49 results on '"Chun JKR"'
Search Results
2. P489Percutaneous LAA closure without contrast media application
- Author
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Perrotta, L., primary, Bordignon, S., additional, Weise, F., additional, Konstantinou, A., additional, Bologna, F., additional, Chun, JKR, additional, and Schmidt, B., additional
- Published
- 2017
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3. P895Individualized Cryoballoon Energy pulmonary vein isolation guided by real time PV recordings: the ICE T concept in a single centre experience
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Perrotta, L., primary, Dugo, D., additional, Bordignon, S., additional, Nagase, T., additional, Bologna, F., additional, Schmidt, B., additional, and Chun, JKR, additional
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- 2017
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4. P898Reduced incidence of periprocedural stroke in AF ablation: a single centre experience
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Perrotta, L., primary, Bordignon, S., additional, Bologna, F., additional, Weise, F., additional, Schmidt, B., additional, and Chun, JKR, additional
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- 2017
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5. Remote catheter ablation of Parahisian accessory pathways using a novel magnetic navigation system -- a report of two cases.
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Ernst S, Hachiya H, Chun JKR, and Ouyang F
- Abstract
Introduction: Ablation of anteroseptal (parahisian) pathways may be difficult using conventional catheters.Methods and Results: Two patients (51 and 20 years old) underwent ablation of a parahisian accessory pathway using the magnetic navigation system Niobe (Stereotaxis, Inc.), which consists of two external permanent magnets (0.08 Tesla) that steer a small magnet embedded in the tip of the ablation catheter. A motor drive allows the advancement or retraction of the catheter. From the control room, the ablation was performed using a single radiofrequency current application (fluoroscopy 3.2 and 6.0 minutes, respectively).Conclusions: The Niobe magnetic navigation system was successfully used to perform completely remote controlled mapping and ablation of parahisian accessory pathways. [ABSTRACT FROM AUTHOR]
- Published
- 2005
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6. 'Sequential' mapping mimicking 'simultaneous' mapping using magnetic navigation during catheter ablation of supraventricular tachycardia: results of the Single DX Study.
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Ernst S, Chun JKR, Ujeyla A, Ouyang F, and Kuck K
- Abstract
Introduction: The magnetic navigation system (MNS) allows remote-controlled navigation of an ablation catheter from the control room. We tested the hypothesis, whether the MNS and a single additional diagnostic nonsteerable catheter would have the potential to identify the tachycardia substrate and allow subsequent ablation in patients with documented supraventricular tachycardia (SVT). Methods and Results: A total of 41 patients (24 females, age 45 ± 16 years) underwent an invasive electrophysiologic (EP) study using the MNS. Together with a conventional diagnostic catheter in the right ventricle, the magnetic catheter (MC) was used to investigate the underlying EP substrate in a sequential fashion and subsequently to perform radiofrequency (RF) ablation. A custom-made device allowed the separate assessment of fluoroscopy deployed from the control and examination room. Using conventional EP criteria, identification of the underlying substrate was possible in all but 4 noninducible patients (no accessory pathway [AP], no dual atrioventricular [AV] node): APs were present in 10 patients, AV node re-entrant tachycardia in 26 patients, and ectopic atrial tachycardia in 1 patient. Despite 3 patients, in which switching to conventional ablation was necessary (8%), all others were successfully treated using the MNS. Overall fluoroscopy amounted to a median of 3.4 minutes (interquartile range, 2.4-5.3) with only a median of 1.0 minute exposure for the investigator. Conclusions: Remote catheter ablation of SVT using the new MNS Niobe and a single conventional diagnostic catheter is feasible. Compared to conventional EP studies, a reduction of radiation exposure for both patients and investigators was demonstrated. [ABSTRACT FROM AUTHOR]
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- 2007
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7. Effects of sodium-glucose co-transporter inhibitors on individual clinical endpoints and quality of life.
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Liao J, Chen Y, Ling Z, Pürerfellner H, Martinek M, Derndorfer M, Niel J, Ebrahimi R, Heukäufer M, Janschel S, Di Vece D, Empen K, Hummel A, Chamling B, Futyma P, Ebrahimi F, Kiuchi MG, Liu S, Yin Y, Schratter A, Acou WJ, Sommer P, Schmidt B, Chun JKR, Meyer C, Dörr M, Templin C, and Chen S
- Abstract
Aims: Sodium-glucose co-transporter inhibitors (SGLTis) have cardiovascular protective effects. We aimed to assess the effects of SGLTis on individual hard clinical endpoints and quality of life (QoL) in patients with cardiovascular risk factors., Methods and Results: Data was searched in PubMed, Embase, Cochrane Library and clinicaltrials.gov databases up to February 2024. Randomized controlled trials (RCTs) comparing SGLTis with placebo were included. The primary outcomes were individual hard clinical endpoints (Subset A) and QoL (Subset B). For Subset A, 13 RCTs including 90 413 patients were enrolled (age 66 ± 10.1 years, 35.7% female, follow-up 2.4 ± 0.3 years); as compared with placebo, SGLTis were associated with significantly lower risk of all-cause mortality [risk ratio (RR): 0.90, 95% confidence interval (CI): 0.86-0.94, P < 0.01], cardiovascular mortality (RR: 0.87, 95% CI: 0.82-0.92, P < 0.01), hospitalization for heart failure (HF) (RR: 0.72, 95% CI: 0.68-0.76, P < 0.01), HF events (RR: 0.72, 95% CI: 0.68-0.75, P < 0.01), hospitalization for any cause (RR: 0.91, 95% CI: 0.88-0.93, P < 0.01) and myocardial infarction (MI) (RR: 0.92, 95% CI: 0.85-0.99, P = 0.03). Notably, the favourable effect of SGLTis on all-cause mortality was more pronounced in younger (<65 years) patients (RR: 0.86, 95% CI: 0.81-0.92) and in studies with less female (RR: 0.84, 95% CI: 0.79-0.90). The favourable effect of SGLTis on MI was only observed in patients who received sotagliflozin (RR: 0.47, 95% CI: 0.31-0.73). For Subset B, nine RCTs including 2552 HF patients were enrolled (age 67.8 ± 12.4 years, 36.4% female, follow-up 3.4 ± 1.9 months); SGLTis were associated with significant improvement in QoL as compared with placebo., Conclusions: In patients with a broad spectrum of cardiovascular risk factors, SGLTis substantially improve individual hard clinical outcomes and QoL., (© 2024 The Author(s). ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)
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- 2024
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8. Bipolar radiofrequency ablation of refractory ventricular arrhythmias: results from a multicentre network.
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Futyma P, Sultan A, Zarębski Ł, Imnadze G, Maslova V, Bordignon S, Kousta M, Knecht S, Pavlović N, Peichl P, Lian E, Kueffer T, Scherr D, Pfeffer M, Moskal P, Cismaru G, Antolič B, Wałek P, Chen S, Martinek M, Kollias G, Derndorfer M, Seidl S, Schmidt B, Lüker J, Steven D, Sommer P, Jastrzębski M, Kautzner J, Reichlin T, Sticherling C, Pürerfellner H, Enriquez A, Wörmann J, and Chun JKR
- Subjects
- Humans, Male, Female, Middle Aged, Aged, Treatment Outcome, Europe, Feasibility Studies, Tachycardia, Ventricular surgery, Tachycardia, Ventricular physiopathology, Ventricular Premature Complexes surgery, Ventricular Premature Complexes physiopathology, Ventricular Premature Complexes diagnosis, Catheter Ablation methods, Registries, Recurrence
- Abstract
Aims: Advanced ablation strategies are needed to treat ventricular tachycardia (VT) and premature ventricular complexes (PVC) refractory to standard unipolar radiofrequency ablation (Uni-RFA). Bipolar radiofrequency catheter ablation (Bi-RFA) has emerged as a treatment option for refractory VT and PVC. Multicentre registry data on the use of Bi-RFA in the setting of refractory VT and PVC are lacking. The aim of this Bi-RFA registry is to determine its real-world safety, feasibility, and efficacy in patients with refractory VT/PVC., Methods and Results: Consecutive patients undergoing Bi-RFA at 16 European centres for recurring VT/PVC after at least one standard Uni-RFA were included. Second ablation catheter was used instead of a dispersive patch and was positioned at the opposite site of the ablation target. Between March 2021 and August 2024, 91 patients underwent 94 Bi-RFA procedures (74 males, age 62 ± 13, and prior Uni-RFA range 1-8). Indications were recurrence of PVC (n = 56), VT (n = 20), electrical storm (n = 13), or PVC-triggered ventricular fibrillation (n = 2). Procedural time was 160 ± 73 min, Bi-RFA time 426 ± 286 s, and mean Uni-RFA time 819 ± 697 s. Elimination of clinical VT/PVC was achieved in 67 (74%) patients and suppression of VT/PVC in a further 10 (11%) patients. In the remaining 14 patients (15%), no effect on VT/PVC was observed. Three major complications occurred: coronary artery occlusion, atrioventricular block, and arteriovenous fistula. Follow-up lasted 7 ± 8 months. Nineteen patients (61%) remained VT free. ≥80% PVC burden reduction was achieved in 45 (78%)., Conclusion: These real-world registry data indicate that Bi-RFA appears safe, is feasible, and is effective in the majority of patients with VT/PVC., Competing Interests: Conflict of interest: P.F. reports patents related to high-voltage and bipolar ablation and has equity in CorSystem. J.K. reports personal fees from Biosense Webster, Boston Scientific, GE Healthcare, Medtronic, and St. Jude Medical (Abbott) for participation in scientific advisory boards and has received speaker honoraria from Biosense Webster, Biotronik, Boston Scientific, Medtronic, ProMed CS, St. Jude Medical (Abbott), and Viatris. All remaining authors have declared no conflicts of interest., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)
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- 2024
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9. Pulsed field ablation for atrial fibrillation when in proximity to LAA AtriClip: the LAA-Clip does not inhibit the pulse.
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Ebrahimi R, Chun JKR, Schmidt B, and Chen S
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- 2024
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10. Cryoablation of atrial fibrillation in "very severe" obese patients (BMI ≥ 40): Indications, feasibility, procedural safety and efficacy, and clinical outcome (the ICE-Obese Extreme).
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Urbanek L, Schmidt B, Bordignon S, Schaack D, Ebrahimi R, Tohoku S, Hirokami J, Efe TH, Plank K, Schulte-Hahn B, Nowak B, Chun JKR, and Chen S
- Subjects
- Humans, Male, Female, Treatment Outcome, Middle Aged, Aged, Risk Factors, Time Factors, Heart Rate, Severity of Illness Index, Action Potentials, Retrospective Studies, Recurrence, Atrial Fibrillation surgery, Atrial Fibrillation physiopathology, Atrial Fibrillation diagnosis, Cryosurgery adverse effects, Feasibility Studies, Body Mass Index, Obesity diagnosis, Obesity complications, Obesity physiopathology, Pulmonary Veins surgery, Pulmonary Veins physiopathology
- Abstract
Background: Management of atrial fibrillation (AF) in very severe obese patients is challenging. Cryoballoon ablation (CBA) represents an effective rhythm control strategy. However, data in this patient group were limited., Methods: Highly symptomatic AF patients with body mass index (BMI) ≥ 40 kg/m
2 who had failed antiarrhythmic drug therapy and electrocardioversion and failure to achieve targeted body-weight-reduction underwent CBA., Results: Data of 72 very severe obese AF patients (Group A) and 129 AF patients with normal BMI (Group B, BMI < 25 kg/m2 ) were consecutively collected. Group A had significantly younger age (60.6 ± 10.4 vs. 69.2 ± 11.2 years), higher BMI (44.3 ± 4.3 vs. 22.5 ± 1.6 kg/m2 ). Procedural pulmonary vein isolation (PVI) was successful in all patients (2 touch-up ablation in Group A). Compared to Group B, Group A had similar procedural (61.3 ± 22.6 vs. 57.5 ± 19 min), similar fluoroscopy time (10.1 ± 5.5 vs. 9.2 ± 4.8 min) but significantly higher radiation dose (2852 ± 2095 vs. 884 ± 732 µGym2 ). We observed similar rates of real-time-isolation (78.6% vs. 78.5%), single-shot-isolation (86.5% vs. 88.8%), but significantly longer time-to-sustained-isolation (53.5 ± 33 vs. 43.2 ± 25 s). There was significantly higher rate of puncture-site-complication (6.9% vs. 1.6%) in Group A. One-year clinical success in paroxysmal AF was (Group A: 69.4% vs. Group B: 80.2%; p < .001), in persistent AF was (Group A: 58.1% vs. Group B: 62.8%; p = .889). In Re-Do procedures Group A had a numerically lower PVI durability (75.0% vs. 83.6%, p = .089)., Conclusion: For very severe obese AF patients, CBA appears feasible, leads to relatively good clinical outcome., (© 2024 The Authors. Journal of Cardiovascular Electrophysiology published by Wiley Periodicals LLC.)- Published
- 2024
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11. Management of ventricular tachycardias: insights on centre settings, procedural workflow, endpoints, and implementation of guidelines-results from an EHRA survey.
