Maria Cecilia Hospital, GVM Care & Research, Cotignola (RA), Italy.
Cardiotoracovascolare, Ospedale Careggi, University of Florence, Florence, Italy.
J Cardiovasc Electrophysiol. 2020 Jan;31(1):80-88. doi: 10.1111/jce.14271. Epub 2019 Nov 27.
Four generations of the cryoballoon (CB) catheter were retrospectively evaluated in a real-world examination of patients with atrial fibrillation (AF).
Four hundred eighty patients (27% female and 60 ± 10 years) suffering from AF, underwent pulmonary vein (PV) ablation with one-of-four generations of the CB catheter. The total cohort was divided into four groups of patients: 120 with first-generation (CB-1); 120 with second-generation (CB-2); 120 with third-generation (CB-3); and 120 with fourth-generation (CB-4). Equal group sizes were achieved by examining the last 120 patients treated in each cohort, attempting to minimize the effect of a learning curve between the generations of CB catheter. Baseline clinical and patient characteristics were similar between the four cohorts, excepting age and the number of tested antiarrhythmic drugs. Procedure, fluoroscopy, and left atrial dwell times were significantly lower in the CB-4 cohort compared to previous generations of the CB catheters, while the acute procedural success rate was comparable across all catheter groups (>99%). Total acute procedural complications were low (2.5%), and acute complications were comparable within the CB-2, CB-3, and CB-4 groups (0.8% reported in each cohort). The rate of time-to-isolation (TTI) visualization increased with later generations of the CB catheters.
The novel CB-4 achieved significantly faster procedural ablation times in comparison to the previous generations, while still maintaining a low rate of acute complications. Also, the rate of TTI visualization was observed to be higher with the CB-4 catheter. Further long-term evaluation is necessary, including an assessment of AF recurrence and PV reconnection(s).
在一项对心房颤动(AF)患者的真实检查中,回顾性评估了四代冷冻球囊(CB)导管。
480 名(27%为女性,60±10 岁)患有 AF 的患者接受了肺静脉(PV)消融术,使用了四种 CB 导管中的一种。总队列分为四组患者:第一代(CB-1)患者 120 例;第二代(CB-2)患者 120 例;第三代(CB-3)患者 120 例;第四代(CB-4)患者 120 例。通过检查每个队列中最后 120 例接受治疗的患者,试图最小化 CB 导管几代之间的学习曲线效应,从而实现了各组患者数量相等。除年龄和测试抗心律失常药物的数量外,四组患者的基线临床和患者特征相似。与前几代 CB 导管相比,CB-4 组的手术、透视和左心房驻留时间明显降低,而所有导管组的急性手术成功率相当(>99%)。总急性手术并发症发生率较低(2.5%),且 CB-2、CB-3 和 CB-4 组的急性并发症相当(每个队列报告 0.8%)。时间至隔离(TTI)可视化的速度随着 CB 导管的发展而增加。
与前几代相比,新型 CB-4 实现了更快的程序消融时间,同时仍保持较低的急性并发症发生率。此外,观察到 CB-4 导管的 TTI 可视化率更高。还需要进行进一步的长期评估,包括评估 AF 复发和 PV 再连接。