Key PointsQuestionAmong patients with persistent atrial fibrillation (AF), does the addition of magnetic resonance imaging (MRI)-guided fibrosis ablation to conventional catheter ablation affect atrial arrhythmia recurrence?FindingsIn this randomized clinical trial that included 843 patients with persistent AF, there was no significant difference in atrial arrhythmia recurrence in the MRI-guided fibrosis ablation group compared with the pulmonary vein isolation only group (hazard ratio, 0.95).MeaningFindings do not support the use of MRI-guided fibrosis ablation for the treatment of persistent atrial fibrillation.
Introduction
Success rates of catheter ablation in persistent atrial fibrillation (AF) remain suboptimal. A better and more targeted ablation strategy is urgently needed to optimize outcomes of AF treatment. We sought to assess the safety and efficacy of targeting atrial fibrosis during ablation of persistent AF patients in improving procedural outcomes.
Methods
The DECAAF II trial (ClinicalTrials. gov identifier number NCT02529319) is a prospective, randomized, multicenter trial of patients with persistent AF. Patients with persistent AF undergoing a first‐time ablation procedure were randomized in a 1:1 fashion to receive conventional pulmonary vein isolation (PVI) ablation (Group 1) or PVI + fibrosis‐guided ablation (Group 2). Left atrial fibrosis and ablation induced scarring were defined by late gadolinium enhancement magnetic resonance imaging at baseline and at 3–12 months postablation, respectively. The primary endpoint is the recurrence of atrial arrhythmia postablation, including atrial fibrillation, atrial flutter, or atrial tachycardia after the 90‐day postablation blanking period. Patients were followed for a period of 12–18 months with a smartphone ECG Device (ECG Check Device, Cardiac Designs Inc.). With an anticipated enrollment of 900 patients, this study has an 80% power to detect a 26% reduction in the hazard ratio of the primary endpoint.
Results and Conclusion
The DECAAF II trial is the first prospective, randomized, multicenter trial of patients with persistent AF using imaging defined atrial fibrosis as a treatment target. The trial will help define an optimal approach to catheter ablation of persistent AF, further our understanding of influencers of ablation lesion formation, and refine selection criteria for ablation based on atrial myopathy burden.
Background
- Recent data demonstrates promising effects on left ventricular (LV) dysfunction and LV ejection fraction (EF) improvement following ablation for atrial fibrillation (AF) in patients with heart failure (HF). We sought to study the relationship between LVEF, NYHA class on presentation and the endpoints of mortality and HF admissions in the CASTLE-AF study population. Furthermore, predictors for LVEF improvement were examined.
Methods
- The CASTLE-AF patients with coexisting HF and AF (n=363) were randomized in a multicenter prospective controlled fashion to ablation (n=179) vs pharmacological therapy (n=184). LV function and NYHA class were assessed at baseline (after randomization) and at each follow-up visit.
Results
- In the ablation arm, a significantly higher number of patients experienced an improvement in their LVEF to >35% at the end of the study (OR=2.17; p<0.001). Compared to the pharmacological therapy arm, both ablation patient groups with severe (<20%) or moderate/severe (≥20% and <35%)) baseline LVEF had a significantly lower number of composite endpoints (hazard ratio (HR) =0.60; p=0.006), all-cause mortality (HR=0.54; p=0.019) and cardiovascular (CV) hospitalizations (HR=0.66; p=0.017). In the ablation group, NYHA I/II patients at the time of treatment had the strongest improvement in clinical outcomes (primary endpoint: HR=0.43; p<0.001; mortality: HR=0.30; p=0.001).
Conclusions
- Compared to pharmacological treatment, AF ablation was associated with a significant improvement in LVEF, independent from the severity of LV dysfunction. AF ablation should be performed at early stages of the patient's HF symptoms.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.