Aims: Leadless pacing has emerged as an alternative to conventional transvenous pacemakers to mitigate the risks of pocket- and lead-related complications but its use remains controversial in young adults mostly because experience in this patient population is limited. We sought to examine the feasibility and safety of implanting leadless single chamber pacemakers in young adults.
Methods: This multicenter, retrospective, observational study sought to evaluate the safety, efficacy, and electrical performance of the Micra VR Transcatheter Pacemaker System (Medtronic) in patients between 18 and 40 years who underwent implantation of a leadless pacemaker for any indication at the university medical centers of Bordeaux, Clermont-Ferrand, Toulouse, and Tours (France), between 2015 and 2021.
Background: Temporary transvenous pacing in critically ill patients requiring prolonged cardiac pacing is associated with a high risk of complications. We sought to evaluate the safety and efficacy of self-contained intracardiac leadless pacemaker (LPM) implantation in this population.
Methods And Results: Consecutive patients implanted with a Micra LPM during the hospitalization in an intensive care unit were retrospectively included.
Introduction: MARVEL 2 assessed the efficacy of mechanical atrial sensing by a ventricular leadless pacemaker, enabling a VDD pacing mode. The behavior of the enhanced MARVEL 2 algorithm during variable atrio-ventricular conduction (AVC) and/or arrhythmias has not been characterized and is the focus of this study.
Methods: Of the 75 patients enrolled in the MARVEL 2 study, 73 had a rhythm assessment and were included in the analysis.
Background: Frequency and distribution of left ventricular (LV) venous collaterals were studied in vivo to evaluate the ease and feasibility of implanting a new ultra-thin LV quadripolar microlead for cardiac resynchronization therapy (CRT).
Methods and results: Evaluable venograms were analyzed to define the prevalence of venous collaterals (>0.5 mm diameter) between: (1) different LV segments; and (2) different major LV veins in: unselected patients who underwent CRT from 2008 to 2012 at Rouen Hospital, France (retrospective); and CRT patients from the Axone Acute pilot study in 2018 (prospective).
Aims: We aimed to provide contemporary real-world data on wearable cardioverter-defibrillator (WCD) use, not only in terms of effectiveness and safety but also compliance and acceptability.
Methods And Results: Across 88 French centres, the WEARIT-France study enrolled retrospectively patients who used the WCD between May 2014 and December 2016, and prospectively all patients equipped for WCD therapy between January 2017 and March 2018. All patients received systematic education session through a standardized programme across France at the time of initiation of WCD therapy and were systematically enrolled in the LifeVest Network remote services.
Background: The Heart Rhythm Society, the European Heart Rhythm Association, the Asia Pacific Heart Rhythm Society, the Latin American Heart Rhythm Society expert consensus statement on optimal implantable cardioverter-defibrillator programming recommends burst antitachycardia pacing (ATP) for the treatment of ventricular tachycardia (VT) up to high rates. The number of bursts is not specified, and treatment by ramps or low-energy shocks is not recommended.
Objectives: We investigated the efficacy and safety of progressive therapies for VTs between 150 and 200 beats/min.
Background: The MARVEL (Micra Atrial TRacking Using a Ventricular AccELerometer) 2 study assessed the efficacy of atrioventricular (AV) synchronous pacing with a Micra leadless pacemaker. Average atrioventricular synchrony (AVS) was 89.2%.
View Article and Find Full Text PDFBackground: Morphology algorithms are currently recommended as a standalone discriminator in single-chamber implantable cardioverter defibrillators (ICDs). However, these proprietary algorithms differ in both design and nominal programming.
Objective: To compare three different algorithms with nominal versus advanced programming in their ability to discriminate between ventricular (VT) and supraventricular tachycardia (SVT).
Background: Loss of biventricular stimulation can result in nonresponse to cardiac resynchronization therapy (CRT). Problems associated with the left ventricular (LV) lead and LV sensing can be challenging to detect and their incidence is unclear. The purpose of this study was to investigate mechanisms of loss of biventricular pacing due to LV lead- and LV sensing-associated problems.
View Article and Find Full Text PDFIntroduction: We investigated whether pacing-induced electrical dyssynchrony at the time of cardiac resynchronization therapy (CRT) device implantation was associated with chronic CRT response.
Methods And Results: We included a total of 69 consecutive heart failure patients who received a CRT device. Left (LVp-RVs) and right (RVp-LVs) pacing-induced interlead delays were measured intraoperatively and used to determine if there was paced left ventricular (LV) dyssynchrony, defined as present when LVp-RVs is larger than RVp-LVs.
Objectives: This study reports on the performance of a leadless ventricular pacemaker with automated, enhanced accelerometer-based algorithms that provide atrioventricular (AV) synchronous pacing.
Background: Despite many advantages, leadless pacemakers are currently only capable of single-chamber ventricular pacing.
Methods: The prospective MARVEL 2 (Micra Atrial tRacking using a Ventricular accELerometer 2) study assessed the performance of an automated, enhanced accelerometer-based algorithm downloaded to the Micra leadless pacemaker for up to 5 h in patients with AV block.
