Should MitraClip also be used in less severe functional mitral regurgitation? The RESHAPE-HF2 study DOI Creative Commons
Piera Capranzano,

Bianca Pellizzeri,

Luca Lombardo

et al.

European Heart Journal Supplements, Journal Year: 2025, Volume and Issue: 27(Supplement_3), P. iii60 - iii63

Published: March 1, 2025

Abstract Transcatheter edge-to-edge repair (TEER) is currently indicated in symptomatic patients with severe functional mitral regurgitation (MR) who are not eligible for surgery and have a high likelihood of responding to treatment. This recommendation based on two randomized trials suggesting that the benefits TEER may be limited MR, defined by an effective regurgitant orifice area (EROA) ≥0.40 cm2, non-excessively remodelled left ventricle. The RESHAPE-HF2 study recently showed compared medical therapy alone, treatment MitraClip heart failure less lower EROA (mean 0.23 cm2), associated significant reduction hospitalizations failure, improvement symptoms quality life, without clear benefit mortality. However, within cohort MR enrolled study, alone seem more selected characteristics higher risk exacerbation, importance careful selection could from TEER.

Language: Английский

The year in cardiovascular medicine 2024: the top 10 papers in heart failure DOI Creative Commons
Johann Bauersachs, Shelley Zieroth, Rudolf A. de Boer

et al.

European Heart Journal, Journal Year: 2025, Volume and Issue: unknown

Published: Jan. 22, 2025

Graphical AbstractThe year in cardiovascular medicine 2024: The top 10 papers heart failure Left: Studies with preserved/mildly reduced ejection fraction (HFpEF/mrEF). Right: (HFrEF). 6MWD, 6-minute walking distance; CSS, clinical summary score; CV, cardiovascular; GRMT, guideline-recommended medical therapy; HF, failure; HFpEF, preserved fraction; HFmrEF, mildly HFrEF, KCCQ, Kansas City Cardiomyopathy Questionnaire; LVAD, left ventricular assist device; LVEF, MR, mitral regurgitation; M-TEER, valve transcatheter edge-to edge repair; NYHA, New York Heart Association; OS score, overall PA, pulmonary artery pressure; PH, hypertension; PPCM, peripartum cardiomyopathy; SOC, standard of care; T2DM, type 2 diabetes mellitus; VKA, vitamin K antagonists.Open new tabDownload slide

Language: Английский

Citations

2

Rationale and design of the FAIRHF2‐DZHK05 trial: Ferric carboxymaltose assessment of morbidity and mortality in patients with iron deficiency and chronic heart failure DOI Creative Commons
Stefan D. Anker, Tim Friede,

Javed Butler

et al.

European Journal of Heart Failure, Journal Year: 2025, Volume and Issue: unknown

Published: Jan. 28, 2025

Abstract Aims While it is widely accepted that intravenous (IV) iron improves functional capacity, symptoms, and cardiovascular outcomes in patients with heart failure (HF) reduced ejection fraction (HFrEF) diagnosed deficiency (ID), three recently published outcome trials (AFFIRM‐AHF, IRONMAN HEART‐FID) of IV supplementation HF failed to demonstrate a significant benefit on their respective primary endpoints. Dosing after the initial correction baseline ID – by design or as result trial circumstances was relatively low (i.e. <500 mg/year). The objective FAIR‐HF2 evaluate treatment effect ferric carboxymaltose (FCM) compared placebo ambulatory HFrEF using higher dose during follow‐up >1000 second study create prospective evidence for fulfilling new definition HF, i.e. those transferrin saturation <20%. Methods an investigator‐initiated, multicentre, randomized, double‐blind, placebo‐controlled has recruited 1105 chronic left ventricular ≤45% concomitant ID, defined serum ferritin <100 ng/ml 100–299 Patients were consented randomized receive either FCM (treatment) saline (placebo). During estimated median over 2 years, underwent repletion maintenance phase, up 2000 mg, followed 500 mg every 4 months unless stop criteria haemoglobin >16 mg/dl >800 are met repeat visits. will hypotheses: (i) time first event death hospitalization (ii) rate total (first recurrent) hospitalizations (both analysed full population), (iii) <20% at baseline. familywise type I error across endpoint hypotheses be controlled Hochberg procedure (alpha 0.05). Conclusion efficacy improving utilizing more aggressive approach towards ensuring prevention transitional targets have been met.

Language: Английский

Citations

2

Hospitalization of Symptomatic Patients With Heart Failure and Moderate to Severe Functional Mitral Regurgitation Treated With MitraClip DOI Creative Commons
Piotr Ponikowski, Tim Friede, Ralph Stephan von Bardeleben

et al.

Journal of the American College of Cardiology, Journal Year: 2024, Volume and Issue: 84(24), P. 2347 - 2363

Published: Aug. 31, 2024

For patients with functional mitral regurgitation (FMR) and symptomatic heart failure (HF), randomized trials of transcatheter edge-to-edge repair (M-TEER) have produced conflicting results.

Language: Английский

Citations

11

Percutaneous Transcatheter Edge-To-Edge Repair for Functional Mitral Regurgitation in Heart Failure DOI Creative Commons
Markus S. Anker, Jan Porthun, Guillaume Bonnet

et al.

