Cardioangiologisches Centrum Bethanien, Medizinische Klinik III, Markus Krankenhaus, Frankfurt am Maim, Germany.
J Cardiovasc Electrophysiol. 2013 May;24(5):492-7. doi: 10.1111/jce.12082. Epub 2013 Feb 11.
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).
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.
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.
冷冻球囊技术有可能通过单次能量应用来隔离肺静脉（PV）。然而，使用第一代冷冻球囊（CB-1G）通常需要反复冷冻或额外的焦点消融。新型第二代冷冻球囊（CB-2G）具有更宽的最佳冷却区域，包括整个额半球。本研究旨在探讨新型设计对冷冻球囊 PV 隔离（CB-PVI）程序疗效的影响。
60 例连续患者行经房间隔单球囊 CB-PVI（CB-1G，28mm，应用时间 300 秒：30 例；CB-2G，28mm，应用时间 240 秒：30 例）。与 CB-1G 相比，使用 CB-2G 使单次 PVI 率从 51%增加到 84%（P<0.001），并减少了手术时间（128±27 对 98±30 分钟；P<0.001）和透视曝光时间（19.5±7.4 对 13.4±5.3 分钟；P=0.001）。有效 CB-2G PVI 可通过增加实时 PVI 可视化率（49%对 76%；P<0.001）来实现。CB-2G 组的 PVI 时间（T（PVI））更短（79±60 对 52±36 秒；P=0.049）。CB-1G 组有 2 例和 CB-2G 组有 1 例发生与程序相关的并发症。
CB-2G 与 CB-1G 相比，显著提高了程序疗效，并提供了可靠的 T（PVI）测量。在未来的研究中，T（PVI）可能被用于单独调整应用时间和次数。关于 CB-2G 的安全性概况的最终结论需要进一步研究。
