Michele Brignole1,2, Francesco Pentimalli3, Pietro Palmisano4, Maurizio Landolina5, Fabio Quartieri6, Eraldo Occhetta7, Leonardo Calò8, Giuseppe Mascia9, Lluis Mont10, Kevin Vernooy11, Vincent van Dijk12, Cor Allaart13, Laurent Fauchier14, Maurizio Gasparini15, Gianfranco Parati2,16, Davide Soranna17, Michiel Rienstra18, Isabelle C Van Gelder18. 1. Department of Cardiology, Ospedali del Tigullio, Lavagna, Italy. 2. Department of Cardiology, IRCCS Istituto Auxologico Italiano, Ospedale San Luca, Piazzale Brescia 20, 20149 Milan, Italy. 3. Department of Cardiology, Ospedale S. Paolo, Savona, Italy. 4. Department of Cardiology, Ospedale Panico, Tricase, Italy. 5. Department of Cardiology, Ospedale Maggiore, Crema, Italy. 6. Department of Cardiology, Ospedale S. Maria Nuova, Reggio Emilia, Italy. 7. Department of Cardiology, Ospedale Maggiore della Carità, Novara, Italy. 8. Department of Cardiology, Policlinico Casilino, Roma, Italy. 9. Department of Cardiology, Ospedale San Giovanni di Dio, Firenze, Italy. 10. Department of Cardiology, Hospital Clinic, Barcelona, Spain. 11. Department of Cardiology, University Medical Center, Maastricht, The Netherlands. 12. Department of Cardiology, University Medical Center, Nieuwegein, The Netherlands. 13. Department of Cardiology, University Medical Center, Amsterdam, The Netherlands. 14. Department of Cardiology, Centre Hospitalier Universitaire Trousseau, Université François Rabelais, Tours, France. 15. Department of Cardiology, Istituto Clinico Humanitas, Rozzano, Italy. 16. Department of Cardiology, University of Milano Bicocca, Milan, Italy. 17. Department of Cardiology, IRCCS Istituto Auxologico Italiano, Biostatistic Unit, Milan, Italy. 18. Department of Cardiology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
Abstract
AIMS: In patients with atrial fibrillation (AF) and heart failure (HF), strict and regular rate control with atrioventricular junction ablation and biventricular pacemaker (Ablation + CRT) has been shown to be superior to pharmacological rate control in reducing HF hospitalizations. However, whether it also improves survival is unknown. METHODS AND RESULTS: In this international, open-label, blinded outcome trial, we randomly assigned patients with severely symptomatic permanent AF >6 months, narrow QRS (≤110 ms) and at least one HF hospitalization in the previous year to Ablation + CRT or to pharmacological rate control. We hypothesized that Ablation + CRT is superior in reducing the primary endpoint of all-cause mortality. A total of 133 patients were randomized. The mean age was 73 ± 10 years, and 62 (47%) were females. The trial was stopped for efficacy at interim analysis after a median of 29 months of follow-up per patient. The primary endpoint occurred in 7 patients (11%) in the Ablation + CRT arm and in 20 patients (29%) in the Drug arm [hazard ratio (HR) 0.26, 95% confidence interval (CI) 0.10-0.65; P = 0.004]. The estimated death rates at 2 years were 5% and 21%, respectively; at 4 years, 14% and 41%. The benefit of Ablation + CRT of all-cause mortality was similar in patients with ejection fraction (EF) ≤35% and in those with >35%. The secondary endpoint combining all-cause mortality or HF hospitalization was significantly lower in the Ablation + CRT arm [18 (29%) vs. 36 (51%); HR 0.40, 95% CI 0.22-0.73; P = 0.002]. CONCLUSIONS: Ablation + CRT was superior to pharmacological therapy in reducing mortality in patients with permanent AF and narrow QRS who were hospitalized for HF, irrespective of their baseline EF. STUDY REGISTRATION: ClinicalTrials.gov Identifier: NCT02137187. Published on behalf of the European Society of Cardiology. All rights reserved.
AIMS: In patients with atrial fibrillation (AF) and heart failure (HF), strict and regular rate control with atrioventricular junction ablation and biventricular pacemaker (Ablation + CRT) has been shown to be superior to pharmacological rate control in reducing HF hospitalizations. However, whether it also improves survival is unknown. METHODS AND RESULTS: In this international, open-label, blinded outcome trial, we randomly assigned patients with severely symptomatic permanent AF >6 months, narrow QRS (≤110 ms) and at least one HF hospitalization in the previous year to Ablation + CRT or to pharmacological rate control. We hypothesized that Ablation + CRT is superior in reducing the primary endpoint of all-cause mortality. A total of 133 patients were randomized. The mean age was 73 ± 10 years, and 62 (47%) were females. The trial was stopped for efficacy at interim analysis after a median of 29 months of follow-up per patient. The primary endpoint occurred in 7 patients (11%) in the Ablation + CRT arm and in 20 patients (29%) in the Drug arm [hazard ratio (HR) 0.26, 95% confidence interval (CI) 0.10-0.65; P = 0.004]. The estimated death rates at 2 years were 5% and 21%, respectively; at 4 years, 14% and 41%. The benefit of Ablation + CRT of all-cause mortality was similar in patients with ejection fraction (EF) ≤35% and in those with >35%. The secondary endpoint combining all-cause mortality or HF hospitalization was significantly lower in the Ablation + CRT arm [18 (29%) vs. 36 (51%); HR 0.40, 95% CI 0.22-0.73; P = 0.002]. CONCLUSIONS: Ablation + CRT was superior to pharmacological therapy in reducing mortality in patients with permanent AF and narrow QRS who were hospitalized for HF, irrespective of their baseline EF. STUDY REGISTRATION: ClinicalTrials.gov Identifier: NCT02137187. Published on behalf of the European Society of Cardiology. All rights reserved.
Authors: Leonard Bergau; Philipp Bengel; Vanessa Sciacca; Thomas Fink; Christian Sohns; Philipp Sommer Journal: J Clin Med Date: 2022-04-29 Impact factor: 4.964
Authors: Nadeev Wijesuriya; Mark K Elliott; Vishal Mehta; Jonathan M Behar; Steven Niederer; Bruce L Wilkoff; Christopher A Rinaldi Journal: Front Physiol Date: 2022-08-11 Impact factor: 4.755