TY - JOUR
T1 - Catheter Ablation in End-Stage Heart Failure with Atrial Fibrillation.
AU - Sohns, Christian
AU - Fox, Henrik
AU - Marrouche, Nassir F.
AU - Crijns, Harry J. G. M.
AU - Costard-Jaeckle, Angelika
AU - Bergau, Leonard
AU - Hindricks, Gerhard
AU - Dagres, Nikolaos
AU - Sossalla, Samuel
AU - Schramm, Rene
AU - Fink, Thomas
AU - el Hamriti, Mustapha
AU - Moersdorf, Maximilian
AU - Sciacca, Vanessa
AU - Konietschke, Frank
AU - Rudolph, Volker
AU - Gummert, Jan
AU - Tijssen, Jan G. P.
AU - Sommer, Philipp
N1 - Funding Information: CASTLE-HTx was a single-center, open-label, investigator-initiated, superiority, randomized clinical trial. The rationale for and design of the trial have been published previously. This trial was conducted at Herz- und Diabeteszentrum Nordrhein-Westfalen (Bad Oeynhausen, Germany), a referral center for heart transplantation with an annual volume of approximately 80 transplantations and a total volume of approximately 3000 since 1989. The trial was supported by an unrestricted educational grant from Else Kröner-Fresenius-Stiftung, a foundation that had no role in the design or execution of the trial or in the preparation of the manuscript. The German health insurance system covered all costs related to catheter ablation, including materials. Publisher Copyright: © 2023 Massachusetts Medical Society.
PY - 2023/12/28
Y1 - 2023/12/28
N2 - Background The role of catheter ablation in patients with symptomatic atrial fibrillation and end-stage heart failure is unknown. Methods We 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. Results A 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. Conclusions Among 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.)
AB - Background The role of catheter ablation in patients with symptomatic atrial fibrillation and end-stage heart failure is unknown. Methods We 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. Results A 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. Conclusions Among 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.)
KW - Arrhythmias/Pacemakers/Defibrillators
KW - Cardiology
KW - Cardiology General
KW - Heart Failure
KW - Heart Transplantation
UR - http://www.scopus.com/inward/record.url?scp=85170573468&partnerID=8YFLogxK
U2 - 10.1056/NEJMoa2306037
DO - 10.1056/NEJMoa2306037
M3 - Article
C2 - 37634135
SN - 0028-4793
VL - 389
SP - 1380
EP - 1389
JO - New England journal of medicine
JF - New England journal of medicine
IS - 15
ER -