Evidence map›Paper›PMID 33787324›Full record

Observational studyJournal of the American Heart Association2021

Dutch Outcome in Implantable Cardioverter-Defibrillator Therapy: Implantable Cardioverter-Defibrillator-Related Complications in a Contemporary Primary Prevention Cohort.

Marit van Barreveld, Tom E Verstraelen, Pascal F H M van Dessel, Lucas V A Boersma, Peter Paul H M Delnoy, Anton E Tuinenburg, Dominic A M J Theuns, Pepijn H van der Voort, Geert-Jan Kimman, Erik Buskens and 4 more

2 registry-linked trialsAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Journal of the American Heart Association, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
–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.

NCT07343466 recruitingnot on this mapstarted 2025, after this paper: background citation

Klinische Studie Zur Untersuchung Der Lebensqualität Und Des Einflusses Von Stress Auf Den Postoperativen Verlauf Von Patienten Nach Device-Implantation

TypeobservationalSponsorUniversity Hospital, EssenRan2025 to 2029Enrolled300ConditionsQuality of Life (QOL) and Impact of StressArmsSurvey using a questionnaire.
NCT07604727 nanot yet recruitingnot on this mapstarted 2026, after this paper: background citation

AV Nodal Ablation With Conduction System Pacing Versus Cardiac Resynchronization for Symptomatic Heart Failure Patients With Atrial Fibrillation: The APAF-CSP All-cause Mortality and Quality of Life Trial

TypeinterventionalSponsorUniversity Medical Center GroningenRan2026 to 2030Enrolled292ConditionsAtrial Fibrillation (AF), Heart Failure, Cardiac PacingArmsConduction System Pacing, Cardiac resynchronization therapy
3 · Its place in the literature

Who cites it

15 citing papers in PubMed.

  1. Article
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  11. Hospital utilisation and the costs associated with complications of ICD implantation in a contemporary primary prevention cohort.Netherlands heart journal : monthly journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation · 2023
    Article
  12. Review
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  14. Article
  15. Observational
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

14 authors.

Marit van BarreveldDepartment of Cardiology, Heart Center Amsterdam UMC, University of Amsterdam the Netherlands.
Tom E VerstraelenDepartment of Cardiology, Heart Center Amsterdam UMC, University of Amsterdam the Netherlands.
Pascal F H M van DesselDepartment of Cardiology, Thorax Center Twente Medisch Spectrum Twente Enschede the Netherlands.
Lucas V A BoersmaDepartment of Cardiology, Heart Center Amsterdam UMC, University of Amsterdam the Netherlands.
Peter Paul H M DelnoyDepartment of Cardiology Isala Klinieken Zwolle the Netherlands.
Anton E TuinenburgDivision of Heart and Lungs Department of Cardiology University Medical Centre Utrecht the Netherlands.
Dominic A M J TheunsDepartment of Cardiology Erasmus MC Rotterdam the Netherlands.
Pepijn H van der VoortDepartment of Cardiology Catharina Ziekenhuis Eindhoven Eindhoven the Netherlands.
Geert-Jan KimmanDepartment of Cardiology Noordwest Ziekenhuisgroep Alkmaar the Netherlands.
Erik BuskensDepartment of Epidemiology University Medical Centre Groningen Groningen the Netherlands.
Aeilko H ZwindermanDepartment of Epidemiology and Data Science Amsterdam UMC, University of Amsterdam the Netherlands.
Arthur A M WildeDepartment of Cardiology, Heart Center Amsterdam UMC, University of Amsterdam the Netherlands.
Marcel G W DijkgraafDepartment of Epidemiology and Data Science Amsterdam UMC, University of Amsterdam the Netherlands.
DO‐IT Registry Investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background One third of primary prevention implantable cardioverter-defibrillator patients receive appropriate therapy, but all remain at risk of defibrillator complications. Information on these complications in contemporary cohorts is limited. This study assessed complications and their risk factors after defibrillator implantation in a Dutch nationwide prospective registry cohort and forecasts the potential reduction in complications under distinct scenarios of updated indication criteria. Methods and Results Complications in a prospective multicenter registry cohort of 1442 primary implantable cardioverter-defibrillator implant patients were classified as major or minor. The potential for reducing complications was derived from a newly developed prediction model of appropriate therapy to identify patients with a low probability of benefitting from the implantable cardioverter-defibrillator. During a follow-up of 2.2 years (interquartile range, 2.0-2.6 years), 228 complications occurred in 195 patients (13.6%), with 113 patients (7.8%) experiencing at least one major complication. Most common ones were lead related (n=93) and infection (n=18). Minor complications occurred in 6.8% of patients, with lead-related (n=47) and pocket-related (n=40) complications as the most prevailing ones. A surgical reintervention or additional hospitalization was required in 53% or 61% of complications, respectively. Complications were strongly associated with device type. Application of stricter implant indication results in a comparable proportional reduction of (major) complications. Conclusions One in 13 patients experiences at least one major implantable cardioverter-defibrillator-related complication, and many patients undergo a surgical reintervention. Complications are related to defibrillator implantations, and these should be discussed with the patient. Stricter implant indication criteria and careful selection of device type implanted may have significant clinical and financial benefits.

Indexed as

Death, Sudden, CardiacDefibrillators, ImplantableElectric CountershockPostoperative ComplicationsAgedEquipment Failure AnalysisFemaleHumansMaleNeeds AssessmentNetherlandsPatient SelectionProsthesis ImplantationRegistriesReoperationRisk Assessmentcomplicationsimplantable cardioverter‐defibrillatorinappropriate shocksindication

Identifiers

PMID33787324
PMCPMC8174382

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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.