Evidence map›Paper›PMID 35738745›Full record

ArticleJACC. Cardiovascular interventions2022

Transcatheter Mitral Cerclage Ventriculoplasty: From Bench to Bedside.

Toby Rogers, Adam B Greenbaum, Vasilis C Babaliaros, Jason R Foerst, Jaffar M Khan, Christopher G Bruce, Annette M Stine, Lowell F Satler, Emily Perdoncin, Patrick T Gleason and 6 more

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

Article in JACC. Cardiovascular interventions, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03929913 (NHLBI DIR Transcatheter Mitral Cerclage Annuloplasty Early Feasibility Study), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.1field-weighted citation impact, top 21% 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.

NCT03929913 nacompletednot on this map

NHLBI DIR Transcatheter Mitral Cerclage Annuloplasty Early Feasibility Study

TypeinterventionalSponsorNational Heart, Lung, and Blood Institute (NHLBI)Ran2019 to 2026Enrolled19ConditionsFunctional Mitral RegurgitationArmsTransmural Systems Transcatheter Mitral Cerclage Annuloplasty (TMCA)
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 7 citations in OpenAlex.

  1. Review
  2. Article
  3. Transcatheter Myotomy to Reduce Left Ventricular Outflow Obstruction.Journal of the American College of Cardiology · 2024
    Article
  4. Article
  5. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors at 4 institutions in 1 country.

Toby RogersCardiovascular Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland, USA; MedStar Washington Hospital Center, Washington, DC, USA.
Adam B GreenbaumEmory Midtown Hospital, Atlanta, Georgia, USA.
Vasilis C BabaliarosEmory Midtown Hospital, Atlanta, Georgia, USA.
Jason R FoerstCarilion Clinic, Roanoke, Virginia, USA.
Jaffar M KhanCardiovascular Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland, USA.
Christopher G BruceCardiovascular Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland, USA.
Annette M StineCardiovascular Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland, USA.
Lowell F SatlerMedStar Washington Hospital Center, Washington, DC, USA.
Emily PerdoncinEmory Midtown Hospital, Atlanta, Georgia, USA.
Patrick T GleasonEmory Midtown Hospital, Atlanta, Georgia, USA.
John C LiskoEmory Midtown Hospital, Atlanta, Georgia, USA.
Xin TianOffice of Biostatistics Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland, USA.
Rui MiaoOffice of Biostatistics Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland, USA.
Vandana SachdevCardiovascular Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland, USA.
Marcus Y ChenCardiovascular Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland, USA.
Robert J LedermanCardiovascular Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland, USA. Electronic address: lederman@nih.gov.
National Institutes of Health · USEmory University Hospital Midtown · USMedStar Washington Hospital Center · USCarilion Clinic · US

Funding

Novel catheter treatment of valve diseaseZIAHL006040 · NHLBI · NATIONAL HEART, LUNG, AND BLOOD INSTITUTE · PI LEDERMAN, ROBERT J · 2010 to 2025
$23.6M
Cardiovascular CT Clinical ResearchZIAHL006220 · NHLBI · NATIONAL HEART, LUNG, AND BLOOD INSTITUTE · PI CHEN, MARCUS · 2017 to 2025
$22.5M
MRI catheter design and fabricationZIAHL006041 · NHLBI · NATIONAL HEART, LUNG, AND BLOOD INSTITUTE · PI LEDERMAN, ROBERT J · 2014 to 2025
$12.2M
Cardiovascular Clinical Section StudiesZICHL006199 · NHLBI · NATIONAL HEART, LUNG, AND BLOOD INSTITUTE · PI SACK, MICHAEL · 2017 to 2025
$8.8M
Framingham Project/LevyZ01HL006001 · NHLBI · NATIONAL HEART, LUNG, AND BLOOD INSTITUTE · PI LEVY, DANIEL · 2008 to 2008
$1.1M
Intramural NIH HHS Z01 HL006001Intramural NIH HHS ZIA HL006040Intramural NIH HHS ZIA HL006041Intramural NIH HHS ZIA HL006045NHLBI NIH HHS HHSN268201500008C
6 · The paper itself

Abstract

backgroundTranscatheter mitral valve repair is beneficial in patients with mitral regurgitation (MR), left ventricular dysfunction, and persistent symptoms despite maximally tolerated medical therapy.

objectivesThe aim of this study was to evaluate the safety and feasibility of transcatheter mitral cerclage ventriculoplasty in patients with MR and either heart failure with reduced ejection fraction or preserved ejection fraction and in subjects with prior edge-to-edge repair but persistent or recurrent symptomatic MR.

methodsThe National Heart, Lung, and Blood Institute Division of Intramural Research Transcatheter Mitral Cerclage Ventriculoplasty Early Feasibility Study (NCT03929913) was an investigator-initiated prospective multicenter study. The primary endpoint was technical success measured at exit from the catheterization laboratory. Follow-up included heart failure quality-of-life assessments and serial imaging with echocardiography and cardiac computed tomography.

resultsNineteen subjects consented and underwent cerclage, 63% with heart failure with reduced ejection fraction and 37% with heart failure with preserved ejection fraction, with ischemic cardiomyopathy in 26% and nonischemic cardiomyopathy in 74%. There were no procedural deaths, strokes, or transient ischemic attacks or other major cardiovascular adverse events. The primary endpoint was met in 17 subjects. Cerclage induced sustained reductions in mitral regurgitant volume (-41%) and effective orifice area (-33%) after a median of 337 days. Cerclage resulted in improvements in 6-minute walking distance (+78 m) and Kansas City Cardiomyopathy Questionnaire Overall Summary Score (+22 points) at 30 days that were maintained after a median of 265 days. New complete heart block developed in 6 of 17 subjects. Three deaths occurred on postprocedural days 79, 159, and 756, unrelated to cerclage.

conclusionsTranscatheter mitral cerclage ventriculoplasty resulted in significant and sustained improvements in mitral regurgitation and in heart failure quality-of-life assessments.

Indexed as

Heart FailureHeart Valve Prosthesis ImplantationMitral Valve InsufficiencyVentricular Dysfunction, LeftCardiac CatheterizationHumansMitral ValveProspective StudiesTreatment Outcomecardiomyopathyheart failuresecondary mitral regurgitationtranscatheter annuloplastytranscatheter ventriculoplastyventricular repair

Identifiers

PMID35738745
PMCPMC9236160
OpenAlexW4283217299

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.