SynthesisJournal of the American Heart Association2021
Safety and Efficacy of Leadless Pacemakers: A Systematic Review and Meta-Analysis.
Synthesis in Journal of the American Heart Association, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 58 papers, 5 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
58 citing papers in PubMed, 5 syntheses or guidelines pooled it, 91 citations in OpenAlex.
- Pacing-Induced Cardiomyopathy in Leadless and Transvenous Pacemakers: A Meta-Analysis and Meta-Regression.Pacing and clinical electrophysiology : PACE · 2026Pooled it
- Systematic Review and Meta-Analysis of Acute Mortality and Complication Rates Following Leadless Pacemaker Placement Using National-Level Data.Medicina (Kaunas, Lithuania) · 2025Pooled it
- The Effectiveness and Safety of Leadless Pacemakers: An Updated Meta-Analysis.Current cardiology reports · 2024Pooled it
- Outcomes of primary leadless pacemaker implantation: A systematic review.Annals of noninvasive electrocardiology : the official journal of the International Society for Holter and Noninvasive Electrocardiology, Inc · 2023Pooled it
- Safety and Efficacy of Leadless Pacemakers: A Systematic Review and Meta-Analysis.Journal of the American Heart Association · 2021Pooled it
- EACTS Expert Consensus Document on Civil Aviation Following Cardiothoracic Surgery and Transcatheter Procedures.Interdisciplinary cardiovascular and thoracic surgery · 2026Review
- Leadless pacemaker implantation during pregnancy: Quantitative assessment of fetal radiation exposure.Heart rhythm O2 · 2026Article
- Pacemaker Lead Perforation Leading to Cardiac Tamponade and Subsequent Anterior STEMI.JACC. Case reports · 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
- [Update on the perioperative management of cardiac implantable electronic devices].Die Anaesthesiologie · 2026Review
- Safety and efficacy of leadless pacemakers: A systematic review and meta-analysis.Heart rhythm O2 · 2026Review
- Successful Retrieval of a Drifting Dislodged Leadless Pacemaker From the Left Common Iliac Artery.Cureus · 2026Article
- Extraction and reimplantation of cardiac implantable electronic devices in patients with non-surgically treated infective endocarditis: a nationwide cohort study.European heart journal open · 2026Article
- Safety and efficacy of completely transthoracic echocardiography guided leadless pacemaker implantation assisted by Panna guide wire: initial clinical experience.Frontiers in cardiovascular medicine · 2026Article
- Article
- Pacing-induced cardiomyopathy following leadless and transvenous pacemaker implantation: A multicenter retrospective study.Heart rhythm O2 · 2025Article
- Article
- Article
- Advancements in biodegradable implants: evaluation in large animal surgical models.Annals of medicine and surgery (2012) · 2025Review
- Materials Advances in Devices for Heart Disease Interventions.Advanced materials (Deerfield Beach, Fla.) · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background Leadless pacemaker is a novel technology, and evidence supporting its use is uncertain. We performed a systematic review and meta-analysis to examine the safety and efficacy of leadless pacemakers implanted in the right ventricle. Methods and Results We searched PubMed and Embase for studies published before June 6, 2020. The primary safety outcome was major complications, whereas the primary efficacy end point was acceptable pacing capture threshold (≤2 V). Pooled estimates were calculated using the Freedman-Tukey double arcsine transformation. Of 1281 records screened, we identified 36 observational studies of Nanostim and Micra leadless pacemakers, with most (69.4%) reporting outcomes for the Micra. For Micra, the pooled incidence of complications at 90 days (n=1608) was 0.46% (95% CI, 0.08%-1.05%) and at 1 year (n=3194) was 1.77% (95% CI, 0.76%-3.07%). In 5 studies with up to 1-year follow-up, Micra was associated with 51% lower odds of complications compared with transvenous pacemakers (3.30% versus 7.43%; odds ratio [OR], 0.49; 95% CI, 0.34-0.70). At 1 year, 98.96% (95% CI, 97.26%-99.94%) of 1376 patients implanted with Micra had good pacing capture thresholds. For Nanostim, the reported complication incidence ranged from 6.06% to 23.54% at 90 days and 5.33% to 6.67% at 1 year, with 90% to 100% having good pacing capture thresholds at 1 year (pooled result not estimated because of the low number of studies). Conclusions Most studies report outcomes for the Micra, which is associated with a low risk of complications and good electrical performance up to 1-year after implantation. Further data from randomized controlled trials are needed to support the widespread adoption of these devices in clinical practice.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.