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Sultan A, Futyma P, Metzner A, Anic A, Richter S, Roten L, Badertscher P, Conte G, and Chun JKR
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- Humans, Workflow, Arrhythmias, Cardiac surgery, Treatment Outcome, Tachycardia, Ventricular diagnosis, Tachycardia, Ventricular surgery, Myocardial Ischemia, Catheter Ablation methods
- Abstract
Ventricular tachycardia (VT), and its occurrence, is still one of the main reasons for sudden cardiac death and, therefore, for increased mortality and morbidity foremost in patients with structural heart [Kahle A-K, Jungen C, Alken F-A, Scherschel K, Willems S, Pürerfellner H et al. Management of ventricular tachycardia in patients with ischaemic cardiomyopathy: contemporary armamentarium. Europace 2022;24:538-51]. Catheter ablation has become a safe and effective treatment option in patients with recurrent VT [Cronin EM, Bogun FM, Maury P, Peichl P, Chen M, Namboodiri N et al. 2019 HRS/EHRA/APHRS/LAHRS expert consensus statement on catheter ablation of ventricular arrhythmias. Heart Rhythm 2020;17:e2-154]. Previous and current guidelines provide guidance on indication for VT ablation and risk assessment and evaluation of underlying disease. However, no uniform recommendation is provided regarding procedural strategies, timing of ablation, and centre setting. Therefore, these specifics seem to differ largely, and recent data are sparse. This physician-based European Heart Rhythm Association survey aims to deliver insights on not only infrastructural settings but also procedural specifics, applied technologies, ablation strategies, and procedural endpoints. Therefore, these findings might deliver a real-world scenario of VT management and potentially are of guidance for other centres., Competing Interests: Conflict of interest: I have read the journal’s policy, and the authors of this manuscript have the following competing interests: A.S. has received speaker honoraria and consulting fees from Abbott, Boston Scientific, J&J, and Medtronic. L.R. has received speaker honoraria from Abbott and consulting honoraria from Medtronic. He also has received a research grant to the institution from Medtronic. All remaining authors declare that no competing interests exist., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)
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- 2024
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12. Prevention of venous thromboembolism in right heart-sided electrophysiological procedures: results of an European Heart Rhythm Association survey.
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Mugnai G, Farkowski M, Tomasi L, Roten L, Migliore F, de Asmundis C, Conte G, Boveda S, and Chun JKR
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- Humans, Anticoagulants therapeutic use, Fibrinolytic Agents therapeutic use, Heparin, Aspirin, Surveys and Questionnaires, Venous Thromboembolism epidemiology, Venous Thromboembolism prevention & control, Pulmonary Embolism prevention & control, Pulmonary Embolism drug therapy
- Abstract
Limited data are available regarding venous thromboembolism (VTE), specifically deep vein thrombosis (DVT) and pulmonary embolism (PE), following right-sided ablations and electrophysiological (EP) studies. Compared to left-sided procedures, no guidelines on antithrombotic management strategies for the prevention of DVT and PE are available. The main purpose of the present European Heart Rhythm Association (EHRA) survey is to report the current management of right-sided EP procedures, focusing on anticoagulation and prevention of VTE. An online survey was conducted using the EHRA infrastructure. A total of 244 participants answered a 19-items questionnaire on the periprocedural management of EP studies and right-sided catheter ablations. The right femoral vein is the most common access for EP studies and right-sided procedures. An ultrasound-guided approach is employed by more than 2/3 of respondents. Intravenous heparin is not commonly given by the majority of participants. About 1/3 of participants (34%) routinely prescribe VTE prophylaxis during (mostly aspirin and low molecular weight heparin) and 1/4 of respondents (25%) commonly prescribe VTE prophylaxis after discharge (mostly aspirin). Of note, respectively 13% and 9% of participants observed at least one DVT and one PE related to right-sided ablation or EP study within the last year in their center. The present survey shows that only a minority of operators routinely gives intraprocedural intravenous heparin and prescribes VTE prophylaxis after right-sided EP procedures. Compared to left-sided procedures like atrial fibrillation (AF) ablation, there are no consistent systematic antithrombotic management strategies., Competing Interests: Conflict of interest: M.F. received speaker and consultation fees from Pfizer and Boehringer Ingelheim Poland. L.R. has received speaker and consulting fees from Abbott and Medtronic and a research grant to the institution from Medtronic. C.d.A. received compensation for teaching purposes and proctoring from Medtronic, Abbott, Biotronik, Livanova, Boston Scientific, Atricure, Acutus Medical, and Daiichi Sankyo. G.C. has received honoraria fees from Biosense Webster and Boston Scientific and research grants from Boston Scientific. S.B. is a consultant for Medtronic, Boston Scientific, Microport, and Zoll. J.K.R.C. received speaker, consultation, teaching, and proctoring honoraria from Medtronic, Boston Scientific, and Biosense Webster., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)
- Published
- 2023
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13. Persistent and Recurrent Device-Related Thrombus After Left Atrial Appendage Closure: Incidence, Predictors, and Outcomes.
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Mesnier J, Simard T, Jung RG, Lehenbauer KR, Piayda K, Pracon R, Jackson GG, Flores-Umanzor E, Faroux L, Korsholm K, Chun JKR, Chen S, Maarse M, Montrella K, Chaker Z, Spoon JN, Pastormerlo LE, Meincke F, Sawant AC, Moldovan CM, Qintar M, Aktas MK, Branca L, Radinovic A, Ram P, El-Zein RS, Flautt T, Ding WY, Sayegh B, Benito-González T, Lee OH, Badejoko SO, Paitazoglou C, Karim N, Zaghloul AM, Agarwal H, Kaplan RM, Alli O, Ahmed A, Suradi HS, Knight BP, Alla VM, Panaich SS, Wong T, Bergmann MW, Chothia R, Kim JS, Pérez de Prado A, Bazaz R, Gupta D, Valderrábano M, Sanchez CE, El Chami MF, Mazzone P, Adamo M, Ling F, Wang DD, O'Neill W, Wojakowski W, Pershad A, Berti S, Spoon DB, Kawsara A, Jabbour G, Boersma LVA, Schmidt B, Nielsen-Kudsk JE, Freixa X, Ellis CR, Fauchier L, Demkow M, Sievert H, Main ML, Hibbert B, Holmes DR Jr, Alkhouli M, and Rodés-Cabau J
- Subjects
- Humans, Female, Incidence, Treatment Outcome, Atrial Appendage diagnostic imaging, Atrial Fibrillation epidemiology, Atrial Fibrillation therapy, Atrial Fibrillation complications, Thromboembolism diagnostic imaging, Thromboembolism epidemiology, Thromboembolism etiology, Thrombosis diagnostic imaging, Thrombosis epidemiology, Thrombosis etiology, Stroke etiology
- Abstract
Background: Scarce data exist on the evolution of device-related thrombus (DRT) after left atrial appendage closure (LAAC)., Objectives: This study sought to assess the incidence, predictors, and clinical impact of persistent and recurrent DRT in LAAC recipients., Methods: Data were obtained from an international multicenter registry including 237 patients diagnosed with DRT after LAAC. Of these, 214 patients with a subsequent imaging examination after the initial diagnosis of DRT were included. Unfavorable evolution of DRT was defined as either persisting or recurrent DRT., Results: DRT resolved in 153 (71.5%) cases and persisted in 61 (28.5%) cases. Larger DRT size (OR per 1-mm increase: 1.08; 95% CI: 1.02-1.15; P = 0.009) and female (OR: 2.44; 95% CI: 1.12-5.26; P = 0.02) were independently associated with persistent DRT. After DRT resolution, 82 (53.6%) of 153 patients had repeated device imaging, with 14 (17.1%) cases diagnosed with recurrent DRT. Overall, 75 (35.0%) patients had unfavorable evolution of DRT, and the sole predictor was average thrombus size at initial diagnosis (OR per 1-mm increase: 1.09; 95% CI: 1.03-1.16; P = 0.003), with an optimal cutoff size of 7 mm (OR: 2.51; 95% CI: 1.39-4.52; P = 0.002). Unfavorable evolution of DRT was associated with a higher rate of thromboembolic events compared with resolved DRT (26.7% vs 15.1%; HR: 2.13; 95% CI: 1.15-3.94; P = 0.02)., Conclusions: About one-third of DRT events had an unfavorable evolution (either persisting or recurring), with a larger initial thrombus size (particularly >7 mm) portending an increased risk. Unfavorable evolution of DRT was associated with a 2-fold higher risk of thromboembolic events compared with resolved DRT., Competing Interests: Funding Support and Author Disclosures Dr Rodés-Cabau holds the Research Chair “Fondation Famille Jacques Larivière” for the Development of Structural Heart Disease Interventions (Laval University, Quebec City, Canada). He also has received institutional research grants from Boston Scientific. Dr Maarse has received an unrestricted grant from Boston Scientific. Dr Pérez de Prado has served as a proctor for Boston Scientific. Dr Gupta has served as a proctor for Abbott. Dr Sanchez has served as a speaker and proctor for Boston Scientific. Dr Wang has served as a consultant for Edwards Lifesciences, Boston Scientific, and Neochord; and received research grant support from Boston Scientific assigned to his employer, the Henry Ford Health System. Dr Demkow has served as a proctor for Abbott and Boston Scientific. Dr Alkhouli has served as a consultant for Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
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- 2023
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14. Pulsed field ablation-based pulmonary vein isolation in atrial fibrillation patients with cardiac implantable electronic devices: practical approach and device interrogation (PFA in CIEDs).
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Chen S, Chun JKR, Bordignon S, Tohoku S, Urbanek L, Schaack D, Ebrahimi R, Schulte-Hahn B, and Schmidt B
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- Humans, Treatment Outcome, Atrial Fibrillation surgery, Pulmonary Veins surgery, Catheter Ablation
- Published
- 2023
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15. Pulsed field ablation of incessant superior vena cava-triggered atrial fibrillation: watch out for the sinoatrial node.
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Chen S, Schaack D, Hirokami J, Schmidt B, and Chun JKR
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- Humans, Sinoatrial Node, Vena Cava, Superior surgery, Atrial Fibrillation surgery, Catheter Ablation
- Published
- 2023
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16. Occupational radiation exposure of electrophysiology staff with reproductive potential and during pregnancy: an EHRA survey.
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Adeliño R, Malaczynska-Rajpold K, Perrotta L, Manninger M, Vanduynhoven P, Nesti M, Goanță EV, Waldmann V, Pavlovic N, Farkowski MM, Guerra JM, Penela D, Boveda S, and Chun JKR
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- Male, Pregnancy, Female, Humans, Adolescent, Surveys and Questionnaires, Reproduction, Cardiac Electrophysiology, Radiation Dosage, Radiation Injuries, Radiation Exposure adverse effects, Radiation Exposure prevention & control, Occupational Exposure adverse effects, Occupational Exposure prevention & control
- Abstract
Aims: Electrophysiology (EP) is a growing field in cardiology, with an increasing involvement of young people. Nevertheless, concerns about radiation exposure and its impact on reproduction and pregnancy may discourage the choice of an EP career. The study is aimed at investigating the level of awareness and main sources of concern about the effects of radiation on reproductive potential and pregnancy, exploring the safety measures adopted in different EP labs, and verifying the adherence to the current guidelines., Methods and Results: An online survey was conducted using the European Heart Rhythm Association (EHRA) infrastructure from April to June 2022. A total of 252 EP personnel (42% women) participated, from 50 countries and different professional roles. Most participants expressed concerns regarding the effects of radiation on reproductive capacity (67.1%) and offspring diseases (68.2%). Only 37.9% of participants were aware of the EHRA 2017 consensus document about occupational radiation exposure. Most participants (80.9%) considered that occupational radiation during pregnancy is not safe. EP female staff were not allowed to work in the EP lab during pregnancy in 48.1% of cases. Zero-fluoroscopy was the preferred choice to continue working in the EP lab during pregnancy., Conclusion: EP staff, including both men and women, have concerns about the effects of radiation on reproductive capacity. Despite the recommendations issued by international bodies, implementation of the policies regarding pregnancy and occupational radiation exposure is heterogeneous. Zero-fluoroscopy is the preferred approach to ensure safety during pregnancy in the EP lab., Competing Interests: Conflict of interest: The authors declare that there are no conflicts of interest regarding this article., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)
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- 2023
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17. Efficacy and safety in patients treated with a novel radiofrequency balloon: a two centres experience from the AURORA collaboration.
