Background: Pulsed field ablation (PFA) is a promising treatment for atrial fibrillation. We report 1-year freedom from atrial arrhythmia outcomes using monopolar PFA delivered through 3 commercial, contact force-sensing focal catheters.
Methods: ECLIPSE AF (NCT04523545) was a prospective, single-arm, multicenter study evaluating acute and chronic safety and performance using the CENTAURI system to deliver focal PFA with TactiCath SE, StablePoint, and ThermoCool ST.
Background: Atrial fibrillation (AF) and heart failure (HF) coexist, increasing morbidity and mortality. Studies have demonstrated improved outcomes following AF ablation in HF patients with reduced ejection fraction (EF).
Objective: To assess the outcomes of pulsed-field ablation (PFA) in HF.
Background: Atrial fibrillation (AF) and heart failure (HF) coexist, increasing morbidity and mortality. Studies have demonstrated improved outcomes following AF ablation in HF patients with reduced ejection fraction (EF).
Objective: This study sought to assess the outcomes of pulsed field ablation (PFA) in HF.
Introduction: The unique safety profile of pulsed field ablation (PFA) has made pulmonary vein isolation (PVI) + left atrial posterior wall (LAPW) ablation promising for treating persistent atrial fibrillation (PerAF). The goal of this study was to assess long-term freedom from atrial fibrillation, atrial flutter, and atrial tachycardia (AF/AFL/AT), as well as the safety and feasibility of LAPW PFA using multipolar, pentaspline Farawave catheter.
Methods: Retrospective observational study at a single institution.
Background: We previously presented the safety and early efficacy of the inspIRE study (Study for Treatment of Paroxysmal Atrial Fibrillation [PAF] by Pulsed-field Ablation [PFA] System With Irreversible Electroporation [IRE]). With the study's conclusion, we report the outcomes of the full pivotal study cohort, with an additional analysis of predictors of success.
Methods: InspIRE was a prospective, multicenter, single-arm clinical trial of drug-refractory paroxysmal atrial fibrillation.
Background: Ablation of accessory pathways (APs) is the cornerstone for treatment of patients with Wolff-Parkinson-White syndrome and manifestation of atrioventricular reentrant tachycardia. Pulsed field ablation (PFA) is a new type of nonthermal energy source delivered to the underlying tissue via the ablation catheter and used for ablation of arrhythmic substrates.
Objective: The purpose of this study was to determine the efficiency and long-term outcome of ablation of APs of different localizations using a focal pulsed electrical field.
Introduction: Cryoablation therapy for pulmonary vein isolation (PVI) to treat paroxysmal atrial fibrillation (PAF) is well established. A novel 28 mm cryoballoon system designed to operate under low pressure to safely reach a lower nadir temperature and maintain constant balloon size during cooling has not been prospectively studied in a large patient population for safety and efficacy. The FROZEN AF (NCT04133168) trial was an international multicenter, open-label, prospective, single-arm study on the safety and performance of a novel cryoballoon system for treatment of PAF.
View Article and Find Full Text PDFJ Cardiovasc Electrophysiol
April 2024
Introduction: Pulsed electric field (PEF) ablation relies on the intersection of a critical voltage gradient with tissue to cause cell death. Field-based lesion formation with PEF technologies may still depend on catheter-tissue contact (CTC). The purpose of this study was to assess the impact of CTC on PEF lesion formation with an investigational large area focal (LAF) catheter in a preclinical model.
View Article and Find Full Text PDFIntroduction: With the entry of pulsed-field ablation (PFA) into electrophysiology, new possibilities for ablation of different substrates such as epicardial foci of premature ventricular contractions (PVCs) from coronary venous system (CVS) have been opened.
Methods: This article focuses on a case of a 27-year-old patient with frequent monomorphic PVCs of epicardial origin, treated by radiofrequency ablation, followed by PFA.
Results: After unsuccessful focus ablation through CVS with RFA, successful ablations from the same region with PFA were achieved.
Aims: Although guidelines for the management of atrial fibrillation (AF) are regularly published, many controversial issues remain, limiting their implementation. We aim to describe current clinical practice among European Heart Rhythm Association (EHRA) community according to last guidelines.
