Evidence map›Paper›PMID 33619896›Full record

ArticleESC heart failure2021

Functional outcomes with Carillon device over 1 year in patients with functional mitral regurgitation of Grades 2+ to 4+: results from the REDUCE-FMR trial.

Muhammad Shahzeb Khan, Tariq Jamal Siddiqi, Javed Butler, Tim Friede, Wayne C Levy, Klaus K Witte, Janusz Lipiecki, Horst Sievert, Andrew J Stewart Coats

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in ESC heart failure, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.3field-weighted citation impact, top 20% 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.

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

6 citing papers in PubMed, 10 citations in OpenAlex.

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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

9 authors at 8 institutions in 5 countries.

Muhammad Shahzeb KhanDepartment of Medicine, University of Mississippi, Jackson, MS, USA.
Tariq Jamal SiddiqiDepartment of Medicine, Dow University of Health Sciences, Karachi, Pakistan.
Javed ButlerDepartment of Medicine, University of Mississippi, Jackson, MS, USA.
Tim FriedeDepartment of Medical Statistics, University Medical Center Göttingen, Göttingen, Germany.
Wayne C LevyUW Heart Institute, University of Washington, Seattle, WA, USA.
Klaus K WitteLeeds Institute for Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK.
Janusz LipieckiCentre de Cardiologie Interventionnelle, Pôle Santé République, Clermont-Ferrand, France.
Horst SievertCardioVascular Center Frankfurt, Frankfurt, Germany.
Andrew J Stewart CoatsWarwick Medical School, University of Warwick, Coventry, CV4 7AL, UK.
University of Mississippi · USCardiovascular Center Frankfurt · DECentre Hospitalier Universitaire de Clermont-Ferrand · FRDow University of Health Sciences · PKHope Heart Institute · USUniversitätsmedizin Göttingen · DEUniversity of Leeds · GBUniversity of Warwick · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsThe objective of this study was to compare functional outcomes through 1 year in patients with core-lab verified moderate to severe (Grades 2+ to 4+) functional mitral regurgitation (FMR) treated with the Carillon device or control in the blinded sham-controlled REDUCE-FMR (Carillon Mitral Contour System for Reducing Functional Mitral Regurgitation) study. METHODS AND

resultsThe main outcomes of this analysis were the change in 6 min walk test (6MWT) distance, incidence of heart failure hospitalization or death, change in New York Heart Association (NYHA) class, and change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score through 1 year of follow-up. The minimum clinically important difference (MCID) was defined as a ≥30 m increase in 6MWT distance, an NYHA decrease in ≥1 class, and a ≥3 point increase in KCCQ score. The proportion of patients achieving the MCID in each treatment group was compared using Fisher's exact test, and the number needed to treat (NNT) with the Carillon device was calculated. Among 83 patients (62 Carillon and 21 sham), no statistically significant group differences were observed in the baseline characteristics. All outcomes at 1 year numerically favoured the Carillon group, including MCID for the 6MWT distance (59% vs. 23%, P = 0.029; NNT = 2.8), NYHA class (48% vs. 33%, P = 0.38; NNT = 6.9), KCCQ score (69% vs. 47%, P = 0.14; NNT = 4.5), and freedom from heart failure hospitalization or death (60% vs. 48%, P = 0.45; NNT = 8.3).

conclusionsREDUCE-FMR was the first blinded sham-controlled trial to report outcomes with percutaneous therapy for the treatment of FMR. Trends towards improvement in mean 6MWT distance, KCCQ score, and NYHA class were observed with the Carillon device. A substantially higher number of patients achieved MCID for all patient-centred outcomes with the Carillon device compared with the sham procedure.

Indexed as

Mitral Valve InsufficiencyHumansIncidenceTreatment OutcomeHeart failurePercutaneous deviceQuality of lifeSecondary mitral regurgitation

Identifiers

PMID33619896
PMCPMC8006711
OpenAlexW3130348394

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Registered trials

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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.