The second-generation cryoballoon significantly increased the single-shot pulmonary vein isolation rate compared to the first-generation device (84% vs 51%; P<0.001).
Observational (n=60)
Does the second-generation cryoballoon improve procedural efficacy compared to the first-generation cryoballoon in patients undergoing pulmonary vein isolation?
The second-generation cryoballoon significantly improves procedural efficacy, including higher single-shot PVI rates and shorter procedure times, compared to the first-generation device.
Absolute Event Rate: 84% vs 51%
p-value: p=< 0.001
INTRODUCTION: The cryoballoon technology has the potential to isolate a pulmonary vein (PV) with a single energy application. However, using the first-generation cryoballoon (CB-1G) repeated freezing or additional focal ablation is often necessary. The novel second-generation cryoballoon (CB-2G) features a widened zone of optimal cooling comprising the whole frontal hemisphere. The aim of this study was to investigate the impact of the novel design on procedural efficacy of cryoballoon PV isolation (CB-PVI). METHODS AND RESULTS: Single transseptal CB-PVI using an endoluminal spiral mapping catheter was performed in 60 consecutive patients (CB-1G, 28 mm, 300 seconds application time: 30 patients; CB-2G, 28 mm, 240 seconds application time: 30 patients). When compared to the CB-1G, using the CB-2G increased single-shot PVI rate from 51% to 84% (P < 0.001) and decreased procedure duration (128 ± 27 vs 98 ± 30 minutes; P < 0.001), and fluoroscopy exposure time (19.5 ± 7.4 vs 13.4 ± 5.3 min; P = 0.001). Effective CB-2G PVI could be performed with increased real-time PVI visualization rate (49% vs 76%; P < 0.001). Time to PVI (T(PVI)) was shorter in the CB-2G group (79 ± 60 vs. 52 ± 36 seconds; P = 0.049). Procedure-related complications occurred in 2 patients in the CB-1G group and 1 patient in the CB-2G group. CONCLUSIONS: The CB-2G significantly improved procedural efficacy compared to the CB-1G and provided reliable T(PVI) measurement. T(PVI) may be used to adjust application time and number individually in future studies. Final conclusions regarding the safety profile of the CB-2G requires additional research.
Fürnkranz et al. (2012) conducted an observational in Patients undergoing pulmonary vein isolation (n=60). Second-generation cryoballoon (CB-2G) vs. First-generation cryoballoon (CB-1G) was evaluated on Single-shot pulmonary vein isolation rate (p=< 0.001). The second-generation cryoballoon significantly increased the single-shot pulmonary vein isolation rate compared to the first-generation device (84% vs 51%; P<0.001).