Evidence map›Paper›PMID 37515396›Full record

ArticleAnnals of noninvasive electrocardiology : the official journal of the International Society for Holter and Noninvasive Electrocardiology, Inc2023

Design and characteristics of the prophylactic intra-operative ventricular arrhythmia ablation in high-risk LVAD candidates (PIVATAL) trial.

David T Huang, Igor Gosev, Katherine L Wood, Hima Vidula, William Stevenson, Frank Marchlinski, Gregory Supple, Sandip K Zalawadiya, J Peter Weiss, Roderick Tung and 24 more

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Annals of noninvasive electrocardiology : the official journal of the International Society for Holter and Noninvasive Electrocardiology, Inc, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing 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

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

  1. Pooled it
  2. Ventricular arrhythmias following left ventricular assist device implantation: a systematic review and meta-analysis of incidence and clinical impact.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 · 2025
    Pooled it
  3. Prediction of late ventricular arrhythmias in patients with left ventricular assist device: insights from the VT-LVAD consortium.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 · 2025
    Article
  4. Review
  5. Drug therapy and catheter ablation for management of arrhythmias in continuous flow left ventricular assist device's patients: a Clinical Consensus Statement of the European Heart Rhythm Association and the Heart Failure Association of the ESC.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. Percutaneous mechanical support in catheter ablation of ventricular arrhythmias: hype or hope?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
    Review
  7. Review
  8. Article
  9. Review
  10. Review
  11. Design and characteristics of the prophylactic intra-operative ventricular arrhythmia ablation in high-risk LVAD candidates (PIVATAL) trial.Annals of noninvasive electrocardiology : the official journal of the International Society for Holter and Noninvasive Electrocardiology, Inc · 2023
    Article
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

34 authors.

David T HuangDivision of Cardiology, University of Rochester Medical Center, Rochester, New York, USA.
Igor GosevDivision of Cardiothoracic Surgery, University of Rochester Medical Center, Rochester, New York, USA.
Katherine L WoodDivision of Cardiothoracic Surgery, University of Rochester Medical Center, Rochester, New York, USA.ORCID 0000-0003-4628-6852
Hima VidulaDivision of Cardiology, University of Pennsylvania Medical Center, Philadelphia, Pennsylvania, USA.
William StevensonDivision of Cardiovascular Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Frank MarchlinskiDivision of Cardiology, University of Pennsylvania Medical Center, Philadelphia, Pennsylvania, USA.
Gregory SuppleDivision of Cardiology, University of Pennsylvania Medical Center, Philadelphia, Pennsylvania, USA.
Sandip K ZalawadiyaDivision of Cardiovascular Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
J Peter WeissThe University of Arizona College of Medicine-Phoenix, Banner University Medical Center, Phoenix, Arizona, USA.
Roderick TungThe University of Arizona College of Medicine-Phoenix, Banner University Medical Center, Phoenix, Arizona, USA.
Wendy S TzouDivision of Cardiology, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.
Joshua D MossDivision of Cardiology, University of California-San Francisco, San Francisco, California, USA.
Krishna KancharlaDepartment of Medicine, Heart and Vascular Institute, University of Pittsburgh Medical Center and School of Medicine, Pittsburgh, Pennsylvania, USA.
Sunit-Preet ChaudhryDivision of Cardiology, Ascension St. Vincent Heart Center, Indianapolis, Indiana, USA.
Parin J PatelDivision of Cardiology, Ascension St. Vincent Heart Center, Indianapolis, Indiana, USA.
Arfaat M KhanHenry Ford Heart and Vascular Institute, Henry Ford Hospital, Detroit, Michigan, USA.
Claudio SchugerHenry Ford Heart and Vascular Institute, Henry Ford Hospital, Detroit, Michigan, USA.
Guy RozenCardiovascular Center, Tufts Medical Center, Boston, Massachusetts, USA.
Michael S KiernanCardiovascular Center, Tufts Medical Center, Boston, Massachusetts, USA.
Gregory S CouperCardiovascular Center, Tufts Medical Center, Boston, Massachusetts, USA.
Marzia LeaccheDepartment of Cardiothoracic Surgery, Spectrum Health, Grand Rapids, Michigan, USA.
Ezequiel J MolinaDepartment of Cardiothoracic Surgery, Piedmont Heart Institute, Atlanta, Georgia, USA.
Anand D ShahSection of Cardiac Electrophysiology, Emory University School of Medicine, Atlanta, Georgia, USA.
Michael LloydSection of Cardiac Electrophysiology, Emory University School of Medicine, Atlanta, Georgia, USA.
Jakub SroubekHeart Vascular and Thoracic Institute, Cleveland Clinic, Cleveland, Ohio, USA.
Edward SolteszDepartment of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, Ohio, USA.
Kalyanam ShivkumarUCLA Cardiac Arrhythmia Center, UCLA Health System, David Geffen School of Medicine at UCLA, Los Angeles, California, USA.
Casey WhiteDivision of Cardiology, University of Rochester Medical Center, Rochester, New York, USA.ORCID 0000-0002-0412-222X
Sinan TankutDivision of Cardiology, University of Rochester Medical Center, Rochester, New York, USA.
Brent A JohnsonDepartment of Biostatistics and Computational Biology, University of Rochester, Rochester, New York, USA.
Scott McNittClinical Cardiovascular Research Center, University of Rochester Medical Center, Rochester, New York, USA.
Valentina KutyifaClinical Cardiovascular Research Center, University of Rochester Medical Center, Rochester, New York, USA.ORCID 0000-0002-0016-289X
Wojciech ZarebaClinical Cardiovascular Research Center, University of Rochester Medical Center, Rochester, New York, USA.
Ilan GoldenbergClinical Cardiovascular Research Center, University of Rochester Medical Center, Rochester, New York, USA.

