Pressure-Volume Analysis Demonstrates Short- and Long-Term Hemodynamic Effects of Atrioventricular Interval Modulation Therapy in Hypertension.

Background: Prior studies show that atrioventricular interval modulation (AVIM) therapy provides immediate, substantial, and sustained clinically meaningful reductions in ambulatory and office systolic blood pressures (SBPs) in hypertensive patients with pacemakers.

Objectives: The goal of this study was to assess the acute and chronic mechanisms by which AVIM therapy reduces blood pressure and assess the impact of lead location on these mechanisms.

Methods: Acute hemodynamic effects were assessed by invasive pressure-volume (PV) analysis in hypertensive subjects (N = 16) with intact atrioventricular (AV) conduction.

Cardio-microcurrent device treatment for heart failure with reduced ejection fraction: Results from the C-MIC II open-label randomized controlled trial.

Aims: In patients with heart failure, alterations in electrical fields generated within the myocardium have been associated with myocardial oedema which can act as a substrate for left ventricular dysfunction. Safety and efficacy of a direct microcurrent therapy using an implanted generator (C-MIC) remain uncertain.

Methods And Results: Ambulatory patients with non-ischaemic dilated cardiomyopathy with left ventricular ejection fraction (LVEF) of 25% to 35% and New York Heart Association (NYHA) class III-IV were randomized to C-MIC (device) or control group in addition to guideline-directed medical therapy.

Safety and efficacy of a lattice-tip catheter for ventricular arrhythmia ablation: the Affera Ventricular Arrhythmia Ablation (AVAAR) Registry.

Background: The feasibility and safety of the lattice-tip catheter for ventricular arrhythmia (VA) ablation in humans remain largely unknown. This study aimed to assess feasibility, safety profile as well as patient outcomes after VA ablation with a lattice-tip catheter in a multicenter European registry.

Methods: All 18 European centers using the AFFERA system on September 2024 agreed to participate.

Is the esophagus spared during pulsed field ablation? Early histopathology and in vivo esophageal retraction.

Background: Preclinical studies of pulsed field ablation (PFA) have demonstrated an absence of esophageal lesions. However, esophageal assessments are typically performed weeks after PFA, precluding an understanding of acute effects.

Objective: This study aimed to characterize the mechanism of esophageal safety with PFA, using preclinical and clinical assessments.

Battery longevity of a helix-fixation dual-chamber leadless pacemaker: results from the AVEIR DR i2i Study.

Aims: A dual-chamber leadless pacemaker (LP) system that employs distinct atrial and ventricular LP devices (ALP, VLP) has been introduced to clinical practice. Proprietary, low-energy, implant-to-implant (i2i) communication at each beat enables the devices to maintain synchronous atrioventricular sensing and pacing. We evaluated device longevities and contributing factors, such as i2i communication.

Catheters and Tools with Pulsed Field Ablation-Pulmonary Vein Isolation and Nanosecond Pulse Field Ablation.

Pulse field ablation (PFA) has gained attention in the field of atrial fibrillation catheter treatment recently. All currently used or developed technologies use ultrashort pulses (on the order of microseconds). The Emerging CellFX System (Pulse Biosciences, Inc, Inc) utilizes nanosecond PFA (nsPFA) and is thus several orders of magnitude shorter than the initial PFA systems.

PVI With CF-Sensing Large-Tip Focal PFA Catheter With 3D Mapping for Paroxysmal AF: Omny-IRE 3-Month Results.

Background: Omny-IRE (A Study For Treatment of Paroxysmal Atrial Fibrillation [PAF] With the OMNYPULSE Catheter and the TRUPULSE Generator) evaluated safety and effectiveness of a novel large-tip focal, multielectrode, contact force-sensing, pulsed field ablation catheter with electroanatomic mapping integration.

Objectives: This study sought to assess 3-month safety and effectiveness of the platform for treating symptomatic paroxysmal atrial fibrillation.

Methods: Pulmonary vein isolation (PVI) was performed using the OMNYPULSE Platform.

First-in-human study of a leadless pacemaker system for left bundle branch area pacing.

Background: Leadless pacemakers (LPs) are limited by the current inability to perform left bundle branch area pacing (LBBAP).

Objective: The purpose of this first-in-human acute feasibility study was to evaluate the safety and performance of a novel helix-based LP with an extended electrode for LBBAP (LP).

Methods: After obtaining informed consent, the LP (Aveir CSP LP) was temporarily deployed in patients with indications for LP implantation.

Safety and effectiveness of a novel balloon-in-basket pulsed-field ablation catheter for the treatment of paroxysmal and persistent AF: Volt-AF IDE trial acute results.

Background: Increasing use of Pulsed Field Ablation (PFA) to treat atrial fibrillation (AF) has led to concerns related to tissue contact, hemolysis, and electroanatomic mapping integration. A novel balloon-in-basket PFA catheter offers form and function to address these concerns.

Objective: The VOLT-AF Investigational Device Exemption (IDE) study is a prospective, single-arm global IDE study designed to demonstrate the Volt PFA system (Abbott Laboratories, Chicago, Illinois) is safe and effective for the treatment of paroxysmal AF (PAF) and persistent AF (PersAF).

One-year outcomes of a conformable single-shot pulsed-field ablation catheter for the treatment of paroxysmal atrial fibrillation.

Background: Most single-shot pulsed-field ablation (PFA) catheters require extensive repositioning for pulmonary vein isolation (PVI), posing a challenge for obtaining contiguous, durable lesions.

Objective: To determine 1-year outcomes of a single-shot, all-in-one mapping and ablation PFA catheter for treating paroxysmal atrial fibrillation (PAF).

