Evidence map›Paper›PMID 29748177›Full record

ArticleJournal of the American Heart Association2018

Risk Factors and Temporal Trends of Complications Associated With Transvenous Implantable Cardiac Defibrillator Leads.

Jayanthi N Koneru, Paul W Jones, Eric F Hammill, Nicholas Wold, Kenneth A Ellenbogen

Abstract read
In one paragraph

Article in Journal of the American Heart Association, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 52 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
52citing papers in PubMed, 2 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

52 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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  17. Implantable Defibrillators: Which Is the Best Device for Each Patient?Journal of cardiovascular electrophysiology · 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

5 authors.

Jayanthi N KoneruVCU School of Medicine, Medical College of Virginia Hospitals, Richmond, VA jayanthi.koneru@vcuhealth.org.
Paul W JonesBoston Scientific, Marlborough, MA.
Eric F HammillBoston Scientific, Marlborough, MA.
Nicholas WoldBoston Scientific, Marlborough, MA.
Kenneth A EllenbogenVCU School of Medicine, Medical College of Virginia Hospitals, Richmond, VA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe transvenous implantable cardioverter-defibrillator (ICD) lead is the most common source of complications in a traditional ICD system. This investigation aims to determine the incidence, predictors, and costs associated with these complications using a large insurance database. METHODS AND

resultsData from the OptumLabs™ Data Warehouse, which include diagnosis, physician and procedure codes, and claims from patient hospitalizations, were analyzed. Patients with a de novo ICD or cardiac resynchronization therapy defibrillator implanted from January 1, 2003, through June 30, 2015, were included; those who did not have continuous coverage beginning 1 year before implantation were excluded, resulting in 40 837 patients followed up over an average of 2.3±2.1 years. Patients were followed up until they had the procedure or their last active date in the database. Of 20 580 device procedures, 2165 (5.3%) and 771 (1.9%) had mechanical and infectious complications, respectively. The 5-year rate of freedom from mechanical complication was 92.0% and 89.3% for ICDs and cardiac resynchronization therapy defibrillators, respectively. Infectious complications were more likely in patients with a history of atrial fibrillation, diabetes mellitus, and renal disease, and the risk increased with subsequent device procedures. Younger age, female sex, lack of comorbidities, and implantations between 2003 and 2008 were associated with more mechanical complications.

conclusionsIncidence of mechanical and infectious complications of transvenous ICD leads over long-term follow-up is much higher in the real world than in clinical studies. In our study cohort, 1 of 4 transvenous ICD leads had mechanical complications when followed up to 10 years. The high rate of reintervention leads to additional complications.

Indexed as

Administrative Claims, HealthcareAgedData WarehousingDefibrillators, ImplantableElectric CountershockFemaleHealth Care CostsHumansIncidenceMaleMiddle AgedProgression-Free SurvivalProsthesis FailureProsthesis-Related InfectionsRisk AssessmentRisk Factorscomplicationimplantable cardioverter‐defibrillatorinfection

Identifiers

PMID29748177
PMCPMC6015312

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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.