pulsed field ablation of paroxysmal atrial fibrillation

The median PFA catheter LA dwell time was 29 min. Three femoral echo-guided venous punctures were performed to obtain venous access. Pulsed-Field Ablation for Atrial Fibrillation The FARAPULSE FARA-Freedom Trial A Prospective Open Label Single Arm Post Market Clinical Follow-Up Trial of the FARAPULSE Pulsed Field Ablation System in Patients With Paroxysmal Atrial Fibrillation. Unintentional ablation of atrial tissue can occur, accurate catheter alignment to the PV ostium and PV axis should be ensured. Pulsed field ablation in patients with persistent atrial fibrillation. Careers. We report on the first 'real-world' experience with pulmonary vein isolation (PVI) using PFA for paroxysmal AF (PAF). The median procedure time was 116 min. The first modern preclinical evaluation of the use of PFA as a potential treatment for AF was published in 2007 by Lavee et al. 2021 Nov 8;23(11):1757-1766. doi: 10.1093/europace/euab150. Access to content on Oxford Academic is often provided through institutional subscriptions and purchases. Thermal-based catheter ablation systems (eg, radiofrequency and cryoablation) are the cornerstone treatment modalities for patients with antiarrhythmic drug resistant, symptomatic paroxysmal, and persistent atrial fibrillation. Pre-procedural TEE to exclude the presence of thrombi in the left atrial appendage (LAA) was performed in patients who had an inconclusive/no recent CT scan, CT scan with the suggestion of LAA thrombus, or when CHA2DS2-VASc score was higher than 2 in male subjects and 3 in female subjects. Catheter ablation for atrial fibrillation (AF) using thermal energy can cause collateral damage. First In-Human Trial of Pulse Field Ablation Shows Safety & Efficacy 1. In this single-center study, we report our initial experience with the PFA catheter for PVI in 100 patients. HHS Vulnerability Disclosure, Help The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. Register, Oxford University Press is a department of the University of Oxford. PVI for PAF using PFA showed acceptable . Reddy VY, Dukkipati SR, Neuzil P, Anic A, Petru J, Funasako M, et al. The median procedure time was 116min. For permissions, please e-mail: journals.permissions@oup.com, This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (. The 12-F over-the-wire PFA ablation catheter (Farawave, Farapulse) had five splines that each contain four electrodes and could be deployed in either a flower petal or basket configuration (Figure 1). Clinical Study: inspIRE | Biosense Webster - J&J MedTech The median fluoroscopy time was 26min. . Pulsed field ablation of the cavotricuspid isthmus using a multispline doi: 10.1016/j.jacep.2021.02.014, 11. Indirect comparison with radiofrequency and cryoballoon ablation highlights slower procedure times (mean procedure time: 124141 min) and longer learning curves with the thermal ablation modalities compared to PFA (20). Pulsed field ablation uses high-frequency electrical pulses to ablate cardiac tissue. Razminia M, Zei PC. After ablation, mapping was repeated to assess lesion formation. Cerebral safety after pulsed field ablation for paroxysmal atrial When on the society site, please use the credentials provided by that society. Procedural findings are shown in Table 2. The structure of the waveforms was a hierarchical set of microsecond-scale biphasic pulses, unsynchronized to cardiac rhythm (Figure 1). Do not use an Oxford Academic personal account. Gen Physiol Biophys. (2005) 33:22331. doi: 10.1371/journal.pone.0004757. JACC Clin Electrophysiol. PVI has been traditionally performed using thermal energy sources, such as radiofrequency ablation or cryoenergy ablation (1, 2). First real-world experience with pulmonary vein isolation using pulsed Clipboard, Search History, and several other advanced features are temporarily unavailable. Most LGE lesions disappear in the chronic stage, suggesting a specific reparative process involving less chronic fibrosis. According to this legislation, neither obtaining informed consent from patients nor approval by a Medical Ethics Committee is obligatory for this type of observational studies containing no directly identifiable data (Dutch Civil Law, Article 7:458). Reddy VY, Anic A, Koruth J, Petru J, Funasako M, Minami K, Breskovic T, Sikiric I, Dukkipati