Evidence map›Paper›PMID 36036679›Full record

ArticleEuropace : 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

Rate and nature of complications with leadless transcatheter pacemakers compared with transvenous pacemakers: results from an Italian multicentre large population analysis.

Pietro Palmisano, Domenico Facchin, Matteo Ziacchi, Gerardo Nigro, Antonino Nicosia, Maria Grazia Bongiorni, Luca Tomasi, Andrea Rossi, Paolo De Filippo, Giuseppe Sgarito and 3 more

Registry-linked trialOpen access · hybridAbstract readMulticenter Study
In one paragraph

Article 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 NCT06656468 (Outcome of Patients Undergoing Leadless Pacemaker Implantaton), which is not on this map. Cited by 21 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 1 pooled it
5.7field-weighted citation impact, top 3% of its field
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.

NCT06656468 enrolling by invitationnot on this map

Outcome of Patients Undergoing Leadless Pacemaker Implantaton

Typeobservational_patient_registrySponsorAzienda Ospedaliera Cardinale G. PanicoRan2019 to 2026Enrolled900ConditionsBradyarrhythmiasArmsPacemaker and defibrillator
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 1 synthesis or guideline pooled it, 37 citations in OpenAlex.

  1. Success and complication rates of conduction system pacing: a meta-analytical observational comparison of left bundle branch area pacing and His bundle pacing.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2024
    Pooled it
  2. Two-year outcomes of leadless vs. transvenous single-chamber ventricular pacemaker in high-risk subgroups.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
    Trial
  3. Article
  4. Article
  5. Article
  6. Article
  7. Review
  8. 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 · 2025
    Article
  9. 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 · 2025
    Article
  10. Review
  11. Article
  12. Article
  13. Leadless pacing in young patients.European heart journal supplements : journal of the European Society of Cardiology · 2025
    Article
  14. Article
  15. Article
  16. Review
  17. Article
  18. Article
  19. Tissue-induced winding of permanent pacemaker passive-fixation leads.Quantitative imaging in medicine and surgery · 2023
    Article
  20. Review
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

13 authors at 8 institutions in 1 country.

Pietro PalmisanoCardiology Unit, "Card. G. Panico" Hospital, Tricase, Italy.ORCID 0000-0001-6705-6218
Domenico FacchinSOC Cardiologia-Dipartimento Cardiotoracico, Azienda Sanitaria Universitaria Friuli Centrale, Udine, Italy.
Matteo ZiacchiIstituto di Cardiologia, Policlinico Sant'Orsola Malpighi, Università degli Studi di Bologna, Bologna, Italy.
Gerardo NigroA.O. Monaldi, Napoli, Italy.ORCID 0000-0003-1776-8449
Antonino NicosiaAzienda Sanitaria Provinciale, Ospedale Giovanni Paolo II, Ragusa, Italy.
Maria Grazia BongiorniAzienda Ospedaliera Universitaria Ospedale Cisanello, Pisa, Italy.
Luca TomasiAzienda Ospedaliera Universitaria, Ospedale Borgo Trento, Verona, Italy.
Andrea RossiFondazione Toscana Gabriele Monasterio, Pisa.Italy.
Paolo De FilippoOspedale Giovanni Paolo XXIII, Bergamo, Italy.
Giuseppe SgaritoOspedale Civico, Palermo, Italy.
Roberto VerlatoULSS 6 Euganea, Camposampiero-Cittadella, Cittadella, Italy.
Michele Di SilvestroAzienda Sanitaria Provinciale, Ospedale Umberto I, Enna, Italy.
Saverio IacopinoMaria Cecilia Hospital, Cotignola, Italy.
Fondazione Toscana Gabriele Monasterio · ITIRCCS Azienda Ospedliero-Universitaria di Bologna Policlinico di Sant'Orsola · ITMaria Cecilia Hospital · ITOspedale Cisanello · ITOspedale Monaldi · ITOspedale Papa Giovanni XXIII · ITOspedali Riuniti Umberto I · ITProvincia Autonoma di Trento · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsThe safety and efficacy of leadless intracardiac-permanent pacemaker (L-PM) have been demonstrated in multiple clinical trials, but data on comparisons with conventional transvenous-permanent pacemaker (T-PM) collected in a consecutive, prospective fashion are limited. The aim of this analysis was to compare the rate and the nature of device-related complications between patients undergoing L-PM vs. T-PM implantation. METHODS AND

resultsProspective, multicentre, observational project enrolling consecutive patients who underwent L-PM or T-PM implantation. The rate and nature of device-related complications were analysed and compared between the two groups. Individual 1:1 propensity matching of baseline characteristics was performed. A total of 2669 (n = 665 L-PM) patients were included and followed for a median of 39 months, L-PM patients were on average older and had more co-morbidities. The risk of device-related complications at 12 months was significantly lower in the L-PM group (0.5% vs. 1.9%, P = 0.009). Propensity matching yielded 442 matched pairs. In the matched cohort, L-PM patients trended toward having a lower risk of overall device-related complications (P = 0.129), had a similar risk of early complications (≤30 days) (P = 1.000), and had a significantly lower risk of late complications (>30 days) (P = 0.031). All complications observed in L-PM group were early. Most (75.0%) of complications observed in T-PM group were lead- or pocket-related.

conclusionIn this analysis, the risk of device-related complications associated with L-PM implantation tended to be lower than that of T-PM. Specifically, the risk of early complications was similar in two types of PMs, while the risk of late complications was significantly lower for L-PM than T-PM.

Indexed as

Arrhythmias, CardiacPacemaker, ArtificialEquipment DesignHumansTime FactorsTreatment OutcomeComplicationsDevice infectionLeadless pacemakerLead-related complicationsPocket-related complicationsTransvenous pacemaker

Identifiers

PMID36036679
PMCPMC10103553
OpenAlexW4293445953

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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.