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Percutaneous repair of moderate‐to‐severe or severe functional mitral regurgitation in patients with symptomatic heart failure: Baseline characteristics of patients in the RESHAPE‐HF2 trial and comparison to COAPT and MITRA‐FR trials

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dc.contributor.authorAnker, Stefan D.
dc.contributor.authorFriede, Tim
dc.contributor.authorvon Bardeleben, Ralph Stephan
dc.contributor.authorButler, Javed
dc.contributor.authorKhan, Muhammad Shahzeb
dc.contributor.authorDiek, Monika
dc.contributor.authorHeinrich, Jutta
dc.contributor.authorGeyer, Martin
dc.contributor.authorPlaczek, Marius
dc.contributor.authorFerrari, Roberto
dc.contributor.authorAbraham, William T.
dc.contributor.authorAlfieri, Ottavio
dc.contributor.authorAuricchio, Angelo
dc.contributor.authorBayes‐Genis, Antoni
dc.contributor.authorCleland, John G. F.
dc.contributor.authorFilippatos, Gerasimos
dc.contributor.authorGustafsson, Finn
dc.contributor.authorHaverkamp, Wilhelm
dc.contributor.authorKelm, Malte
dc.contributor.authorKuck, Karl‐Heinz
dc.contributor.authorLandmesser, Ulf
dc.contributor.authorMaggioni, Aldo P.
dc.contributor.authorMetra, Marco
dc.contributor.authorNinios, Vlasis
dc.contributor.authorPetrie, Mark C.
dc.contributor.authorRassaf, Tienush
dc.contributor.authorRuschitzka, Frank
dc.contributor.authorSchäfer, Ulrich
dc.contributor.authorSchulze, P. Christian
dc.contributor.authorSpargias, Konstantinos
dc.contributor.authorVahanian, Alec
dc.contributor.authorZamorano, Jose Luis
dc.contributor.authorZeiher, Andreas
dc.contributor.authorKarakas, Mahir
dc.contributor.authorKoehler, Friedrich
dc.contributor.authorLainscak, Mitja
dc.contributor.authorÖner, Alper
dc.contributor.authorMezilis, Nikolaos
dc.contributor.authorTheofilogiannakos, Efstratios K.
dc.contributor.authorNinios, Ilias
dc.contributor.authorChrissoheris, Michael
dc.contributor.authorKourkoveli, Panagiota
dc.contributor.authorPapadopoulos, Konstantinos
dc.contributor.authorSmolka, Grzegorz
dc.contributor.authorWojakowski, Wojciech
dc.contributor.authorReczuch, Krzysztof
dc.contributor.authorPinto, Fausto J.
dc.contributor.authorZmudka, Krzysztof
dc.contributor.authorKalarus, Zbigniew
dc.contributor.authorAdamo, Marianna
dc.contributor.authorSantiago‐Vacas, Evelyn
dc.contributor.authorRuf, Tobias Friedrich
dc.contributor.authorGross, Michael
dc.contributor.authorTongers, Joern
dc.contributor.authorHasenfuß, Gerd
dc.contributor.authorSchillinger, Wolfgang
dc.contributor.authorPonikowski, Piotr
dc.date.accessioned2024-06-14T14:26:59Z
dc.date.available2024-06-14T14:26:59Z
dc.date.issued2024
dc.description© 2024 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.pt_PT
dc.description.abstractAim: The RESHAPE-HF2 trial is designed to assess the efficacy and safety of the MitraClip device system for the treatment of clinically important functional mitral regurgitation (FMR) in patients with heart failure (HF). This report describes the baseline characteristics of patients enrolled in the RESHAPE-HF2 trial compared to those enrolled in the COAPT and MITRA-FR trials. Methods and results: The RESHAPE-HF2 study is an investigator-initiated, prospective, randomized, multicentre trial including patients with symptomatic HF, a left ventricular ejection fraction (LVEF) between 20% and 50% with moderate-to-severe or severe FMR, for whom isolated mitral valve surgery