Transcatheter Valve Repair in Heart Failure with Moderate to Severe Mitral Regurgitation
Authors: Stefan D Anker, Tim Friede, Ralph-Stephan von Bardeleben, Javed Butler, Muhammad-Shahzeb Khan, Monika Diek, Jutta Heinrich, Martin Geyer, Marius Placzek, Roberto Ferrari, William T Abraham, Ottavio Alfieri, Angelo Auricchio, Antoni Bayes-Genis, John G F Cleland, Gerasimos Filippatos, Finn Gustafsson, Wilhelm Haverkamp, Malte Kelm, Karl-Heinz Kuck, Ulf Landmesser, Aldo P Maggioni, Marco Metra, Vlasis Ninios, Mark C Petrie, Tienush Rassaf, Frank Ruschitzka, Ulrich Schäfer, P Christian Schulze, Konstantinos Spargias, Alec Vahanian, Jose Luis Zamorano, Andreas Zeiher, Mahir Karakas, Friedrich Koehler, Mitja Lainscak, Alper Öner, Nikolaos Mezilis, Efstratios K Theofilogiannakos, Ilias Ninios, Michael Chrissoheris, Panagiota Kourkoveli, Konstantinos Papadopoulos, Grzegorz Smolka, Wojciech Wojakowski, Krzysztof Reczuch, Fausto J Pinto, Łukasz Wiewiórka, Zbigniew Kalarus, Marianna Adamo, Evelyn Santiago-Vacas, Tobias F Ruf, Michael Gross, Joern Tongers, Gerd Hasenfuss, Wolfgang Schillinger, Piotr Ponikowski
Journal: New England Journal of Medicine (2024)

BackgroundWhether transcatheter mitral-valve repair improves outcomes in patients with heart failure and functional mitral regurgitation is uncertain.MethodsWe conducted a randomized, controlled trial involving patients with heart failure and moderate to severe functional mitral regurgitation from 30 sites in nine countries. The patients were assigned in a 1:1 ratio to either transcatheter mitral-valve repair and guideline-recommended medical therapy (device group) or medical therapy alone (control group). The three primary end points were the rate of the composite of first or recurrent hospitalization for heart failure or cardiovascular death during 24 months; the rate of first or recurrent hospitalization for heart failure during 24 months; and the change from baseline to 12 months in the score on the Kansas City Cardiomyopathy Questionnaire–Overall Summary (KCCQ-OS; scores range from 0 to 100, with higher scores indicating better health status).ResultsA total of 505 patients underwent randomization: 250 were assigned to the device group and 255 to the control group. At 24 months, the rate of first or recurrent hospitalization for heart failure or cardiovascular death was 37.0 events per 100 patient-years in the device group and 58.9 events per 100 patient-years in the control group (rate ratio, 0.64; 95% confidence interval [CI], 0.48 to 0.85; P=0.002). The rate of first or recurrent hospitalization for heart failure was 26.9 events per 100 patient-years in the device group and 46.6 events per 100 patient-years in the control group (rate ratio, 0.59; 95% CI, 0.42 to 0.82; P=0.002). The KCCQ-OS score increased by a mean (±SD) of 21.6±26.9 points in the device group and 8.0±24.5 points in the control group (mean difference, 10.9 points; 95% CI, 6.8 to 15.0; P<0.001). Device-specific safety events occurred in 4 patients (1.6%).ConclusionsAmong patients with heart failure with moderate to severe functional mitral regurgitation who received medical therapy, the addition of transcatheter mitral-valve repair led to a lower rate of first or recurrent hospitalization for heart failure or cardiovascular death and a lower rate of first or recurrent hospitalization for heart failure at 24 months and better health status at 12 months than medical therapy alone. (Funded by Abbott Laboratories; RESHAPE-HF2 ClinicalTrials.gov number, NCT02444338.)