Evidence map›Paper›PMID 33387130›Full record

ArticleJournal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing2021

Reliability and longevity of implantable defibrillators.

Robert G Hauser, Susan A Casey, Christopher B Gitter, Chuen Y Tang, Raed H Abdelhadi, Charles C Gornick, Larissa Stanberry, Jay D Sengupta

Open access · hybridAbstract read
In one paragraph

Article in Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
2.8field-weighted citation impact, top 8% 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

9 citing papers in PubMed, 25 citations in OpenAlex.

  1. Worldwide data analysis of BIOTRONIK ICD and CRT-D battery longevity.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2026
    Article
  2. Incidence of premature battery depletion in subcutaneous cardioverter-defibrillator patients: insights from a multicenter registry.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2025
    Article
  3. Review
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  5. Occurrence of premature battery depletion in a large multicentre registry of subcutaneous cardioverter-defibrillator patients.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
    Article
  6. Review
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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

8 authors at 1 institution in 1 country.

Robert G HauserMinneapolis Heart Institute Foundation, 920 East 28th Street, Minneapolis, MN, 55407, USA. rhauser747@gmail.com.ORCID http://orcid.org/0000-0001-9172-1089
Susan A CaseyMinneapolis Heart Institute Foundation, 920 East 28th Street, Minneapolis, MN, 55407, USA.
Christopher B GitterMinneapolis Heart Institute Foundation, 920 East 28th Street, Minneapolis, MN, 55407, USA.
Chuen Y TangMinneapolis Heart Institute Foundation, 920 East 28th Street, Minneapolis, MN, 55407, USA.
Raed H AbdelhadiMinneapolis Heart Institute Foundation, 920 East 28th Street, Minneapolis, MN, 55407, USA.
Charles C GornickMinneapolis Heart Institute Foundation, 920 East 28th Street, Minneapolis, MN, 55407, USA.
Larissa StanberryMinneapolis Heart Institute Foundation, 920 East 28th Street, Minneapolis, MN, 55407, USA.
Jay D SenguptaMinneapolis Heart Institute Foundation, 920 East 28th Street, Minneapolis, MN, 55407, USA.
Minneapolis Heart Institute Foundation · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeWe hypothesized that data in manufacturers' product performance reports (PPRs) can provide clinically valuable ICD and cardiac resynchronization defibrillator (CRT-D) reliability and longevity information.

methodsData were obtained from 2019 PPRs. Kaplan-Meier (K-M) probabilities of freedom from malfunction, normal battery depletion (NBD), and NBD + malfunction were calculated for ICD and CRT-D pulse generators (PGs) with LiMnO2 or LiSVO/CFx batteries marketed in the USA from 2010 to 2019 and compared using the log-rank test. Malfunctions (MAL) included PGs that were found outside specifications.

resultsStudy population included 1,149,803 ICD and CRT-D PGs: Abbott (ABT; 35.1%), Biotronik (BIO; 4.6%), Boston Scientific (BSC; 23.5%), and Medtronic (MDT; 36.9%). Significant differences in reliability (p < 0.001), defined by freedom from MAL, were found between manufacturers; the majority of 6808 MAL occurred in ABT devices (n = 4045; 59.4%), followed by BSC (n = 2384; 35.0%), MDT (n = 338;5.0%), and BIO (n = 41; 0.6%). Battery failure (n = 890; 57.9%) was the most common cause of MAL compromising therapy; analysis of unique ABT battery MAL-indicated problem appeared a year prior to advisory. Significant differences (p < 0.001) in battery longevity, as defined by freedom from NBD, were found between manufacturers. Overall performance (freedom from NBD + MAL) favored BSC for CRT-D PGs and MDT and BIO for ICDs. BSC subcutaneous ICD reliability was inferior to its transvenous ICD (p < 0.001).

conclusionPPRs contain valuable data that can be aggregated and analyzed to inform physicians. Differences in product reliability exist between manufacturers. Battery longevity has improved, but MAL have significantly impacted performance. PPR data may be useful for assessing product problems and new technology.

Indexed as

Defibrillators, ImplantableDevice RemovalEquipment FailureHumansReproducibility of ResultsTime FactorsBatteryCardiac resynchronizationImplantable defibrillatorLongevityMalfunctionReliability

Identifiers

PMID33387130
PMCPMC8645539
OpenAlexW3115801265

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.