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Bordignon S, My I, Tohoku S, Rillig A, Schaack D, Chen S, Reißmann B, Urbanek L, Hirokami J, Efe T, Ebrahimi R, Butt M, Ouyang F, Chun JKR, Metzner A, and Schmidt B
- Subjects
- Humans, Male, Female, Treatment Outcome, Heart Atria, Catheter Ablation adverse effects, Catheter Ablation methods, Atrial Fibrillation diagnosis, Atrial Fibrillation surgery, Atrial Fibrillation etiology, Pulmonary Veins surgery
- Abstract
Aims: A novel irrigated radiofrequency (RF) balloon (RFB) for pulmonary vein (PV) isolation (PVI) was released in selected centres. We pooled the procedural data on efficacy and safety of RFB-PVI from two high volume German centres., Methods and Results: Consecutive patients with RFB procedures were enrolled. A 3D electroanatomical left atrial map guided the RFB navigation. Every RF delivery lasted 60 s, and duration was automatically reduced to 20 s for electrodes facing the posterior wall. Procedural data and post-procedural endoscopy data (<48 h) were analysed. Data from 140 patients were collected (57% male, 67 ± 11 years, 57% paroxysmal atrial fibrillation). There were 547 PVs identified, and 99.1% could be isolated using solely the RFB. Single-shot PVI was recorded in 330/547 (60%) PVs. Median time to isolation during the first application was 10 s (IQR 8-13). A total of 2.1 ± 1.8 applications per PV were delivered, with the left superior PV requiring more application compared to other PVs. Median procedure and fluoroscopy time were 77 min (61-99) and 13 min (10-17), respectively. Major safety events were recorded only in the first 25 cases at each centre and included 1/140(0.7%) cardiac tamponade, 1/140(0.7%) phrenic nerve palsy, and 2/140 strokes (1.4%). An oesophageal temperature rise was recorded in 81/547 (15%) PVs, and endoscopy detected oesophageal lesions in 7/85 (8%) patients undergoing endoscopy., Conclusion: The RFB showed a high efficacy allowing for fast PVI procedures, and 60% of PVs could be isolated at the first application. Most safety events were recorded during the learning phase. An oesophageal temperature monitoring is suggested: oesophageal lesions were detected in 8% of patients., Competing Interests: Conflict of interest: S.B., B.S., K.R.J.C., A.M., and A.R. report speaking honoraria from Biosense Webster. The Aurora Project is partially funded by Biosense Webster., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)
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- 2023
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18. Regional disparity on patient characteristics and perceptions after implantable cardioverter-defibrillator implantation: results from an EHRA patient survey.
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Januszkiewicz Ł, Barra S, Providencia R, Chun JKR, Conte G, Farkowski MM, Guerra JM, Marijon E, de Asmundis C, and Boveda S
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- Male, Humans, Female, Quality of Life, Prospective Studies, Surveys and Questionnaires, Europe epidemiology, Defibrillators, Implantable
- Abstract
Aims: The aim of this study was to identify potential regional disparities in characteristics of implantable cardioverter-defibrillator (ICD) recipients, patient perceptions and perspectives after implantation and level of information provided to patients., Methods and Results: The prospective, multicentre, and multinational European Heart Rhythm Association patient Survey 'Living with an ICD' included patients already implanted with an ICD (median ICD dwell time - 5 years, interquartile range 2-10). An online questionnaire was filled-in by patients invited from 10 European countries. A total of 1809 patients (the majority in their 40s to 70s, 65.5% men) were enrolled, with 877 (48.5%) from Western Europe (group 1), followed by 563 from Central/Eastern Europe (group 2, 31.1%), and 369 from Southern Europe (group 3, 20.4%). A total of 52.9% of Central/Eastern Europe patients reported increased satisfaction after ICD placement compared with 46.6% from Western and 33.1% from Southern Europe (1 vs. 2 P = 0.047, 1 vs. 3 P < 0.001, 2 vs. 3 P < 0.001). About 79.2% of Central/Eastern and 76.0% of Southern Europe patients felt optimally informed at the time of device implantation compared with just 64.6% from Western Europe (1 vs. 2 P < 0.001, 1 vs. 3 P < 0.001, 2 vs. 3 P = ns)., Conclusions: While physicians in Southern Europe should address the patients' concerns about the impact of the ICD on quality of life, physicians from Western Europe should focus on improving the quality of information provided to their prospective ICD patients. Novel strategies to address regional differences in patients' quality of life and provision of information are warranted., Competing Interests: Conflict of interest: Ł.J. has received speaker/consultant fees from Biotronik, Medtronic. G.C. has received research grants from the Swiss National Foundation and research grants and speaker fees from Boston Scientific. M.M.F. has received speaker/proctoring fees from Abbott Medical Poland and Medtronic Poland. J.M.G. has served as consultant for Boston-Scientific, Abbott and ZOLL, received speaker fees from Boston-Scientific, Microport, Abbott and ZOLL, and received research grants from Medtronic and Abbott. E.M. has served as a consultant for Boston Scientific, Medtronic and Abbott and received research grants from Boston Scientific, Medtronic, Abbott, Biotronik, and Microport. S.B. has served as consultant for Medtronic, Boston Scientific, Microport, and Zoll. All the other authors have no conflict of interest to declare., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)
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- 2023
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19. Pulsed field ablation as first-line treatment to reduce atrial fibrillation burden documented by pacemaker.
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Chen S, Schmidt B, Bordignon S, Tohoku S, Urbanek L, and Chun JKR
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- Humans, Treatment Outcome, Recurrence, Atrial Fibrillation, Catheter Ablation methods, Pulmonary Veins surgery
- Abstract
Pulsed field ablation (PFA) using high-voltage electrical energy is a novel and powerful ablation modality. However, PFA as a first-line rhythm control in atrial fibrillation (AF) has been rarely described; whether PFA interacts with the pacemaker (PM) has been seldom reported. We reported PFA of AF in a patient with PM who needed effective rhythm control. Pulmonary vein isolation (PVI) was successfully performed without complication, and the procedure was extremely fast (skin-to-skin 25 min.) with short fluoroscopic time (3.9 min). PFA had no influence on the PM function. Six months' follow-up showed good clinical outcome and significantly decreased AF burden., (© 2022 The Authors. Pacing and Clinical Electrophysiology published by Wiley Periodicals LLC.)
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- 2023
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20. Pulsed field ablation as first-line "efficient" rhythm control for atrial fibrillation complicated with heart failure: proof-of-concept.
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Chen S, Schmidt B, Bordignon S, Tohoku S, Urbanek L, Schaack D, and Chun JKR
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- Humans, Anti-Arrhythmia Agents therapeutic use, Atrial Fibrillation complications, Atrial Fibrillation surgery, Heart Failure, Catheter Ablation
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- 2023
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21. Major gaps in the information provided to patients before implantation of cardioverter defibrillators: a prospective patient European evaluation.
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Januszkiewicz Ł, Barra S, Marijon E, Providencia R, de Asmundis C, Chun JKR, Farkowski MM, Conte G, and Boveda S
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- Male, Humans, Female, Prospective Studies, Electric Countershock adverse effects, Europe, Death, Sudden, Cardiac etiology, Death, Sudden, Cardiac prevention & control, Quality of Life, Defibrillators, Implantable adverse effects
- Abstract
Aims: Information provided to patients prior to implantable cardioverter-defibrillator (ICD) insertion and their participation in the decision-making process are crucial for understanding ICD function and accepting this lifelong therapy. The aim of this study is to evaluate the extent to which different aspects related to ICD and quality of life were transmitted to patients prior to ICD implantation., Methods and Results: Prospective, multicenter European study with an online questionnaire initiated by the European Heart Rhythm Association. The questionnaire was filled-in directly and personally by the ICD patients who were invited to participate. A total of 1809 patients (majority in their 40s-70s, with 624 women, 34.5%) from 10 European countries participated in the study. The median time from first ICD implantation was 5 years (interquartile range 2-10). Overall, 1155 patients (71.5%) felt optimally informed at the time of device implantation, however many respondents received no information about ICD-related complications (n = 801, 49.6%), driving restrictions (n = 718, 44.5%), and possibility of end-of-life ICD deactivation (n = 408, 25.4%). Of note, women were less frequently involved in the decision-making process than men (47.3% vs. 55.9%, P = 0.003) and reported to be less often optimally informed before ICD implantation than men (61.2% vs. 76.8%, P < 0.001). More women mentioned the desire to have learned more about ICD therapy and the benefit/risk balance (45.4% vs. 33.7% of men; P < 0.001)., Conclusions: This patient-based evaluation provides alarming findings on the lack of information provided to patients prior ICD implantation, particularly for women., Competing Interests: Conflict of interest: Ł.J. has received speaker/consultant fees from Biotronik, Medtronic. E.M. has served as a consultant for Medtronic, Boston Scientific, Abbott, and Zoll. Research grants from Medtronic, Abbott, Boston Scientific, Biotronik, and Microport. M.M.F. has received speaker/proctoring fees from Abbott Medical Poland and Medtronic Poland. G.C. has received research grants from the Swiss National Foundation and research grants and speaker fees from Boston Scientific. S.B. has served as consultant for Medtronic, Boston Scientific, Microport, and Zoll. All the other authors have no conflict of interest to declare., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)
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- 2023
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22. Implantable Cardioverter-Defibrillators in Poland Compared with other European Countries from the Patient's Perspective: Insights from the EHRA Patient Survey.
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Januszkiewicz Ł, Grabowski M, Farkowski MM, Życiński P, Jędrychowski T, Pytkowski M, Chun JKR, Guerra JM, Conte G, Barra S, Boveda S, and Kempa M
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- Humans, Poland, Quality of Life, Europe, Surveys and Questionnaires, Defibrillators, Implantable
- Abstract
Background: The aim of this study was to compare differences between Polish ICD recipients and ICD recipients from other European countries in terms of quality of life, information provision before ICD implantation, and end-of-life issues., Methods: This is a sub-analysis of the "Living with an ICD" patient survey (25-item questionnaire) organized by the European Heart Rhythm Association between 12 April 2021 and 5 July 2021 in ten European countries., Results: There were 410 (22.7%) patients from Poland and 1399 (77.3%) from other European countries. A total of 51.0% of Polish patients reported improvement in their quality of life compared with 44.3% in other countries ( p = 0.041). Remote monitoring was three times more often utilized in other countries than in Poland (66.8% vs. 21.0%, p < 0.001). While 78.1% of Poles felt well informed before ICD implantation compared with 69.6% of subjects from other countries ( p = 0.001), they were less familiar with the ICD deactivation process than others (38.9% vs. 52.5%, p < 0.001)., Conclusions: Despite the less frequent use of remote monitoring and gaps in end-of-life issues, Polish ICD recipients reported more favorable quality of life and a higher level of information received before device placement than patients in other European countries.
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- 2023
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23. Rhythm monitoring, success definition, recurrence, and anticoagulation after atrial fibrillation ablation: results from an EHRA survey.
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Schwab AC, Anic A, Farkowski MM, Guerra J, Iliodromitis KE, Jubele K, Providencia R, Chun JKR, and Boveda S
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- Humans, Treatment Outcome, Europe epidemiology, Anticoagulants adverse effects, Surveys and Questionnaires, Recurrence, Atrial Fibrillation diagnosis, Atrial Fibrillation surgery, Atrial Fibrillation drug therapy, Catheter Ablation adverse effects, Catheter Ablation methods
- Abstract
Atrial fibrillation (AF) is a major challenge for the healthcare field. Pulmonary vein isolation is the most effective treatment for the maintenance of sinus rhythm. However, clinical endpoints for the procedure vary significantly among studies. There is no consensus on the definition of recurrence and no clear roadmap on how to deal with recurrences after a failed ablation. The purpose of this study was to perform a survey in order to show how clinicians currently approach this knowledge gap. An online survey, supported by the European Heart Rhythm Association (EHRA) Scientific Initiatives Committee, was conducted between 1 April 2022 and 8 May 2022. An anonymous questionnaire was disseminated via social media and EHRA newsletters, for clinicians to complete. This consisted of 18 multiple-choice questions regarding rhythm monitoring, definitions of a successful ablation, clinical practices after a failed AF ablation, and the continuance of anticoagulation. A total of 107 replies were collected across Europe. Most respondents (82%) perform routine monitoring for AF recurrences after ablation, with 51% of them preferring a long-term monitoring strategy. Cost was reported to have an impact on the choice of monitoring strategy. Self-screening was recommended by most (71%) of the respondents. The combination of absence of symptoms and recorded AF was the definition of success for most (83%) of the respondents. Cessation of anticoagulation after ablation was an option mostly for patients with paroxysmal AF and a low CHA2DS2-VASc score. The majority of physicians perform routine monitoring after AF ablation. For most physicians, the combination of the absence of symptoms and electrocardiographic endpoints defines a successful result after AF ablation., Competing Interests: Conflict of interest: A.A. received consulting fees and speaking honoraria from Boston Scientific Inc., Farapulse Inc., Galaxy MedicalInc., and Biosense & Webster Contracted research from Boston Scientific Inc., Farapulse Inc., Galaxy Medical Inc., Biosense & Webster. M.M.F. received proctoring/speaker fees from BMS/Pfizer, Boehringer Ingelheim, Medtronic, Abbott, and Boston Scientific. S.B. is consultant for Medtronic, Boston Scientific, Microport, and Zoll. J.G. has served as consultant for Medtronic, Boston Scientific, Microport, and Abbott, received speaker fees from Medtronic, Boston Scientific, and Abbott, and received a research grant from Abbott., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology.)