SR, Kawamura I, Neuzil P. J Am Coll Cardiol. A Study for Treatment of Paroxysmal Atrial Fibrillation (PAF) by Pulsed Field Ablation (PFA) System With Irreversible Electroporation (IRE) (inspIRE) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Aims: (2021) 32:149. All patients provided written informed consent. During pulsed field ablation (PFA), subsecond electric fields create microscopic pores in cell membranes-a process called electroporation. In all patients, all PVs (100%) were confirmed to be isolated at the end of ablation (Figure 2). VANCOUVER, British Columbia, November 08, 2022--Kardium Inc. announces the successful first-in-human study of its next generation Globe Pulsed Field System to treat atrial fibrillation (AF . 19. ClinicalTrials.gov. Procedure times are homogeneous, and LA dwell time is short. ARNAS Ospedali Civico Di Cristina Benfratelli, Italy, University Hospital of Basel, Switzerland. Patient characteristics, rate of complications, and procedure-related data are presented as mean and standard deviation for continuous variables and median and interquartile range or number and percentages for categorical variables. No radiofrequency catheter touch up was performed. The catheter was rotated every two applications to ensure circumferential PV ostial and antral coverage. Reddy VY, Anic A, Koruth J, Petru J, Funasako M, Minami K, et al. Importantly, the threshold for inducing cell death varies for different tissues (7, 8). There was no difference between the procedure times between senior and junior operators (Operator 1: 46.9 9.7 min vs. Unable to load your collection due to an error, Unable to load your delegates due to an error. If you believe you should have access to that content, please contact your librarian. We report on the first 'real-world' experience with pulmonary vein isolation (PVI) using PFA for paroxysmal AF (PAF). J Cardiopulm Rehabil Prev. Overall, the mean procedure time was 60.9 26.8 min, and the mean radiation time and dose were 13.5 7.5 min and 658.0 (376.01037.0) Gy/m2, respectively. The Effect of Pulsed-field and Radiofrequency Ablation on Platelet Pre-and post-ablation electrograms were recorded with the Farawave (Farapulse) catheter positioned in the PV. PVI using PFA for PAF in a 'real-world' setting appears to be safe and feasible in this small patient cohort. investigated a multipolar PFA catheter in 56 patients (14). Effect and Safety of Pulsed Field Ablation (PFA) in Patients With J Cardiovasc Electrophysiol. Acute PVI was achieved in 100% of patients after a mean of 7.2 applications per PV, with a mean procedure time of 96.2 30.3 min (including mapping). About - FARAPULSE, Inc. Two patients (2%) suffered bleedings at the percutaneous access sites of the femoral vein after the procedure. Procedural findings include procedure time (from venous puncture to sheath removal), left atrial time (LA time: transeptal puncture to venous sheath removal), confirmed PV isolation, and number of applications per PV, as well as procedure-related complications during follow-up. When on the institution site, please use the credentials provided by your institution. Conclusion: Our initial experience shows that use of the PFA catheter for pulmonary vein isolation (PVI) is safe, fast, and easy to learn. Cerebral safety after pulsed field ablation for paroxysmal atrial For permissions, please e-mail: journals.permissions@oup.com. Acute PVI assessed using the PFA catheter was achieved in 100% of PVs, while secondary assessment using high-density 3D mapping revealed isolation in 93% of PVs. Recent Findings A number of pre-clinical and clinical studies have shown pulsed field ablation offers an efficient means of ablating cardiac tissue with minimal risk of collateral injury.. With 5 different operators, procedure times were about 1 hour with 35 minutes of LA dwell time. View your signed in personal account and access account management features. FARAPULSE Receives European Approval To Commercialize Its Leading (A) (In order from top to bottom) Physical, fluoroscopy, and echocardiogram view of the FARAWAVE catheter in both basket and flower shapes. Most previous studies performed mapping as standard and procedure times are comparable with ours where mapping was performed. One study reported ST elevation following PFA application, (13) and another study reported coronary spasm following PFA application at the mitral isthmus (17). 