Five-year safety and efficacy of leadless pacemakers in a Dutch cohort.

Background: Adequate real-world safety and efficacy of leadless pacemakers (LPs) have been demonstrated up to 3 years after implantation. Longer-term data are warranted to assess the net clinical benefit of leadless pacing.

Objective: The purpose of this study was to evaluate the long-term safety and efficacy of LP therapy in a real-world cohort.

On-screen image-guided lead placement in cardiac resynchronization therapy: Feasibility and outcome in a multicenter setting.

Background: Image guidance to assist left ventricular (LV) lead placement may improve outcome after cardiac resynchronization therapy (CRT), but previous approaches and results varied greatly, and multicenter feasibility is lacking altogether.

Objective: We sought to investigate the multicenter feasibility of image guidance for periprocedural assistance of LV lead placement for CRT.

Methods: In 30 patients from 3 hospitals, cardiac magnetic resonance imaging was performed within 3 months prior to CRT to identify myocardial scar and late mechanical activation (LMA).

Patient related outcomes of mechanical lead extraction techniques (PROMET) study: A comparison of two professions.

Background: With an increasing number of cardiac implantable electronic devices (CIEDs), there has been a paralleled increase in demand for transvenous lead extraction (TLE). Cardiac surgeons (CS) and cardiologists perform TLE; however, data comparing the two groups of operators is scarce.

Objective: We compared the outcomes of TLE performed by cardiologists and CS from six European lead extraction units.

Experience with malfunctioning leadless pacemakers: Troubleshooting and management during medium-term follow-up.

Background: The Nanostim leadless pacemaker (LP) was launched in 2012. However, the use of Nanostim LP was suspended because of safety concerns.

Objective: The aim of this study was to report our experience with the management of malfunctioning Nanostim LPs, including premature battery depletion.

Advanced image-supported lead placement in cardiac resynchronisation therapy: protocol for the multicentre, randomised controlled ADVISE trial and early economic evaluation.

Introduction: Achieving optimal placement of the left ventricular (LV) lead in cardiac resynchronisation therapy (CRT) is a prerequisite in order to achieve maximum clinical benefit, and is likely to help avoid non-response. Pacing outside scar tissue and targeting late activated segments may improve outcome. The present study will be the first randomised controlled trial to compare the efficacy of image-guided LV lead delivery to conventional CRT implantation.

Significantly less inappropriate shocks in ischemic patients compared to non-ischemic patients: The S-ICD experience of a high volume single-center.

Background: The subcutaneous cardioverter-defibrillator (S-ICD) continues to be preferentially used in relatively young patients, with less advanced heart disease.

Objective: We, therefore, studied the short and long-term efficacy and safety of the S-ICD in subgroups of patients, which are underreported at present.

Methods: A total of 218 patients between November 2010 and February 2019 undergoing S-ICD with a follow up of at least 6 months implantation were included in a prospective registry.

Transvenous lead extraction: The influence of age on patient outcomes in the PROMET study cohort.

Background: Cardiac implantable electronic device (CIED) therapy contributes to an improvement in morbidity and mortality across all patient demographics. Patient age is a recognized risk factor for unfavorable outcomes in invasive procedures. This is the largest series of non-laser transvenous lead extraction (TLE) evaluating the association between patient age and procedure outcomes.

Performance and outcomes of transvenous rotational lead extraction: Results from a prospective, monitored, international clinical study.

Background: Transvenous lead extraction (TLE) plays a critical role in managing patients with cardiovascular implantable electronic devices. Mechanical TLE tools, including rotational sheaths, are used to overcome fibrosis and calcification surrounding leads. Prospective clinical data are limited regarding the safety and effectiveness of use of mechanical TLE devices, especially rotational tools.

Hemodynamic monitoring by intracardiac impedance measured by cardiac resynchronization defibrillators: Evaluation in a controlled clinical setting (BIO.Detect HF II study).