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- 2023
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24. Impact of cryoballoon application abortion due to phrenic nerve injury on reconnection rates: a YETI subgroup analysis.
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Heeger CH, Popescu SȘ, Sohns C, Pott A, Metzner A, Inaba O, Straube F, Kuniss M, Aryana A, Miyazaki S, Cay S, Ehrlich JR, El-Battrawy I, Martinek M, Saguner AM, Tscholl V, Yalin K, Lyan E, Su W, Papiashvili G, Botros MSN, Gasperetti A, Proietti R, Wissner E, Scherr D, Kamioka M, Makimoto H, Urushida T, Aksu T, Chun JKR, Aytemir K, Jędrzejczyk-Patej E, Kuck KH, Dahme T, Steven D, Sommer P, and Tilz RR
- Subjects
- Humans, Phrenic Nerve, Recurrence, Time Factors, Treatment Outcome, Atrial Fibrillation diagnosis, Atrial Fibrillation surgery, Atrial Fibrillation etiology, Catheter Ablation adverse effects, Cryosurgery adverse effects, Cryosurgery methods, Pulmonary Veins surgery
- Abstract
Aims: Cryoballoon (CB)-based pulmonary vein isolation (PVI) is an effective treatment for atrial fibrillation (AF). The most frequent complication during CB-based PVI is right-sided phrenic nerve injury (PNI) which is leading to premature abortion of the freeze cycle. Here, we analysed reconnection rates after CB-based PVI and PNI in a large-scale population during repeat procedures., Methods and Results: In the YETI registry, a total of 17 356 patients underwent CB-based PVI in 33 centres, and 731 (4.2%) patients experienced PNI. A total of 111/731 (15.2%) patients received a repeat procedure for treatment of recurrent AF. In 94/111 (84.7%) patients data on repeat procedures were available. A total of 89/94 (94.7%) index pulmonary veins (PVs) have been isolated during the initial PVI. During repeat procedures, 22 (24.7%) of initially isolated index PVs showed reconnection. The use of a double stop technique did non influence the PV reconnection rate (P = 0.464). The time to PNI was 140.5 ± 45.1 s in patients with persistent PVI and 133.5 ± 53.8 s in patients with reconnection (P = 0.559). No differences were noted between the two populations in terms of CB temperature at the time of PNI (P = 0.362). The only parameter associated with isolation durability was CB temperature after 30 s of freezing. The PV reconnection did not influence the time to AF recurrence., Conclusion: In patients with cryoballon application abortion due to PNI, a high rate of persistent PVI rate was found at repeat procedures. Our data may help to identify the optimal dosing protocol in CB-based PVI procedures., Clinical Trial Registration: https://clinicaltrials.gov/ct2/show/NCT03645577?term=YETI&cntry=DE&draw=2&rank=1 ClinicalTrials.gov Identifier: NCT03645577., Competing Interests: Conflict of interest: C.H.H. received travel grants and research grants from Medtronic, Boston Scientific, Biosense Webster and Cardiofocus and is a proctor and lecturer of Medtronic, Boston Scientific, Cardiofocus and Biosense Webster. K.H.K. received travel grants and research grants from Biosense Webster, Stereotaxis, Prorhythm, Medtronic, Edwards, Cryocath, and is a consultant to St. Jude Medical, Biosense Webster, Prorhythm, and Stereotaxis. He received speaker's honoraria from Medtronic. R.R.T. received travel grants from St. Jude Medical, Biosense Webster, Daiichi Sankyo, SentreHeart and Speaker’s Bureau Honoraria from Biosense Webster, Biotronik, Boston scientific, Pfizer, Topera, Bristol-Myers Squibb, Bayer, Sanofi Aventis, and research grants by Cardiofocus, Boston Scientific and Lifetech. K.A. is a proctor and lecturer for Medtronic, Biosense Webster, and Abbott. A.M. received speaker's honoraria and travel grants from Medtronic, Biosense Webster and Cardiofocus. F.S. received honoraria for lectures from Medtronic, Philips EPD Solutions, and Bristol-Myers-Squibb, outside the submitted work; and educational support from Pfizer. S.C. received travel grants and speaker’s honoraria from Medtronic, Biosense Webster and Abbott, and is a proctor of Medtronic. E.J.P. received consultant fees from Medtronic, Biotronik, Abbott, Boston Scientific. E.W. is a consultant to Medtronic. All other authors have no relevant disclosures., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology.)
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- 2023
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25. Evolving Role of Catheter Ablation for Atrial Fibrillation: Early and Effective Rhythm Control.
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Chen S, Yin Y, Ling Z, Meyer C, Pürerfellner H, Martinek M, Kiuchi MG, Futyma P, Zhu L, Schratter A, Wang J, Acou WJ, Sommer P, Ouyang F, Liu S, Chun JKR, and Schmidt B
- Abstract
Catheter Ablation (CA) is an effective therapeutic option in treating atrial fibrillation (AF). Importantly, recent data show that CA as a rhythm control strategy not only significantly reduces AF burden, but also substantially improves clinical hard endpoints. Since AF is a progressive disease, the time of Diagnosis-to-Intervention appears crucial. Recent evidence shows that earlier rhythm control is associated with a lower risk of adverse cardiovascular outcomes in patients with early AF. Particularly, CA as an initial first line rhythm control strategy is associated with significant reduction of arrhythmia recurrence and rehospitalization in patients with paroxysmal AF. CA is shown to significantly lower the risk of progression from paroxysmal AF to persistent AF. When treating persistent AF, the overall clinical success after ablation remains unsatisfactory, however the ablation outcome in patients with "early" persistent AF appears better than those with "late" persistent AF. "Adjunctive" ablation on top of pulmonary vein isolation (PVI), e.g., ablation of atrial low voltage area, left atrial posterior wall, vein of Marshall, left atrial appendage, etc., may further reduce arrhythmia recurrence in selected patient group. New ablation concepts or new ablation technologies have been developing to optimize therapeutic effects or safety profile and may ultimately improve the clinical outcome.
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- 2022
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26. The blanking period after atrial fibrillation ablation: an European Heart Rhythm Association survey on contemporary definition and management.
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Bordignon S, Barra S, Providencia R, de Asmundis C, Marijon E, Farkowski MM, Anic A, Guerra JM, Kosiuk J, Iliodromitis K, Schmidt B, Conte G, Chun JKR, and Boveda S
- Subjects
- Humans, Recurrence, Surveys and Questionnaires, Treatment Outcome, Atrial Fibrillation diagnosis, Atrial Fibrillation surgery, Catheter Ablation adverse effects, Catheter Ablation methods, Cryosurgery methods, Pulmonary Veins surgery
- Abstract
The use of a blanking period (BP) after an atrial fibrillation (AF) ablation procedure is a common practice, but recent data questions the benign nature of early recurrences of atrial tachyarrhythmias (ERATs). A physician-based survey was carried out by the European Heart Rhythm Association (EHRA) to investigate the current definition and applicability of BP and ERAT management. An online questionnaire was sent to clinical and interventional electrophysiologists. A total of 436 respondents (88% interventional electrophysiologists) reported observing ERATs in 25% (interquartile range 15-35) of patients, less commonly in paroxysmal AF (PAF) compared with persistent AF (persAF). The median reported duration of BP used by respondents was 90 days, with 22% preferring a shorter BP duration for PAF patients compared with persAF. Half of the patients with ERATs are expected to also experience late recurrences (LR). Isolated episodes of ERATs are treated conservatively by 99% of the respondents, but repeat ablation during the BP is preferred by 20% of electrophysiologists for multiple ERATs and by 16% in patients with organized atrial tachyarrhythmias. In conclusion, ERATs are commonly observed after AF ablation, particularly in persAF patients, and are perceived as predictors of LR by half of the respondents. A general adherence to a 90-day BP duration was observed. During this time period, ERAT is mainly treated conservatively, but repeat ablation during the BP is occasionally offered to patients with multiple ERATs and those with organized atrial tachyarrhythmias., Competing Interests: Conflict of interest: S.B.: speaking and proctoring honoraria from Biosense & Webster, Boston Scientific, Medtronic. S.B.: no conflict of interest. R.P.: no conflict of interest. C.d.A.: no conflict of interest. E.M.: no conflict of interest. M.M.F.: speaker and proctoring honoraria from Abbott and Medtronic. A.A.: consulting fees and speaking honoraria: Boston Scientific Inc., Farapulse Inc., Galaxy Medical Inc., Biosense & Webster, contracted research: Boston Scientific Inc., Farapulse Inc., Galaxy Medical Inc., Biosense & Webster. J.M.G.: consultant honoraria from Medtronic, Boston Scientific, Johnson & Johnson and Abbott, speaker fees from Medtronic, Boston Scientific and Abbott, research grants from Johnson & Johnson, Medtronic, and Abbott. J.K.: no conflict of interest. K.I.: no conflict of interest. B.S.: speaking and proctoring honoraria from Abbot Medical, Biosense Webster, Boston Scientific, Cardiofocus, Medtronic; consulting for Abbot Medical and Boston Scientific. G.C.: no conflict of interest. K.R.J.C.: speaking and proctoring honoraria from Biosense & Webster, Boston Scientific, Medtronic. S.B.: consultant honoraria from Medtronic, Boston Scientific, Microport, and Zoll., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)
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- 2022
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27. Current practices and expectations to reduce environmental impact of electrophysiology catheters: results from an EHRA/LIRYC European physician survey.
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Boussuge-Roze J, Boveda S, Mahida S, Anic A, Conte G, Chun JKR, Marijon E, Sacher F, and Jais P
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- Humans, Surveys and Questionnaires, Cardiac Electrophysiology, Environment, Motivation, Physicians
- Abstract
The healthcare sector accounts for nearly 5% of global greenhouse gas emissions (GHG) and is a significant contributor to complex waste. Reducing the environmental impact of technology-heavy medical fields such as cardiac electrophysiology (EP) is a priority. The aim of this survey was to investigate the practice and expectations in European centres on EP catheters environmental sustainability. A 24-item online questionnaire on EP catheters sustainability was disseminated by the EHRA Scientific Initiatives Committee in collaboration with the Lyric Institute. A total of 278 physicians from 42 centres were polled; 62% were motivated to reduce the environmental impact of EP procedures. It was reported that 50% of mapping catheters and 53% of ablation catheters are usually discarded to medical waste, and only 20% and 14% of mapping and ablation catheters re-used. Yet, re-use of catheters was the most commonly cited potential sustainability solution (60% and 57% of physicians for mapping and ablation catheters, respectively). The majority of 69% currently discarded packaging. Reduced (42%) and reusable (39%) packaging also featured prominently as potential sustainable solutions. Lack of engagement from host institutions was the most commonly cited barrier to sustainable practices (59%). Complexity of the process and challenges to behavioral change were other commonly cited barriers (48% and 47%, respectively). The most commonly cited solutions towards more sustainable practices were regulatory changes (31%), education (19%), and product after-use recommendations (19%). In conclusion, EP physicians demonstrate high motivation towards sustainable practices. However, significant engagement and behavioural change, at local institution, regulatory and industry level is required before sustainable practices can be embedded into routine care., Competing Interests: Conflicts of interest: J.B.-R.: educational grant from Boston Scientific. S.B.: consultant for Medtronic, Boston Scientific, Microport, Zoll; A.A.: consulting fees and speaking honoraria: Boston Scientific Inc., FarapulseInc., Galaxy Medical Inc., Biosense&Webster—Contracted research: Boston Scientific Inc., FarapulseInc., Galaxy Medical Inc., Biosense&Webster; S.M.: speaking honoraria, consulting fees, research funding from Biosense Webster—Speaking honoraria from Abbott and Boston Scientific Frederic Sacher: Speaking Honorarium modest: Biosense Webster, Boston Scientific, Abbott, Microport, Bayer—Salary from Inheart; P.J.: lecture fees: Biosense Webster, Boston Scientific—Shareholder: Affera; G.C., J.K.R.C. and E.M.: No conflicts of interests., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)
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- 2022
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28. Contemporary clinical management of monomorphic idiopathic premature ventricular contractions: results of the European Heart Rhythm Association survey.
