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 an...
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| Main Authors: | , , , |
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| Format: | Article |
| Language: | Russian |
| Published: |
«SILICEA-POLIGRAF» LLC
2017-02-01
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| Series: | Кардиоваскулярная терапия и профилактика |
| Subjects: | |
| Online Access: | https://cardiovascular.elpub.ru/jour/article/view/562 |
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| Summary: | 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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| ISSN: | 1728-8800 2619-0125 |