Evidence map›Paper›PMID 39243268›Full record

Trial reportJACC. Cardiovascular interventions2024

5-Year Outcomes of Anterior Mitral Leaflet Laceration to Prevent Outflow Obstruction.

Jaffar M Khan, Vasilis C Babaliaros, Adam B Greenbaum, James M McCabe, Toby Rogers, Marvin H Eng, Jason R Foerst, Shahram Yazdani, Gaetano Paone, Patrick T Gleason and 5 more

Registry-linked trialAbstract readMulticenter StudyClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in JACC. Cardiovascular interventions, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03015194 (NHLBI DIR LAMPOON Study), which is not on this map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
–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.

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

10 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
  4. Article
  5. Review
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  7. Review
  8. Review
  9. Review
  10. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors.

Jaffar M KhanCardiovascular Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland, USA; St. Francis Hospital and Heart Center, Roslyn, New York, USA.
Vasilis C BabaliarosStructural Heart and Valve Center, Emory University Hospital, Atlanta, Georgia, USA. Electronic address: https://twitter.com/BabaliarosArgos.
Adam B GreenbaumStructural Heart and Valve Center, Emory University Hospital, Atlanta, Georgia, USA. Electronic address: https://twitter.com/AdamGreenbaumMD.
James M McCabeUniversity of Washington, Seattle, Washington, USA. Electronic address: https://twitter.com/jamiemccabeMD.
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.
Marvin H EngCenter for Structural Heart Disease, Division of Cardiology, and Division of Cardiac Surgery, Henry Ford Health System, Detroit, Michigan, USA.
Jason R FoerstCarilion Roanoke Memorial Hospital, Roanoke, Virginia, USA.
Shahram YazdaniInova Fairfax Hospital, Fairfax, Virginia, USA.
Gaetano PaoneStructural Heart and Valve Center, Emory University Hospital, Atlanta, Georgia, USA.
Patrick T GleasonStructural Heart and Valve Center, Emory University Hospital, Atlanta, Georgia, USA.
Rim N HalabyCardiovascular 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.
Xin TianOffice of Biostatistics Research, 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.
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.

Funding

Novel catheter treatment of valve diseaseZIAHL006040 · NHLBI · NATIONAL HEART, LUNG, AND BLOOD INSTITUTE · PI LEDERMAN, ROBERT J · 2010 to 2025
$23.6M
Intramural NIH HHS ZIA HL006040
6 · The paper itself

Abstract

backgroundLeft ventricular outflow tract (LVOT) obstruction is a common, often fatal complication of transcatheter mitral valve replacement (TMVR). Laceration of the anterior mitral leaflet to prevent outflow obstruction (LAMPOON) was safe and effective at preventing LVOT obstruction at 30 days in the National Heart, Lung, and Blood Institute LAMPOON trial.

objectivesThe authors report the 5-year outcomes of intentional anterior mitral leaflet laceration before SAPIEN 3 TMVR, in patients at risk of LVOT obstruction.

methodsThe National Heart, Lung, and Blood Institute LAMPOON trial was a prospective, multicenter, single-arm safety and feasibility study of LAMPOON and transseptal SAPIEN 3 TMVR in annuloplasty rings (valve-in-ring) or native mitral annular calcification (MAC) (valve-in-MAC). All subjects had high predicted risk for LVOT obstruction. Subjects were not excluded for excessive frailty or comorbidity. The primary endpoints were technical success and safety at 30 days. Secondary clinical and echocardiographic endpoints were assessed at 1 year and clinical follow-up at 5 years.

resultsThirty subjects were enrolled between June 2017 and June 2018, equally between the valve-in-MAC and valve-in-ring arms. At 30 days, LAMPOON was successful in all 30 subjects, with no strokes, 1 (3%) death, and 1 (3%) moderate LVOT obstruction. Eighteen (65%) survived to 1 year, and 7 (25%) survived to 5 years. Six (20%) were hospitalized for heart failure in the first year. From baseline to 1 year, there was a 24-point improvement in Kansas City Cardiomyopathy Questionnaire score and a 60-m improvement in 6-minute walk distance. There was no significant change in N-terminal pro-brain natriuretic peptide. At 1 year, LVOT gradients remained low.

conclusionsLAMPOON enabled TMVR despite the risk for LVOT obstruction. There were no long-term complications associated with LAMPOON. The selection of inoperable patients limited assessment of long-term survival following TMVR. (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

Cardiac CatheterizationFeasibility StudiesHeart Valve ProsthesisHeart Valve Prosthesis ImplantationMitral ValveMitral Valve InsufficiencyVentricular Outflow ObstructionAgedAged, 80 and overFemaleHemodynamicsHumansMaleMiddle AgedMitral Valve AnnuloplastyProspective StudiesLAMPOONleft ventricular outflow tract obstructionmitral annular calcificationmitral valve diseasetranscatheter electrosurgerytranscatheter mitral valve replacement

Identifiers

PMID39243268
PMCPMC11424260

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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.