Funding

Prophylactic Intra-Operative VT Ablation in High-Risk LVAD CandidatesR01HL159401 · NHLBI · UNIVERSITY OF ROCHESTER · PI HUANG, DAVID T · 2021 to 2025
$3.6M
NHLBI NIH HHS R01 HL159401NIH HHS R01HL159401
6 · The paper itself

Abstract

backgroundThe use of a Left Ventricular Assist Device (LVAD) in patients with advanced heart failure refractory to optimal medical management has progressed steadily over the past two decades. Data have demonstrated reduced LVAD efficacy, worse clinical outcome, and higher mortality for patients who experience significant ventricular tachyarrhythmia (VTA). We hypothesize that a novel prophylactic intra-operative VTA ablation protocol at the time of LVAD implantation may reduce the recurrent VTA and adverse events postimplant.

methodsWe designed a prospective, multicenter, open-label, randomized-controlled clinical trial enrolling 100 patients who are LVAD candidates with a history of VTA in the previous 5 years. Enrolled patients will be randomized in a 1:1 fashion to intra-operative VTA ablation (n = 50) versus conventional medical management (n = 50) with LVAD implant. Arrhythmia outcomes data will be captured by an implantable cardioverter defibrillator (ICD) to monitor VTA events, with a uniform ICD programming protocol. Patients will be followed prospectively over a mean of 18 months (with a minimum of 9 months) after LVAD implantation to evaluate recurrent VTA, adverse events, and procedural outcomes. Secondary endpoints include right heart function/hemodynamics, healthcare utilization, and quality of life.

conclusionThe primary aim of this first-ever randomized trial is to assess the efficacy of intra-operative ablation during LVAD surgery in reducing VTA recurrence and improving clinical outcomes for patients with a history of VTA.

Indexed as

Defibrillators, ImplantableHeart-Assist DevicesHeart FailureTachycardia, VentricularArrhythmias, CardiacElectrocardiographyHumansMulticenter Studies as TopicProspective StudiesQuality of LifeRandomized Controlled Trials as TopicRisk FactorsTreatment Outcomeablationleft ventricular assist deviceventricular tachycardia

Identifiers

PMID37515396
PMCPMC10475893

What OpenQuestion holds

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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.