Publications by authors named "Pascal Defaye"

Aims: Clinical studies with protocol-mandated workflow and monitoring have analysed performance of pulsed field ablation (PFA) for treating atrial fibrillation (AF). The FARADISE registry captures global use of the pentaspline PFA catheter in real-world clinical practice with a follow-up of 3 years.

Methods And Results: FARADISE is a prospective, non-randomized, multi-national registry (NCT05501873) that enrolled subjects clinically indicated for ablation using the pentaspline PFA catheter per medical judgement and hospital standard-of-care.

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Background: Pulmonary vein (PV) isolation (PVI) using pulsed field ablation (PFA) is an emerging technique for the treatment of atrial fibrillation (AF). However, the recurrence rate of AF remains significant, and the durability of PVI is insufficient.

Objective: This study aimed to assess the impact of anatomical and geometrical features of the PV ostia on the PVI durability.

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Background: Most data on atrial fibrillation (AF) ablation using the first available pentaspline pulsed field ablation (PFA) catheter (Farapulse, Boston Scientific Inc) come from retrospective center-level registries collected in highly experienced centers.

Objective: This study aimed to provide exhaustive and prospective patient-level data on this new ablation modality.

Methods: FRANCE-PFA is a nationwide registry (NCT06497933) that included all patients undergoing a first AF ablation using the pentaspline PFA catheter since the introduction of this technology in France.

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Background: The subcutaneous implantable cardioverter-defibrillator (S-ICD) overcomes transvenous lead-related complications. Its extrathoracic design results in a generator twice the size of transvenous ICDs.

Objective: We investigated pain after S-ICD implantation and explore predictors for severe pain.

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Background: Defibrillation testing (DT) remains recommended during subcutaneous implantable cardioverter defibrillator (S-ICD) implantation due to limited supporting evidence.

Objectives: The objective of this study was to evaluate the long-term impact of DT during S-ICD implantation.

Methods: The HONEST (coHOrte fraNcaise des dEfibrillateurs Sous cuTanés) study is a nationwide, ongoing observational study, including all S-ICD recipients in France (2012-2019).

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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.

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Background And Aims: Current evidence on catheter ablation for patients with congenital heart disease (CHD) is derived from small, retrospective studies. This study aims to provide insights from a nationwide contemporary registry.

Methods: This prospective study included all CHD patients referred for catheter ablation from 2020 to July 2024 across 28 French centres.

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Background: Subcutaneous implantable cardioverter-defibrillators (S-ICDs) can be a viable option for patients with transvenous ICDs experiencing complications (rescue S-ICD).

Objectives: This study sought to evaluate the outcomes of rescue S-ICD implantation using data from the HONEST French nationwide S-ICD cohort.

Methods: All rescue S-ICD patients were identified.

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Up to one-third of patients referred for transcatheter tricuspid valve intervention (TTVI) have a transvalvular pacemaker (PPM) or implantable cardioverter-defibrillator (ICD) lead in place. Both the electrophysiology and interventional cardiology communities have been alerted to the complexity of decision-making in this situation due to potential interactions between the leads and the TTVI material, including the risk of jailing or damage to the leads. This document, commissioned by the European Heart Rhythm Association and the European Association of Percutaneous Cardiovascular Interventions of the ESC, reviews the scientific evidence to inform Heart Team discussions on the management of patients with a PPM or ICD who are scheduled for or have undergone TTVI.

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Aims: Cardiac resynchronization therapy (CRT) via biventricular pacing (BIVP) is an effective treatment, but non-responders are at a higher risk of death and heart failure (HF) hospitalizations compared with CRT responders. The MORE-CRT MPP trial aimed to evaluate whether CRT with multipoint pacing (MPP) is associated with improved clinical outcomes in CRT non-responders.

Methods And Results: Cardiac resynchronization therapy patients were treated with conventional BIVP for 6 months and then assessed for CRT response (left ventricular end-systolic volume relative reduction >15% vs.

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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.

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Introduction: Pulmonary vein isolation (PVI) using a cryoballoon is well-established for the treatment of paroxysmal atrial fibrillation (PAF). Compared to other available technologies, the usage of a stable, low-pressure cryoballoon (POLARx, Boston Scientific) has demonstrated lower nadir temperatures and longer thawing times. However, 1-year efficacy and safety still needs to be proven.

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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.

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Background: Cardiac amyloidosis (CA) is an increasingly recognized cardiomyopathy with an associated risk of arrhythmias and conduction disorders; however, managing arrhythmias and conductive disorders remains largely undefined.

Objectives: This study aims to gather French expert experience on current practices and treatment strategies for managing arrhythmias and conduction disorders in CA. The main areas of interest included atrial fibrillation (AF) management, anticoagulation therapy, and criteria for implanting cardiac rhythm devices.

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Background: Patient characteristics, technology and clinical practice surrounding primary prevention implantable cardioverter defibrillators have evolved continuously over time.

Aim: To explore the temporal changes in patient characteristics, pharmacological therapy and device types among implantable cardioverter defibrillator recipients implanted for the primary prevention of sudden cardiac death over the last two decades in France.

Methods: Characteristics of participants and type of device from the retrospective DAI-PP Pilot Study (2002-2012) were compared with those from the ongoing prospective DAI-PP Consortium (2018 onwards).

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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.

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Cardiac implantable electronic devices and their integrated thoracic impedance sensors have been used to detect sleep apnea for over a decade now. Despite their usage in daily clinical practice, there are only limited data on their diagnostic accuracy. AIRLESS and UPGRADE were prospective investigator-driven trials meant to validate the AP scan (Boston Scientific, Marlborough, MA, USA) in heart failure cohorts.

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Background: Adherence to recommended follow-up schedules for remote monitoring (RM) of patients with implantable cardioverter-defibrillators (ICDs) is inconsistent, which may influence clinical outcomes. Systematic organization through a "third-party" universal monitoring system (UMS) may be beneficial.

Objective: We aimed to evaluate the clinical impact of RM and any incremental benefit of UMS vs conventional RM.

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Article Synopsis
  • A new dual chamber leadless pacemaker system utilizes a temperature-based sensor to monitor heart rate response during exercise, focusing on its effectiveness in both the right ventricle and right atrium.
  • An exercise test was conducted 6 weeks post-implant on eligible subjects to evaluate the pacing response of the ventricular and atrial devices, measuring if the rate increased proportionately with metabolic workload.
  • Results showed that both the ventricular and atrial devices had mean rate-response slopes (0.93 and 0.91, respectively) within the acceptable range, indicating that the temperature-based sensor effectively adjusts pacing to meet increased metabolic demands.
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Background: On the one hand, climate change affects health and healthcare systems worldwide. On the other hand, the healthcare system contributes to environmental pollution. These environmental issues concern rhythmology, particularly because of the use of complex, often plastic, single-use devices.

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Atrial fibrillation (AF) is the primary cause of ischaemic stroke and transient ischaemic attack (TIA). AF is associated with a high risk of recurrence, which can be reduced using optimal prevention strategies, mainly anticoagulant therapy. The availability of effective prophylaxis justifies the need for a significant, coordinated and thorough transdisciplinary effort to screen for AF associated with stroke.

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