Methods And Results: A 30 multiple-choice questionnaire covering the most controversial topics related to AF management was distributed through the EHRA Research Network, National Societies, and social media between January and February 2023.
Importance: Previous studies evaluating the association of patient sex with clinical outcomes using conventional thermal ablative modalities for atrial fibrillation (AF) such as radiofrequency or cryoablation are controversial due to mixed results. Pulsed field ablation (PFA) is a novel AF ablation energy modality that has demonstrated preferential myocardial tissue ablation with a unique safety profile.
Objective: To compare sex differences in patients undergoing PFA for AF in the Multinational Survey on the Methods, Efficacy, and Safety on the Postapproval Clinical Use of Pulsed Field Ablation (MANIFEST-PF) registry.
Aims: Patients with atrial fibrillation who despite taking oral anti-coagulant therapy (OAT) suffer a stroke or systemic embolism (SSE) without vascular cause or who develop left atrial appendage (LAA) thrombus (LAAT) should be considered as having malignant LAA. The optimal treatment strategy to reduce SSE risk in such patients is unknown. The aim of the study is to investigate the diagnostic and therapeutic pathways for malignant LAA practiced in European cardiac centres.
View Article and Find Full Text PDFAims: Pulsed field ablation (PFA) has emerged as a promising alternative to thermal ablation for treatment of atrial fibrillation (AF). We report performance and safety using the CENTAURI™ System (Galvanize Therapeutics) with three commercial, focal ablation catheters.
Methods And Results: ECLIPSE AF (NCT04523545) was a prospective, single-arm, multi-centre study evaluating safety and acute and chronic pulmonary vein isolation (PVI) durability using the CENTAURI System in conjunction with the TactiCath SE, StablePoint, and ThermoCool ST ablation catheters.
Background: Pulsed field ablation is a novel nonthermal cardiac ablation modality using ultra-rapid electrical pulses to cause cell death by a mechanism of irreversible electroporation. Unlike the traditional ablation energy sources, pulsed field ablation has demonstrated significant preferentiality to myocardial tissue ablation, and thus avoids certain thermally mediated complications. However, its safety and effectiveness remain unknown in usual clinical care.
View Article and Find Full Text PDFJ Cardiovasc Dev Dis
February 2023
The autonomic nervous system is crucial in initiating and maintaining atrial fibrillation (AF). Catestatin is a multipurpose peptide that regulates cardiovascular systems and reduces harmful, excessive activity of the sympathetic nervous system by blocking the release of catecholamines. We aimed to determine whether serum catestatin concentrations are associated with AF severity, duration indices, and various clinical and laboratory indicators in these individuals to better define the clinical value of catestatin in patients with AF.
View Article and Find Full Text PDFIntroduction: Pulmonary vein isolation (PVI) is well established as a primary treatment for atrial fibrillation (AF). The POLAR ICE study was designed to collect prospective real world data on the safety and effectiveness of the POLARx cryoballoon for PVI to treat paroxysmal AF.
Methods: POLAR ICE, a prospective, non-randomized, multicenter (international) registry (NCT04250714), enrolled 399 patients across 19 European centers.
Background: The inspIRE study (Study for Treatment of Paroxysmal Atrial Fibrillation [PAF] by Pulsed Field Ablation [PFA] System With Irreversible Electroporation [IRE]) evaluated safety and effectiveness of a fully integrated biphasic pulsed field ablation (PFA) system with a variable-loop circular catheter for the treatment of drug-refractory paroxysmal atrial fibrillation.
Methods: Subjects underwent pulmonary vein (PV) isolation with the PFA system, using at least 12 applications per vein; adenosine/isoproterenol was administered to confirm entrance block. Wave I assessed initial safety, including for esophageal lesions, silent cerebral lesions, and PV stenosis.
With the increasing interest in conduction system pacing (CSP) over the last few years and the inclusion of this treatment modality in the current guidelines, our aim was to provide a snapshot of current practice across Europe. An online questionnaire was sent to physicians participating in the European Heart Rhythm Association research network as well as to national societies and over social media. Data on previous experience with CSP, current indications, preferred tools, unmet needs, and perceptions for the future are reported and discussed.
View Article and Find Full Text PDFAtrial 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.
View Article and Find Full Text PDFThe 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.
View Article and Find Full Text PDF