학술논문
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.
Document Type
Academic Journal
Author
Anker SD; Department of Cardiology (CVK) of German Heart Center Charité; Institute of Health Center for Regenerative Therapies (BCRT), German Centre for Cardiovascular Research (DZHK) Partner Site Berlin, Charité Universitätsmedizin, Berlin, Germany.; Department of Cardiology and Pneumology, University Medical Centre Göttingen, Georg August University of Göttingen, Göttingen, Germany.; German Centre for Cardiovascular Research (DZHK), Partner Site Göttingen, Göttingen, Germany.; Friede T; Department of Medical Statistics, University Medical Center Göttingen, Göttingen, Germany.; German Centre for Cardiovascular Research (DZHK), partner site Göttingen, Göttingen, Germany.; von Bardeleben RS; Department of Cardiology, University Medical Center of the Johannes Gutenberg-University Mainz, Mainz, Germany.; Butler J; Department of Medicine, University of Mississippi Medical Center, Jackson, MS, USA.; Baylor Scott and White Research Institute, Dallas, TX, USA.; Khan MS; Division of Cardiology, Duke University School of Medicine, Durham, NC, USA.; Diek M; Department of Cardiology (CVK) of German Heart Center Charité; Institute of Health Center for Regenerative Therapies (BCRT), German Centre for Cardiovascular Research (DZHK) Partner Site Berlin, Charité Universitätsmedizin, Berlin, Germany.; Department of Cardiology and Pneumology, University Medical Centre Göttingen, Georg August University of Göttingen, Göttingen, Germany.; German Centre for Cardiovascular Research (DZHK), Partner Site Göttingen, Göttingen, Germany.; Heinrich J; Clinical Trial Unit, University Medical Center Göttingen, Göttingen, Germany.; Geyer M; Department of Cardiology, University Medical Center of the Johannes Gutenberg-University Mainz, Mainz, Germany.; Placzek M; Department of Medical Statistics, University Medical Center Göttingen, Göttingen, Germany.; German Centre for Cardiovascular Research (DZHK), partner site Göttingen, Göttingen, Germany.; Ferrari R; Department of Translational Medicine, University of Ferrara, Ferrara, Italy.; Abraham WT; Division of Cardiovascular Medicine, The Ohio State University, Columbus, OH, USA.; Alfieri O; Cardiac Surgery Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy.; Auricchio A; Department of Cardiology, Cardiocentro Ticino Institute-EOC, Lugano, Switzerland.; Bayes-Genis A; Heart Institute, Hospital Universitari Germans Trias i Pujol, Barcelona, Spain.; Cleland JGF; School of Cardiovascular and Metabolic Health, University of Glasgow, British Heart Foundation Glasgow Cardiovascular Research Centre, Glasgow, UK.; Filippatos G; Department of Cardiology, Attikon University Hospital, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.; Gustafsson F; Department of Cardiology, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.; Haverkamp W; Department of Cardiology (CVK) of German Heart Center Charité; Institute of Health Center for Regenerative Therapies (BCRT), German Centre for Cardiovascular Research (DZHK) Partner Site Berlin, Charité Universitätsmedizin, Berlin, Germany.; Kelm M; Department of Cardiology, Pulmonology and Vascular Medicine, University Hospital Düsseldorf, Medical Faculty of the Heinrich Heine University Düsseldorf, Düsseldorf, Germany.; CARID, Cardiovascular Research Institute, Medical Faculty and University Hospital Düsseldorf, Heinrich-Heine University, Düsseldorf, Germany.; Kuck KH; Department of Rhythmology, University Heart Center Lübeck, University Hospital Schleswig-Holstein, Lübeck, Germany.; Landmesser U; Department of Cardiology, Angiology and Intensive Care Medicine, Deutsches Herzzentrum der Charité, Campus Benjamin Franklin, Berlin, Germany.; Berlin Institute of Health, Berlin, Germany.; DZHK (German Centre for Cardiovascular Research), Partner Site Berlin, Berlin, Germany.; Maggioni AP; ANMCO Research Center, Heart Care Foundation, Florence, Italy.; Metra M; Institute of Cardiology, ASST Spedali Civili and Department of Medical and Surgical Specialties, Radiological Sciences and Public Health, University of Brescia, Brescia, Italy.; Ninios V; European Interbalkan Medical Center, Thessaloniki, Greece.; Petrie MC; School of Cardiovascular and Metabolic Health, University of Glasgow, British Heart Foundation Glasgow Cardiovascular Research Centre, Glasgow, UK.; Rassaf T; West German Heart and Vascular Center, Department of Cardiology and Vascular Medicine, University Hospital Essen, University Duisburg-Essen, Essen, Germany.; Ruschitzka F; Department of Cardiology, University Heart Center, University Hospital Zurich and University of Zurich, Zurich, Switzerland.; Center for