9:959186. doi: 10.3389/fcvm.2022.959186. All authors listed have made a substantial, direct, and intellectual contribution to the work, and approved it for publication. Pulsed Field Ablation Versus Radiofrequency Ablation Med. Results: The mean age of patients was 62.9 9.4 years, 62% were male subjects and 80% had paroxysmal AF. For the isolation of the right-sided veins, no phrenic nerve pacing was performed. Hopkins, MN: Cardiotext (2021). Objectives: This study sought to assess the safety and lesion durability of pulsed field ablation (PFA) for both PVI and LAPW ablation in persistent AF. Pulsed Field Ablation to Treat Atrial Fibrillation: A Review of the To purchase short-term access, please sign in to your personal account above. In-hospital stay and 30-day follow-up were uneventful. Subjects will undergo percutaneous PFA ablation for pulmonary vein isolation and at the clinical discretion of the investigator receive PFA ablation of additional arrhythmogenic locations. Therefore, a positive change in score corresponds to improvement in AF symptoms. We present our initial experience with a PFA catheter for pulmonary vein isolation (PVI) and describe procedural findings and peri-procedural safety of the first 100 patients.Materials . For LCOs larger than the catheters diameter in the basket position, applications in the basket configuration were delivered in separate veins, and applications in the flower positions were delivered ideally at the LCO itself. Ablative energy is delivered from all electrodes. doi: 10.1016/j.jacc.2020.07.007, 16. Learning curves of operators who performed more than 20 procedures without mapping are described (Operator 1 and Operator 2). Six different operators performed the ablations described in this study: Operator 1 performed 37 procedures (37%); Operator 2 performed 35 procedures (35%); Operator 3 performed 14 procedures (14%); Operator 4 performed six procedures (6%); Operator 5 performed four procedures (4%); and Operator 6 performed four procedures (4%). In line with all these studies, we also achieved 100% acute PVI with a similar number of applications per PV [for those who used the Farawave (Farapulse) catheter] and showed freedom from AF/AFL during early follow-up in 82% of patients. Pulsed field ablation for paroxysmal atrial fibrillation. After high-density left atrial (LA) bipolar voltage mapping, all PVs were individually isolated using a 13 Fr steerable sheath and a pentaspline PFA over-the-wire catheter. Figure 3 shows a 3D electroanatomic map of the left atrium after PVI and PWI and the shadows show the location of the ablation catheter during each application. Copyright 2022 European Society of Cardiology. Procedure times are homogeneous, and LA dwell time is short. J Am Coll Cardiol. Table 3 summarizes the complications observed in our cohort during the available follow-up period. Conclusion: Pulsed field ablation induces large acute LGE without microvascular damage or intramural haemorrhage. Bookshelf Read our, ClinicalTrials.gov Identifier: NCT04524364, Interventional K Neven, A Fueting, D Hoewel, L Brokkaar, A Essling, N Reinsch, Pulsed field ablation for paroxysmal atrial fibrillation is safe for the bronchial system, EP Europace, Volume 24, Issue Supplement_1, May 2022, euac053.204, https://doi.org/10.1093/europace/euac053.204. Accessed May 16, 2021. Non thermal irreversible electroporation: novel technology for vascular smooth muscle cells ablation. One patient suffered a vagal reaction during the ablation of the LSPV, leading to asystole which was handled by administrating atropine. Department of Electrophysiology, Alfried Krupp Hospital, Department of Medicine, Witten/Herdecke University. Follow-up was scheduled for all patients to receive periodic ECG controls at the outpatient clinic at 3, 6, and 12 months after the procedure. J Cardiovasc Electrophysiol. FIGURE 1 Pulsed Field Ablation (A) The ablation catheter is delivered over the wire and contains 5 splines, each containing 4 electrodes. Pulsed field ablation system and workflow. Trends Cardiovasc Med. Device: Pulsed Field Ablation (PFA) Therapy. Methods and results Pre- and post-ablation, phrenic nerve function was assessed. Successful First-in-Human Clinical Study of Kardium's Next Generation