Evidence map›Paper›PMID 32165181›Full record

ArticleHeart rhythm2020

Real-world experience of leadless left ventricular endocardial cardiac resynchronization therapy: A multicenter international registry of the WiSE-CRT pacing system.

Benjamin J Sieniewicz, Timothy R Betts, Simon James, Andrew Turley, Christian Butter, Martin Seifert, Lucas V A Boersma, Sam Riahi, Petr Neuzil, Mauro Biffi and 10 more

Registry-linked trialOpen access · hybridAbstract readMulticenter Study
In one paragraph

Article in Heart rhythm, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02610673 (WiCS-LV Post Market Surveillance Registry), which is not on this map. Cited by 44 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
44citing papers in PubMed, 2 pooled it
8.7field-weighted citation impact, top 1% 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.

NCT02610673 active not recruitingnot on this map

WiCS-LV Post Market Surveillance Registry

Typeobservational_patient_registrySponsorEBR Systems, Inc.Ran2016 to 2027Enrolled100ConditionsCardiac Resynchronization TherapyArmsWiCS-LV System
3 · Its place in the literature

Who cites it

44 citing papers in PubMed, 2 syntheses or guidelines pooled it, 82 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Efficacy of leadless left ventricular endocardial stimulation for non-responders to cardiac resynchronization therapy.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2026
    Observational
  4. Mitigations for extra stimuli of the left ventricular endocardium with the WiSE-CRT System.International journal of cardiology. Heart & vasculature · 2026
    Article
  5. Review
  6. [Endocardial left ventricular pacing in 2025].Herzschrittmachertherapie & Elektrophysiologie · 2025
    Review
  7. Evolution of leadless pacemaker technology.European heart journal supplements : journal of the European Society of Cardiology · 2025
    Article
  8. Article
  9. Review
  10. Article
  11. Beyond Medical Therapy-An Update on Heart Failure Devices.Journal of cardiovascular development and disease · 2024
    Review
  12. Computational Modelling Enabling In Silico Trials for Cardiac Physiologic Pacing.Journal of cardiovascular translational research · 2024
    Review
  13. Cost-effectiveness analysis of leadless cardiac resynchronization therapy.Journal of cardiovascular electrophysiology · 2023
    Article
  14. Article
  15. Article
  16. The evolving state of cardiac resynchronization therapy and conduction system pacing: 25 years of research at EP Europace journal.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 · 2023
    Review
  17. Cardiac resynchronization therapy: present and future.European heart journal supplements : journal of the European Society of Cardiology · 2023
    Article
  18. Article
  19. Leadless Cardiac Pacing: New Horizons.Cardiology and therapy · 2023
    Review
  20. Leadless Pacing: Therapy, Challenges and Novelties.Arrhythmia & electrophysiology review · 2023
    Review
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

20 authors at 14 institutions in 8 countries.

