Article Impact Level: HIGH Data Quality: STRONG Summary of New England Journal of Medicine, NEJMoa2306037. https://doi.org/10.1056/NEJMoa2306037 Dr. Christian Sohns et al.
Points
- Research conducted in Germany assessed catheter ablation’s impact on patients with symptomatic atrial fibrillation and end-stage heart failure, an unexplored study area.
- Participants were randomly assigned to either catheter ablation plus guideline-directed medical therapy or medical therapy alone, with the primary endpoint being a composite of death, left ventricular assist device implantation, or urgent heart transplantation.
- After a year, the trial was halted due to positive efficacy findings. In the catheter ablation group, 84% underwent the procedure, compared to only 16% in the medical therapy group.
- Results showed a significant reduction in the composite endpoint in the catheter ablation group (8%) compared to the medical therapy group (30%). This effect extended to lower death rates (6% vs. 20%) and fewer procedure-related complications.
- The study concludes that combining catheter ablation with guideline-directed medical therapy offers a promising approach to improving outcomes in patients with atrial fibrillation and end-stage heart failure compared to medical therapy alone.
Summary
This research paper addresses the uncharted territory of catheter ablation’s efficacy in patients suffering from symptomatic atrial fibrillation combined with end-stage heart failure. The study was conducted as a single-center, open-label trial in Germany and targeted individuals referred for heart transplantation evaluation. The participants were randomly assigned to undergo catheter ablation alongside guideline-directed medical therapy or receive medical therapy exclusively. The primary outcome measure focused on a composite endpoint involving death from any cause, a left ventricular assist device implantation, or the necessity for an urgent heart transplant.
Ninety-seven patients were allocated to the catheter ablation group, while another 97 were placed in the medical therapy group. One year after randomization, the trial was halted due to favorable efficacy findings by the data and safety monitoring board. Of the participants in the ablation group, 84% (81 of 97 patients) underwent catheter ablation, whereas only 16% (16 of 97 patients) in the medical therapy group received this intervention. Over a median follow-up period of 18.0 months (interquartile range: 14.6 to 22.6 months), primary endpoint events occurred in 8% (8 patients) of the ablation group and 30% (29 patients) of the medical therapy group (hazard ratio: 0.24; 95% confidence interval [CI]: 0.11 to 0.52; P<0.001). Notably, deaths from any cause were reported in 6% (6 patients) of the ablation group versus 20% (19 patients) of the medical therapy group (hazard ratio: 0.29; 95% CI: 0.12 to 0.72). Procedure-related complications were observed in 3 patients in the ablation group and one in the medical therapy group.
This study’s findings suggest that in patients dealing with atrial fibrillation and end-stage heart failure, the combination of catheter ablation and guideline-directed medical therapy significantly reduces the likelihood of experiencing the composite outcome involving death from any cause, left ventricular assist device implantation, or urgent heart transplantation, compared to medical therapy alone.
Link to the article: https://www.nejm.org/doi/10.1056/NEJMoa2306037
References Sohns, C., Fox, H., Marrouche, N. F., Crijns, H. J. G. M., Costard-Jaeckle, A., Bergau, L., Hindricks, G., Dagres, N., Sossalla, S., Schramm, R., Fink, T., El Hamriti, M., Moersdorf, M., Sciacca, V., Konietschke, F., Rudolph, V., Gummert, J., Tijssen, J. G. P., & Sommer, P. (2023). Catheter ablation in end-stage heart failure with atrial fibrillation. New England Journal of Medicine, NEJMoa2306037. https://doi.org/10.1056/NEJMoa2306037