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Sorgente A, Farkowski MM, Iliodromitis K, Guerra JM, Jubele K, Chun JKR, de Asmundis C, and Boveda S
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- Anti-Arrhythmia Agents therapeutic use, Humans, Surveys and Questionnaires, Treatment Outcome, Catheter Ablation, Ventricular Premature Complexes diagnosis, Ventricular Premature Complexes therapy
- Abstract
On behalf of the European Heart Rhythm Association, we designed a survey, whose aim was to understand the trend(s) in the clinical management of idiopathic monomorphic premature ventricular contractions (PVCs) among European cardiologists and cardiac electrophysiologists. A total of 202 participants in the survey answered 27 multiple-choice questions on the clinical presentation, diagnosis and treatment of idiopathic monomorphic PVCs. The most common symptom in patients with idiopathic monomorphic PVCs is palpitations, according to the majority of responders (87%), followed by fatigue (29%) and dizziness (18%). Complete blood cell count, renal function with electrolytes levels, and thyroid function are the blood tests requested by the majority of respondents (65%, 92%, and 93%, respectively). Coronary artery disease and structural heart disease needs to be ruled out, according to the vast majority of participants (99%). A 24-h Holter ECG is the preferred ECG modality to assess the burden of PVCs (86% of respondents). Among the different option treatments, beta-blockers and class I antiarrhythmic drugs are by far (81% of respondents) the preferred pharmacological option in comparison with calcium antagonists and class III antiarrhythmic drugs. Catheter ablation has also a good reputation: 99% of responders are keen to use it, especially in patients with high burden of PVCs and when signs of cardiomyopathy occur., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2022. For permissions, please email: journals.permissions@oup.com.)
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- 2022
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29. Anticoagulation in atrial fibrillation and liver disease: a pooled-analysis of >20 000 patients.
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Chen S, Pürerfellner H, Meyer C, Sommer P, Kiuchi MG, Martinek M, Futyma P, Zanchi S, Zhu L, Schratter A, Wang J, Acou WJ, Liu S, Ling Z, Yin Y, Ouyang F, Chun JKR, and Schmidt B
- Subjects
- Administration, Oral, Aged, Aged, 80 and over, Anticoagulants adverse effects, Gastrointestinal Hemorrhage chemically induced, Gastrointestinal Hemorrhage diagnosis, Gastrointestinal Hemorrhage epidemiology, Humans, Intracranial Hemorrhages, Middle Aged, Atrial Fibrillation complications, Atrial Fibrillation diagnosis, Atrial Fibrillation drug therapy, Brain Ischemia, Liver Diseases complications, Liver Diseases drug therapy, Stroke diagnosis, Stroke epidemiology, Stroke etiology, Thromboembolism etiology
- Abstract
Aims: Anticoagulation for atrial fibrillation patients with liver disease represents a clinical dilemma. We sought to evaluate the efficacy/safety of different anticoagulation, i.e. vitamin K antagonist (VKA) and non-VKA oral anticoagulants (NOACs) in such patient group., Methods and Results: This was a pooled-analysis enrolling up-to-date clinical data. Two subsets: subset A (VKA vs. Non-Anticoagulation) and subset B (NOACs vs. VKA) were pre-specified. The study outcomes were ischaemic stroke (IS)/thromboembolism (TE), major bleeding (MB), intracranial bleeding (ICB), gastrointestinal bleeding (GIB), and all-cause mortality. A total of 20 042 patients' data were analysed (subset A: N = 10 275, subset B: N = 9767). Overall mean age: 71 ± 11 years, mean CHA2DS2-VASc score: 4.0 ± 1.8, mean HAS-BLED score: 3.6 ± 1.2. The majority of the patients had Child-Pugh category (A-B). As compared with Non-Anticoagulation, VKA seemed to reduce the risk of IS/TE [odds ratio (OR): 0.60, P = 0.05], but heighten the risk of all-bleeding events including MB (OR: 2.81, P = 0.01), ICB (OR: 1.60, P = 0.01), and GIB (OR: 3.32, P = 0.01). When compared with VKA, NOACs had similar efficacy in reducing the risk of IS/TE (OR: 0.82, P = 0.64), significantly lower risk of MB (OR: 0.54, P = 0.0003) and ICB (OR: 0.35, P < 0.0001), and trend towards reduced risk of GIB (OR: 0.72, P = 0.12) and all-cause mortality (OR: 0.79, P = 0.35). The favourable effects were maintained in subgroups of individual NOAC., Conclusions: VKA appears to reduce the risk of IS/TE but increase all-bleeding events. NOACs have similar effect in reducing the risk of IS/TE and have significantly lower risk of MB and ICB as compared with VKA. NOACs seem to be associated with better clinical outcome than VKA in patients with mild-moderate liver disease., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2021. For permissions, please email: journals.permissions@oup.com.)
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- 2022
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30. What we have learned: is pulmonary vein isolation still the cornerstone of atrial fibrillation ablation?
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Metzner A, Kuck KH, and Chun JKR
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- Humans, Recurrence, Treatment Outcome, Atrial Fibrillation diagnosis, Atrial Fibrillation surgery, Catheter Ablation adverse effects, Catheter Ablation methods, Cryosurgery adverse effects, Pulmonary Veins surgery
- Abstract
Ablation of atrial fibrillation (AF) is an established treatment option for symptomatic patients. The cornerstone of all ablation strategies is electrical isolation of the pulmonary veins (PVs). Ablation strategies going beyond PV isolation (PVI) might be considered in the setting of recurrent AF despite durably isolated PVs. The lack of persistent PVI, however, limits the opportunities to perceive the real impact of this endpoint on AF suppression and to fully understand the benefit of extended ablation strategies going beyond. To overcome this limitation, novel and innovative ablation systems have been developed to facilitate acute PVI and to increase its durability. These systems include balloon-based ablation devices incorporating different energy sources such as cryo energy, laser, or radiofrequency current, but also new energy sources such as pulsed field ablation as a non-thermal energy source. These technologies could advance catheter ablation of AF to an early stage of the disease and to the primary treatment tool. The current manuscript focuses on the past, the present, and the future value of PVI as the cornerstone for interventional treatment of AF and on how to achieve durable PVI during the first procedure and to further improve the clinical success rates of AF ablation. It also analyses extended ablation strategies going beyond PVI and their impact., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2022. For permissions, please email: journals.permissions@oup.com.)
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- 2022
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31. Long-term quality of life and acceptance of implantable cardioverter-defibrillator therapy: results of the European Heart Rhythm Association survey.
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Januszkiewicz Ł, Barra S, Providencia R, Conte G, de Asmundis C, Chun JKR, Farkowski MM, Guerra JM, Marijon E, and Boveda S
- Subjects
- Female, Humans, Male, Prospective Studies, Quality of Life, Surveys and Questionnaires, Treatment Outcome, Cardiac Resynchronization Therapy methods, Defibrillators, Implantable, Heart Failure therapy
- Abstract
Implantable cardioverter-defibrillator (ICD) may impact patients' life significantly. The aim of this survey was to analyse the impact of the ICD on quality of life (QoL) metrics from the patient's perspective. 'Living with an ICD' was a prospective, multicentre study with an online questionnaire submitted to the European Heart Rhythm Association (EHRA) Research Network centres as well as patient associations from 10 European countries; it was filled-in directly and personally by the patients that were invited to participate, with a minimal interaction or influence from the healthcare professionals. Overall, the questionnaire was completed by 1809 patients (624 women, 34.5%). Patients in their 60s and 70s and from Western Europe were the most represented. The median time from first ICD implantation was 5 years (IQR 2-10). Device-related complications were reported by 505 patients (22.4%), including one or more inappropriate shocks (n = 209, 11.6%). Almost half the respondents reported improved QoL, with a more favourable impact for those receiving cardiac resynchronization therapy-defibrillator (CRT-D), and only a 10th experienced a significant decrease in QoL. The occurrence of complications remained a major predictor of deteriorated QoL (odds ratio 2.1, 95% confidence interval 1.4-3.0, P < 0.001). In conclusion, most patients have a globally positive view and acceptance of ICD therapy, reporting preserved to improved QoL after device implantation. Complications, namely inappropriate shocks, affect the expectation of living a normal life post-implant and are associated with a significant decrease in QoL. Our findings also highlight the importance of a detailed informed consent process and the involvement of the patient in the decision-making process., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2022. For permissions, please email: journals.permissions@oup.com.)
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- 2022
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32. Adjunctive Left Atrial Posterior Wall Isolation in Treating Atrial Fibrillation: Insight From a Large Secondary Analysis.
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Jiang X, Liao J, Ling Z, Meyer C, Sommer P, Futyma P, Martinek M, Schratter A, Acou WJ, Wang J, Zhu L, Kiuchi MG, Pürerfellner H, Schmidt B, Chun JKR, Yin Y, and Chen S
- Subjects
- Aged, Heart Atria surgery, Humans, Middle Aged, Neoplasm Recurrence, Local etiology, Neoplasm Recurrence, Local surgery, Treatment Outcome, Atrial Fibrillation, Catheter Ablation adverse effects
- Abstract
Objectives: This study evaluated the role of adjunctive left atrium posterior wall isolation (PWI) in preventing atrial fibrillation (AF) recurrence., Background: The left atrium posterior wall is an arrhythmogenic substrate that contributes to the development of AF., Methods: This was an updated pooled analysis that included clinical data regarding PWI plus pulmonary vein isolation (PVI) in treating AF. The primary outcome was recurrence of atrial tachyarrhythmias., Results: A total of 26 studies with 3,287 patients with AF (age 61.7 ± 10.8 years) were included. Mean follow-up was 15.2 ± 8.4 months. Procedural success to achieve PWI was 92.8%. In paroxysmal AF, adjunctive PWI did not reduce the recurrence of all atrial arrhythmias (P = 0.21) or AF (P = 0.37); however, in persistent AF, adjunctive PWI was associated with substantially lower recurrence of all atrial arrhythmias (risk ratio: 0.74; P < 0.001) and AF (risk ratio: 0.67; P = 0.01), particularly when randomized data were included. Subgroup analyses based on meta-regression demonstrated that patients with older age, a larger left atrial diameter, and persistent AF benefited more significantly from the adjunctive PWI. Adjunctive PWI using either radiofrequency or a cryoballoon reduced AF recurrence, whereas using radiofrequency seemed to be associated with higher recurrence rate of atrial tachycardias and/or atrial flutter. Non-BOX adjunctive PWI rather than BOX PWI was associated with significantly lower recurrence of AF. The incidence of procedural adverse events between the PVI+PWI (3.2%) and PVI (2.8%) groups was low and similar. PVI+PWI needed longer ablation and/or procedural time but had similar fluoroscopy time., Conclusions: Adjunctive PWI can be achieved in most patients without compromising safety. Patients with persistent AF appear to benefit from this approach. The ablation technology and/or approach may affect the clinical outcome of PWI., Competing Interests: Funding Support and Author Disclosures The authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
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- 2022
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33. Effectiveness and safety of a single freeze strategy of cryoballoon ablation of atrial fibrillation: an EHRA systematic review and meta-analysis.
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Farkowski MM, Karlinski M, Barra S, Providencia R, Golicki D, Pytkowski M, Anic A, Chun JKR, de Asmundis C, Lane DA, and Boveda S
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- Female, Humans, Male, Prospective Studies, Randomized Controlled Trials as Topic, Retrospective Studies, Treatment Outcome, Atrial Fibrillation diagnosis, Atrial Fibrillation etiology, Atrial Fibrillation surgery, Catheter Ablation adverse effects, Cryosurgery adverse effects, Cryosurgery methods, Pulmonary Veins surgery
- Abstract
To conduct a systematic review and meta-analysis to compare the effectiveness and safety of cryoballoon ablation of atrial fibrillation (AF) performed using a single freeze strategy in comparison to an empiric double ('bonus') freeze strategy. We systematically searched MEDLINE, EMBASE, and CENTRAL databases from inception to 12 July 2020, for prospective and retrospective studies of patients undergoing cryoballoon for paroxysmal or persistent AF comparing a single vs. bonus freeze strategy. The main outcome was atrial arrhythmia-free survival and eligible studies required at least 12 months of follow-up; the primary safety outcome was a composite of all complications. Study quality was assessed using the Cochrane risk of bias tool and the Newcastle-Ottawa Scale. Thirteen studies (3 randomized controlled trials and 10 observational studies) comprising 3163 patients were eligible for inclusion (64% males, 71.5% paroxysmal AF, mean CHA2DS2-VASc score 1.3 ± 0.9). There was no significant difference in pooled effectiveness between single freeze strategy compared to double freeze strategy [relative risk (RR) 1.03; 95% confidence interval (CI): 0.98-1.07; I2 = 0%]. Single freeze procedures were associated with a significantly lower adverse event rate (RR 0.72; 95% CI: 0.53-0.98; I2 = 0%) and shorter average procedure time (90 ± 27 min vs. 121 ± 36 min, P < 0.001). A trend for lower risk of persistent phrenic nerve palsy was observed (RR 0.61; 95% CI: 0.37-1.01; I2 = 0%). The quality of included studies was moderate/good, with no evidence of significant publication bias. Single freeze strategy for cryoballoon of AF is as effective as an empiric double ('bonus') freeze strategy while appearing safer and probably quicker (PROSPERO registration number CRD42020158696)., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2021. For permissions, please email: journals.permissions@oup.com.)