Translational and Experimental Cardiology (CTEC), Department of Cardiology, University Hospital Zurich, University of Zurich, Zurich, Switzerland.; Schäfer U; Heart and Vascular Centre, Bad Bevensen, Germany.; Schulze PC; Department of Internal Medicine I, Cardiology, University Hospital Jena, Jena, Germany.; Spargias K; Department of Transcatheter Heart Valves, HYGEIA Hospital, Athens, Greece.; Vahanian A; UFR Medecine, Université de Paris-Cité, site Bichat, GH Bichat, Paris, France.; Zamorano JL; Department of Cardiology, Hospital Universitario Ramón y Cajal, Madrid, Spain.; CIBERCV, Instituto de Salud Carlos III (ISCIII), Madrid, Spain.; Zeiher A; Institute for Cardiovascular Regeneration, Goethe University Frankfurt, Frankfurt am Main, Germany.; German Center of Cardiovascular Research (DZHK), Partner Site Rhein-Main, Frankfurt am Main, Germany.; Karakas M; Department of Intensive Care Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.; German Centre for Cardiovascular Research (DZHK), Partner Site Hamburg/Kiel/Lübeck, Hamburg, Germany.; Koehler F; DZHK (German Centre for Cardiovascular Research), Partner Site Berlin, Berlin, Germany.; Deutsches Herzzentrum der Charité (DHZC), Department of Cardiology, Angiology and Intensive Care Medicine, Campus Charité Mitte, Berlin, Germany.; Center for Cardiovascular Telemedicine, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.; Lainscak M; Division of Cardiology, General Hospital Murska Sobota, Murska Sobota, Slovenia.; Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia.; Öner A; Department of Cardiology, Rostock University Medical Centre, Rostock, Germany.; Mezilis N; Department of Cardiology, St Luke's Hospital, Thessaloniki, Greece.; Theofilogiannakos EK; Department of Cardiology, St Luke's Hospital, Thessaloniki, Greece.; Ninios I; European Interbalkan Medical Center, Thessaloniki, Greece.; Chrissoheris M; Department of Transcatheter Heart Valves, HYGEIA Hospital, Athens, Greece.; Kourkoveli P; Department of Transcatheter Heart Valves, HYGEIA Hospital, Athens, Greece.; Papadopoulos K; European Interbalkan Medical Center, Thessaloniki, Greece.; Department of Transcatheter Heart Valves, HYGEIA Hospital, Athens, Greece.; Smolka G; Division of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland.; Wojakowski W; Division of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland.; Reczuch K; Institute of Heart Diseases, Medical University and University Hospital, Wroclaw, Poland.; Pinto FJ; Centro Academico de Medicina de Lisboa, CCUL@RISE, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal.; Zmudka K; Clinic of Interventional Cardiology, John Paul II Hospital, Kraków, Poland.; Kalarus Z; Department of Cardiology, Congenital Heart Diseases and Electrotherapy, Medical University of Silesia, Katowice, Poland.; Adamo M; Institute of Cardiology, ASST Spedali Civili and Department of Medical and Surgical Specialties, Radiological Sciences and Public Health, University of Brescia, Brescia, Italy.; Santiago-Vacas E; Heart Institute, Hospital Universitari Germans Trias i Pujol, Barcelona, Spain.; Ruf TF; Department of Cardiology, University Medical Center of the Johannes Gutenberg-University Mainz, Mainz, Germany.; Gross M; Department of Medicine, Heart and Vascular Center, Division of Cardiology and Vascular Medicine, Johanniter Hospital Stendal, Stendal, Germany.; Tongers J; Mid-German Heart Center, Department of Cardiology, Angiology and Intensive Care Medicine, University Hospital Halle/Saale, Halle, Germany.; Hasenfuß G; Department of Cardiology and Pneumology, University Medical Centre Göttingen, Georg August University of Göttingen, Göttingen, Germany.; German Centre for Cardiovascular Research (DZHK), Partner Site Göttingen, Göttingen, Germany.; Schillinger W; Department of Cardiology and Pneumology, University Medical Centre Göttingen, Georg August University of Göttingen, Göttingen, Germany.; Heart Center, Department of Cardiology, Georg-August-University Göttingen, Göttingen, Germany.; Ponikowski P; Centro Academico de Medicina de Lisboa, CCUL@RISE, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal.
Source
Publisher: Wiley Country of Publication: England NLM ID: 100887595 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1879-0844 (Electronic) Linking ISSN: 13889842 NLM ISO Abbreviation: Eur J Heart Fail Subsets: MEDLINE
Subject
Language
English
Abstract
Aim: 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.
(© 2024 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)
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 cm
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.
(© 2024 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)