Evidence map›Paper›PMID 34922032›Full record

ReviewIndian pacing and electrophysiology journal

Efficacy and safety of leadless pacemaker: A systematic review, pooled analysis and meta-analysis.

Daniel Darlington, Philip Brown, Vanessa Carvalho, Hayley Bourne, Joseph Mayer, Nathan Jones, Vincent Walker, Shoaib Siddiqui, Ashish Patwala, Chun Shing Kwok

Abstract readReview
In one paragraph

Review in Indian pacing and electrophysiology journal. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Observational
  5. 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 · 2025
    Article
  6. Article
  7. Safety of Leadless Pacemaker Insertion in Nonagenarians.The Journal of innovations in cardiac rhythm management · 2025
    Article
  8. Article
  9. Article
  10. Review
  11. Article
  12. Comparison of in-hospital outcomes and complications of leadless pacemaker and traditional transvenous pacemaker implantation.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
    Article
  13. Initial studies on the implanting sites of high and low ventricular septa using leadless cardiac pacemakers.Annals of noninvasive electrocardiology : the official journal of the International Society for Holter and Noninvasive Electrocardiology, Inc · 2023
    Article
  14. Article
  15. Review
  16. Article
  17. The knowns and unknowns of leadless pacing in 2022.Indian pacing and electrophysiology journal
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Daniel DarlingtonDepartment of Cardiology, Royal Stoke University Hospital, Stoke-on-Trent, UK.
Philip BrownDepartment of Cardiology, Royal Stoke University Hospital, Stoke-on-Trent, UK.
Vanessa CarvalhoDepartment of Cardiology, Royal Stoke University Hospital, Stoke-on-Trent, UK.
Hayley BourneDepartment of Cardiology, Royal Stoke University Hospital, Stoke-on-Trent, UK.
Joseph MayerDepartment of Cardiology, Royal Stoke University Hospital, Stoke-on-Trent, UK.
Nathan JonesDepartment of Cardiology, Royal Stoke University Hospital, Stoke-on-Trent, UK.
Vincent WalkerDepartment of Cardiology, Royal Stoke University Hospital, Stoke-on-Trent, UK.
Shoaib SiddiquiDepartment of Cardiology, Royal Stoke University Hospital, Stoke-on-Trent, UK.
Ashish PatwalaDepartment of Cardiology, Royal Stoke University Hospital, Stoke-on-Trent, UK.
Chun Shing KwokDepartment of Cardiology, Royal Stoke University Hospital, Stoke-on-Trent, UK; School of Medicine, Keele University, Keele, UK. Electronic address: shingkwok@doctors.org.uk.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLeadless pacemakers have been designed as an alternative to transvenous systems which avoid some of the complications associated with transvenous devices. We aim to perform a systematic review of the literature to report the safety and efficacy findings of leadless pacemakers.

methodsWe searched MEDLINE and EMBASE to identify studies reporting the safety, efficacy and outcomes of patients implanted with a leadless pacemaker. The pooled rate of adverse events was determined and random-effects meta-analysis was performed to compare rates of adverse outcomes for leadless compared to transvenous pacemakers.

resultsA total of 18 studies were included with 2496 patients implanted with a leadless pacemaker and success rates range between 95.5 and 100%. The device or procedure related death rate was 0.3% while any complication and pericardial tamponade occurred in 3.1% and 1.4% of patients, respectively. Other complications such as pericardial effusion, device dislodgement, device revision, device malfunction, access site complications and infection occurred in less than 1% of patients. Meta-analysis of four studies suggests that there was no difference in hematoma (RR 0.67 95%CI 0.21-2.18, 3 studies), pericardial effusion (RR 0.59 95%CI 0.15-2.25, 3 studies), device dislocation (RR 0.33 95%CI 0.06-1.74, 3 studies), any complication (RR 0.44 95%CI 0.17-1.09, 4 studies) and death (RR 0.45 95%CI 0.15-1.35, 2 studies) comparing patients who received leadless and transvenous pacemakers.

conclusionLeadless pacemakers are safe and effective for patients who have an indication for single chamber ventricular pacing and the findings appear to be comparable to transvenous pacemakers.

Indexed as

Leadless pacemakerOutcomesSafetyTransvenous pacemaker

Identifiers

PMID34922032
PMCPMC8981159

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.