective single centre study, 60 patients with long-standing, persistent atrial fibrillation (AF) LARIAT were treated. The major hormones of the adrenergic system, renin-angiotensin-aldosterone system (RAAS), and natriuretic peptides were assessed before the intervention and at regular intervals during the following two years., Results: In patients with epicardial LAAC, atrial natriuretic peptide (ANP) levels were significantly increased from baseline at 24 h and decreased at 7 days, 1 month, and 3 months, while remaining unchanged at 12 and 24 months. Noradrenaline levels were significantly lower at 24 h, 7 days, 1 month, 6 months, 12 months, and 24 months, while epinephrine levels decreased significantly at 1 month, 6 months, 12 months, and 24 months. Plasma renin activity significantly decreased at 7 days, 1 month, 6 months, 12 months, and 24 months, while aldosterone levels significantly decreased at 6 months, 12 months, and 24 months. Endothelin-1 and vasopressin showed a significant increase and decrease, respectively, at 24 h, 7 days, 1 month, 6 months, 12 months, and 24 months. There was also a significant decrease in systolic and diastolic blood pressure at 3 months, 6 months, 1 year, and 2 years after the intervention., Conclusions: Epicardial LAAC in AF patients is associated with persistent neurohormonal changes favouring blood pressure reduction.

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: Increasing interest in physiological pacing has been countered with challenges such as accurate lead deployment and increasing pacing thresholds with His-bundle pacing (HBP). More recently, left bundle branch area pacing (LBBAP) has emerged as an alternative approach to physiologic pacing., Objective: To compare procedural outcomes and pacing parameters at follow-up during initial adoption of HBP and LBBAP at a single center., Methods: Retrospective review, from September 2016 to January 2020, identified the first 50 patients each who underwent successful HBP or LBBAP. Pacing parameters were then assessed at first follow-up after implantation and after approximately 1 year, evaluating for acceptable pacing parameters defined as sensing R-wave amplitude >5 mV, threshold <2.5 V @ 0.5 ms, and impedance between 400 and 1200 Ω., Results: The HBP group was younger with lower ejection fraction compared to LBBAP (73.2 ± 15.3 vs. 78.2 ± 9.2 years, p = .047; 51.0 ± 15.9% vs. 57.0 ± 13.1%, p = .044). Post-procedural QRS widths were similarly narrow (119.8 ± 21.2 vs. 116.7 ± 15.2 ms; p = .443) in both groups. Significantly fewer patients with HBP met the outcome for acceptable pacing parameters at initial follow-up (56.0% vs. 96.4%, p = .001) and most recent follow-up (60.7% vs. 94.9%, p ≤ .001; at 399 ± 259 vs. 228 ± 124 days, p ≤ .001). More HBP patients required lead revision due to early battery depletion or concern for pacing failure (0% vs. 13.3%, at a mean of 664 days)., Conclusion: During initial adoption, HBP is associated with a significantly higher frequency of unacceptable pacing parameters, energy consumption, and lead revisions compared with LBBAP., (© 2021 Wiley Periodicals LLC.)

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.)

During the clinical care of hospitalized patients with COVID-19, diminished QRS amplitude on the surface electrocardiogram (ECG) was observed to precede clinical decompensation, culminating in death. This prompted investigation into the prognostic utility and specificity of low QRS complex amplitude (LoQRS) in COVID-19. We retrospectively analyzed consecutive adults admitted to a telemetry service with SARS-CoV-2 (n = 140) or influenza (n = 281) infection with a final disposition-death or discharge. LoQRS was defined as a composite of QRS amplitude <5 mm or <10 mm in the limb or precordial leads, respectively, or a ≥50% decrease in QRS amplitude on follow-up ECG during hospitalization. LoQRS was more prevalent in patients with COVID-19 than influenza (24.3% vs 11.7%, p = 0.001), and in patients who died than survived with either COVID-19 (48.1% vs 10.2%, p <0.001) or influenza (38.9% vs 9.9%, p <0.001). LoQRS was independently associated with mortality in patients with COVID-19 when adjusted for baseline clinical variables (odds ratio [OR] 11.5, 95% confidence interval [CI] 3.9 to 33.8, p <0.001), presenting and peak troponin, D-dimer, C-reactive protein, albumin, intubation, and vasopressor requirement (OR 13.8, 95% CI 1.3 to 145.5, p = 0.029). The median time to death in COVID-19 from the first ECG with LoQRS was 52 hours (interquartile range 18 to 130). Dynamic QRS amplitude diminution is a strong independent predictor of death over not only the course of COVID-19 infection, but also influenza infection. In conclusion, this finding may serve as a pragmatic prognostication tool reflecting evolving clinical changes during hospitalization, over a potentially actionable time interval for clinical reassessment., (Copyright © 2021 Elsevier Inc. All rights reserved.)

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

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 role of secondary prevention implantable cardioverter-defibrillator (ICD) remains uncertain in spontaneous coronary artery dissection (SCAD) patients presenting with sudden cardiac arrest (SCA)., Methods: We aimed at assessing the outcomes following SCA and the role of ICD therapy in SCAD. The meta-analysis was performed using a meta-package for R version 4.0/RStudio version 1.2 and the Freeman-Tukey double arcsine method to establish the variance of raw proportions. Outcomes measured included-(1) incidence of ICD implantation, (2) appropriate and inappropriate ICD therapy, (3) recurrence of SCAD and SCA, and (4) all-cause mortality., Results: Five studies, including 139 SCAD patients with SCA met study inclusion criteria. The mean age was 47.3 ± 12.8 years, mean left ventricular ejection fraction 43.8 ± 10.8%, 88% were female (12% had pregnancy-associated SCAD. Causes of SCA included ventricular arrhythmia (97.9%, n = 136) and pulseless electrical activity (2.1%, n = 3). Overall, 20% patients (95% confidence interval [CI]: 7.1%-36.6%, I 2 = 68%) received ICD, of which 1.2% (95% CI: 0%-15.8%, I 2 = 0%) and 1% (95% CI: 0%-15.3%, I 2 = 0%) patients received appropriate and inappropriate ICD therapies, respectively, during follow-up period (4.1 ± 3.3 years). Incidence of recurrent SCAD was 9% (95% CI: 2.85%-17.5%, I 2 = 25%), and recurrent SCA was 3.85% patients (95% CI: 0.65%-8.7%, I 2 = 0%; one patient with appropriate ICD therapy). The pooled incidence of all-cause mortality was 6.2% (95% CI: 0.6%-15.1%, I 2 = 44%)., Conclusion: Although ICD therapy is beneficial in patients (all comers) presenting with cardiac arrest; the risk-benefit ratio of secondary prevention ICD arrest remains unclear. Patient-centered shared decision-making and risk-benefit ratio assessment should be performed before consideration for ICD implantation., (© 2021 Wiley Periodicals LLC.)