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- 2022
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34. Phrenic Nerve Injury During Cryoballoon-Based Pulmonary Vein Isolation: Results of the Worldwide YETI Registry.
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Heeger CH, Sohns C, Pott A, Metzner A, Inaba O, Straube F, Kuniss M, Aryana A, Miyazaki S, Cay S, Ehrlich JR, El-Battrawy I, Martinek M, Saguner AM, Tscholl V, Yalin K, Lyan E, Su W, Papiashvili G, Botros MSN, Gasperetti A, Proietti R, Wissner E, Scherr D, Kamioka M, Makimoto H, Urushida T, Aksu T, Chun JKR, Aytemir K, Jędrzejczyk-Patej E, Kuck KH, Dahme T, Steven D, Sommer P, and Richard Tilz R
- Subjects
- Aged, Atrial Fibrillation diagnosis, Atrial Fibrillation epidemiology, Female, Humans, Incidence, Male, Middle Aged, Peripheral Nerve Injuries diagnosis, Registries, Retrospective Studies, Risk Assessment, Risk Factors, Time Factors, Treatment Outcome, Atrial Fibrillation surgery, Cryosurgery adverse effects, Iatrogenic Disease, Peripheral Nerve Injuries epidemiology, Phrenic Nerve injuries, Pulmonary Veins surgery
- Abstract
Background: Cryoballoon-based pulmonary vein isolation (PVI) has emerged as an effective treatment for atrial fibrillation. The most frequent complication during cryoballoon-based PVI is phrenic nerve injury (PNI). However, data on PNI are scarce., Methods: The YETI registry is a retrospective, multicenter, and multinational registry evaluating the incidence, characteristics, prognostic factors for PNI recovery and follow-up data of patients with PNI during cryoballoon-based PVI. Experienced electrophysiological centers were invited to participate. All patients with PNI during CB2 or third (CB3) and fourth-generation cryoballoon (CB4)-based PVI were eligible., Results: A total of 17 356 patients underwent cryoballoon-based PVI in 33 centers from 10 countries. A total of 731 (4.2%) patients experienced PNI. The mean time to PNI was 127.7±50.4 seconds, and the mean temperature at the time of PNI was -49±8°C. At the end of the procedure, PNI recovered in 394/731 patients (53.9%). Recovery of PNI at 12 months of follow-up was found in 97.0% of patients (682/703, with 28 patients lost to follow-up). A total of 16/703 (2.3%) reported symptomatic PNI. Only 0.06% of the overall population showed symptomatic and permanent PNI. Prognostic factors improving PNI recovery are immediate stop at PNI by double-stop technique and utilization of a bonus-freeze protocol. Age, cryoballoon temperature at PNI, and compound motor action potential amplitude loss >30% were identified as factors decreasing PNI recovery. Based on these parameters, a score was calculated. The YETI score has a numerical value that will directly represent the probability of a specific patient of recovering from PNI within 12 months., Conclusions: The incidence of PNI during cryoballoon-based PVI was 4.2%. Overall 97% of PNI recovered within 12 months. Symptomatic and permanent PNI is exceedingly rare in patients after cryoballoon-based PVI. The YETI score estimates the prognosis after iatrogenic cryoballoon-derived PNI. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03645577. Graphic Abstract: A graphic abstract is available for this article.
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- 2022
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35. Catheter ablation vs. antiarrhythmic drugs as 'first-line' initial therapy for atrial fibrillation: a pooled analysis of randomized data.
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Chen S, Pürerfellner H, Ouyang F, Kiuchi MG, Meyer C, Martinek M, Futyma P, Zhu L, Schratter A, Wang J, Acou WJ, Ling Z, Yin Y, Liu S, Sommer P, Schmidt B, and Chun JKR
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- Anti-Arrhythmia Agents adverse effects, Female, Humans, Male, Middle Aged, Quality of Life, Recurrence, Tachycardia etiology, Treatment Outcome, Atrial Fibrillation diagnosis, Atrial Fibrillation drug therapy, Atrial Fibrillation surgery, Catheter Ablation adverse effects, Catheter Ablation methods
- Abstract
Aims: Catheter ablation (CA) is recommended for patients with atrial fibrillation (AF) after failure of antiarrhythmic drugs (AADs). The role of CA as 'initial therapy' for AF is to be determined., Methods and Results: Following PRISMA guideline an up-to-date pooled analysis of randomized data comparing ablation vs. AADs as first-line therapy for symptomatic AF was performed. The primary outcome was recurrence of atrial tachyarrhythmia. The secondary outcomes were improvement in quality-of-life (QoL) and major adverse events. A total of 997 patients from five randomized trials were enrolled (mean age 57.4 years, 68.6% male patients, 98% paroxysmal AF, mean follow-up 1.4 years). The baseline characteristics were similar between the ablation and AADs group. Overall pooled analysis showed that, as compared with AADs, CA as first-line therapy was associated with significantly higher freedom from arrhythmia recurrence (69% vs. 48%, odds ratio: 0.36, 95% confidence interval: 0.27-0.48, P < 0.001). This significance was maintained in subgroup analyses of 1- and 2-year follow-up (P < 0.001). Catheter ablation was associated with significantly greater improvement in QoL regarding AFEQT score and 36-Item Short-Form Health Survey score. The incidence of serious adverse events between ablation and AADs group (5.6% vs. 4.9%, P = 0.62) was similar., Conclusions: Catheter ablation as 'initial therapy' was superior to AADs in maintenance of sinus rhythm and improving QoL for patients with symptomatic paroxysmal AF, without increasing risk of serious adverse events., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2021. For permissions, please email: journals.permissions@oup.com.)
- Published
- 2021
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36. Antithrombotic treatment management in low stroke risk patients undergoing cardioversion of atrial fibrillation <48 h duration: results of an EHRA survey.
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Migliore F, Providencia R, Farkowski MM, Dan GA, Daniel S, Potpara TS, Jubele K, Chun JKR, de Asmundis C, Zorzi A, and Boveda S
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- Administration, Oral, Anticoagulants adverse effects, Electric Countershock, Female, Fibrinolytic Agents adverse effects, Humans, Male, Risk Factors, Surveys and Questionnaires, Treatment Outcome, Atrial Fibrillation diagnosis, Atrial Fibrillation drug therapy, Stroke diagnosis, Stroke prevention & control
- Abstract
Data supporting the safety of cardioversion (CV) of atrial fibrillation (AF) without anticoagulation in patients with AF duration <48 h are scarce. Observational studies suggest that the risk of stroke in these patients is very low when the definite duration of the AF episode is of <48 h and the clinical risk profile as estimated through the CHA2DS2VASc score is low (a score of 0 for men and 1 for women). As the recent 2020 European Society of Cardiology (ESC) guidelines indication for this clinical scenario is based mainly on consensus, we sent out a survey to assess the current clinical practice on anticoagulation prior to and post-CV in patients with AF <24-48 h duration and low stroke risk across centres in Europe. Of the 136 respondents, half were affiliated to university hospitals (68/136; 50%). Non-university hospitals (50/136; 36%) and private hospitals (2/136; 1.4%) accounted over a third of respondents. The main findings of our survey were (i) heterogeneity in the anticoagulation management both before and post-CV in low stroke-risk patients with AF <48 h, (ii) higher utilization of periprocedural low-molecular-weight heparin than of non-vitamin K antagonist oral anticoagulant, (iii) higher utilization of pre-CV transoesophageal echocardiography for electrical CV than for pharmacological CV regardless of the duration of AF, (iv) high adherence to a 4-week post-CV oral anticoagulant (OAC) therapy, mainly for electrical CV, and finally, (v) perceived higher acceptance of lack of post-CV OAC therapy in patients with <24 h than 24-48 h episode duration. The results obtained in this survey highlight the need for more research providing definitive clarification on the safety of CV without anticoagulation in patients with short duration AF., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2021. For permissions, please email: journals.permissions@oup.com.)
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- 2021
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37. Predictors of Device-Related Thrombus Following Percutaneous Left Atrial Appendage Occlusion.
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Simard T, Jung RG, Lehenbauer K, Piayda K, Pracoń R, Jackson GG, Flores-Umanzor E, Faroux L, Korsholm K, Chun JKR, Chen S, Maarse M, Montrella K, Chaker Z, Spoon JN, Pastormerlo LE, Meincke F, Sawant AC, Moldovan CM, Qintar M, Aktas MK, Branca L, Radinovic A, Ram P, El-Zein RS, Flautt T, Ding WY, Sayegh B, Benito-González T, Lee OH, Badejoko SO, Paitazoglou C, Karim N, Zaghloul AM, Agrawal H, Kaplan RM, Alli O, Ahmed A, Suradi HS, Knight BP, Alla VM, Panaich SS, Wong T, Bergmann MW, Chothia R, Kim JS, Pérez de Prado A, Bazaz R, Gupta D, Valderrabano M, Sanchez CE, El Chami MF, Mazzone P, Adamo M, Ling F, Wang DD, O'Neill W, Wojakowski W, Pershad A, Berti S, Spoon D, Kawsara A, Jabbour G, Boersma LVA, Schmidt B, Nielsen-Kudsk JE, Rodés-Cabau J, Freixa X, Ellis CR, Fauchier L, Demkow M, Sievert H, Main ML, Hibbert B, Holmes DR Jr, and Alkhouli M
- Subjects
- Aged, Atrial Appendage diagnostic imaging, Echocardiography, Transesophageal, Europe epidemiology, Female, Follow-Up Studies, Heart Diseases diagnosis, Heart Diseases epidemiology, Heart Diseases etiology, Humans, Incidence, Male, Postoperative Complications diagnosis, Postoperative Complications epidemiology, Risk Factors, Survival Rate trends, Thrombosis diagnosis, Thrombosis epidemiology, Time Factors, Treatment Outcome, Atrial Appendage surgery, Atrial Fibrillation surgery, Cardiac Catheterization adverse effects, Postoperative Complications etiology, Registries, Septal Occluder Device adverse effects, Thrombosis etiology
- Abstract
Background: Device-related thrombus (DRT) has been considered an Achilles' heel of left atrial appendage occlusion (LAAO). However, data on DRT prediction remain limited., Objectives: This study constructed a DRT registry via a multicenter collaboration aimed to assess outcomes and predictors of DRT., Methods: Thirty-seven international centers contributed LAAO cases with and without DRT (device-matched and temporally related to the DRT cases). This study described the management patterns and mid-term outcomes of DRT and assessed patient and procedural predictors of DRT., Results: A total of 711 patients (237 with and 474 without DRT) were included. Follow-up duration was similar in the DRT and no-DRT groups, median 1.8 years (interquartile range: 0.9-3.0 years) versus 1.6 years (interquartile range: 1.0-2.9 years), respectively (P = 0.76). DRTs were detected between days 0 to 45, 45 to 180, 180 to 365, and >365 in 24.9%, 38.8%, 16.0%, and 20.3% of patients. DRT presence was associated with a higher risk of the composite endpoint of death, ischemic stroke, or systemic embolization (HR: 2.37; 95% CI, 1.58-3.56; P < 0.001) driven by ischemic stroke (HR: 3.49; 95% CI: 1.35-9.00; P = 0.01). At last known follow-up, 25.3% of patients had DRT. Discharge medications after LAAO did not have an impact on DRT. Multivariable analysis identified 5 DRT risk factors: hypercoagulability disorder (odds ratio [OR]: 17.50; 95% CI: 3.39-90.45), pericardial effusion (OR: 13.45; 95% CI: 1.46-123.52), renal insufficiency (OR: 4.02; 95% CI: 1.22-13.25), implantation depth >10 mm from the pulmonary vein limbus (OR: 2.41; 95% CI: 1.57-3.69), and non-paroxysmal atrial fibrillation (OR: 1.90; 95% CI: 1.22-2.97). Following conversion to risk factor points, patients with ≥2 risk points for DRT had a 2.1-fold increased risk of DRT compared with those without any risk factors., Conclusions: DRT after LAAO is associated with ischemic events. Patient- and procedure-specific factors are associated with the risk of DRT and may aid in risk stratification of patients referred for LAAO., Competing Interests: Funding Support and Author Disclosures Dr Maarse has received an unrestricted grant from Boston Scientific. Dr Pérez de Prado has served as a proctor for Boston Scientific. Dr Gupta has served as a proctor for Abbott. Dr Sanchez has served as a speaker and proctor for Boston Scientific. Dr Demkow has served as a proctor for Abbott and Boston Scientific. Dr Alkhouli has served as a consultant for Boston Scientific. Dr Wang has been a consultant for Edwards LifeSciences, Boston Scientific, and Neochord; and has received research grant support from Boston Scientific assigned to employer Henry Ford health system. 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.)
