Underreporting of complications following AF ablation: Comparison of the manufacturer and user facility device experience FDA database and a voluntary invitation-based registry: The POTTER-AF 3 study.

Background: The Manufacturer and User Facility Device Experience (MAUDE) database houses medical device reports of adverse events involving medical devices marketed in the United States submitted to the U.S. Food and Drug Administration (FDA) by mandatory and voluntary reporters.

Initial experience, safety, and feasibility using remote access or onsite technical support for complex ablation procedures: results of the REMOTE study.

Aims: Electroanatomical mapping (EAM) systems are essential for the treatment of cardiac arrhythmias. The EAM system is usually operated by qualified staff or field technical engineers from the control room. Novel remote support technology allows for remote access of EAM via online services.

Pulmonary vein isolation durability after very high-power short-duration ablation utilizing a very-close protocol - The FAST AND FURIOUS redo study.

Background: Very high-power short-duration (vHP-SD) radiofrequency (RF) ablation of atrial fibrillation (AF) treatment by pulmonary vein isolation (PVI) aims for safer, more effective and faster procedures. Although acute efficacy and safety for PVI was recently shown data on chronic PVI durability is limited. Here chronic PVI durability was evaluated during repeat electrophysiological procedures in patients after initial vHP-SD and conventional RF based PVI.

Impact of pulsed field ablation on intraluminal esophageal temperature.

Introduction: Atrio-esophageal fistula after esophageal thermal injury (ETI) is one of the most devastating complications of available energy sources for atrial fibrillation (AF) ablation. Pulsed field ablation (PFA) uses electroporation as a new energy source for catheter ablation with promising periprocedural safety advantages over existing methods due to its unique myocardial tissue sensitivity. In preclinical animal studies, a dose-dependent esophageal temperature rise has been reported.

Very high-power short-duration catheter ablation for treatment of cardiac arrhythmias: Insights from the FAST and FURIOUS study series.

The QDOT MICRO™ Catheter is a novel open-irrigated contact force-sensing radiofrequency ablation catheter. It offers very high-power short-duration (vHPSD) ablation with 90 W for 4 s to improve safety and efficacy of catheter ablation procedures. Although the QDOT MICRO™ Catheter was mainly designed for pulmonary vein isolation (PVI) its versatility to treat atrial fibrillation (AF) and other types of arrhythmias was recently evaluated by the FAST and FURIOUS study series and other studies and will be presented in this article.

Pulsed Field Ablation-Based Pulmonary Vein Isolation Using a Simplified Single-Access Single-Catheter Approach - The Fast and Furious PFA Study.

Background: Pulsed field ablation (PFA) is a non-thermal energy source with promising safety and efficacy advantages. We aimed to develop a convenient, safe, effective and fast method of pulmonary vein isolation (PVI) utilizing a penta-spline PFA catheter via a single femoral vein and a venous closure system.

Methods and results: Consecutive patients (n=50; mean age: 63.

Wide antral circumferential vs. ostial pulmonary vein isolation using pulsed field ablation-the butterfly effect.

Background: Wide antral circumferential ablation (WACA) in comparison to ostial pulmonary vein (PV) isolation (PVI) has been attributed with improved rhythm outcome. We investigated the feasibility, lesion formation, and rhythm outcome of WACA-PVI in comparison to ostial-PVI using pulsed field ablation (PFA).

Methods: Symptomatic atrial fibrillation (AF) patients (69 years, 67% male; 67% paroxysmal AF) were prospectively enrolled into our single-center registry and underwent first-time ostial-PFA or WACA-PFA,  = 15 each.

Has COVID-19 changed the spectrum of arrhythmias and the incidence of sudden cardiac death?

Arrhythmic manifestations of COVID-19 include atrial arrhythmias such as atrial fibrillation or atrial flutter, sinus node dysfunction, atrioventricular conduction abnormalities, ventricular tachyarrhythmias, sudden cardiac arrest, and cardiovascular dysautonomias including the so-called long COVID syndrome. Various pathophysiological mechanisms have been implicated, such as direct viral invasion, hypoxemia, local and systemic inflammation, changes in ion channel physiology, immune activation, and autonomic dysregulation. The development of atrial or ventricular arrhythmias in hospitalized COVID-19 patients has been shown to portend a higher risk of in-hospital death.

A worldwide survey on incidence, management, and prognosis of oesophageal fistula formation following atrial fibrillation catheter ablation: the POTTER-AF study.

Aims: Oesophageal fistula represents a rare but dreadful complication of atrial fibrillation catheter ablation. Data on its incidence, management, and outcome are sparse.

Methods And Results: This international multicentre registry investigates the characteristics of oesophageal fistulae after treatment of atrial fibrillation by catheter ablation.

Very high-power short-duration ablation for pulmonary vein isolation utilizing a very-close protocol-the FAST AND FURIOUS PVI study.

