Evidence map›Paper›PMID 39210643›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 Cardiology2024

Comprehensive analysis of substernal lead removal: experience from EV ICD Pilot, Pivotal, and Continued Access Studies.

Venkata Sagi, Francis Murgatroyd, Lucas V A Boersma, Jaimie Manlucu, Bradley P Knight, Christophe Leclercq, Anish Amin, Ulrika Maria Birgersdotter-Green, Joseph Yat Sun Chan, Henri Roukoz and 8 more

Abstract read
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, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 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

14 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Evaluation of a second-generation intercostal extravascular implantable cardioverter defibrillator lead with a pectoral pulse generator for sensing, defibrillation, and anti-tachycardia pacing.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
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  10. The extravascular implantable defibrillator: a novel opportunity for the paediatric population.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
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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

18 authors.

Venkata SagiBaptist Heart Specialists, 836 Prudential Drive, Suite 1700, Jacksonville, FL 32207  USA.
Francis MurgatroydKing's College Hospital, London, UK.ORCID 0000-0002-5527-7504
Lucas V A BoersmaCardiology Department, St. Antonius Hospital Nieuwegein, Nieuwegein, The Netherlands.ORCID 0000-0003-4591-4220
Jaimie ManlucuDivision of Cardiology, London Health Sciences Centre, London, ON, Canada.
Bradley P KnightDivision of Cardiology, Northwestern University, Chicago, IL, USA.ORCID 0000-0002-2129-0401
Christophe LeclercqCardiology Department, CHU de Rennes-Hôpital Pontchaillou, Rennes, France.ORCID 0000-0002-4399-5568
Anish AminRiverside Methodist Hospital, Columbus, OH, USA.
Ulrika Maria Birgersdotter-GreenDivision of Cardiovascular Medicine, University of California San Diego (UCSD), San Diego, CA, USA.
Joseph Yat Sun ChanPrince of Wales Hospital, Chinese University of Hong Kong, Hong Kong, P. R. China.
Henri RoukozCardiology Division, Electrophysiology Section, University of Minnesota, Minneapolis, MN, USA.
Mauro BiffiIRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.ORCID 0000-0003-4590-8584
Haris HaqqaniSt. Vincent's Private Hospital Northside, Chermside, QLD, Australia.ORCID 0000-0003-1543-6686
Russell DenmanSt. Vincent's Private Hospital Northside, Chermside, QLD, Australia.ORCID 0000-0003-4819-6922
Christopher WiggenhornCardiac Rhythm Management, Medtronic Inc., Mounds View, MN, USA.
Thomas R HolmesCardiac Rhythm Management, Medtronic Inc., Mounds View, MN, USA.
Thomas LulicCardiac Rhythm Management, Medtronic Inc., Mounds View, MN, USA.
Paul FriedmanDepartment of Cardiovascular Medicine, Mayo Clinic, Rochester, MN, USA.ORCID 0000-0001-5052-2948
Ian CrozierChristchurch Hospital, Christchurch, New Zealand.ORCID 0000-0003-4652-7791

Funding

Medtronic Inc
6 · The paper itself

Abstract

aimsThe extravascular implantable cardioverter-defibrillator (EV ICD) has been shown to be safe and effective for patients at risk of sudden cardiac death, but little is known about EV ICD lead removal in humans. This analysis aimed to characterize the EV ICD lead removal experience thus far. METHODS AND

resultsThis was a retrospective analysis of lead removals from the EV ICD Pilot, Pivotal, and Continued Access Studies. Patients with a successful EV ICD implant who underwent lead removal were included. The main objective was lead removal success. Ancillary objectives included characterizing technique used, procedure complications, and reimplantation status. An EV ICD system was successfully implanted in 347 patients across the 3 studies (25.9% female; 53.4 ± 13.3 years; left ventricular ejection fraction: 39.7 ± 15.9). Of these patients, 29 (8.4%) underwent lead removal with a mean lead dwell time of 12.6 ± 14.3 months (0.2-58.4). The main reason for lead removal was lead dislodgement (n = 9, 31.0%). Lead removal was successful in 27/29 (93.1%) cases [100% (19/19) success rate <1 year and 80% (8/10) success rate >1 year post-implant]. Simple traction was used in 22/26 (84.6%) and extraction tools in 4/26 (15.4%) successful cases where technique was known. No complications were reported for any of the removal procedures. All 11 EV ICD reimplant attempts were successful.

conclusionComplete removal of the EV ICD lead was successful in 93.1% of cases, and simple traction was sufficient in most instances. Based on these results, lead removal from the substernal space was safe and achievable up to 3 years post-implant.

Indexed as

Defibrillators, ImplantableDevice RemovalAdultAgedDeath, Sudden, CardiacElectric CountershockFemaleHumansMaleMiddle AgedPilot ProjectsRetrospective StudiesTime FactorsTreatment OutcomeExplantExtractionExtravascular ICDLead removalSubsternal

Identifiers

PMID39210643
PMCPMC11420630

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Registered trials

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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.