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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.).
An important study for those caring for patients with end-stage heart disease. It's a shame that quality-of-life was not also assessed.
Although limited by being an open-label single center study, it still adds value to ablation in patients with end-stage heart failure with atrial fibrillation. The intention-to=treat and as-treated numbers work out the same in this study, as 16 of 97 ablation-assigned patients did not undergo procedure, and 16 of 97 non-ablation patients actually got ablation. For "event reduction" at median 18 months, the NNT with ablation is an impressive 4.6. For death at median 18 months, the NNT with ablation is approximately 7.7. These are strong NNT results, although generalizability of the study is limited by not being an RCT. Also, the cost of the treatment and the outcomes will likely be less favorable in the US commercial system versus the mostly better outcomes produced by European national health systems.
In the past decade, AF has gone from a disease we watch to a disease we treat very aggressively. AF East and other recent trials have shown us that being aggressive with AF has a mortality benefit; in this important trial, patients at high risk for death with end-stage heart failure were significantly impacted by ablation. This will likely guide therapy for this small subset of very sick patients.