Aims: The very high-power short-duration (vHP-SD) radiofrequency (RF) ablation concept of atrial fibrillation (AF) treatment by pulmonary vein isolation (PVI) aims for safer, more effective, and faster procedures. Utilizing conventional ablation, the 'close protocol' has been verified. Since lesion formation of vHP-SD ablation creates wider but shallower lesions we adapted the close protocol to an individualized and tighter 'very-close protocol' of 3-4 mm of inter-lesion distance (ILD) at the anterior and 5-6 mm at the posterior aspect of the left atrium using vHP-SD only.

Safety and Feasibility of Catheter Ablation Procedures in Patients with Bleeding Disorders.

Aims/Objectives: Patients with bleeding disorders are a rare and complex population in catheter ablation (CA) procedures. The most common types of bleeding disorders are von Willebrand disease (VWD) and hemophilia A (HA). Patients with VWD or HA tend to have a higher risk of bleeding complications compared to other patients.

Impact of cryoballoon application abortion due to phrenic nerve injury on reconnection rates: a YETI subgroup analysis.

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.

Novel cryoballoon ablation system for pulmonary vein isolation: multicenter assessment of efficacy and safety-ANTARCTICA study.

Aims: Pulmonary vein isolation (PVI) either by balloon devices or radiofrequency forms the cornerstone of invasive atrial fibrillation (AF) treatment. Although equally effective cryoballoon (CB)-based PVI offers shorter procedure duration and a better safety profile. Beside the worldwide established Arctic Front Advance system, a novel CB device, POLARx, was recently introduced.

Phrenic Nerve Injury During Cryoballoon-Based Pulmonary Vein Isolation: Results of the Worldwide YETI Registry.

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.

Individualized or fixed approach to pulmonary vein isolation utilizing the fourth-generation cryoballoon in patients with paroxysmal atrial fibrillation: the randomized INDI-FREEZE trial.

Aims: Cryoballoon (CB) based pulmonary vein isolation (PVI) is a widely used technique for treatment of atrial fibrillation (AF); however the ideal energy dosing has not yet been standardized. This was a single-centre randomized clinical trial aiming at assessing the safety, acute efficacy, and clinical outcome of an individualized vs. a fixed CB ablation protocol using the fourth-generation CB (CB4) guided by pulmonary vein (PV) potential recordings and CB temperature.

Novel Cryoballoon Ablation System for Single Shot Pulmonary Vein Isolation - The Prospective ICE-AGE-X Study.

Background: The arctic front cryoballoon (AF-CB) provides effective and durable pulmonary vein isolation (PVI) associated with encouraging clinical outcome. The POLARx cryoballoon incorporates unique features and design changes that may translate into improved efficacy, safety and further simplified balloon-based procedures. Efficacy and safety of the novel POLARx cryoballoon was compared to the fourth generation AF-CB (AF-CB4).

Clinical outcomes of cryoballoon ablation for pulmonary vein isolation: Impact of intraprocedural heart rhythm.

Background: The current study sought to assess the impact of the intraprocedural heart rhythm (sinus rhythm [SR] vs. atrial fibrillation [AF]) on acute procedural characteristics, durability of pulmonary vein isolation (PVI) and long-term clinical outcomes of cryoballoon (CB) ablation.

Methods: A total of 195 patients with symptomatic paroxysmal (n = 136) or persistent AF (n = 59) underwent CB-based PVI.

Safety and Efficacy of Cryoballoon Ablation for the Treatment of Atrial Fibrillation in Diabetic Patients.

Background: Cryoballoon based catheter ablation (CB-CA) is an established therapy for treatment of symptomatic atrial fibrillation (AF). However, data about AF ablation using the CB in the diabetic population is sparse. The aim of this single center retrospective study is to evaluate the safety and efficacy of CB ablation in patients with diabetes mellitus (DM) as compared to patients without DM.

Rapid pulmonary vein isolation utilizing the third-generation laserballoon - The PhoeniX registry.

Background: Balloon-based ablation systems for pulmonary vein isolation (PVI) are providing procedural safety and efficacy as well as favourable clinical outcome. Although second-generation laser balloon (LB2) based PVI has been shown safety and efficacy relatively long procedural duration was a strong limitation. The third-generation laser balloon (LB3) offers and automized ablation for rapid PVI.

Stroke and left atrial thrombi after cryoballoon ablation of atrial fibrillation: incidence and predictors. Results from a long-term follow-up.

Stroke after catheter ablation (CA) of atrial fibrillation (AF) is a potential complication with long term consequences. Aim of this study was to determine incidence and potential predictors of stroke and left atrial appendage (LAA) thrombi after AF ablation with cryo-energy. Two hundred nine consecutive patients with symptomatic drug refractory AF (65% male; 61 ± 11 yo, 69% paroxysmal AF, mean CHADS-VASc score 2 ± 1.