Aims: Patient selection is a key component of securing optimal patient outcomes with leadless pacing. We sought to describe and compare patient characteristics and outcomes of Micra patients with and without a primary pacing indication associated with atrial fibrillation (AF) in the Micra IDE trial.
Methods And Results: The primary outcome (risk of cardiac failure, pacemaker syndrome, or syncope related to the Micra system or procedure) was compared between successfully implanted patients from the Micra IDE trial with a primary pacing indication associated with AF or history of AF (AF group) and those without (non-AF group).
Background: Optimal timing of the atrioventricular delay in cardiac resynchronization therapy (CRT) can improve synchrony in patients suffering from heart failure. The purpose of this study was to evaluate the impact of SyncAV™ on electrical synchrony as measured by vectorcardiography (VCG) derived QRS metrics during bi-ventricular (BiV) pacing.
Methods: Patients implanted with a cardiac resynchronization therapy (CRT) device and quadripolar left ventricular (LV) lead underwent 12‑lead ECG recordings.
Aims: To identify independent electrocardiogram (ECG) predictors of long-term clinical outcome based on standardized analysis of the surface ECG in a large multicentre cohort of patients with sarcomeric hypertrophic cardiomyopathy (HCM).
Methods And Results: Retrospective observational study from the REMY French HCM clinical research observatory. Primary endpoint was a composite of all-cause mortality, major non-fatal arrhythmic events, hospitalization for heart failure (HF), and stroke.
J Interv Card Electrophysiol
December 2019
Background: Subcutaneous implantable cardioverter-defibrillator (S-ICD) implantations are rapidly expanding. However, the subcutaneous detection and interpretation of cardiac signals in S-ICDs is much more challenging than by conventional devices. There is a complete paradigm shift in cardiac signal sensing with subcutaneous signal detection, leading in some cases to oversensing with restricted programming options.
View Article and Find Full Text PDFBackground: The Micra clinical trials have enrolled more than 2500 patients without any reported device-related infections that required removal during follow-up. Leadless pacemakers might be more resistant to bacterial seeding due to smaller surface area and a greater tendency for encapsulation.
Objective: To analyze the incidence and outcomes of serious infectious events (SIEs: bacteremia or endocarditis) that developed during follow-up in patients with history of Micra leadless pacemaker implantation.
Introduction: Some cardiac resynchronization therapy (CRT) device manufacturers (Biotronik, Germany; Boston Scientific, United States) have implemented left ventricular (LV) sensing functionality to prevent pacing into the vulnerable phase. Physicians are only partially aware of programming pitfalls related to LV sensing and general programming advice is lacking.
Methods And Results: We provide an illustrative case-series-based review of the variety of potential problems with LV sensing.
Background The natural history and long-term outcome in pediatric patients with idiopathic ventricular fibrillation ( IVF ) are poorly characterized. We sought to define the clinical characteristics and long-term outcomes of a pediatric cohort with an initial diagnosis of IVF . Methods and Results Patients were included from an International Registry of IVF (consisting of 496 patients).
View Article and Find Full Text PDFHeart Rhythm
September 2019
Background: Inappropriate shocks (IS) continue to have a major negative impact on patients implanted with defibrillators.
Objective: The purpose of this study was to assess IS reduction with the PARAD+ discrimination algorithm in a general population implanted for primary or secondary prevention.
Methods: ISIS-ICD (Inappropriate Shock Reduction wIth PARAD+ Rhythm DiScrimination-Implantable Cardioverter Defibrillator) was a 2-year international, interventional study in patients implanted with a dual implantable cardioverter-defibrillator (ICD) or triple-chamber defibrillator (cardiac resynchronization therapy-defibrillator [CRT-D]) featuring PARAD+.
Objective: Mechanical evaluation of dyssynchrony by echocardiography has not replaced ECG in routine cardiac resynchronisation therapy (CRT) evaluation because of its complexity and lack of reproducibility. The objective of this study was to evaluate the potential correlations between electromechanical parameters (atrioventricular, interventricular and intraventricular from the dyssynchrony model presented in 2000), their ability to describe dyssynchrony and their potential use in resynchrony.
Methods: 455 sets of the 18 parameters of the model obtained in 91 patients submitted to various pacing configurations were evaluated two by two using a Pearson correlation test and then by groups according to their ability to describe dyssynchrony, using the Column selection method of machine learning.
Introduction: The MARVEL study demonstrated at a single time point that accelerometer (ACC)-based atrial sensing improves atrioventricular (AV) synchrony (AVS) in patients with AV block and a Micra pacemaker (Medtronic, Minneapolis, MN, USA). The purpose of the MARVEL Evolve substudy was to assess the performance over time.
Methods: This prospective single-center study compared AVS and ACC signals at two visits ≥6 months apart.
Background: Patient-specific programming of cardiac resynchronization therapy (CRT) is often neglected, despite significant nonresponse rates. The device-based SyncAV CRT algorithm dynamically adjusts atrioventricular delays to the intrinsic AV interval, reduced by a programmable offset, to accommodate each patient's changing needs.
Objective: The purpose of this study was to evaluate the acute effect of biventricular (BiV) pacing enhanced by SyncAV on electrical synchrony in a broad patient population.