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Randomized Controlled Trial Comparative Study
Catheter Ablation in End-Stage Heart Failure with Atrial Fibrillation.
- Christian Sohns, Henrik Fox, Nassir F Marrouche, CrijnsHarry J G MHJGM0000-0003-1073-5337From the Clinics for Electrophysiology (C.S., L.B., T.F., M.E.H., M.M., V.S., P.S.), Thoracic and Cardiovascular Surgery (H.F., A.C.-J., R.S., J.G.), and General and Interventional Cardiology-Angiology (V.R.) and th, Angelika Costard-Jaeckle, Leonard Bergau, Gerhard Hindricks, Nikolaos Dagres, Samuel Sossalla, Rene Schramm, Thomas Fink, Mustapha El Hamriti, Maximilian Moersdorf, Vanessa Sciacca, Frank Konietschke, Volker Rudolph, Jan Gummert, TijssenJan G PJGPFrom the Clinics for Electrophysiology (C.S., L.B., T.F., M.E.H., M.M., V.S., P.S.), Thoracic and Cardiovascular Surgery (H.F., A.C.-J., R.S., J.G.), and General and Interventional Cardiology-Angiology (V.R.) and the Center for Interdisci, Philipp Sommer, and CASTLE HTx Investigators.
- From the Clinics for Electrophysiology (C.S., L.B., T.F., M.E.H., M.M., V.S., P.S.), Thoracic and Cardiovascular Surgery (H.F., A.C.-J., R.S., J.G.), and General and Interventional Cardiology-Angiology (V.R.) and the Center for Interdisciplinary Management of Advanced Heart Failure (H.F., A.C.J., R.S., J.G.), Herz- und Diabeteszentrum Nordrhein-Westfalen, Ruhr-Universität Bochum, Bad Oeynhausen, the Department of Cardiology, Angiology, and Intensive Care Medicine, Charité Campus Mitte, German Heart Center of Charité-University Medicine Berlin (G.H.), and the Institute of Biometry and Clinical Epidemiology, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin (F.K.), Berlin, the Department of Electrophysiology, Heart Center Leipzig, Leipzig (N.D.), and the Department of Cardiology and Angiology, University of Giessen and Kerckhoff Heart Center, Bad Nauheim (S.S.) - all in Germany; the Cardiology Department, Tulane University School of Medicine, New Orleans (N.F.M.); and the Department of Cardiology and Cardiovascular Research Institute Maastricht, Maastricht University, Maastricht (H.J.G.M.C.), and the Department of Cardiology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (J.G.P.T.) - both in the Netherlands.
- N. Engl. J. Med. 2023 Oct 12; 389 (15): 138013891380-1389.
BackgroundThe role of catheter ablation in patients with symptomatic atrial fibrillation and end-stage heart failure is unknown.MethodsWe conducted a single-center, open-label trial in Germany that involved patients with symptomatic atrial fibrillation and end-stage heart failure who were referred for heart transplantation evaluation. Patients were assigned to receive catheter ablation and guideline-directed medical therapy or medical therapy alone. The primary end point was a composite of death from any cause, implantation of a left ventricular assist device, or urgent heart transplantation.ResultsA total of 97 patients were assigned to the ablation group and 97 to the medical-therapy group. The trial was stopped for efficacy by the data and safety monitoring board 1 year after randomization was completed. Catheter ablation was performed in 81 of 97 patients (84%) in the ablation group and in 16 of 97 patients (16%) in the medical-therapy group. After a median follow-up of 18.0 months (interquartile range, 14.6 to 22.6), a primary end-point event had occurred in 8 patients (8%) in the ablation group and in 29 patients (30%) in the medical-therapy group (hazard ratio, 0.24; 95% confidence interval [CI], 0.11 to 0.52; P<0.001). Death from any cause occurred in 6 patients (6%) in the ablation group and in 19 patients (20%) in the medical-therapy group (hazard ratio, 0.29; 95% CI, 0.12 to 0.72). Procedure-related complications occurred in 3 patients in the ablation group and in 1 patient in the medical-therapy group.ConclusionsAmong patients with atrial fibrillation and end-stage heart failure, the combination of catheter ablation and guideline-directed medical therapy was associated with a lower likelihood of a composite of death from any cause, implantation of a left ventricular assist device, or urgent heart transplantation than medical therapy alone. (Funded by Else Kröner-Fresenius-Stiftung; CASTLE-HTx ClinicalTrials.gov number, NCT04649801.).Copyright © 2023 Massachusetts Medical Society.
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