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- 2021
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38. Optimizing cryoballoon pulmonary vein isolation: lessons from >1000 procedures- the Frankfurt approach.
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Bordignon S, Chen S, Bologna F, Thohoku S, Urbanek L, Willems F, Zanchi S, Bianchini L, Trolese L, Konstantinou A, Fuernkranz A, Schmidt B, and Chun JKR
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- Aged, Female, Humans, Male, Middle Aged, Recurrence, Treatment Outcome, Atrial Fibrillation diagnosis, Atrial Fibrillation surgery, Catheter Ablation, Cryosurgery adverse effects, Pulmonary Veins surgery
- Abstract
Aims: Cryoballoon (CB) pulmonary vein isolation (PVI) is an accepted ablation strategy for rhythm control in atrial fibrillation (AF). We describe efficacy and safety in a high volume centre with a long experience in the use of the second-generation CB (CB2)., Methods and Results: Consecutive paroxysmal AF (PAF) or persistent AF (persAF) patients undergoing CB2-PVI were enrolled. Procedural data, efficacy, and safety issues were systematically collected. The 28 mm CB2 was used in combination with an inner lumen spiral catheter, a luminal oesophageal temperature (LET) probe was used with a cut-off of 15°C, the phrenic nerve (PN) monitored during septal PVs ablation. Freeze duration was mainly set at 240 s with a bonus application in case of delayed time-to-isolation (TTI > 75 s). A total of 1017 CB2 procedures were analysed (58% male, 66 ± 12 years old, 70% with PAF). 3964 PVs were identified, 99.8% PVs isolated using solely the 28 mm CB. Mean procedure time was 69 ± 25 min, TTI during the first application was recorded in 77% of PVs after a mean of 48 ± 31 s. We recorded 0.2% cardiac tamponade, 4.8% PN injury (1.6% of PN palsy), and 19% of LET < 15°C. Among 725 patients with follow-up data, 84% with PAF and 75% with persAF were in stable SR at 1 year. Shorter freezing duration and longer TTI were procedural predictors for recurrence., Conclusion: Cryoballoon procedures are fast and associated with a benign safety profile. Shorter TTI and longer freeze durations are associated with sinus rhythm during follow-up., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2021. For permissions, please email: journals.permissions@oup.com.)
- Published
- 2021
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39. [Typical atrial flutter catheter ablation complicated by right coronary artery spasm and occlusion. Case report and review of the literature].
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Zanchi S, Bianchini L, Bordignon S, Tohoku S, Chen S, Bologna F, Tondo C, Schmidt B, and Chun JKR
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- Coronary Vessels, Humans, Spasm, Atrial Flutter etiology, Atrial Flutter surgery, Catheter Ablation, Coronary Occlusion diagnostic imaging, Coronary Occlusion etiology
- Abstract
Right coronary artery lesion is an uncommon and serious complication of typical atrial flutter ablation. We report a case of right coronary artery occlusion during atrial flutter ablation managed with percutaneous coronary intervention, combined with a review of the literature, in order to obtain pathogenetic and epidemiological information about this complication.
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- 2021
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40. Cryoballoon Versus Laserballoon: Insights From the First Prospective Randomized Balloon Trial in Catheter Ablation of Atrial Fibrillation.
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Chun JKR, Bordignon S, Last J, Mayer L, Tohoku S, Zanchi S, Bianchini L, Bologna F, Nagase T, Urbanek L, Chen S, and Schmidt B
- Subjects
- Aged, Atrial Fibrillation physiopathology, Female, Follow-Up Studies, Humans, Male, Prospective Studies, Recurrence, Treatment Outcome, Atrial Fibrillation surgery, Catheter Ablation methods, Cryosurgery methods, Laser Therapy methods, Pulmonary Veins surgery
- Abstract
Background: Pulmonary vein isolation (PVI) represents the cornerstone in atrial fibrillation ablation. Cryoballoon and laserballoon catheters have emerged as promising devices but lack randomized comparisons. Therefore, we sought to compare efficacy and safety comparing both balloons in patients with persistent and paroxysmal atrial fibrillation (AF)., Methods: Symptomatic AF patients (n=200) were prospectively randomized (1:1) to receive either cryoballoon or laserballoon PVI (cryoballoon: n=100: 50 paroxysmal atrial fibrillation + 50 persistent AF versus laserballoon: n=100: 50 paroxysmal atrial fibrillation + 50 persistent AF). All antiarrhythmic drugs were stopped after ablation. Follow-up included 3-day Holter-ECG recordings and office visits at 3, 6, and 12 months. Primary efficacy end point was defined as freedom from atrial tachyarrhythmia between 90 and 365 days after a single ablation. Secondary end points included procedural parameters and periprocedural complications., Results: Patient baseline parameters were not different between both groups. In all (n=200) complete PVI was obtained and the entire follow-up accomplished. Balloon only PVI was obtained in 98% (cryoballoon) versus 95% (laserballoon) requiring focal touch-up in 2 and 5 patients, respectively. Procedure but not fluoroscopy time was significantly shorter in the cryoballoon group (50.9±21.0 versus 96.0±20.4 minutes; P <0.0001 and 7.4±4.4 versus 8.4±3.2 minutes, P =0.083). Overall, the primary end point of no atrial tachyarrhythmia recurrence was met in 79% (cryoballoon: 80.0% versus laserballoon: 78.0%, P =ns). No death, atrio-esophageal fistula, tamponade, or vascular laceration requiring surgery occurred. In the cryoballoon group, 8 transient but no persistent phrenic nerve palsy were noted compared with 2 persistent phrenic nerve palsy and one transient ischemic attack in the laserballoon group., Conclusions: Both balloon technologies represent highly effective and safe tools for PVI resulting in similar favorable rhythm outcome after 12 months. Use of the cryoballoon is associated with significantly shorter procedure but not fluoroscopy time.
- Published
- 2021
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41. Left atrial appendage (LAA) electrical isolation by Maze-like catheter substrate modification in presence of LAA-occluder device: A case report.
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Zanchi S, Bianchini L, Bordignon S, Bologna F, Tohoku S, Chen S, Chun JKR, and Schmidt B
- Abstract
Maze-like linear substrate modification in atrial fibrillation patients nonresponders to pulmonary vein isolation represents a feasible technique to gain left atrial appendage electrical isolation even in the presence of a Watchman occluder device., Competing Interests: None declared., (© 2020 The Authors. Clinical Case Reports published by John Wiley & Sons Ltd.)
- Published
- 2020
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42. Current Status of Atrial Fibrillation Ablation with Balloon Strategy.
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Chun JKR, Bordignon S, Chen S, Tohoku S, Bologna F, Urbanek L, and Schmidt BH
- Abstract
Catheter ablation of atrial fibrillation (AF) has been established worldwide and is recommended for symptomatic paroxysmal AF patients according to international guidelines. Importantly, the cornerstone of any AF ablation represents pulmonary vein isolation (PVI). Traditional radiofrequency (RF) point by point ablation within a 3D electroanatomic left atrial (LA) map requires profound understanding of LA anatomy and electrophysiology. This ablation strategy can be highly efficient and safe if performed in experienced hands and centers. However, procedural complexity causes a long learning curve and has limited its wide spread utilization. In contrast, balloon based PVI ablation strategies are based on an anatomic principle. Currently, two balloon types (cryoballoon and laserballoon) have been adopted to clinical routine. Both balloons are positioned at the target PV and circumferential energy ablation is enabled. This simplified anatomic approach facilitates reaching the procedural endpoint of PVI and demonstrated less operator dependency. Therefore, balloon PVI appears to be associated with improved procedural reproducibility and safety. Importantly, large scale randomized trials proved non-inferiority of balloon guided AF ablation (cryothermal and laser energy) vs. experienced operators using traditional "gold standard" RF ablation in paroxysmal and persistent AF. Ongoing technological refinements of both balloons as well as the introduction of novel energy dosing strategies and ablation targets may potentially impact the current way of ablating AF in future. This review will summarize current clinical experience of contemporary balloon devices and will look into future developments., Competing Interests: Dr. Bordignon received speaking and proctoring honoraria from Medtronic nad Cardiofocus. Also, Dr. Boris Heinrich Schmidt received speaker fee from Montana Department of Transportation (MDT). The other authors have no financial conflicts of interest., (Copyright © 2019. The Korean Society of Cardiology.)
- Published
- 2019
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43. Outcomes of cryoballoon or radiofrequency ablation in symptomatic paroxysmal or persistent atrial fibrillation.
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Hoffmann E, Straube F, Wegscheider K, Kuniss M, Andresen D, Wu LQ, Tebbenjohanns J, Noelker G, Tilz RR, Chun JKR, Franke A, Stellbrink C, Garcia-Alberola A, Dorwarth U, Metzner A, Ouarrak T, Brachmann J, Kuck KH, and Senges J
- Subjects
- Aged, Atrial Fibrillation physiopathology, Cohort Studies, Female, Humans, Male, Middle Aged, Operative Time, Patient Readmission, Postoperative Complications epidemiology, Proportional Hazards Models, Prospective Studies, Radiation Dosage, Recurrence, Reoperation, Treatment Outcome, Atrial Fibrillation surgery, Catheter Ablation methods, Cryosurgery methods
- Abstract
Aims: To evaluate the effectiveness and safety of cryoballoon ablation (CBA) compared with radiofrequency ablation (RFA) for symptomatic paroxysmal or drug-refractory persistent atrial fibrillation (AF)., Methods and Results: Prospective cluster cohort study in experienced CBA and RFA centres. Primary endpoint was 'atrial arrhythmia recurrence', secondary endpoints were as follows: procedural results, safety, and clinical course. A total of 4189 patients were included: CBA 2329 (55.6%) and RFA 1860 (44.4%). Cryoballoon ablation population was younger, with fewer comorbidities. Procedure time was longer in the RFA group (P = 0.01). Radiation exposure was 2487 (CBA) and 1792 cGycm2 (RFA) (P < 0.001). Follow-up duration was 441 (CBA) and 511 days (RFA) (P < 0.0001). Primary endpoint occurred in 30.7% (CBA) and 39.4% patients (RFA) [adjusted hazard ratio (adjHR) 0.85, 95% confidence interval (CI) 0.70-1.04; P = 0.12). In paroxysmal AF, CBA resulted in a lower risk of recurrence (adjHR 0.80, 95% CI 0.64-0.99; P = 0.047). In persistent AF, the primary outcome was not different between groups. Major adverse cardiovascular and cerebrovascular event rates were 1.0% (CBA) and 2.8% (RFA) (adjHR 0.53, 95% CI 0.26-1.10; P = 0.088). Re-ablations (adjHR 0.46, 95% CI 0.34-0.61; P < 0.0001) and adverse events during follow-up (adjHR 0.64, 95% CI 0.48-0.88; P = 0.005) were less common after CBA. Higher rehospitalization rates with RFA were caused by re-ablations., Conclusions: The primary endpoint did not differ between CBA and RFA. Cryoballoon ablation was completed rapidly; the radiation exposure was greater. Rehospitalization due to re-ablations and adverse events during follow-up were observed significantly less frequently after CBA than after RFA. Subgroup analysis suggested a lower risk of recurrence after CBA in paroxysmal AF., Trial Registration: ClinicalTrials.gov (NCT01360008), https://clinicaltrials.gov/ct2/show/NCT01360008., (© The Author(s) 2019. Published by Oxford University Press on behalf of the European Society of Cardiology.)
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- 2019
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44. Analysis of procedural data of pulmonary vein isolation for atrial fibrillation with the second-generation laser balloon.
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Nagase T, Bordignon S, Perrotta L, Bologna F, Tsianakas N, Chen S, Konstantinou A, Chun JKR, and Schmidt B
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- Aged, Electrocardiography, Female, Humans, Male, Atrial Fibrillation surgery, Balloon Occlusion methods, Laser Therapy methods, Pulmonary Veins surgery
- Abstract
Background: The procedural data of pulmonary vein (PV) isolation (PVI) for patients with atrial fibrillation using the second-generation laser balloon (LB2), which became available recently, remains unclear and were evaluated., Methods: Thirty consecutive patients (116 PVs) underwent PVI using LB2 (LB2 group) and were matched to 30 patients (116 PVs) treated with the first-generation laser balloon (LB1 group). The left atrial isolated surface area (ISA) (ratio of the total isolated antral surface area excluding PV to the total isolated antral surface area including the posterior wall) was also measured after LB2 PVI., Results: PVI was achieved in 103/116 (89%) PVs and 108/116 (93%) PVs in the LB2 and LB1 groups, respectively, after the initial circular ablation (P = 0.360) and in 115/116 (99%) PVs and 116/116 (100%) PVs in the LB2 and LB1 groups, respectively, at the end of the procedure (P = 1.000). PV occlusion grade, categorized by the degree of PV occlusion, was significantly better in the LB2 group than in the LB1 group (P < 0.001). Zero rotational maneuver was applicable in 23/116 (20%) PVs and 8/116 (7%) in the LB2 and LB1 groups, respectively (P = 0.007). There was no significant difference in the procedural time, fluoroscopic time, or complications. The mean ISA after LB2 PVI was 53 ± 14%. The application number was the only independent predictor of successful PVI after initial circular LB2 ablation (adjusted odds ratio 0.860; 95% confidence interval 0.764-0.968; P = 0.013)., Conclusion: LB2 displays favorable PV occlusion characteristics and enables more zero rotational maneuvers., (© 2019 Wiley Periodicals, Inc.)
