Europace Advance Access originally published online on August 4, 2009
Europace 2009 11(10):1281-1288; doi:10.1093/europace/eup208
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Ablation for Atrial Fibrillation
Pulmonary vein isolation with high-intensity focused ultrasound: results from the HIFU 12F study
Department of Cardiology, Asklepios Klinik St. Georg, II. Med. Abteilung, Lohmühlenstr. 5, 22099 Hamburg, Germany
Aims: High-intensity focused ultrasound (HIFU) applied via a balloon catheter (BC) is a novel technology for simplified pulmonary vein isolation (PVI). Safety and efficacy of the third generation HIFU-BC were assessed.
Methods and results: In 22 patients (10 male, mean age 65 ± 6 years) with paroxysmal atrial fibrillation (PAF), a PVI during real-time PV spike registration and oesophageal temperature measurement was attempted. In 15 patients, a steerable sheath was used along with the HIFU-BC. In 67 of 83 PVs (81%), PVI was achieved exclusively using HIFU. Using the steerable sheath, the acute PVI rate rose from 50% (10/20 PVs) to 90% (57/63 PVs). In the latter, PVI was achieved with a single HIFU application in 60% (38/63 PVs) and mean sonication time of 11 ± 7 s. The mean procedure time was 166 ± 74 min including 58 ± 25 min of HIFU-BC left atrial indwelling time. In four patients, peri-procedural complications occurred (one transient ischaemic attack, one phrenic nerve palsy, and two vascular access complications). During a median follow-up of 342 days (range 272–378 days), 71% patients remained free of any AF/AT recurrence without antiarrhythmic drugs after a single procedure.
Conclusion: The novel defocused 12F HIFU-BC used in conjunction with a steerable sheath allows for very rapid PVI in patients with PAF. The enthusiasm for rapid PVI is still dampened by the potential risk of collateral damage.
Key Words: Pulmonary vein isolation, High-intensity focused ultrasound, Balloon catheter, Atrial fibrillation
* Corresponding author. Tel: +49 4018 1885 4487, Fax: +49 4018 1885 4435, Email: bor.schmidt{at}asklepios.com
Manuscript submitted 23 April 2009. Accepted after revision 8 July 2009.