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ROBOTIC CATHETER ABLATION OF PERSISTENT ATRIAL FIBRILLATION (RANDOMIZED TRIAL RESULTS)

https://doi.org/10.15829/1560-4071-2017-12-68-72

Abstract

Aim. Comparison of efficacy and safety of the robotic catheter and manual catheter ablation in management of patients with persistent atrial fibrillation (PsAF).

Material and methods. In the study, 80 patients included, with PsAF. They were randomized to groups of manual ablation (MA) and robotic ablation (RA). After ablation, patients were followed up during 1 year every 3 months. Sinus rhythm retention was evaluated with Holter 24-hour ECG monitoring and 12-channel ECG. As efficacy criteria, the absence was taken of registered paroxysms of atrial fibrillation and other tachiarrhythmias lasted 30 sec and more. As primary endpoint, the absence was taken of any atrial tachiarrhythmias (AFib/AFlut) after the ablation procedure during 12 months, with every 3 months ECG monitoring. As secondary endpoints the following were taken: complications rate, duration of procedure and x-ray exposition, rate of recovery of conduction through the ablation line in acute phase (in 30 min post ablation) with intravenous ATP.

Results. Mean procedure time and x-rays exposition in MA group was 164±28 min and 45±14 min, respectively. Mean duration of procedure in RA was 200±35 min (p<0,05). However x-ray duration was lower in RA group: 30±12 min, and the time of rentgenoscopy per operator was even lower: 18±6 min (p<0,05) In the MA group, in 9 (25%) patients there was recovery of conduction through the border, with ATP injection at acute stage, and in RA group — in two patients (5%), p<0,05. Total number of adverse events did not differ in groups (p=0,5).

Conclusion. RA in patients with PsAF makes in to effectively isolate pulmonary veins ostia during the surgery, and to block the conduction through the borderline. The percentage of major and minor adverse events in acute and chronic period of RA is not higher than that in MA and is 10%. Application of RA makes it to decrease x-ray exposition per operator 2,5 times, and on a patient — by 30%. Training period in RA is 10 operations that is significantly lower than in MA.

About the Authors

M. A. Naymushin
Federal Almazov North-West Medical Research Centre of the Ministry of Health
Russian Federation

Saint-Petersburg


Competing Interests:

Не находится на рассмотрении в других изданиях и не была ранее опубликована. Рукопись была прочитана и одобрена всеми соавторами, которые несут ответственность за достоверность предоставленных материалов.Настоящее исследование было проведено в соответствии со стандартами надлежащей клинической практики и принципами Хельсинской Декларации.Рукопись является частью диссертационной работы Наймушина М.А.Конфликт интересов авторами не заявляется.



D. S. Lebedev
Federal Almazov North-West Medical Research Centre of the Ministry of Health

Saint-Petersburg



References

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2. Wazni OM, Barrett C, Martin DO, et al. Experience with the Hansen Robotic System for Atrial Fibrillation Ablation-Lessons Learned and Techniques Modified: Hansen in the Real World. J Cardiovasc Electrophysiol 2009. DOI:10.1111/j.1540-8167.2009.01539.x.

3. Saliba W, Reddy VY, Wazni O, et al. Atrial fibrillation ablation using a robotic catheter remote control system: Initial human experience and long-term follow-up results. J Am Coll Cardiol 2008; 51: 2407-11. https://doi.org/10.1016/j.jacc.2008.03.027.

4. Willems S, Steven D, Servatius H, et al. Persistence of pulmonary vein isolation after robotic remote-navigated ablation for atrial fibrillation and its relation to clinical outcome. J Cardiovasc Electrophysiol 2010; 21: 1079-84. DOI: 10.1111/j.1540-8167.2010.01773.x.

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9. Naymushin MA, Mikhailov EN, Lebedev DS. Robot versus manual ablation persistent atrial fibrillation (ru_spb). Translational Medicine. 2016; 3 (3): 79-84. DOI: 10.18705/2311-4495-2016-3-3-79-84. (In Russ.) Наймушин М.А., Михайлов Е.Н., Лебедев Д.С. Робот против рук. Дизайн рандомизированного клинического исследования роботизированной катетерной аблации персистирующей фибрилляции предсердий. Трансляционная медицина. 2016; 3 (3): 79-84.


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For citations:


Naymushin M.A., Lebedev D.S. ROBOTIC CATHETER ABLATION OF PERSISTENT ATRIAL FIBRILLATION (RANDOMIZED TRIAL RESULTS). Russian Journal of Cardiology. 2017;(12):68-72. (In Russ.) https://doi.org/10.15829/1560-4071-2017-12-68-72

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ISSN 1560-4071 (Print)
ISSN 2618-7620 (Online)