Hospitalization of Symptomatic Patients With Heart Failure and Moderate to Severe Functional Mitral Regurgitation Treated With MitraClip : Insights From RESHAPE-HF2
Ponikowski, Piotr (Institute of Heart Diseases. Medical University and University Hospital(Polònia))
Friede, Tim (German Centre for Cardiovascular Research (DZHK))
Von Bardeleben, Ralph Stephan (University Medical Center of the Johannes Gutenberg-University Mainz(Alemanya))
Butler, Javed (Baylor Scott and White Research Institute(Estats Units d'Amèrica))
Shahzeb Khan, Muhammad (Baylor College of Medicine. Temple. Texas. USA. and Baylor Scott and White Health. The Heart Hospital Plano(Estats Units d'Amèrica))
Diek, Monika (German Centre for Cardiovascular Research (DZHK))
Heinrich, Jutta (Clinical Trial Unit. University Medical Center Göttingen(Alemanya))
Geyer, Martin (University Medical Center of the Johannes Gutenberg-University Mainz(alemanya))
Placzek, Marius (German Centre for Cardiovascular Research (DZHK))
Ferrari, Roberto (University of Ferrara. Department of Translational Medicine (Itàlia))
Abraham, William T. (The Ohio State University (Estats Units d'Amèrica))
Alfieri, Ottavio (Cardiac Surgery Unit. IRCCS San Raffaele Scientific Institute (Itàlia))
Auricchio, Angelo (Cardiocentro Ticino Institute-EOC (Suïssa))
Bayés-Genís, Antoni (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Cleland, John G. F. (British Heart Foundation Glasgow Cardiovascular Research Centre (Regne Unit))
Filippatos, Gerasimos (National and Kapodistrian University of Athens (Grècia))
Gustafsson, Finn (Copenhagen University Hospital - Rigshospitalet (Dinamarca))
Haverkamp, Wilhelm (Charité-Universitätsmedizin Berlin)
Kelm, Malte (Heinrich-Heine University (Alemaya))
Kuck, Karl-Heinz (University Heart Center Lübeck. University Hospital Schleswig-Holstein (Alemanya))
Landmesser, Ulf (Campus Benjamin Franklin (Alemanya))
Maggioni, Aldo P. (ANMCO Research Center. Heart Care Foundation)
Metra, Marco (University of Brescia (Itàlia))
Ninios, Vlasis (European Interbalkan Medical Center (Grècia))
Petrie, Mark (British Heart Foundation Glasgow Cardiovascular Research Centre (Regne Unit))
Rassaf, Tienush (University Duisburg-Essen (Alemanya))
Ruschitzka, Frank (University of Zurich (Suïssa))
Schäfer, Ulrich (Heart and Vascular Centre (Alemanya))
Schulze, P. Christian (University Hospital Jena (Alemanya))
Spargias, Konstantinos (HYGEIA Hospital (Grècia))
Vahanian, Alec (Groupe Hospitalier Bichat (França))
Zamorano, Jose Luis (Instituto de Salud Carlos III)
Zeiher, Andreas (German Center of Cardiovascular Research (DZHK)(Alemanya))
Karakas, Mahir (German Centre for Cardiovascular Research (DZHK))
Koehler, Friedrich (Charité-Universitätsmedizin Berlin)
Lainscak, Mitja (Univerza V Ljubljani (Eslovènia))
Öner, Alper (Rostock University Medical Centre (Alemanya))
Mezilis, Nikolaos (St Luke's Hospital (Grècia))
Theofilogiannakos, Efstratios K. (St Luke's Hospital (Grècia))
Ninios, Ilias (European Interbalkan Medical Center (Grècia))
Chrissoheris, Michael (HYGEIA Hospital (Grècia))
Kourkoveli, Panagiota (HYGEIA Hospital (Grècia))
Papadopoulos, Konstantinos (HYGEIA Hospital (Grècia))
Smolka, Grzegorz (Medical University of Silesia (Polònia))
Wojakowski, Wojciech (Medical University of Silesia (Polònia))
Reczuch, Krzysztof (Institute of Heart Diseases. Medical University and University Hospital (Polònia))
Pinto, Fausto J. (Centro Academico de Medicina de Lisboa. Universidade de Lisboa (Portugal))
Wiewiórka, Łukasz (John Paul II Hospital (Polònia))
Streb, Witold (Medical University of Silesia (Polònia))
Adamo, Marianna (University of Brescia (Itàlia))
Santiago Vacas, Evelyn (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Friedrich Ruf, Tobias (University Medical Center of the Johannes Gutenberg-University Mainz (Alemanya))
Gross, Michael (Johanniter Hospital Stendal (Alemanya))
Tongers, Joern (University Hospital Halle/Saale (Alemanya))
Hasenfuß, Gerd (German Centre for Cardiovascular Research (DZHK))
Schillinger, Wolfgang (Georg-August-University Göttingen (Alemanya))
Anker, Stefan (German Centre for Cardiovascular Research (DZHK))
Universitat Autònoma de Barcelona