Background: In patients with cardiac resynchronization therapy defibrillators (CRT-Ds), intracardiac impedance measured by dedicated CRT-D software may be used to monitor hemodynamic changes. We investigated the relationship of hemodynamic parameters assessed by intracardiac impedance and by echocardiography in a controlled clinical setting.

Methods: The study enrolled 68 patients (mean age, 66 ± 9 years; 74% males) at 12 investigational sites.

Modified design of stimulation of the left ventricular endocardium for cardiac resynchronization therapy in nonresponders, previously untreatable and high-risk upgrade patients (SOLVE-CRT) trial.

The WiSE system is a novel, leadless endocardial system that can provide cardiac resynchronization therapy in patients who cannot be treated with a conventional epicardial left ventricular lead. Safety and efficacy were being evaluated in the pivotal, randomized, double-blind SOLVE-CRT Trial (Stimulation of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy.) The trial was initiated in 2018; however, patient enrollment was significantly impacted by the COVID-19 pandemic necessitating a change in design.

Development and external validation of prediction models to predict implantable cardioverter-defibrillator efficacy in primary prevention of sudden cardiac death.

Aims: This study was performed to develop and externally validate prediction models for appropriate implantable cardioverter-defibrillator (ICD) shock and mortality to identify subgroups with insufficient benefit from ICD implantation.

Methods And Results: We recruited patients scheduled for primary prevention ICD implantation and reduced left ventricular function. Bootstrapping-based Cox proportional hazards and Fine and Gray competing risk models with likely candidate predictors were developed for all-cause mortality and appropriate ICD shock, respectively.

Complications in pulmonary vein isolation in the Netherlands Heart Registration differ with sex and ablation technique.

Aims: Pulmonary vein isolation (PVI) has become a cornerstone of the invasive treatment of atrial fibrillation. Severe complications are reported in 1-3% of patients. This study aims to compare complications and follow-up outcome of PVI in patients with atrial fibrillation.

ILEEM-survey on the Heart Team approach and team training for lead extraction procedures.

Background: The Heart Team approach has become an integral part of modern cardiovascular medicine. To evaluate current opinions and real-world practice among lead extraction practitioners, an online survey was created and distributed among a pool of lead extraction specialists participating in the International Lead Extraction Expert Meeting (ILEEM) 2018.

Methods: The online survey consisted of 10 questions and was performed using an online survey tool (www.

Subcutaneous or Transvenous Defibrillator Therapy.

Background: The subcutaneous implantable cardioverter-defibrillator (ICD) was designed to avoid complications related to the transvenous ICD lead by using an entirely extrathoracic placement. Evidence comparing these systems has been based primarily on observational studies.

Methods: We conducted a noninferiority trial in which patients with an indication for an ICD but no indication for pacing were assigned to receive a subcutaneous ICD or transvenous ICD.

Results of the Patient-Related Outcomes of Mechanical lead Extraction Techniques (PROMET) study: a multicentre retrospective study on advanced mechanical lead extraction techniques.

Aims: Several large studies have documented the outcome of transvenous lead extraction (TLE), focusing on laser and mechanical methods. To date there has been no large series addressing the results obtained with rotational lead extraction tools. This retrospective multicentre study was designed to investigate the outcomes of mechanical and rotational techniques.

Design and rationale for the Stimulation Of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy in non-responders and previously untreatable patients (SOLVE-CRT) trial.

Background: Cardiac resynchronization therapy (CRT) improves outcomes, functional capacity and quality of life in patients with heart failure. Despite two decades of experience with CRT, the rate of non-response remains approximately 30%. CRT efficacy is impacted by pacing location, which is anatomically limited in conventional systems.

Cardiac resynchronization therapy non-responder to responder conversion rate in the more response to cardiac resynchronization therapy with MultiPoint Pacing (MORE-CRT MPP) study: results from Phase I.

Aims: To assess the impact of MultiPoint™ Pacing (MPP)-programmed according to the physician's discretion-in non-responders to standard biventricular pacing after 6 months.

