Evidence map›Paper›PMID 36484703›Full record

ArticleEuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology2023

A direct wire pacing device for transcatheter heart valve and coronary interventions: a first-in-human, multicentre study of the Electroducer Sleeve.

Jérôme Wintzer-Wehekind, Thierry Lefèvre, Hakim Benamer, Jacques Monsegu, Didier Tchétché, Philippe Garot, Benjamin Honton, Nicolas Dumonteil, Mohamed Abdellaoui

Open access · greenAbstract readMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology 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. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.9field-weighted citation impact, top 26% 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.

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

2 citing papers in PubMed, 4 citations in OpenAlex.

  1. Review
  2. 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

9 authors at 4 institutions in 1 country.

Jérôme Wintzer-WehekindInstitut Cardiovasculaire de Grenoble, Grenoble, France.
Thierry LefèvreInstitut Cardiovasculaire Paris Sud, Hôpital Privé Jacques Cartier, Massy, France.
Hakim BenamerInstitut Cardiovasculaire Paris Sud, Hôpital Privé Jacques Cartier, Massy, France.
Jacques MonseguInstitut Cardiovasculaire de Grenoble, Grenoble, France.
Didier TchétchéGroupe Cardiovasculaire Interventionnel, Clinique Pasteur, Toulouse, France.
Philippe GarotInstitut Cardiovasculaire Paris Sud, Hôpital Privé Jacques Cartier, Massy, France.
Benjamin HontonGroupe Cardiovasculaire Interventionnel, Clinique Pasteur, Toulouse, France.
Nicolas DumonteilGroupe Cardiovasculaire Interventionnel, Clinique Pasteur, Toulouse, France.
Mohamed AbdellaouiInstitut Cardiovasculaire de Grenoble, Grenoble, France.
Clinique Pasteur · FRMédipole Garonne · FRInstitut Cardiovasculaire Paris Sud · FRHôpital Privé Jacques Cartier · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTranscatheter aortic valve implantation (TAVI) and complex percutaneous coronary interventions (PCI) may require cardiac pacing during device delivery, generally requiring the insertion of a temporary pacing lead via an additional venous access site. The purpose-built Electroducer Sleeve device provides direct wire pacing without the need for a temporary venous pacemaker.

aimsThis study assessed the safety of temporary cardiac pacing using the novel sleeve device during PCI.

methodsThis was a multicentre, non-randomised, prospective, first-in-human, single-arm, pilot study. The primary endpoint was analysis of a safety outcome, defined as the occurrence of haematomas or bleeding complications at the device vascular access site. Secondary endpoints included analyses of effectiveness and qualitative outcomes.

resultsSixty patients (mean age: 77.9±9.6 years) from 4 centres in France were included: 39 (65%) underwent TAVI, and 21 (35%) underwent PCI. Procedures were performed using the sleeve with access through the radial (32 patients; 53.3%) or femoral arteries (26; 43.3%), or the femoral vein (2; 3.3%). Primary endpoint analysis revealed that 2 patients (3.3%) developed EArly Discharge After Transradial Stenting of CoronarY Arteries Study (EASY) grade I/Bleeding Academic Research Consortium (BARC) type I haematomas at the device access site. As a measure of effectiveness, a haemodynamic effect was observed after each spike delivery in 54 patients (90%). Analyses of other secondary endpoints showed that 2 patients (6.3%) presented asymptomatic radial artery occlusion. No allergies were reported.

conclusionsThis first-in-human trial using the Electroducer Sleeve indicated that this novel, purpose-built, temporary pacing device was safe and effective. Larger prospective studies are required to confirm these findings.

Indexed as

Aortic Valve StenosisPercutaneous Coronary InterventionTranscatheter Aortic Valve ReplacementAgedAged, 80 and overAortic ValveHematomaHumansPilot ProjectsProspective StudiesTreatment Outcome

Identifiers

PMID36484703
PMCPMC9976696
OpenAlexW4310962126

What OpenQuestion holds

Textmetadata
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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.