Key Points
- To evaluate the safety and clinical efficacy of a forward-directed, high-intensity focused ultrasound balloon catheter for pulmonary vein antrum isolation in patients with atrial fibrillation.
- Interventional study of 27 patients with paroxysmal (n=19) or persistent (n=8) atrial fibrillation undergoing pulmonary vein antrum isolation using a 14 Fr high-intensity focused ultrasound balloon catheter.
- Acoustic power of 45 watts was delivered via 20-mm, 25-mm, or 30-mm sonicating rings for 40 to 60 seconds outside the pulmonary vein ostia without other ablation systems.
- Successful antral isolation was achieved in 68 of 78 targeted pulmonary veins (87%) using a median of 3 ultrasound applications.
- At 12-month follow-up, 16 of 27 patients (59%) were free of symptomatic atrial fibrillation recurrences following a single procedure, with only 3 of the 16 remaining on antiarrhythmic therapy.
- Procedural complications occurred in 2 patients (one transient pulmonary vein branch bleed and one right phrenic nerve injury), with no instances of pulmonary vein stenosis (>50%) or atrio-esophageal fistula.
Structured PICO
Does a high-intensity focused ultrasound balloon catheter safely and effectively isolate pulmonary veins in patients with atrial fibrillation?
PPopulation27 patients with paroxysmal (n=19) or persistent (n=8) atrial fibrillation
IInterventionHigh-intensity-focused ultrasound balloon catheter (HIFU-BC) for pulmonary vein antrum isolation (acoustic power 45 watts applied for 40-60 seconds)
OOutcomeSafety and efficacy of HIFU-BC for PV antrum isolation (successful isolation of PV antra and freedom from symptomatic AF at 12 months)surrogate
The high-intensity focused ultrasound balloon catheter demonstrated feasibility for pulmonary vein antrum isolation, achieving 87% acute isolation success and 59% freedom from symptomatic AF at 12 months.