Data:	2024
Resum:	Background: For patients with functional mitral regurgitation (FMR) and symptomatic heart failure (HF), randomized trials of mitral transcatheter edge-to-edge repair (M-TEER) have produced conflicting results. Objectives: This study sought to assess the impact of M-TEER on hospitalization rates, and explore the effects of M-TEER on patients who did or did not have a history of recent HF hospitalizations before undergoing M-TEER. Methods: RESHAPE-HF2 (Randomized Investigation of the MitraClip Device in Heart Failure: 2nd Trial in Patients with Clinically Significant Functional Mitral Regurgitation) included patients with symptomatic HF and moderate to severe FMR (mean effective regurgitant orifice area 0. 25 cm; 14% >0. 40 cm, 23% <0. 20 cm) and showed that M-TEER reduced recurrent HF hospitalizations with and without the addition of cardiovascular (CV) death and improved quality of life. We now report the results of prespecified analyses on hospitalization rates and for the subgroup of patients (n = 333) with a HF hospitalization in the 12 months before randomization. Results: At 24 months, the time to first event of CV death or HF hospitalization (HR: 0. 65; 95% CI: 0. 49-0. 85; P = 0. 002), the rate of recurrent CV hospitalizations (rate ratio [RR]: 0. 75; 95% CI: 0. 57-0. 99; P = 0. 046), the composite rate of recurrent CV hospitalizations and all-cause mortality (RR: 0. 74; 95% CI: 0. 57-0. 95; P = 0. 017), and of recurrent CV death and CV hospitalizations (RR: 0. 76; 95% CI: 0. 58-0. 99; P = 0. 040), were all lower in the M-TEER group. The RR of recurrent hospitalizations for any cause was 0. 82 (95% CI: 0. 63-1. 07; P = 0. 15) for patients in the M-TEER group vs control group patients. Patients randomized to M-TEER lost fewer days due to death or HF hospitalization (13. 9% [95% CI: 13. 0%-14. 8%] vs 17. 4% [95% CI: 16. 4%-18. 4%] of follow-up time; P < 0. 0001, and 1,067 vs 1,776 total days lost; P < 0. 0001). Patients randomized to M-TEER also had better NYHA functional class at 30 days and at 6, 12, and 24 months of follow-up (P < 0. 0001). A history of HF hospitalizations before randomization was associated with worse outcomes and greater benefit with M-TEER on the rate of the composite of recurrent HF hospitalizations and CV death (P = 0. 03) and of recurrent HF hospitalizations within 24 months (P = 0. 06). Conclusions: These results indicate that a broader application of M-TEER in addition to optimal guideline-directed medical therapy should be considered among patients with symptomatic HF and moderate to severe FMR, particularly in those with a history of a recent hospitalization for HF.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	M-TEER ; MitraClip ; Clinical trial ; Heart failure ; Hospitalization ; Mitral regurgitation ; Transcatheter repair
Publicat a:	Journal of the American College of Cardiology, Vol. 84 Núm. 24 (october 2024) , p. 2347-2363, ISSN 1558-3597

DOI: 10.1016/j.jacc.2024.08.027
PMID: 39217574

17 p, 795.9 KB

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