ASSESSMENT OF THE EFFICACY OF CATHETER ISOLATION OF PULMONARY VEINS OSTIA FOR TREATMENT OF PAROXYSMAL ATRIAL FIBRILLATION WITH ANTIARRHYTHMIC THERAPY IN EARLY POST-SURGERY PERIOD (THE PRUF STUDY)

Aim. To address the complex approach  to observation and medication therapy  with assessment of efficacy and  safety  of monotherapy  by antiarrhythmic drugs (AAD): propafenon, sotalol, verapamil in comparison  with non-AAD controls,  for prevention of recurrent  atrial tachiarrhytmias  in early  and  later  post-operation  time  of  catheter isolation of pulmonary veins ostia.

Material and methods. Randomized by “envelope” method, and by the design of the study, 243 patinets included, 142 (58,44%) males and 101 (41,56%)  females,  age  25-79  y.o. (mean  — 56,09±10,14  y.o.) with anamnesis  of 4,48±2,6  years,  and selected  to 4 similar groups:  1 gr. (n=61) prescribed  AAD by Vaughan Williams class 4 — verapamil retard 240 mg/day, 2 gr. (n=62) — AAD class 1С — propafenon 450 mg/day, 3 group (n=60) — AAD class 3 — sotalol 160 mg/day, and 4 control group (n=60) — non-AAD. Follow-up lasted from 365 days (±10 days). Study methods:  patient  diary, ECG, Holter ECG, and  half of the  patients underwent implanting of subcutaneous monitor Reveal® (Medtronic).

Results. Total efficacy of ostium isolation after one procedure  was 66,6% (n=162, 95% confidence interval (CI) 61-72%), 67,2% (n=123, 95% CI 60-74%)  at the background  of antiarrhythmic therapy,  and 65% (n=39, 95% CI 52-76) non-AAD (р=0,75). In 81 (33,4%) patients AAD was non-effective, of whom 62 (25,5%) were operated  second time.  After two procedures, total  efficacy reached  88,5%  (n=215, 95% CI 84-92%), with AAD — 88,55% (n=183, 95% CI 83-92%) and non-AAD — 88,33% (n=53, 95% CI 78-94%)  (р=0,83).  There were differences   in  groups  during  early  post-operation  period  by  the number  of  medicational  and  electrical  cardioversions,  as  by  the number  of hospitalizations related  to arrhythmia. Mean number  of hospitalizations in 3 months was 0,654±0,74 cases. In group 1 it was 0,684±0,73  vs controls non-AAD — 0,894±0,88  (р=0,178), group 2 (propafenon)  — 0,447±0,57  vs controls  — 0,894±0,88  (р=0,0016) and  in group  3 (sotalol) — 0,592±0,67  vs controls  — 0,894±0,88, resp. (р=0,044).

Conclusion. AAD  in post-operation therapy  of catheter  isolation of pulmonary veins ostia  does  not  influence  the  outcomes  of invasive treatment   after  one  or  two operations,   however  influences  clinical course  of post-operation period, decreasing the number of medication and electrical cardioversions and significantly decreasing the number of hospitalizations related to cardiac arrhythmias.

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