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 Article Swipe
Muhammad Shahzeb Khan
,
Tariq Jamal Siddiqi
,
Javed Butler
,
Tim Friede
,
Wayne C. Levy
,
Klaus K. Witte
,
Janusz Lipiecki
,
Horst Sievert
,
Andrew J.S. Coats
·
YOU?
·
· 2021
· Open Access
·
· DOI: https://doi.org/10.1002/ehf2.13273
YOU?
·
· 2021
· Open Access
·
· DOI: https://doi.org/10.1002/ehf2.13273
Aims The 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 results The 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). Conclusions REDUCE‐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.
Related Topics
Concepts
Medicine
Minimal clinically important difference
Functional mitral regurgitation
Heart failure
Internal medicine
Cardiology
Randomized controlled trial
Mitral regurgitation
Ejection fraction
Number needed to treat
Confidence interval
Physical therapy
Relative risk
Metadata
- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.1002/ehf2.13273
- https://onlinelibrary.wiley.com/doi/pdfdirect/10.1002/ehf2.13273
- OA Status
- gold
- Cited By
- 9
- References
- 27
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W3130348394
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W3130348394Canonical identifier for this work in OpenAlex
- DOI
-
https://doi.org/10.1002/ehf2.13273Digital Object Identifier
- Title
-
Functional outcomes with Carillon device over 1 year in patients with functional mitral regurgitation of Grades 2+ to 4+: results from the REDUCE‐FMR trialWork title
- Type
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articleOpenAlex work type
- Language
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enPrimary language
- Publication year
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2021Year of publication
- Publication date
-
2021-02-22Full publication date if available
- Authors
-
Muhammad Shahzeb Khan, Tariq Jamal Siddiqi, Javed Butler, Tim Friede, Wayne C. Levy, Klaus K. Witte, Janusz Lipiecki, Horst Sievert, Andrew J.S. CoatsList of authors in order
- Landing page
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https://doi.org/10.1002/ehf2.13273Publisher landing page
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https://onlinelibrary.wiley.com/doi/pdfdirect/10.1002/ehf2.13273Direct link to full text PDF
- Open access
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YesWhether a free full text is available
- OA status
-
goldOpen access status per OpenAlex
- OA URL
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https://onlinelibrary.wiley.com/doi/pdfdirect/10.1002/ehf2.13273Direct OA link when available
- Concepts
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Medicine, Minimal clinically important difference, Functional mitral regurgitation, Heart failure, Internal medicine, Cardiology, Randomized controlled trial, Mitral regurgitation, Ejection fraction, Number needed to treat, Confidence interval, Physical therapy, Relative riskTop concepts (fields/topics) attached by OpenAlex
- Cited by
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9Total citation count in OpenAlex
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2025: 1, 2024: 2, 2023: 2, 2022: 3, 2021: 1Per-year citation counts (last 5 years)
- References (count)
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27Number of works referenced by this work
- Related works (count)
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10Other works algorithmically related by OpenAlex
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