Benjamin J SieniewiczDivision of Imaging Sciences and Biomedical Engineering, King's College London, United Kingdom; Cardiology Department, Guys and St Thomas' NHS Foundation Trust, London, United Kingdom. Electronic address: benjamin.sieniewicz@kcl.ac.uk.
Timothy R BettsOxford University Hospitals NHS Foundation Trust, Oxford, United Kingdom.
Simon JamesThe James Cook Hospital, South Tees Hospitals NHS Foundation Trust, Middlesbrough, United Kingdom.
Andrew TurleyThe James Cook Hospital, South Tees Hospitals NHS Foundation Trust, Middlesbrough, United Kingdom.
Christian ButterImmanuel Klinikum Bernau Herzzentrum Brandenburg, Bernau, Germany.
Martin SeifertImmanuel Klinikum Bernau Herzzentrum Brandenburg, Bernau, Germany.
Lucas V A BoersmaSt. Antonius Ziekenhuis, Nieuwegein, Utrecht, Netherlands/AUMC, Amsterdam, Netherlands.
Sam RiahiAalborg University Hospital, Aalborg, Denmark.
Petr NeuzilNa Homolce Hospital, Prague, Czech Republic.
Mauro BiffiPoliclinico S'Orsola, Bologna, Italy.
Igor DiembergerPoliclinico S'Orsola, Bologna, Italy.
Pasquale VergaraSan Raffaele Hospital, Milan, Italy.
Martin ArnoldUniversity Hospital Erlangen, Department of Cardiology, Erlangen, Germany.
David T KeaneSt. Vincent's University Hospital, Dublin, Ireland.
Pascal DefayeCHU Grenoble Alpes, Grenoble, France.
Jean-Claude DeharoHopital La Timone, Marseille, France.
Anthony ChowSt. Bartholomew's Hospital, London, United Kingdom.
Richard SchillingSt. Bartholomew's Hospital, London, United Kingdom.
Jonathan BeharKing's College London, London, United Kingdom.
Christopher A RinaldiDivision of Imaging Sciences and Biomedical Engineering, King's College London, United Kingdom; Cardiology Department, Guys and St Thomas' NHS Foundation Trust, London, United Kingdom.
Immanuel Klinikum Bernau · DEKing's College London · GBPoliclinico S.Orsola-Malpighi · ITSouth Tees Hospitals NHS Foundation Trust · GBSt Bartholomew's Hospital · GBAalborg University Hospital · DKCentre Hospitalier Universitaire de Grenoble · FRGuy's and St Thomas' NHS Foundation Trust · GBHôpital de la Timone · FRNa Homolce Hospital · CZOxford University Hospitals NHS Trust · GBSt. Antonius Ziekenhuis · NLSt. Vincent's University Hospital · IEUniversitätsklinikum Erlangen · DE

Funding

British Heart Foundation
6 · The paper itself

Abstract

backgroundBiventricular endocardial pacing (BiV ENDO) is a therapy for heart failure patients who cannot receive transvenous epicardial cardiac resynchronization therapy (CRT) or have not responded adequately to CRT. BiV ENDO CRT can be delivered by a new wireless LV ENDO pacing system (WiSE-CRT system; EBR Systems, Sunnyvale, CA), without the requirement for lifelong anticoagulation.

objectiveThe purpose of this study was to assess the safety and efficacy of the WiSE-CRT system during real-world clinical use in an international registry.

methodsData were prospectively collected from 14 centers implanting the WiSE-CRT system as part of the WiCS-LV Post Market Surveillance Registry. (ClinicalTrials.gov Identifier: NCT02610673).

resultsNinety patients from 14 European centers underwent implantation with the WiSE-CRT system. Patients were predominantly male, age 68.2 ± 10.5 years, left ventricular ejection fraction 30.6% ± 8.9%, mean QRS duration 180.7 ± 27.0 ms, and 40% with ischemic etiology. Successful implantation and delivery of BiV ENDO pacing was achieved in 94.4% of patients. Acute (<24 hours), 1- to 30-day, and 1- to 6-month complications rates were 4.4%, 18.8%, and 6.7%, respectively. Five deaths (5.6%) occurred within 6 months (3 procedure related). Seventy percent of patients had improvement in heart failure symptoms.

conclusionBiV ENDO pacing with the WiSE-CRT system seems to be technically feasible, with a high success rate. Three procedural deaths occurred during the study. Procedural complications mandate adequate operator training and implantation at centers with immediately available cardiothoracic and vascular surgical support.

Indexed as

Cardiac Resynchronization Therapy DevicesRegistriesAgedCardiac Resynchronization TherapyEndocardiumEquipment DesignFemaleHeart FailureHeart VentriclesHumansMaleProspective StudiesStroke VolumeTreatment OutcomeVentricular Function, LeftCardiac resynchronization therapyEndocardial pacingHeart failureLeadless pacingNonresponder

Identifiers

PMID32165181
PMCPMC7397503
OpenAlexW3010387947

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.