Evidence map›Paper›PMID 27797979›Full record

ArticleBMJ open2016

Prognosis assessment of persistent left bundle branch block after TAVI by an electrophysiological and remote monitoring risk-adapted algorithm: rationale and design of the multicentre LBBB-TAVI Study.

Grégoire Massoullié, Pierre Bordachar, Didier Irles, Christophe Caussin, Antoine Da Costa, Pascal Defaye, Frédéric Jean, Alexis Mechulan, Pierre Mondoly, Géraud Souteyrand and 3 more

2 registry-linked trialsOpen access · goldAbstract readMulticenter Study
In one paragraph

Article in BMJ open, 2016. 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 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
1.3field-weighted citation impact, top 16% 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.

NCT02482844 phase4unknown statusnot on this map

Assessment of the Prognosis of Persistent Left Bundle Branch Block (LBBB) After Transcatheter Aortic Valve Implantation (TAVI ) by an Electrophysiological and Remote Monitoring Risk-adapted Algorithm

TypeinterventionalSponsorUniversity Hospital, Clermont-FerrandRan2015 to 2017Enrolled200ConditionsPost-TAVIArmspacemaker implantation, holter implantation
NCT06602609 narecruitingnot on this mapstarted 2024, after this paper: background citation

Remote Acute Monitoring-based Same-day Discharge Strategy of Post Transcatheter Aortic Valve Implantation Patients Versus Standard Care at 30-Day Follow-up

TypeinterventionalSponsorImperial College LondonRan2024 to 2028Enrolled216ConditionsAortic Valve Stenosis, Cardiac Conduction Disturbance, Digital Health, Transcatheter Aortic Valve ImplantationArmsRemote Patient Monitoring Strategy, Standard Medical Therapy
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 23 citations in OpenAlex.

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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

13 authors at 10 institutions in 1 country.

Grégoire MassoulliéClermont Université, Université d'Auvergne, Cardio Vascular Interventional Therapy and Imaging (CaVITI), Image Science for Interventional Techniques (ISIT), UMR6284, Clermont-Ferrand, France.
Pierre BordacharHôpital Cardiologique du Haut-Lévêque, CHU Bordeaux, Université Bordeaux, IHU LIRYC, Bordeaux, France.
Didier IrlesCardiology Department, CH Annecy Genèvois, Pringy, France.
Christophe CaussinInstitut Mutualiste Montsouris, Paris, France.
Antoine Da CostaNorth Hospital, Saint-Etienne, France.
Pascal DefayeArrhythmia Unit, Cardiology Department, University Hospital, Grenoble, France.
Frédéric JeanClermont Université, Université d'Auvergne, Cardio Vascular Interventional Therapy and Imaging (CaVITI), Image Science for Interventional Techniques (ISIT), UMR6284, Clermont-Ferrand, France.
Alexis MechulanRamsay Générale de Santé, Hôpital Privé de Clairval, Marseille, France.
Pierre MondolyFederation of Cardiology, University Hospital Rangueil, Toulouse cedex, France.
Géraud SouteyrandClermont Université, Université d'Auvergne, Cardio Vascular Interventional Therapy and Imaging (CaVITI), Image Science for Interventional Techniques (ISIT), UMR6284, Clermont-Ferrand, France.
Bruno PereiraCHU Clermont-Ferrand, Biostatistics unit (Clinical Research and Innovation Direction), Clermont-Ferrand, France.
Sylvain PlouxHôpital Cardiologique du Haut-Lévêque, CHU Bordeaux, Université Bordeaux, IHU LIRYC, Bordeaux, France.
Romain EschalierClermont Université, Université d'Auvergne, Cardio Vascular Interventional Therapy and Imaging (CaVITI), Image Science for Interventional Techniques (ISIT), UMR6284, Clermont-Ferrand, France.
Université Clermont Auvergne · FRCentre Hospitalier Universitaire de Clermont-Ferrand · FRCentre Hospitalier Annecy Genevois · FRCentre Hospitalier Universitaire de Saint-Étienne · FRElectrophysiology and Heart Modeling Institute · FRGénérale de Santé · FRHôpital Cardiologique du Haut-Lévêque · FRHôpital Rangueil · FRInstitute Mutualiste Montsouris · FRUniversité Grenoble Alpes · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPercutaneous aortic valve replacement (transcatheter aortic valve implantation (TAVI)) notably increases the likelihood of the appearance of a complete left bundle branch block (LBBB) by direct lesion of the LBB of His. This block can lead to high-grade atrioventricular conduction disturbances responsible for a poorer prognosis. The management of this complication remains controversial. METHOD AND ANALYSIS: The screening of LBBB after TAVI persisting for more than 24 hours will be conducted by surface ECG. Stratification will be performed by post-TAVI intracardiac electrophysiological study. Patients at high risk of conduction disturbances (≥70 ms His-ventricle interval (HV) or presence of infra-Hisian block) will be implanted with a pacemaker enabling the recording of disturbance episodes. Those at lower risk (HV <70 ms) will be implanted with a loop recorder device with remote monitoring of cardiovascular implantable electronic devices (CIEDs). Clinical, ECG and implanted device follow-up will also be performed at 3, 6 and 12 months. The primary objective is to assess the efficacy and safety of a decisional algorithm based on electrophysiological study and remote monitoring of CIEDs in the prediction of high-grade conduction disturbances in patients with LBBB after TAVI. The primary end point is to compare the incidence (rate and time to onset) of high-grade conduction disturbances in patients with LBBB after TAVI between the two groups at 12 months. Given the proportion of high-grade conduction disturbances (20-40%), a sample of 200 subjects will allow a margin of error of 6-7%. The LBBB-TAVI Study has been in an active recruiting phase since September 2015 (21 patients already included). ETHICS AND DISSEMINATION: Local ethics committee authorisation was obtained in May 2015. We will publish findings from this study in a peer-reviewed scientific journal and present results at national and international conferences. TRIAL REGISTRATION NUMBER: NCT02482844; Pre-results.

Indexed as

AlgorithmsHeart Valve ProsthesisAdultAortic ValveBundle-Branch BlockCardiac CatheterizationCardiac Conduction System DiseaseClinical Decision-MakingElectrocardiographyElectrophysiological PhenomenaHeartHumansMonitoring, PhysiologicPacemaker, ArtificialPostoperative ComplicationsPrognosiscardiac electrophysiologyLeft bundle branch blockremote monitoring.Transcatheter aortic valve implantation

Identifiers

PMID27797979
PMCPMC5093384
OpenAlexW2540936291

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.