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- 2019
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45. Durability of cryoballoon left atrial appendage isolation: Acute and invasive remapping electrophysiological findings.
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Bordignon S, Chen S, Perrotta L, Bologna F, Nagase T, Konstantinou A, Weise F, Fuernkranz A, Schmidt B, and Chun JKR
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- Aged, Epicardial Mapping, Female, Humans, Male, Retrospective Studies, Atrial Appendage surgery, Atrial Fibrillation surgery, Cryosurgery methods
- Abstract
Background: The left atrial appendage (LAA) has been identified as a potential source of atrial fibrillation (AF) and has been described as the "fifth" pulmonary vein (PV). We report our initial experience in LAA isolation (LAAI) using the cryoballoon (CB) and data on durability of CB-LAAI., Methods: Patients treated with a CB-LAAI were retrospectively identified. Six weeks after electrical LAAI, patients were scheduled for staged percutaneous LAA closure. During the second procedure, a subset of patients underwent invasive remapping of the LAA., Results: A total of 32 patients (21 males, 68 ± 10 years old) were treated with CB-LAAI. Acute LAAI was achieved in 29 of 32 (91%) patients: single-shot LAAI was observed in 18 of 32 (56%) patients. Acute procedural sustained LAAI was related with a significantly shorter time to LAAI (sustained LAAI: 84 ± 50 s vs nonsustained LAAI: 166 ± 76 s, P = 0.004). Mean procedure and fluoroscopy time were 61 ± 29 and 8 ± 6 min, respectively. One left-sided phrenic nerve palsy occurred. In 25 of 32 (78%) patients, a second procedure for percutaneous LAA closure device implantation was performed. In 22 patients, persistency of LAAI was tested: durable LAAI was documented in 16/22 patients (73%)., Conclusion: In the present report, CB LAA isolation followed by staged LAA closure appeared to be safe and feasible but more data are required. Time to LAAI played a role in predicting acute sustained LAAI rate. CB LAA ablation leads to 73% of durable LAA isolation., (© 2019 Wiley Periodicals, Inc.)
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- 2019
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46. HEartLight guided - PUre Pulmonary Vein Isolation Regardless of Concomitant Atrial Substrate: HEURECA Study.
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Nagase T, Bordignon S, Perrotta L, Bologna F, Tsianakas N, Chen S, Konstantinou A, Chun JKR, and Schmidt B
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- Aged, Atrial Fibrillation physiopathology, Electrocardiography, Female, Heart Atria, Heart Conduction System physiopathology, Humans, Male, Middle Aged, Prospective Studies, Recurrence, Treatment Outcome, Atrial Fibrillation surgery, Laser Therapy methods, Pulmonary Veins surgery
- Abstract
Background: It remains unclear whether left atrial low-voltage area (LALVA) affects atrial tachyarrhythmia recurrence after laser balloon pulmonary vein isolation (PVI) for atrial fibrillation (AF). We prospectively evaluated the outcome of laser balloon PVI in patients with and without LALVA (≤ 0.5 mV) together with surface/intracardiac electrophysiological criteria., Methods: One hundred consecutive paroxysmal/persistent AF patients underwent laser balloon PVI. The relative extent of LALVA (extent of LALVA/left atrial surface area × 100 [%]: rLALVA), total p-wave duration in lead II (PWD), and time interval from the beginning of p-wave to the local activation in left atrial appendage (TTLAA) were assessed. Patients were divided into patients with LALVA (group A: 23 patients) and those without LALVA (group B: 77 patients). The primary endpoint was freedom from atrial tachyarrhythmia after the blanking periods., Results: Complete PVI was achieved in 99/100 (99%) patients. PWD and TTLAA were longer in group A (both, P < 0.001). During 12 months' follow-up, survival free from atrial tachyarrhythmia recurrence was lower in group A (12/23 [52%] patients vs 67/77 [87%] patients, P < 0.001). Multivariate analysis identified rLALVA as the only independent predictor of atrial tachyarrhythmia recurrence. rLALVA correlated with PWD and TTLAA (r = 0.41, P < 0.001 and r = 0.60, P < 0.001, respectively). Receiver operating characteristic curve for rLALVA revealed PWD of 122 ms and TTLAA of 92 ms as the optimal cut-off value., Conclusion: LALVA was associated with poorer outcome after laser balloon PVI. Patients may be identified by longer PWD and TTLAA., (© 2018 Wiley Periodicals, Inc.)
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- 2019
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47. Benefit of left atrial appendage electrical isolation for persistent and long-standing persistent atrial fibrillation: a systematic review and meta-analysis.
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Romero J, Michaud GF, Avendano R, Briceño DF, Kumar S, Carlos Diaz J, Mohanty S, Trivedi C, Gianni C, Della Rocca D, Proietti R, Perrotta L, Bordignon S, Chun JKR, Schmidt B, Garcia M, Natale A, and Di Biase L
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- Action Potentials, Aged, Atrial Appendage physiopathology, Atrial Fibrillation diagnosis, Atrial Fibrillation epidemiology, Atrial Fibrillation physiopathology, Brain Ischemia epidemiology, Brain Ischemia prevention & control, Catheter Ablation adverse effects, Female, Heart Rate, Humans, Male, Middle Aged, Progression-Free Survival, Recurrence, Risk Factors, Stroke epidemiology, Stroke prevention & control, Time Factors, Treatment Outcome, Atrial Appendage surgery, Atrial Fibrillation surgery, Catheter Ablation methods
- Abstract
Aims: The long-term outcomes of left atrial appendage electrical isolation (LAAEI) in patients with non-paroxysmal atrial fibrillation (AF) have corroborated the significant role of the LAA in this arrhythmia. We sought to investigate the incremental benefit of LAAEI in patients undergoing catheter ablation for persistent AF or long-standing persistent AF (LSPAF)., Methods and Results: A systematic review of Medline, Cochrane, and Embase for all the clinical studies in which assessment LAAEI in non-paroxysmal AF patients was performed. The benefit of LAAEI in patients with AF was analysed from seven studies that enrolled a total of 930 patients [mean age 63 ± 5 years; male: 69%]. All studies included patients with either persistent AF or LSPAF or the combination of them. The overall freedom from all-arrhythmia recurrence at 12 months of follow-up off antiarrhythmic medications in patients who underwent LAAEI was 75.5% vs. 43.9% in those in whom only standard ablation was performed [56% relative reduction and 31.6% absolute reduction; risk ratio (RR) 0.44, 95% confidence interval (95% CI) 0.31-0.64; P < 0.0001]. The rate of ischaemic stroke in the LAAEI group was 0.4% and in the control group 2.1% at 12 months follow-up (RR 0.40, 95% CI 0.12-1.30; P = 0.13). Acute complications rates were identical between groups [LAAEI 5.5%, control 5.5% (RR 0.99, 95% CI 0.46-2.16; P = 0.99)]., Conclusion: Left atrial appendage electrical isolation in addition to standard ablation appears to have a substantial incremental benefit to achieve freedom from ALL atrial arrhythmias in patients with persistent AF and LSPAF without increasing acute procedural complications and without raising the risk of ischaemic stroke.
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- 2018
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48. Low Risk of Pulmonary Vein Stenosis After Contemporary Atrial Fibrillation Ablation - Lessons From Repeat Procedures After Radiofrequency Current, Cryoballoon, and Laser Balloon.
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Nagase T, Bordignon S, Perrotta L, Bologna F, Weise FK, Konstantinou A, Kato R, Schmidt B, and Chun JKR
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- Ablation Techniques adverse effects, Aged, Angioplasty, Balloon, Angioplasty, Balloon, Laser-Assisted, Atrial Fibrillation complications, Balloon Embolectomy, Catheter Ablation adverse effects, Female, Humans, Incidence, Male, Middle Aged, Pulmonary Veins surgery, Radiofrequency Ablation, Risk, Treatment Outcome, Ablation Techniques standards, Atrial Fibrillation therapy, Catheter Ablation methods, Stenosis, Pulmonary Vein etiology
- Abstract
Background: The incidence of pulmonary vein stenosis (PVS) after AF ablation following contemporary procedures remains unclear. We compared the incidence of PVS/narrowing (PVS/N) after PV isolation (PVI) for (1) 3-D mapping-guided wide-area encircling irrigated radiofrequency current (RFC) ablation; (2) first-third-generation big cryoballoon (CB1-3) ablation; and (3) laser balloon (LB) ablation.Methods and Results:All patients undergoing a second procedure between January 2012 and November 2016 were subgrouped according to index ablation (PVI): RFC; CB; or LB. PVS/N was classified using PV diameter ratio (second/index procedure) on selective PV angiogram performed before ablation: mild, 25-49%; moderate, 50-74%; or severe, ≥75%. A total of 344 patients (1,362 PV) were analyzed (RFC, n=211; 840 PV; CB1, n=21; 82 PV; CB2,3, n=64; 250 PV; LB, n=48; 190 PV). In the LB group, 45 patients (94%) were treated with dose ≥8.5 W. Second procedures were performed on average 14.9±14.1 months after the index procedure. Mild PVS/N was observed in 18.4%, 9.5% and 3.6% of PV in the LB, RFC and CB groups, respectively (P<0.01). Moderate PVS was recognized in 2 PV (0.1%; RFC, LB). Severe PVS was never observed, and no PV intervention/surgery was required., Conclusions: The risk for significant PVS is low after RFC/CB. The incidence of mild PVS/N was highest after standard-dose LB ablation and lowest after high-dose CB ablation.
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- 2018
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49. Improved 1-year clinical success rate of pulmonary vein isolation with the second-generation cryoballoon in patients with paroxysmal atrial fibrillation.
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Fürnkranz A, Bordignon S, Dugo D, Perotta L, Gunawardene M, Schulte-Hahn B, Nowak B, Schmidt B, and Chun JKR
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- Aged, Anti-Arrhythmia Agents therapeutic use, Atrial Fibrillation diagnosis, Atrial Fibrillation physiopathology, Cryosurgery adverse effects, Disease-Free Survival, Electrocardiography, Ambulatory, Equipment Design, Female, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Paralysis etiology, Peripheral Nerve Injuries etiology, Phrenic Nerve injuries, Prospective Studies, Pulmonary Veins physiopathology, Recurrence, Risk Factors, Tachycardia, Supraventricular etiology, Time Factors, Treatment Outcome, Atrial Fibrillation surgery, Cryosurgery instrumentation, Pulmonary Veins surgery
- Abstract
Background: The second-generation cryoballoon (CB2) has recently been introduced featuring improved surface cooling. Increased procedural efficacy of pulmonary vein isolation (PVI) when compared to the first-generation balloon (CB1) has been reported. The aim of the study was to investigate the clinical outcome of cryoballoon PVI after 1 year using the CB2 as compared to the CB1., Methods and Results: A total of 105 consecutive patients with paroxysmal atrial fibrillation (AF) were studied. Cryoballoon PVI (28 mm) was performed in 50 patients using the CB1, and in 55 patients using the CB2. Patients were scheduled for 72-hour Holter ECG recording at 3, 6, 9, and 12 months and every 6 months thereafter. The study endpoint was defined as recurrent AF or atrial tachycardia >30 seconds documented after a blanking period of 90 days after the procedure. Complete PVI was achieved in 49/50 (98%) and 55/55 (100%) patients in the CB1 and CB2 group, respectively. After a mean follow-up of 416 ± 75 days, 21 (CB1 group) and 10 (CB2 group) patients reached the study endpoint. Kaplan-Meier estimates of arrhythmia-free survival after a single procedure without AAD therapy after 1 year were 63.9% versus 83.6% (P = 0.008) in the CB1 and CB2 group, respectively. Persistent phrenic nerve palsy with delayed healing occurred in 2 (CB1 group) and 3 (CB2 group) patients., Conclusion: Clinical outcome of PVI using the CB2 was significantly improved when compared to the CB1., (© 2014 Wiley Periodicals, Inc.)
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- 2014
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