Clinical Pearls & Morning Reports
Published October 11, 2023
Sohns et al. conducted a randomized trial that compared catheter ablation plus guideline-directed medical therapy with medical therapy alone in patients with end-stage heart failure and symptomatic atrial fibrillation who were referred to their center for evaluation for heart transplantation or implantation of a left ventricular assist device. Read the NEJM Original Article here.
Q: What clinical question did this trial hope to answer?
A: Patients with heart failure and symptomatic atrial fibrillation who undergo catheter ablation have a lower likelihood of death or worsening heart failure than those who do not. Data from prospective randomized trials on the effectiveness of catheter ablation in improving these outcomes in patients with end-stage heart failure are lacking, and professional society guidelines do not provide recommendations regarding the appropriate strategy to manage atrial fibrillation in these patients.
Q: Did patients need to have symptomatic atrial fibrillation to enroll in this trial?
A: To be eligible for enrollment, patients had to have symptomatic atrial fibrillation, New York Heart Association class II or higher heart failure, a left ventricular ejection fraction of 35% or less, and impaired functional capacity, as assessed with the use of the 6-minute walk test.
A: 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. A primary end-point event 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). A left ventricular assist device was implanted in 1 patient (1%) in the ablation group and in 10 patients (10%) in the medical-therapy group (cause-specific hazard ratio, 0.09; 95% CI, 0.01 to 0.70). In the ablation group, the left ventricular ejection fraction improved by a mean (±SD) of 6.7±6.5 percentage points among 92 patients at 6 months and 7.8±7.6 percentage points among 92 patients at 12 months, as compared with 1.2±6.4 percentage points among 74 patients at 6 months and 1.4±7.2 percentage points among 70 patients at 12 months in the medical-therapy group (mean between-group difference, 5.5 percentage points [95% CI, 3.5 to 7.5] at 6 months and 6.4 percentage points [95% CI, 4.1 to 8.7] at 12 months).
A: One limitation is that the trial was conducted at a single referral center. Another potential limitation is the early termination of the trial based on the recommendation of the data and safety monitoring board, and it is possible that the findings may have differed with longer-term follow-up. The open-label design might have influenced treatment decisions regarding the components of the primary end point. However, these decisions were made without knowledge of the patient’s trial-group assignment during heart-team meetings. Whether the findings are generalizable to patients with asymptomatic atrial fibrillation is unknown.