Journal of the American College of Cardiology, Journal Year: 2024, Volume and Issue: 84(24), P. 2364 - 2368

Published: Aug. 31, 2024

Language: Английский

Citations

10

Transcatheter Edge-to-Edge Repair for Mitral Regurgitation DOI Creative Commons
Philipp von Stein, Christos Iliadis

Trends in Cardiovascular Medicine, Journal Year: 2025, Volume and Issue: unknown

Published: Feb. 1, 2025

Mitral valve transcatheter edge-to-edge repair (M-TEER) has emerged as a transformative therapy for mitral regurgitation (MR), addressing the unmet needs of patients unsuitable surgery. Landmark trials such EVEREST II, COAPT, and MITRA-FR have established safety efficacy M-TEER, in both with primary (PMR) secondary MR (SMR). Recent trials, including RESHAPE-HF2 MATTERHORN, expanded our understanding refueled discussions regarding patient selection appropriate treatment indications SMR. These also contributed to discussion SMR phenotypes most M-TEER. This review summarizes evidence from pivotal discusses selection, device advancements, potential future directions, outlines ongoing that may shape clinical practice.

Language: Английский

Citations

1

Transcatheter Valve Repair in Heart Failure with Moderate to Severe Mitral Regurgitation DOI

Nathan Mewton,

Denis Angoulvant, Claire Bouleti

et al.

New England Journal of Medicine, Journal Year: 2025, Volume and Issue: 392(7), P. 723 - 725

Published: Feb. 12, 2025

Language: Английский

Citations

1

Transcatheter edge-to-edge mitral repair for secondary mitral regurgitation: New evidence, but many questions remain DOI
David Attias,

J F Obadia,

David Messika‐Zeitoun

et al.

Archives of cardiovascular diseases, Journal Year: 2025, Volume and Issue: unknown

Published: Jan. 1, 2025

Language: Английский

Citations

0

Registries on transcatheter edge‐to‐edge repair in heart failure: Current evidence and future perspectives DOI Creative Commons
Gianluigi Savarese, Christian Basile,

Marianna Adamo

et al.

European Journal of Heart Failure, Journal Year: 2025, Volume and Issue: unknown

Published: Jan. 8, 2025

Abstract Aims Secondary mitral regurgitation (SMR) and tricuspid (TR) are the most common valvular heart diseases in patients with failure (HF). Transcatheter edge‐to‐edge repair (TEER) devices designed for treating MR TR have been successfully tested randomized controlled trials, but methodological issues often challenged their interpretation. This manuscript aimed to provide an overview of TEER registries on SMR HF, highlighting key features, describing clinical characteristics outcomes receiving these devices, exploring available data limitations. Methods results PubMed, Web Science, EMBASE were searched reporting or TR. Registries excluded if single‐centre <100 patients. Twenty‐six (46% prospective, 12% ongoing), including a total cohort 18 925 patients, retrieved SMR, six (50% retrospective, 33% ongoing) reported use 1412 Limited geographical representativity outside North America Europe, high number missing values, inconsistency main existing evidence Conclusion represent source setting where it is difficult conduct trials. However, limitations design, patient characterization, restrain use. A novel conceptual framework future prospective registries, as proposed this document, might inform current practice, address relevant questions trial design.

Language: Английский

Citations

0

Death incidents following transcatheter edge-to-edge repair (TEER) with the MitraClip device: analysis of 10-years post-marketing death reports from the Manufacturer and User Facility Device Experience (MAUDE) registry DOI Creative Commons
Xinghe Sun,

Yifei Zhao,

Yan Li

et al.

BMC Cardiovascular Disorders, Journal Year: 2025, Volume and Issue: 25(1)

Published: Jan. 10, 2025

The transcatheter edge-to-edge repair (TEER) technique, facilitated by the MitraClip device, is a minimally invasive intervention designed for high-risk patients with mitral regurgitation (MR). This study conducts retrospective analysis of death events associated implantation over ten-year decade, utilizing data from FDA's Manufacturer and User Facility Device Experience (MAUDE) database to evaluate trends in safety outcomes. A comprehensive search publicly accessible MAUDE was conducted retrieve reports deaths injuries related October 2013 September 2023. Duplicate records unrelated sources were excluded. Cochran-Armitage test performed proportion fatal time. During 10-year period following FDA approval, recorded total 927 9,211 injury MitraClip. After excluding duplicates irrelevant reports, 592 cases analyzed. most commonly reported complications MR (26.69%), tissue damage (24.16%), hypotension (22.13%). frequent device-related issues incomplete coaptation (14.70%), difficulty removing divice (6.42%), failure adhere or bond/positioning failure(4.90%). Notably, 76.94% occurred within one year implantation. demonstrated gradual decline, 15.9% 2014–2015 3.5% 2020–2021 (p < 0.0001). indicates decline implantation, which may be attributed growing operator experience advancements device design. Nonetheless, persistent focus required on managing addressing potential risks further enhance performance optimize its clinical utility.

Language: Английский

Citations

0

Journal Club DOI
Peter Dovjak

Zeitschrift für Gerontologie und Geriatrie, Journal Year: 2025, Volume and Issue: unknown

Published: Jan. 20, 2025

Citations

0