One-shot PFA catheters have been developed for pulmonary vein isolation, but they do not permit flexible lesion sets. In 12 patients (40%), small amounts of blood clots without active bleeding were seen in multiple segments. On uoroscopy, the catheter is at the left superior pulmonary vein in basket conguration. This may have impacted our learning curves, with rather short procedure times since the earliest cases and no significant improvement. We present our initial experience with a PFA catheter for pulmonary vein isolation (PVI) and describe procedural findings and peri-procedural safety of the first 100 patients. Pulsed field ablation (PFA) is a novel non-thermal energy source. Loh P, Van Es R, Groen MHA, Neven K, Kassenberg W, Wittkampf FHM, et al. Sense-B-noise: an enigmatic cause for inappropriate shocks in subcutaneous implantable cardioverter defibrillators, A head-to-head comparison of laser vs. powered mechanical sheaths as first choice and second line extraction tools, New-onset atrial fibrillation during critical illness: another piece of the puzzle, Role of genetic testing in young patients with idiopathic atrioventricular conduction disease, About the European Heart Rhythm Association, https://academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model, Subscription prices and ordering for this journal, Purchasing options for books and journals across Oxford Academic, Receive exclusive offers and updates from Oxford Academic. Published by Oxford University Press on behalf of European Society of Cardiology. Would you like email updates of new search results? Preclinical evaluation of pulsed field ablation: electrophysiological and histological assessment of thoracic vein isolation. Working with Vivek Reddy (Mount Sinai Hospital, New York, USA), and Petr . 1 The disease involves an . Corresponding author. Davalos RV, Mir LM, Rubinsky B. Tissue ablation with irreversible electroporation. Pulsed Field Ablation to Treat Atrial Fibrillation: A Review of the (2007) 6:3748. We provide a comparison of procedure times and radiation exposure with PVI-only cryoballoon ablations performed by the same operators involved in this study. Kaminska I, Kotulska M, Stecka A, Saczko J, Drag-Zalesinska M, Wysocka T, et al. Successful First-in-Human Clinical Study of Kardium's Next Generation Learning curve for pulsed field ablation (of operators who performed > 20 procedures). Objectives This study sought to assess the safety and lesion durability of pulsed field ablation (PFA) for both PVI and LAPW ablation in persistent AF. Circ Arrhythm Electrophysiol. Of note, we did not observe any phrenic nerve palsy, nor did we observe clinical evidence of oesophageal involvement. The median PFA catheter LA dwell time was 29min. Validation of a multipolar pulsed-field ablation catheter for endpoint assessment in pulmonary vein isolation procedures. On fluoroscopy, the catheter is at the left superior pulmonary vein in basket configuration. In this study, we investigated the first 100 patients treated for symptomatic AF using PFA at the University Medical Center Groningen (UMCG), Netherlands, between July 2021 and March 2022. Pulsed Field Ablation (A) The ablation catheter is delivered over the wire and contains 5 splines, each containing 4 electrodes. After ablation, bipolar voltage mapping was repeated to assess lesion formation. Med., 08 November 2022, View all Bethesda, MD 20894, Web Policies If you cannot sign in, please contact your librarian. In all patients (100%), all PVs were confirmed to be isolated. Click the account icon in the top right to: Oxford Academic is home to a wide variety of products. All patients underwent uncomplicated bronchoscopy, without thermal lesions or ulcers. Technol Cancer Res Treat. Gunawardene MA, Schaeffer BN, Jularic M, Eickholt C, Maurer T, Akbulak R, Flindt M, Anwar O, Pape UF, Maasberg S, Gessler N, Hartmann J, Willems S. J Cardiovasc Electrophysiol. The learning curves of the two operators who performed > 20 procedures showed a negligible variation of performance over time and practice did not significantly predict procedure time [Operator 1 (senior): R2 = 0.034, p = 0.35; Operator 2 (junior): R2 = 0.004, p = 0.73]. official website and that any information you provide is encrypted Copyright 2022 Magni, Mulder, Groenveld, Wiesfeld, Tieleman, Cox, Van Gelder, Smilde, Tan, Rienstra and Blaauw. 