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Novel AF ablation balloon appears more effective than drug therapy
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In patients with drug-refractory paroxysmal atrial fibrillation, treatment with a hot balloon catheter was found to be more effective than antiarrhythmic drug therapy.
A favorable safety profile was also found with the hot balloon ablation treatment, according to recent findings.
“Several studies involving other ablation therapies for AF have reported significant adverse events such as pulmonary vein stenosis requiring intervention, atrial-esophageal fistula, permanent phrenic nerve paralysis, pyloric spasm and death. None of the patients in this study experienced these serious events,” Hiroshi Sohara, MD, PhD, of the Heart Rhythm Center, Hayama Heart Center, Kanagawa, Japan, and colleagues wrote.
In a prospective, multicenter, randomized controlled study, researchers in Japan evaluated the effectiveness and safety of treatment of paroxysmal AF with hot balloon ablation (Toray Industries) compared with antiarrhythmic drug therapy.
A total of 143 patients with symptomatic paroxysmal PAF refractory to antiarrhythmic drugs were randomly assigned hot balloon ablation or antiarrhythmic drug therapy at 17 sites in Japan. Patients were randomly assigned at a 2:1 ratio (100 patients in the hot balloon ablation group; 43 in the antiarrhythmic drug therapy group). The researchers assessed for effectiveness with a 9-month follow-up.
Acute complete pulmonary vein isolation was produced in 93% of patients and 98% of pulmonary veins in the hot balloon ablation group. When assessed for effectiveness at a 9-month follow-up, the chronic success rate was 59% in the hot balloon ablation group (95% CI, 48.7-68.7) and 4.7% (95% CI, 0.6-15.8) in the antiarrhythmic drug therapy group (P < .001). Major complications incidence was 11.2% in all patients; pulmonary vein stenosis > 70% was noted in 5.2% of patients, and transient phrenic nerve injury was recorded in 3.7% of patients.
In an accompanying editorial, Paul J. Wang, MD, of Stanford University School of Medicine, wrote: “Because antiarrhythmic drug therapy measured by time to recurrence uniformly results in a low 1-year success, we do not learn much by this comparison. A comparison with another ablation technology in the same patient population using a randomized study design would give us the most insights into advantages and disadvantages of the new ablation technology.” – by Suzanne Reist
Disclosure : The study was funded by Toray Industries. Sohara reports receiving speaker honoraria and/or consultant fees from Japan Lifeline, Johnson & Johnson, K. K. Medical, St. Jude Medical Japan and Toray Industries. Please see the full study for a list of the other researchers’ relevant financial disclosures. Wang reports being a consultant for and receiving honoraria from Amgen, Janssen, Medtronic and St. Jude Medical; receiving fellowship support from Biosense Webster, Boston Scientific, Medtronic and St. Jude Medical; receiving support from ARCA, Cardiofocus, Medtronic and Siemens for other clinical studies; and holding stock options in Vytronus.
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