Methods: After PVI with the large-lattice catheter with expandable tip (Sphere-360), follow-up included Holter monitoring at 180 and 365 days and scheduled/symptomatic trans-telephonic monitoring (TTM) or modeled insertable loop recorder (ILR) data.

Acute Procedural Results of Pulsed Field Cryoablation for Persistent Atrial Fibrillation: Multicenter First-in-Human PARALELL Trial.

Introduction: Pulsed Field Cryoablation (PFCA) is a dual-energy cardiac ablation modality consisting of short-duration ultra-low temperature cryoablation (ULTC) followed immediately by pulsed field ablation (PFA) delivered from the same catheter. It is hypothesized that PFCA may improve contact stability during PFA, while maintaining lesion depth and effectiveness of ULTC.

Methods: PARALELL is a first-in-human multicenter study evaluating safety and effectiveness of a novel PFCA catheter and system in patients with persistent atrial fibrillation (PsAF) using the combination of pulmonary vein (PVI) and posterior wall (PWI) isolation.

Safety and effectiveness of the first balloon-in-basket pulsed field ablation system for the treatment of atrial fibrillation: VOLT CE Mark Study 6-month results.

Aims: Pulsed field ablation (PFA) is a growing ablation modality for pulmonary vein isolation (PVI) in atrial fibrillation (AF) patients. This study assesses the 6-month safety and effectiveness of a novel balloon-in-basket, mapping-integrated PFA system, with a purpose-built form factor for PVI.

Methods And Results: The VOLT CE Mark Study is a prospective, multi-center, pre-market study.

One-Year Safety and Performance of a Dual-Chamber Leadless Pacemaker.

Background: A dual-chamber leadless pacemaker can provide bradycardia therapy to most patients with pacemaker indications without the complications associated with a lead or pulse generator. We sought to confirm whether previously reported 3-month safety and performance outcomes were sustained through 12 months by determining whether 12-month complication-free and performance success rates exceeded their prespecified performance goals.

Methods: Patients were enrolled in the prospective, single-group Aveir DR i2i Study if they had a standard indication for dual-chamber pacing.

Dual-chamber leadless pacemaker implant procedural outcomes: Insights from the AVEIR DR i2i study.

Background: Initial results were recently reported for the AVEIR DR i2i study, which involved the percutaneous implantation of a novel dual-chamber leadless pacemaker (LP) system, with right atrial and right ventricular LPs delivering atrioventricular synchronous pacing.

Objective: The purpose of this study was to evaluate procedural outcomes and learning curve for de novo implantation of the dual-chamber LP (AVEIR DR, Abbott, Abbott Park, IL).

Methods: Implant procedure metrics collected during the study were analyzed, including procedural complications within 30 days of implantation.

Operator learning curve with a novel dual-energy lattice-tip ablation system.

Background: The SPHERE Per-AF trial demonstrated noninferiority for a primary composite effectiveness endpoint in patients with persistent atrial fibrillation (AF) treated with a 9-mm, lattice-tip, pulsed field (PF)/radiofrequency (RF) system (74%) vs conventional contact force-sensing RF (65%). Although operators were highly experienced with the control, the vast majority was new to the investigational system.

Objective: The aim of this study was to assess the learning curve using this novel system.

Repeat procedures after pulsed field ablation for atrial fibrillation: MANIFEST-REDO study.

Aims: Initial clinical studies of pulsed field ablation (PFA) to treat atrial fibrillation (AF) indicated a >90% durability rate of pulmonary vein isolation (PVI). However, these studies were largely conducted in single centres and involved a limited number of operators. We aimed to describe the electrophysiological findings and outcomes in patients undergoing repeat ablation after an initial PF ablation for AF.

Worldwide Chronic Retrieval Experience of Helix-Fixation Leadless Cardiac Pacemakers.

Background: The growing use of leadless pacemaker (LP) technology requires safe and effective solutions for retrieving and removing these devices over the long term.

Objectives: This study sought to evaluate retrieval and removal of an active helix-fixation LP studied in worldwide regulatory clinical trials.

Methods: Subjects enrolled in the LEADLESS II phase 1 investigational device exemption, LEADLESS Observational, or LEADLESS Japan trials with an attempted LP retrieval at least 6 weeks postimplantation were included.

Ten Years of Leadless Cardiac Pacing.

Leadless pacemakers (LPs) are self-contained pacemakers implanted inside the heart, providing a clinical strategy of pacing without pacemaker leads or a subcutaneous pocket. From an experimental therapy first used clinically in 2012, a decade later this technology is an established treatment option. Because of technologic advances and growing evidence, LPs are increasingly being used.

Association of biomarkers of cardiac remodeling, myocardial fibrosis and inflammation with parameters of heart function and structure in patients with arterial hypertension.

Backround And Aims: Early evaluation of cardiac remodeling may be useful in predicting heart failure in patients with arterial hypertension. The identification of biomarkers as useful clinical tools in this regard is ongoing. The aim of this study was to evaluate the association of selected cardiac biomarkers levels with parameters of cardiac structure and function in patients with arterial hypertension.

PVI-only is not enough for all patients with persistent AF: A FLOW-AF subgroup analysis.

Background: Since the Substrate and Trigger Ablation for Reduction of Atrial Fibrillation Trial Part II (STAR-AF II), there has been a trend toward pulmonary vein isolation (PVI)-only ablation strategies for persistent atrial fibrillation (PeAF). Electrographic flow (EGF) mapping can identify active sources of atrial fibrillation (AF) and estimate the electrographic flow consistency (EGFC) of wavefront propagation through substrate, revealing functional AF mechanisms.

Objective: We sought to examine the success of a PVI-only ablation strategy for a redo PeAF/longstanding PeAF population.