Trial reportEuropace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology2023
Two-year outcomes of leadless vs. transvenous single-chamber ventricular pacemaker in high-risk subgroups.
Trial report in Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03039712 (Longitudinal Coverage With Evidence Development Study on Micra Leadless Pacemakers), which is not on this map. Cited by 38 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Longitudinal Coverage With Evidence Development Study on Micra Leadless Pacemakers
Who cites it
38 citing papers in PubMed.
- Battery longevity of a helix-fixation dual-chamber leadless pacemaker: results from the AVEIR DR i2i Study.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2025Trial
- Cost-effectiveness of leadless versus transvenous single-chamber ventricular pacing: a propensity-weighted real-world study in France.Annals of medicine · 2026Article
- Procedural Management of Atrial Fibrillation in Older Patients.Reviews in cardiovascular medicine · 2026Review
- Long-Term Outcomes of Leadless Pacemaker vs. Transvenous Pacemaker in End-Stage Renal Disease.Journal of cardiovascular electrophysiology · 2026Article
- Effective and potentially retrievable: will leadless pacemakers become gold standard for pause prevention pacing?European heart journal supplements : journal of the European Society of Cardiology · 2026Article
- Leadless atrial versus transvenous pacing for sinus node dysfunction: 1-year outcomes from the leadless ARRIVE real-world study.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2026Article
- Navigating the Lead Paradox: Successful Co-Implantation of Cardiac Contractility Modulation Device and a Micra Leadless Pacemaker.Journal of cardiovascular electrophysiology · 2026Article
- Safety of leadless versus transvenous pacemakers in patients with low body surface area: a matched-pair analysis.BMC cardiovascular disorders · 2026Article
- Identifying independent risk factors of mortality among patients receiving a leadless pacemaker: A longitudinal retrospective study in a single center.Heart rhythm O2 · 2026Article
- Precision patient selection for ablate-and-pace: a multi-center study comparing leadless pacemaker vs. standard pacemaker in patients with indication to ablate-and-pace for atrial fibrillation (LEAD-AP).Frontiers in cardiovascular medicine · 2026Article
- Successful Retrieval of a Drifting Dislodged Leadless Pacemaker From the Left Common Iliac Artery.Cureus · 2026Article
- Preferences of Patients and Cardiologists Regarding Pacemaker Characteristics in Spain: A Discrete Choice Experiment.Patient preference and adherence · 2026Article
- Global Research Trends and Hotspots in Cardiac Devices: A Bibliometric and Visual Analysis.Healthcare (Basel, Switzerland) · 2025Review
- [Leadless pacing: DDD-all goals achieved?]Herzschrittmachertherapie & Elektrophysiologie · 2025Review
- Micra leadless pacemaker revisions: incidence, characteristics, and outcomes from a multicentre French cohort.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2025Article
- Extravascular implantable cardioverter and leadless pacemaker interactions.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2025Article
- Leadless vs. transvenous pacemakers following transcatheter aortic valve replacement: a dual-centre propensity score-matched observational study.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2025Article
- Comparison of readmission outcomes and complications between leadless and traditional transvenous pacemakers in older adults: a nationwide readmission analysis of 49852 admission events.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2025Article
- Leadless vs. Transvenous Pacemakers in Patients with End-Stage Renal Disease: A Systematic Review and Meta-Analysis.Biomedicines · 2025Review
- First European experience with a leadless atrial pacemaker.Heart rhythm O2 · 2025Article
Corrections and comments
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Authors and funding
7 authors.
Funding
Abstract
aimsThis study compares clinical outcomes between leadless pacemakers (leadless-VVI) and transvenous ventricular pacemakers (transvenous ventricular permanent-VVI) in subgroups of patients at higher risk of pacemaker complications. METHODS AND
resultsThis study is based on the Micra Coverage with Evidence Development (CED) study. Patients from the Micra CED study were considered in a high-risk subgroup if they had a diagnosis of chronic kidney disease Stages 4-5 (CKD45), end-stage renal disease, malignancy, diabetes, tricuspid valve disease (TVD), or chronic obstructive pulmonary disease (COPD) 12 months prior to pacemaker implant. A pre-specified set of complications and reinterventions were identified using diagnosis and procedure codes. Competing risks models were used to compare reinterventions and complications between leadless-VVI and transvenous-VVI patients within each subgroup; results were adjusted for multiple comparisons. A post hoc comparison of a composite outcome of reinterventions and device complications was conducted. Out of 27 991 patients, 9858 leadless-VVI and 12 157 transvenous-VVI patients have at least one high-risk comorbidity. Compared to transvenous-VVI patients, leadless-VVI patients in four subgroups [malignancy, HR 0.68 (0.48-0.95); diabetes, HR 0.69 (0.53-0.89); TVD, HR 0.60 (0.44-0.82); COPD, HR 0.73 (0.55-0.98)] had fewer complications, in three subgroups [diabetes, HR 0.58 (0.37-0.89); TVD, HR 0.46 (0.28-0.76); COPD, HR 0.51 (0.29-0.90)) had fewer reinterventions, and in four subgroups (malignancy, HR 0.52 (0.32-0.83); diabetes, HR 0.52 (0.35-0.77); TVD, HR 0.44 (0.28-0.70); COPD, HR 0.55 (0.34-0.89)] had lower rates of the combined outcome.
conclusionIn a real-world study, leadless pacemaker patients had lower 2-year complications and reinterventions rates compared with transvenous-VVI pacing in several high-risk subgroups.
trial registrationClinicalTrials.gov ID NCT03039712.
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