was not recommended. Patients were randomized 1:1 to a strategy of delivering or withholding MitraClip. Of 506 patients randomized, the mean age of the patients was 70 ± 10 years, and 99 of them (20%) were women. The median EuroSCORE II was 5.3 (2.8-9.0) and median plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP) was 2745 (1407-5385) pg/ml. Most patients were prescribed beta-blockers (96%), diuretics (96%), angiotensin-converting enzyme inhibitors/angiotensin receptor blockers/angiotensin receptor-neprilysin inhibitors (82%) and mineralocorticoid receptor antagonists (82%). The use of sodium-glucose cotransporter 2 inhibitors was rare (7%). Cardiac resynchronization therapy (CRT) devices had been previously implanted in 29% of patients. Mean LVEF, left ventricular end-diastolic volume and effective regurgitant orifice area (EROA) were 31 ± 8%, 211 ± 76 ml and 0.25 ± 0.08 cm2, respectively, whereas 44% of patients had mitral regurgitation severity of grade 4+. Compared to patients enrolled in COAPT and MITRA-FR, those enrolled in RESHAPE-HF2 were less likely to have mitral regurgitation grade 4+ and, on average, HAD lower EROA, and plasma NT-proBNP and higher estimated glomerular filtration rate, but otherwise had similar age, comorbidities, CRT therapy and LVEF. Conclusion: Patients enrolled in RESHAPE-HF2 represent a third distinct population where MitraClip was tested in, that is one mainly comprising of patients with moderate-to-severe FMR instead of only severe FMR, as enrolled in the COAPT and MITRA-FR trials. The results of RESHAPE-HF2 will provide crucial insights regarding broader application of the transcatheter edge-to-edge repair procedure in clinical practice.pt_PT
dc.description.sponsorshipOpen Access funding enabled and organized by Projekt DEALpt_PT
dc.description.versioninfo:eu-repo/semantics/publishedVersionpt_PT
dc.identifier.citationEur J Heart Fail. 2024 Jun 7pt_PT
dc.identifier.doi10.1002/ejhf.3286pt_PT
dc.identifier.eissn1879-0844
dc.identifier.issn1388-9842
dc.identifier.urihttp://hdl.handle.net/10451/65037
dc.language.isoengpt_PT
dc.peerreviewedyespt_PT
dc.publisherWileypt_PT
dc.relation.publisherversionhttps://onlinelibrary.wiley.com/journal/18790844pt_PT
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/pt_PT
dc.subjectMitraClippt_PT
dc.subjectMitral regurgitationpt_PT
dc.subjectTranscatheter edge‐to‐edge repairpt_PT
dc.titlePercutaneous repair of moderate‐to‐severe or severe functional mitral regurgitation in patients with symptomatic heart failure: Baseline characteristics of patients in the RESHAPE‐HF2 trial and comparison to COAPT and MITRA‐FR trialspt_PT
dc.typejournal article
dspace.entity.typePublication
oaire.citation.titleEuropean Journal of Heart Failurept_PT
person.familyNamePinto
person.familyNamePonikowski
person.givenNameFausto J.
person.givenNamePiotr
person.identifier1308889
person.identifier.ciencia-idC311-AEDD-6DBB
person.identifier.orcid0000-0002-8034-4529
person.identifier.orcid0000-0002-3391-7064
person.identifier.ridG-9363-2015
person.identifier.ridO-6454-2015
person.identifier.scopus-author-id7102740158
rcaap.rightsopenAccesspt_PT
rcaap.typearticlept_PT
relation.isAuthorOfPublication5f44176f-69f5-482c-83cd-ab94425a6ec3
relation.isAuthorOfPublication9b3566d4-4e49-4eb3-a0f8-f34c8adc436a
relation.isAuthorOfPublication.latestForDiscovery5f44176f-69f5-482c-83cd-ab94425a6ec3

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