Long-term clinical outcome following pulmonary vein isolation with high-intensity focused ultrasound balloon catheters in patients with paroxysmal atrial fibrillation.

AIMS High-intensity focused ultrasound (HIFU) applied via a balloon catheter is a novel technology for pulmonary vein isolation (PVI) in patients with paroxysmal atrial fibrillation (PAF). The long-term success rate is unknown. METHODS AND RESULTS Thirty-two patients (22 male, age 60 +/- 9 years) with a long history [5 (4;9) years] of drug refractory [3 +/- 1 anti-arrhythmic drugs (AADs)], symptomatic PAF were included into the analysis. Pulmonary vein isolation was performed using the first- and second-generation HIFU balloon catheters (ProRhythm, Ronkonkoma, NY, USA). Follow-up (F/U) included regular telephonic interviews, trans-telephonic Holter ECG, and event recording. Recurrence was defined as a documented or symptomatic AF episode >30 s without a blanking period. In total 101/116 targeted PVs (87%) were acutely isolated exclusively using HIFU. During a median F/U of 1400 (930;1568) days, 18 patients (56%) were free of AF without AAD after a single HIFU procedure. In nine patients with AF recurrence, 20 PVs exhibited electrical reconduction and re-isolation was performed using irrigated radiofrequency current (RFC) ablation. CONCLUSION Patients treated with the first- and second-generation HIFU balloon catheters due to symptomatic PAF show long-term success rates similar to RFC-based PVI procedures. The major determinant of AF recurrence after HIFU treatment seems to be reconduction of previously isolated PVs. However, the favourable effectiveness is offset by the severe complications reported following HIFU treatment. This led to a halt of its clinical use.