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No difference in outcome between remote robotic navigation, manual ablation for AF
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Remote robotic navigation and manual ablation do not yield significantly different success rates when used for catheter ablation in patients with atrial fibrillation, according to recent findings.
In a prospective randomized trial, researchers evaluated patients who underwent first-time catheter ablation for AF at Saint Bartholomew’s Hospital in London. Participants were randomly assigned to manual ablation or remote robotic navigation (RRN) ablation and classified as having paroxysmal AF (PAF), persistent AF (PeAF) or long-standing PeAF according to Heart Rhythm Society guidelines. The same ablation protocol was used for both study groups.
The target patient population was 170 patients per group; however, the trial was terminated early due to results from an interim analysis suggesting that it was unlikely to indicate superiority of RRN. Upon termination, 166 patients had been randomly assigned and 157 had undergone ablation, with 78 receiving manual and 70 receiving RRN ablation.
Patients underwent follow-up at 3, 6 and 12 months. The primary endpoint was the single-procedure success rate at 12 months, with success defined as freedom from AF or atrial tachycardia of ≥30 seconds while off antiarrhythmic medications. Secondary endpoints included complication rates, periprocedural catheter stability, procedure and fluoroscopy times and doses and operator fatigue.
Within the cohort, 74% of patients had PeAF, with 58% of these cases classified as long-standing PeAF. No significant differences were observed in the 12-month single-procedure success rates for RRN ablation (24%) and manual ablation (33%; P=.29). The two procedures also did not differ significantly in terms of acute wide-area circumferential ablation reconnection rates, complication rates or procedure times; however, multivariable analysis indicated significantly shorter fluoroscopy times in the RRN group (P=.003). The RRN group also had fewer catheter displacements (one vs. five; P<.0005) and lower rates of subjectively evaluated operator fatigue (P=.001).
Researchers noted a 14% rate of crossover from RRN to manual ablation; which, they wrote, was primarily due to technical problems with the RRN system. They also wrote that RRN fluoroscopy and procedure times decreased significantly after the first 10 cases performed by an individual operator, suggesting a learning curve for this procedure.
These findings suggest that RRN is comparable to manual ablation, but clinicians should weigh its risks and benefits carefully when considering its use, the researchers concluded.
“Although there appear certain advantages to the RRN system, the crossover rate and lack of outcomes benefits are important considerations for the uptake of this technology,” they wrote.
Disclosure: One researcher reported receiving research funding and research fellow support from Hansen Medical Inc.
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