Evidence map›Paper›PMID 31118146›Full record

Trial reportJournal of the American College of Cardiology2019

Anterior Leaflet Laceration to Prevent Ventricular Outflow Tract Obstruction During Transcatheter Mitral Valve Replacement.

Jaffar M Khan, Vasilis C Babaliaros, Adam B Greenbaum, Jason R Foerst, Shahram Yazdani, James M McCabe, Gaetano Paone, Marvin H Eng, Bradley G Leshnower, Patrick T Gleason and 6 more

Erratum issued Registry-linked trialAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in Journal of the American College of Cardiology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT03015194 (NHLBI DIR LAMPOON Study), which is not on this map. Cited by 102 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
102citing papers in PubMed, 4 pooled it
20.6field-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.

NCT03015194 nacompletednot on this map

NHLBI DIR LAMPOON Study: Intentional Laceration of the Anterior Mitral Leaflet to Prevent Left Ventricular Outflow Tract Obstruction During Transcatheter Mitral Valve Implantation

TypeinterventionalSponsorNational Heart, Lung, and Blood Institute (NHLBI)Ran2017 to 2023Enrolled32ConditionsMitral Valve FailureArmsEdwards SAPIEN 3 transcatheter heart valve, ASHI INTECC Astato XS 20
3 · Its place in the literature

Who cites it

102 citing papers in PubMed, 4 syntheses or guidelines pooled it, 204 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Trial
  6. Article
  7. Review
  8. Valve-in-Ring TMVR Following Antegrade Base-to-Tip LAMPOON With ELASTIC on VA-ECMO Support: A Case Report.Journal of the Society for Cardiovascular Angiography & Interventions · 2026
    Article
  9. Review
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  11. Review
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42 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors at 6 institutions in 1 country.

Jaffar M KhanCardiovascular Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.
Vasilis C BabaliarosStructural Heart and Valve Center, Emory University Hospital, Atlanta, Georgia.
Adam B GreenbaumStructural Heart and Valve Center, Emory University Hospital, Atlanta, Georgia; Center for Structural Heart Disease, Division of Cardiology, and Division of Cardiac Surgery, Henry Ford Health System, Detroit, Michigan.
Jason R FoerstCarilion Roanoke Memorial Hospital, Roanoke, Virginia.
Shahram YazdaniInova Fairfax Hospital, Fairfax, Virginia.
James M McCabeUniversity of Washington, Seattle, Washington.
Gaetano PaoneCenter for Structural Heart Disease, Division of Cardiology, and Division of Cardiac Surgery, Henry Ford Health System, Detroit, Michigan.
Marvin H EngCenter for Structural Heart Disease, Division of Cardiology, and Division of Cardiac Surgery, Henry Ford Health System, Detroit, Michigan.
Bradley G LeshnowerStructural Heart and Valve Center, Emory University Hospital, Atlanta, Georgia.
Patrick T GleasonStructural Heart and Valve Center, Emory University Hospital, Atlanta, Georgia.
Marcus Y ChenCardiovascular Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.
Dee Dee WangCenter for Structural Heart Disease, Division of Cardiology, and Division of Cardiac Surgery, Henry Ford Health System, Detroit, Michigan.
Xin TianOffice of Biostatistics Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.
Annette M StineCardiovascular Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.
Toby RogersCardiovascular Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland; Medstar Washington Hospital Center, Washington, DC.
Robert J LedermanCardiovascular Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland. Electronic address: lederman@nih.gov.
National Institutes of Health · USHenry Ford Health System · USEmory University Hospital · USCarilion Roanoke Memorial Hospital · USInova Fairfax Hospital · USUniversity of Washington · 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
Cardiovascular Clinical Section StudiesZICHL006199 · NHLBI · NATIONAL HEART, LUNG, AND BLOOD INSTITUTE · PI SACK, MICHAEL · 2017 to 2025
$8.8M
Intramural NIH HHS ZIA HL006040
6 · The paper itself

Abstract

backgroundLeft ventricular outflow tract (LVOT) obstruction is a leading cause of mortality and exclusion from transcatheter mitral valve replacement (TMVR). Intentional laceration of the anterior mitral valve leaflet to prevent LVOT obstruction (LAMPOON) is a transcatheter mimic of surgical chord-sparing leaflet resection.

objectivesThe purpose of this prospective multicenter trial was to study LAMPOON with transseptal (Edwards Lifesciences, Irvine, California) TMVR in annuloplasty rings or native mitral annular calcification (MAC).

methodsSubjects at high or extreme surgical risk and prohibitive risk of LVOT obstruction from TMVR were included. Eligibility was modified midtrial to exclude subjects with threatened LVOT obstruction from a Sapien 3 valve fabric skirt. The primary endpoint was procedure survival with successful LAMPOON, with successful TMVR, without reintervention, and with LVOT gradient <30 mm Hg ("optimal") or <50 mm Hg ("acceptable"). Secondary endpoints included 30-day mortality and major adverse cardiovascular events. There was universal source-data verification and independent monitoring. All endpoints were independently adjudicated. Central laboratories analyzed echocardiogram and CT images.

resultsBetween June 2017 and June 2018, 30 subjects were enrolled equally between the MAC and ring arms. LAMPOON traversal and midline laceration was successful in 100%. Procedure survival was 100%, and 30-day survival was 93%. Primary success was achieved in 73%, driven by additional procedures for paravalvular leak (10%) and high-skirt neo-LVOT gradients observed before a protocol amendment. There were no strokes.

conclusionsLAMPOON was feasible in native and annuloplasty ring anatomies in patients who were otherwise ineligible for treatment, with acceptable safety. LAMPOON was effective in preventing LVOT obstruction from TMVR. Despite LAMPOON, TMVR using Sapien 3 in annuloplasty rings and MAC still exhibits important limitations. (NHLBI DIR LAMPOON Study: Intentional Laceration of the Anterior Mitral Leaflet to Prevent Left Ventricular Outflow Tract Obstruction During Transcatheter Mitral Valve Implantation; NCT03015194).

Indexed as

AgedAged, 80 and overCardiac CatheterizationEchocardiography, TransesophagealElectrosurgeryFemaleFollow-Up StudiesHeart SeptumHeart Valve DiseasesHeart Valve Prosthesis ImplantationHumansIntraoperative PeriodMaleMiddle AgedMitral ValveProspective Studiesmitral annular calcificationstructural heart diseasetranscatheter electrosurgerytranscatheter mitral valve replacementtransseptal interventionsvalve-in-ring

Identifiers

PMID31118146
PMCPMC6664295
OpenAlexW2944944000

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.