Abstract 12118: Immediate Procedural Outcomes and Chronic Freedom From Atrial Fibrillation After Pulmonary Vein Isolation Using the Second Generation 28-mm Cryoballoon Catheter With a Transluminal Circular Mapping Guide: Comparison With the First Generation Catheter
Introduction: The second-generation cryoballoon catheter (CB-Gen2) delivers refrigerant more uniformly over the distal hemisphere of the balloon. We examined the acute procedural outcomes and long-term freedom from AF using the CB-Gen2 during pulmonary vein isolation (PVI) and its comparison with the first generation balloon (CB-Gen1).
Methods: Acute lesion data including time to achieve PVI during the initial lesion at each vein as well as the temperature parameters of each lesion were collected from the first 56 patients treated with the CB-Gen2. Previously reported data collected from 26 patients treated with CB-Gen1 served as a comparator group. Data is expressed as median (IQR). Statistical analysis was performed using GraphPad Prism. Tubular common LPVs (3.9% of all veins) were excluded from the analysis. The long-term clinical endpoint was freedom from AF symptoms or recurrence documented on 7 day event monitor after a 90 day blanking period.
Results: A total of 227 veins were treated with CB-Gen2. Real-time EGMs during lesion delivery were observed at 72% of veins. Isolation was achieved during the first lesion at 91% of veins with acute reconnection during the procedure at only 2% of veins. Higher initial lesion success was seen at the right PVs. The median time to isolation was 32 sec (25-45 sec). Faster isolation was observed at the RSPV (25.5 sec, IQR 21-37.5 sec). There was no difference in the frequency of PVI during the first lesion with CB-Gen2 v CB-Gen1 (91% v 87%, p=0.21). Fewer veins acutely reconnected using CB-Gen2 (2% v 9.5%, p=0.0004). Compared with CB-Gen1, CB-Gen2 yielded a shorter time to isolation at all veins (32 vs 41.5 sec, p=0.001) driven by lower isolation time at the LSPV (39 v 61 sec, p=0.001) and RIPV (30.5 v 42 s, p=0.04). Coldest lesion temperature was lower with CB-Gen2 (-51°C v -47.5°C, p≤0.001). Event monitors were available in 70% of patients. After a median of 6 months, 88% of subjects achieved the endpoint. Complications included a single TIA, one retroperitoneal hemorrhage not requiring intervention and a single episode of pericarditis treated medically. No persistent phrenic nerve injury was observed.
Conclusion: Acutely,CB-Gen2 is more effective than CB-Gen1 for PVI. Early in follow-up, long-term results are acceptable.
- © 2013 by American Heart Association, Inc.