Initial experience using a forward directed, high-intensity focused ultrasound balloon catheter for pulmonary vein antrum isolation in patients with atrial fibrillation

Background: A high-intensity-focused ultrasound balloon catheter (HIFU-BC) is designed to isolate pulmonary veins (PV) outside the ostia (PV antrum). This catheter uses a parabolic CO₂ balloon (behind water balloon) to focus a 20-, 25-, or 30-mm diameter ring of ultrasound forward of the balloon (parallel to catheter shaft). The purpose of this study is to test the safety and efficacy of the HIFU-BC for PV antrum isolation in patients with atrial fibrillation (AF).
Methods and Results: Twenty-seven patients with paroxysmal (19 patients) or persistent (8 patients) AF were studied. Double transseptal puncture was performed for left atrial deployment of a Lasso catheter (for PV mapping) and the 14 Fr HIFU-BC. The HIFU-BC was positioned outside the PV orifice over a guidewire. HIFU energy (acoustic power 45 watts) was applied for 40 seconds with a 20-mm sonicating ring and 40 or 60 seconds with a 25-mm or 30-mm sonicating ring. No other ablation system was utilized. PV antrum isolation was attempted using HIFU-BC in 78 of 104 PVs (25/27 RSPVs, all 23 LSPVs, all 23 LIPVs, all four left common trunks and 3/27 RIPVs). HIFU-BC successfully isolated 68 (87%) of the 78PV antra with 1–26 (median 3) HIFU applications. The complications include transient bleeding from a distal branch of the left superior PV resulting from guidewire manipulation in one patient and right phrenic nerve injury in another patient. No PV stenosis (>50% narrowing) and no LA-esophageal fistula occurred. At the 12-month follow-up, 16 (59%) of the 27 patients were free of symptomatic episodes of AF (only 3 of the 16 patients were receiving antiarrhythmic medications).
Conclusions: Forward-focused HIFU applications isolated PVs outside the PV ostium with elimination of AF in 16 (59%) of the 27 patients at 12 months following the single ablation procedure.