Rational antiarrhythmic therapy in postoperative period of pulmonary vein ostia catheter isolation according to the efficacy and safety, for prevention of early recurrences of atrial tachyarrhythmias

The PROOF study is a randomized, prospective, open, comparative trial with the control group. The aim of the study is to investigate the complex approach in management and treatment and to estimate the efficacy and safety of antiarrhythmic drugs (AAD) monotherapy: propafenone, sotalol and verapamil in comparison with the control group of patients without AAD application for prevention of recurrences of atrial tachyarrhythmias (ATA) in the early and following postoperative periods of pulmonary vein (PV) ostia catheter isolation (LV). Material and methods: Patients’ diary, electrocardiography, 24-hour Holter ECG monitoring and percutaneous heart monitor - Reveal (Medtronic) were used to detect asymptomatic arrhythmias. 243 patients (mean age 56.09±10.14 years) were included according to the design of a randomized study. They are divided into 4 groups. Patients of Group 1 (n=61) received verapamil retard 240 mg/day, Group 2 (n=62) - propafenone 450 mg/day, Group 3 (n=60) - sotalol 160 mg/day, Group 4 - control group (n = 60) without AAD application. Results. The overall effectiveness of PV ostia isolation after one surgery was 66.6%: 67.2% - on applying protective antiarrhythmic drugs (AAD) and 65% - without AAD (p=0.75). The treatment was ineffective in 81 (33.4%) patients and 62 (25.5%) patients among them were offered repeat surgery. The overall effectiveness of invasive treatment after two manipulations was 88.5%: 88.55% - on applying AAD and 88.33% - without AAD (r = 0.83). During the first 3 months of the observation we registered 1.016±1.74 median number of electrical cardioversions in Group 1 (p=0.607), 0.40±1.03 - in Group 2 (p=0.0096) (statistically significant difference) and 1.033±1.52 - in Group 3 (p=0.152). The median number of hospitalizations during 3 months was 0.654±0.74 cases. The number of hospitalizations was 0.684±0.73 in Group 1 (p=0.178), 0.447±0.57 - in Group 2 (propafenone), 0.592±0.67 - in Group 3 (sotalol) (p=0.044) and 0.894±0.88 - in control group (without AAD) (p=0.0016). Propafenone and verapamil showed satisfactory safety profile of AAD application in the early postoperative period, but the result did not differ from the control group, however, in sotalol Grope we registered statistically significant increase of number of proaritmic effects - disorders of automatism associated with significant pauses in rhythm. Conclusion. AAD in postoperative period of PV ostia catheter isolation do not effect on the outcomes of invasive treatment after one or two surgeries, but can effect on the clinical course of postoperative period, by reducing the number of medication and electrical cardioversions and the number of hospitalizations, associated with irregular heart rhythm. We showed that propafenone was the rational AAD IC-class during that period, according to the efficiency and safety for prevention of early recurrence of ATA.

atrial fibrillation, radiofrequency ablation of pulmonary veins, the early postoperative period, verapamil, propafenone, sotalol, PROOF study