Single Transseptal Big Cryoballoon Pulmonary Vein Isolation using an Inner Lumen Mapping Catheter

BACKGROUND: The single big cryoballon technique for pulmonary vein isolation (PVI) has been limited by the need for two transseptal punctures (TP). We therefore investigated feasibility and safety of a simplified approach using a single TP and a novel circumferential mapping catheter (CMC). METHODS: Patients underwent 28-mm cryoballoon PVI using a single TP. The CMC (Achieve(©) Medtronic Inc., Minneapolis, MN, USA) served as (1) guidewire and (2) as a PV mapping tool. Primary endpoint was PVI without switching to a regular guidewire. Secondary endpoints included: (1) PV signal quality during freezing, (2) time to PVI, (3) classification of successful ablation technique, (4) complications, and (5) procedural data. RESULTS: A total of 32 patients (126 PVs) were studied (mean age: 62 ± 11 years, 24 males, left atrium: 40 ± 4 mm). The primary endpoint was achieved in 29/32 patients (91%) and 123/126 PVs (98%) with a procedure and fluoroscopy time of 126 ± 26 minutes and 18.9 ± 7.5 minutes, respectively. Real-time visualization of PVI could be observed in 61/126 (48%) PVs. Time to sustained PVI versus nonsustained PVI was 66 ± 56 seconds versus 129 ± 76 seconds (P < 0.001). One phrenic nerve palsy was observed. After a follow-up of 250 ± 84 days 23/32 patients (72%) remained in sinus rhythm. CONCLUSION: The "simplified single big cryoballoon" PVI strategy appears to be safe and feasible. However, real-time PV recording was achieved in <50% of PVs. Therefore, further catheter refinements are warranted. (PACE 2012; 35:1304-1311).