Results of hybrid technology in the treatment of nonparoxysmal atrial fibrillation: results of a randomized single center trial

Based on the analysis of immediate and long-term results of treatment of a randomized cohort of patients with idiopathic non-paroxysmal atrial fibrillation, the safety and effectiveness of minimally invasive biatrial epicardial bipolar radiofrequency ablation both in the format of hybrid treatment in combination with endocardial ablation of pulmonary veins and in a stand-alone variant have been shown. 

Aim: To evaluate the effectiveness of hybrid and staged treatment of idiopathic persistent atrial fibrillation (AF) by analyzing immediate and long-term (2 years) treatment results in a single-center randomized clinical controlled trial.

Methods: A single-center randomized trial included 33 patients with non-paroxysmal AF. All patients underwent minimally invasive video-assisted epicardial radiofrequency ablation (RFA) as the first procedure in accordance with Patent for invention of the Republic of Belarus № 22432 dated 12.06.2016. "A method of bipolar minimally invasive epicardial radiofrequency ablation in patients with isolated persistent atrial fibrillation". Depending on the distribution of the group, the patient received an endocardial ablation procedure either during the current hospitalization, or in the period 3-6 months after the epicardial stage in case of recurrence of atrial arrhythmia (Atrial Fibrillation/Atrial Flutter). The primary endpoints included the frequency of AF recurrence at the hospital stage, the frequency of sinus rhythm retention (SR) at the end of hospitalization, the need for pacemakers, the frequency of major adverse cardio- and cerebrovascular events (MACCE). Secondary endpoints included retention of SR at the end of observe, the need to take class I/III antiarrhytmic drugs (AAD) and anticoagulants outside the "blind" period, as well as the need for repeated procedures.

Results: There were no differences in the results between the groups for the primary endpoints. By the time of discharge from the hospital, sinus rhythm (SR) occurred in 100% of patients. We did not observe major adverse cardiovascular and cerebrovascular events at the hospital stage. AF paroxysms at the end of the study period in patients using class I/III AAD were observed in 2 (13.33%) cases in the "hybrid" group and 2 (11.1%) cases in the "staged" treatment group. The need for repeated procedures for atrial arrhythmias was 2 (13.3%) cases in the "hybrid" treatment group and 5 (27.78%) cases in the "staged" treatment group. The cumulative mid-term SR retention rate at 1 year was 94.5% in both groups; after 2 years, the rate was 86.7% in the "hybrid" treatment group and 88.9% in the "staged" group.

Conclusion: Epicardial bipolar biatrial ablation has shown high efficacy in the treatment of non-paroxysmal forms of AF, but often requires repeated procedures to eliminate typical atrial flutter. To perform more effective pulmonary veins isolation, it is reasonable to perform separate pulmonary vein ablation in addition to antral ablation. The staged treatment of persistent forms of AF is justified from the clinical and economic point of view.

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