TY  - JOUR
ID  - enlighten331366
UR  - https://eprints.gla.ac.uk/331366/
IS  - 7
A1  - Anker, Stefan D.
A1  - Friede, Tim
A1  - von Bardeleben, Ralph Stephan
A1  - Butler, Javed
A1  - Khan, Muhammad Shahzeb
A1  - Diek, Monika
A1  - Heinrich, Jutta
A1  - Geyer, Martin
A1  - Placzek, Marius
A1  - Ferrari, Roberto
A1  - Abraham, William T.
A1  - Alfieri, Ottavio
A1  - Auricchio, Angelo
A1  - Bayes?Genis, Antoni
A1  - Cleland, John G.F.
A1  - Filippatos, Gerasimos
A1  - Gustafsson, Finn
A1  - Haverkamp, Wilhelm
A1  - Kelm, Malte
A1  - Kuck, Karl?Heinz
A1  - Landmesser, Ulf
A1  - Maggioni, Aldo P.
A1  - Metra, Marco
A1  - Ninios, Vlasis
A1  - Petrie, Mark C.
A1  - Rassaf, Tienush
A1  - Ruschitzka, Frank
A1  - Schäfer, Ulrich
A1  - Schulze, P. Christian
A1  - Spargias, Konstantinos
A1  - Vahanian, Alec
A1  - Zamorano, Jose Luis
A1  - Zeiher, Andreas
A1  - Karakas, Mahir
A1  - Koehler, Friedrich
A1  - Lainscak, Mitja
A1  - Öner, Alper
A1  - Mezilis, Nikolaos
A1  - Theofilogiannakos, Efstratios K
A1  - Ninios, Ilias
A1  - Chrissoheris, Michael
A1  - Kourkoveli, Panagiota
A1  - Papadopoulos, Konstantinos
A1  - Smolka, Grzegorz
A1  - Wojakowski, Wojciech
A1  - Reczuch, Krzysztof
A1  - Pinto, Fausto J.
A1  - Zmudka, Krzysztof
A1  - Kalarus, Zbigniew
A1  - Adamo, Marianna
A1  - Santiago?Vacas, Evelyn
A1  - Ruf, Tobias Friedrich
A1  - Gross, Michael
A1  - Tongers, Joern
A1  - Hasenfuß, Gerd
A1  - Schillinger, Wolfgang
A1  - Ponikowski, Piotr
N2  - 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.
VL  - 26
TI  - 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
AV  - public
EP  - 1615
Y1  - 2024/07//
PB  - Wiley
JF  - European Journal of Heart Failure
KW  - Mitral regurgitation
KW  -  MitraClip
KW  -  transcatheter edge-to-edge repair.
SN  - 1388-9842
SP  - 1608
ER  -