Methods And Results: The study enrolled 1921 patients receiving a quadripolar cardiac resynchronization therapy (CRT) system capable of MPP™ therapy. A core laboratory assessed echocardiography at baseline and 6 months and defined volumetric non-response to biventricular pacing as <15% reduction in left ventricular end-systolic volume (LVESV).

Rationale and design of a randomized clinical trial to assess the safety and efficacy of multipoint pacing therapy: MOre REsponse on Cardiac Resynchronization Therapy with MultiPoint Pacing (MORE-CRT MPP-PHASE II).

Background: Although cardiac resynchronization therapy (CRT) is beneficial in most heart failure patients, up to 40% do not respond to CRT. Data from the MultiPoint Pacing (MPP) IDE trial and MORE-CRT MPP-PHASE I study suggest improved response in subjects in the MPP arm-programmed with wide left ventricular (LV) electrode anatomical separation (≥30 mm) and shortest timing delays of 5 milliseconds (MPP-AS)-compared with quadripolar biventricular (BiV) pacing.

Study Design: The MORE-CRT MPP-PHASE II trial is a prospective, randomized, multicenter study to assess the 6-month impact of MPP programmed to mandated MPP-AS settings in subjects who do not respond to 6 months of BiV pacing (MPP OFF).

The learning curve associated with the implantation of the Nanostim leadless pacemaker.

Purpose: Use of novel medical technologies, such as leadless pacemaker (LP) therapy, may be subjected to a learning curve effect. The objective of the current study was to assess the impact of operators' experience on the occurrence of serious adverse device effects (SADE) and procedural efficiency.

Methods: Patients implanted with a Nanostim LP (Abbott, USA) within two prospective studies (i.

Primary safety results from the LEADLESS Observational Study.

Aims: A prospective, single-arm, multicentre, post-market study was conducted to confirm the short-term safety of the Nanostim™ leadless pacemaker (LP). In this study, we report the primary results of the LEADLESS Observational Study.

Methods And Results: Subjects meeting VVIR pacemaker indications were enrolled and followed up after successful LP implantation, prior to discharge and post-implantation at 90 days, 180 days, and every 6 months thereafter for the assessment of adverse events.

Cardiac Resynchronization Therapy With Wireless Left Ventricular Endocardial Pacing: The SELECT-LV Study.

Background: A total of 30% to 40% of patients with congestive heart failure eligible for cardiac resynchronization therapy (CRT) either do not respond to conventional CRT or remain untreated due to an inability or impediment to coronary sinus (CS) lead implantation. The WiSE-CRT system (EBR Systems, Sunnyvale, California) was developed to address this at-risk patient population by performing biventricular pacing via a wireless left ventricular (LV) endocardial pacing electrode.

Objectives: The SELECT-LV (Safety and Performance of Electrodes implanted in the Left Ventricle) study is a prospective multicenter non-randomized trial assessing the safety and performance of the WiSE-CRT system.

Contractility sensor-guided optimization of cardiac resynchronization therapy: results from the RESPOND-CRT trial.

Aims: Although cardiac resynchronization therapy (CRT) is effective in patients with systolic heart failure (HF) and a wide QRS interval, a substantial proportion of patients remain non-responsive. The SonR contractility sensor embedded in the right atrial lead enables individualized automatic optimization of the atrioventricular (AV) and interventricular (VV) timings. The RESPOND-CRT study investigated the safety and efficacy of the contractility sensor system in HF patients undergoing CRT.

Bifocal left ventricular stimulation or the optimal left ventricular stimulation site in cardiac resynchronization therapy: a pressure-volume loop study.

Aims: Several implantation strategies have been proposed to improve response to cardiac resynchronization therapy (CRT), including bifocal left ventricular (LV) stimulation and optimal single-LV lead placement. This study aimed to compare these two strategies during invasive pressure-volume (PV) loop measurements.

Methods And Results: Thirty-three patients eligible for CRT were included [21 (64%) men, 20 (61%) ischaemic aetiology, QRS 155 ± 23 ms], and underwent cardiac magnetic resonance (CMR) imaging and invasive PV loop measurements.