Evidence map›Paper›PMID 36459310›Full record

Observational studyJournal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing2023

CRT-D replacement strategy: results of the BioCONTINUE study.

Daniel Gras, Nicolas Clémenty, Sylvain Ploux, Yves Guyomar, Damien Legallois, Luca Segreti, Hugues Blangy, Gabriel Laurent, Olivier Bizeau, Sophie Fauquembergue and 2 more

Registry-linked trialAbstract readObservational Study
PubMed Publisher
In one paragraph

Observational study in Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02323503 (BIOtronik Study to Assess the CONTINUation of Existing Risk of Ventricular Arrhythmias After CRT-D Replacement for Patients With Primary Prevention Indication), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

NCT02323503 completednot on this map

BIOtronik Study to Assess the CONTINUation of Existing Risk of Ventricular Arrhythmias After CRT-D Replacement for Patients With Primary Prevention Indication

Typeobservational_patient_registrySponsorBiotronik SE & Co. KGRan2015 to 2020Enrolled289ConditionsCardiac Resynchronization, Biventricular Pacemakers, Artificial, Cardioverter-Defibrillators, Implantable, Device ReplacementArmsCRT-D device replacement
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Downgrade from CRT-D to CRT-P at time of generator replacement: a true clinical conundrum or just an academic debate?Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2023
    Article
  3. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors.

Daniel GrasHôpital Privé du Confluent, 2-4 Rue Eric Tabarly, 44200, Nantes, France. dangras@aol.com.ORCID http://orcid.org/0000-0002-7980-6036
Nicolas ClémentyCentre Hospitalier Universitaire Tours, Tours, France.
Sylvain PlouxIHU Liryc, Electrophysiology and Heart Modeling Institute, Fondation Bordeaux Université, Bordeaux University Hospital (CHU), Cardio-Thoracic Unit, 33600, Pessac, France.
Yves GuyomarCentre Hospitalier Saint Philibert, Lomme, France.
Damien LegalloisCentre Hospitalier Universitaire Caen, Caen, France.
Luca SegretiHospital Santa Chiara, Cisanello, Italy.
Hugues BlangyHôpital Brabois, Nancy, France.
Gabriel LaurentCentre Hospitalier Universitaire du Bocage, Dijon, France.
Olivier BizeauCentre Hospitalier Régional Orléans La Source, Orléans, France.
Sophie FauquembergueBIOTRONIK France SAS, Rungis, France.
Arnaud LazarusClinique Ambroise Paré, Neuilly Sur Seine, France.
BioCONTINUE study Investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn patients with cardiac resynchronization therapy defibrillators (CRT-Ds), the need for implantable cardioverter-defibrillator (ICD) back-up may be questionable at time of CRT-D replacement (REP) if ICD implant criteria are no longer met due to an improved left ventricular ejection fraction (LVEF) and if no major ventricular arrhythmic event (VAE) occurred during the CRT-D lifetime. The aim of our study was to assess the relevance of ICD back-up and predictors of VAE after REP in primary prevention CRT-D patients.

methodsThe prospective, observational, international BioCONTINUE study investigated the rate of patients with at least 1 sustained VAE (sVAE) post-REP and searched for predictive factors of sVAE.

resultsTwo hundred seventy-six patients (70 ± 10 years, 77% men, mean LVEF 40.6 ± 12.6%) were followed for 28.4 ± 10.2 months. The rate of patients with sVAE was 8.3%, 10.3%, and 21.2% at 1, 2, and 4 years post-REP. Patients without persistent ICD indication at REP still had a sVAE rate of 5.7% (95% CI 2.3-11.5%) at 2 years. In multivariate analysis, predictive factors of subsequent sVAE were (i) persistent ICD indication (hazard ratio (HR) 3.6; 95% CI 1.6-8.3; p = 0.003); (ii) 64-72 years of age as compared to ≥ 79 years (HR 3.7; 95% CI 1.4-9.7; p = 0.008); and (iii) ischemic heart disease (HR 4.4; 95% CI 2.1-9.3; p < 0.0001).

conclusionsThe risk of sVAE (21.2% at 4 years post-REP) depends on age, ischemic heart disease, and ICD indication at the time of REP. A non-trivial risk of sVAE remains in patients without persistent ICD indication. CLINICAL

trial registrationNCT02323503.

Indexed as

Cardiac Resynchronization TherapyDefibrillators, ImplantableHeart FailureMyocardial IschemiaTachycardia, VentricularAgedFemaleHumansMaleMiddle AgedProspective StudiesRisk FactorsStroke VolumeTreatment OutcomeVentricular Function, LeftCardiac resynchronization therapy (CRT)ICD replacementImplantable cardioverter-defibrillator (ICD)Primary ICD indicationsSudden deathVentricular arrhythmia

Identifiers

PMID36459310

What OpenQuestion holds

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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.