Key result
Robotic navigation during pulmonary vein isolation significantly reduced overall fluoroscopy time compared to conventional ablation (9 vs 22 minutes; P<0.001) with similar 6-month outcomes.
Why the study?
Does robotic navigation guided ablation reduce fluoroscopy exposure in patients undergoing pulmonary vein isolation for paroxysmal atrial fibrillation?
RCT (n=60)
randomly assigned
Does robotic navigation guided ablation reduce fluoroscopy exposure in patients undergoing pulmonary vein isolation for paroxysmal atrial fibrillation?
Absolute Event Rate: 9% vs 22%
p-value: p=<0.001
Robotic navigation during pulmonary vein isolation for paroxysmal atrial fibrillation significantly reduces fluoroscopy time and operator radiation exposure without compromising 6-month efficacy.
Reduces radiation exposure risks for patients and operators during PVI; confirms robotic navigation as a safe, effective alternative in paroxysmal AF.
BACKGROUND: Recently, a nonmagnetic robotic navigation system (RN, Hansen-Sensei) has been introduced for remote catheter manipulation. OBJECTIVE: To investigate the influence of RN combined with intuitive 3-dimensional mapping on the fluoroscopy exposure to operator and patient during pulmonary vein isolation (PVI) for paroxysmal atrial fibrillation (PAF) in a prospective randomized trial. METHODS: Sixty patients were randomly assigned to undergo PVI either using a RN guided (group 1; n = 30, 20 male, 62 +/- 7.7 years) or conventional ablation approach (group 2; n = 30, 14 male, 61 +/- 7.6 years). A 3-dimensional mapping system (NavX) was used in both groups. RESULTS: Electrical disconnection of the ipsilateral pulmonary veins (PVs) was achieved in all patients. Use of RN significantly lowered the overall fluoroscopy time (9 +/- 3.4 vs 22 +/- 6.5 minutes; P < 0.001) and reduced the operator's fluoroscopy exposure (7 +/- 2.1 vs 22 +/- 6.5 minutes; P < 0.001). The difference in fluoroscopy duration between both groups was most pronounced during the ablation part of the procedure (3 +/- 2.4 vs 17 +/- 6.3 minutes; P < 0.001). The overall procedure duration tended to be prolonged using RN without reaching statistical significance (156 +/- 44.4 vs 134 +/- 12 minutes, P = 0.099). No difference regarding outcome was found during a midterm follow-up of 6 months (AF freedom group 1 = 73% vs 77% in group 2 [P = 0.345]). CONCLUSION: The use of RN for PVI seems to be effective and significantly reduces overall fluoroscopy time and operator's fluoroscopy exposure without affecting mid-term outcome after 6-month follow-up.
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Steven et al. (2009) conducted an RCT in Paroxysmal atrial fibrillation (PAF) (n=60). Robotic navigation system (RN) vs. Conventional ablation approach was evaluated on Overall fluoroscopy time (minutes) (p=<0.001). Robotic navigation during pulmonary vein isolation significantly reduced overall fluoroscopy time compared to conventional ablation (9 vs 22 minutes; P<0.001) with similar 6-month outcomes.
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