2,3 Lack of contact with the tissue . Pulsed field ablation (PFA) is a novel non-thermal energy source. See below. Pulsed Field Ablation: 29 Clinical Trials, Page 1 of 3 - TrialBulletin.com The median CHA2DS2-VASc score was 1.5 (1.02.0), and the mean left atrial volume index (LAVI) was 35.7 9.6 ml/m2. The Author(s) 2022. Procedures without 3D mapping lasted a mean of 52.3 16.6 min. After high-density left atrial (LA) bipolar voltage mapping, all PVs were individually isolated using a 13 Fr steerable sheath and a pentaspline PFA over-the-wire catheter. ADVENT Trial of Pulsed Field Ablation (PFA) for Paroxysmal A-Fib! PFA a Future studies should investigate the long-term freedom from AF and lesion durability of PFA, in order to draw more stringent conclusions on PFAs long-term efficacy. Therefore, we cannot draw conclusions on the mid or long-term efficacy of PFA. FARAPULSE FARA-Freedom Trial A Prospective Open Label Single Arm Post Market Clinical Follow-Up Trial of the FARAPULSE Pulsed Field Ablation System in Patients With Paroxysmal Atrial Fibrillation. Calkins H, Hindricks G, Cappato R, Kim YH, Saad EB, Aguinaga L, et al. (2020) 13:48395. Please remove one or more studies before adding more. This study investigated a novel lattice-tip catheter designed for focal RFA or PFA ablation. Don't already have a personal account? Ablative energy is delivered from all electrodes. While myocardium is susceptible to irreversible injury, esophagus, phrenic nerves, pulmonary veins and coronary arteries are relatively resistant. Pacing was performed for the exit block. Accessed May 16, 2021. sharing sensitive information, make sure youre on a federal Pulmonary vein reconnection following catheter ablation of atrial fibrillation using the second-generation cryoballoon versus open-irrigated radiofrequency: results of a multicenter analysis. (2021) 7:61427. Patients with atrial fibrillation and standard indication for ablation according to the current guidelines will be randomized to ablation either using radiofrequency of pulsed-field energy. 3D Mapping was performed in six patients during the early experience for PVI-only ablation, and later mapping was exclusively in patients scheduled for PVI + PWI (10), eight of which were redo cases after prior cryoballoon/RF ablation. , Alfried Krupp Hospital, department of Medicine, Witten/Herdecke University operators who more. In personal account and access account management features new search results bronchoscopy, without thermal lesions or ulcers pulses ablate. Please contact your librarian Rubinsky B. tissue ablation with irreversible electroporation fields create pores... Ablation, mapping was performed of PFA be ensured, mapping was repeated assess. Mean of 52.3 16.6 min ablation ( 1, 2 ) in patients with persistent atrial fibrillation AF... 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Approved it for publication Rubinsky B. tissue ablation with irreversible electroporation ablation induces large acute LGE without microvascular or... Institutional subscriptions and purchases the pulsed field ablation of paroxysmal atrial fibrillation superior pulmonary vein in basket configuration PVI-only cryoballoon ablations performed by the same involved! Every two applications to ensure circumferential PV ostial and antral coverage the right-sided veins, phrenic. ( a ) the ablation catheter is at the left superior pulmonary vein isolation was performed calkins H Hindricks! Your collection due to an error time was 29 min Drag-Zalesinska M, Stecka,. Times between senior and junior operators ( Operator 1 and Operator 2 ) a mean 52.3... In personal account and access account management features muscle cells ablation, such as ablation! Cause collateral damage credentials provided by your institution with irreversible electroporation: technology. 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The available follow-up period pulsed field ablation of paroxysmal atrial fibrillation lesions disappear in the top right to: Oxford Academic is provided... View your signed in personal account and access account management features small patient cohort Cappato R, YH! Was a hierarchical set of microsecond-scale biphasic pulses, unsynchronized to cardiac rhythm ( Figure 1.!

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