Evidence map›Paper›PMID 35090007›Full record

ArticleEuropean heart journal2022

Subcutaneous implantable cardioverter-defibrillators: long-term results of the EFFORTLESS study.

Pier D Lambiase, Dominic A Theuns, Francis Murgatroyd, Craig Barr, Lars Eckardt, Petr Neuzil, Marcoen Scholten, Margaret Hood, Jȕrgen Kuschyk, Amy J Brisben and 4 more

Open access · hybridAbstract read
In one paragraph

Article in European heart journal, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 52 papers.

0numbers the graph read from it
0cells of the map it votes in
52citing papers in PubMed
10.5field-weighted citation impact, top 1% 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

52 citing papers in PubMed, 95 citations in OpenAlex.

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  11. Antithrombotic therapy and the risk of pocket hematoma after subcutaneous implantable cardioverter-defibrillator implantation.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2025
    Article
  12. Intermuscular two-incision technique for implantation of the subcutaneous implantable cardioverter defibrillator: a 3-year follow-up.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2025
    Article
  13. Article
  14. Subcutaneous cardioverter defibrillator implanted intermuscularly in patients with end-stage renal disease requiring hemodialysis: 5-year follow-up.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2025
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors at 12 institutions in 6 countries.

Pier D LambiaseInstitute of Cardiovascular Science, University College of London & Barts Heart Centre, West Smithfield, London EC1A 7BE, UK.ORCID 0000-0002-9055-9267
Dominic A TheunsDepartment of Cardiology, Erasmus Medical Center, Rotterdam, The Netherlands.ORCID 0000-0002-5160-9700
Francis MurgatroydDepartment of Cardiology, King's College Hospital, London, UK.ORCID 0000-0002-5527-7504
Craig BarrDepartment of Cardiology, Russells Hall Hospital, Dudley, UK.
Lars EckardtDepartment of Cardiology II, University Hospital, Muenster, Germany.
Petr NeuzilDepartment of Cardiology, Na Homolce Hospital, Prague, Czechia.ORCID 0000-0003-4334-8165
Marcoen ScholtenThorax Center, Medical Spectrum Twente, Enschede, The Netherlands.ORCID 0000-0002-2741-3775
Margaret HoodDepartment of Cardiology, Auckland City Hospital, Auckland, New Zealand.ORCID 0000-0002-8306-096X
Jȕrgen KuschykCardiology, Angiology, Hemostaseology and Internal Intensive Care Medicine, Faculty of Medicine Mannheim, University of Heidelberg, Heidelberg, Germany.
Amy J BrisbenRhythm Management Division, Boston Scientific, St Paul, MN, USA.ORCID 0000-0002-6519-3320
Nathan CarterRhythm Management Division, Boston Scientific, St Paul, MN, USA.
Timothy M StivlandRhythm Management Division, Boston Scientific, St Paul, MN, USA.ORCID 0000-0001-8169-1701
Reinoud KnopsDepartment of Cardiology, Amsterdam University Medical Centers, Amsterdam, The Netherlands.ORCID 0000-0002-0772-3573
Lucas V A BoersmaDepartment of Cardiology, Amsterdam University Medical Centers, Amsterdam, The Netherlands.ORCID 0000-0003-4591-4220
Boston Scientific (United States) · USAmsterdam University Medical Centers · NLAuckland City Hospital · NZBritish Heart Foundation · GBErasmus MC · NLHeidelberg University · DEKing's College Hospital · GBMedisch Spectrum Twente · NLNa Homolce Hospital · CZRussells Hall Hospital · GBSt. Antonius Ziekenhuis · NLUniversity Hospital Münster · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsTo report 5-year outcomes of EFFORTLESS registry patients with early generation subcutaneous implantable cardioverter-defibrillator (S-ICD) devices. METHODS AND

resultsKaplan-Meier, trend and multivariable analyses were performed for mortality and late (years 2-5) complications, appropriate shock (AS) and inappropriate shock (IAS) rates. Nine hundred and eighty-four of 994 enrolled patients with diverse diagnoses (28% female, 48 ± 17 years, body mass index 27 ± 6 kg/m2, ejection fraction 43 ± 18%) underwent S-ICD implantation. Median follow-up was 5.1 years (interquartile range 4.7-5.5 years). All-cause mortality was 9.3% (95% confidence interval 7.2-11.3%) at 5 years; 703 patients remained in follow-up on study completion, 171 withdrew including 87 (8.8%) with device explanted, and 65 (6.6%) lost to follow-up. Of the explants, only 20 (2.0%) patients needed a transvenous device for pacing indications. First and final shock efficacy for discrete ventricular arrhythmias was consistent at 90% and 98%, respectively, with storm episode final shock efficacy at 95.2%. Time to therapy remained unaltered. Overall 1- and 5-year complication rates were 8.9% and 15.2%, respectively. Early complications did not predict later complications. There were no structural lead failures. Inappropriate shock rates at 1 and 5 years were 8.7% and 16.9%, respectively. Self-terminating inappropriately sensed episodes predicted late IAS. Predictors of late AS included self-terminating appropriately sensed episodes and earlier AS.

conclusionIn this diverse S-ICD registry population, spontaneous shock efficacy was consistently high over 5 years. Very few patients underwent S-ICD replacement with a transvenous device for pacing indications. Treated and self-terminating arrhythmic episodes predict future shock events, which should encourage more personalized device optimization.

Indexed as

Defibrillators, ImplantableArrhythmias, CardiacDeath, Sudden, CardiacFemaleFollow-Up StudiesHumansMaleStroke VolumeTreatment OutcomeImplantable cardioverter-defibrillatorPrimary preventionSecondary preventionSubcutaneous ICDSudden death

Identifiers

PMID35090007
PMCPMC9156377
OpenAlexW4205265925

What OpenQuestion holds

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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.