新型环形导管行脉冲电场消融隔离猪肺静脉的有效性和安全性
Efficacy and safety of a novel circular multi-electrode pulsed field ablation catheter for pulmonary vein isolation in pigs using pulsed field ablation
陈世权 1蒋汝红 1刘强 1蒋晨阳1
作者信息
- 1. 浙江大学医学院附属邵逸夫医院心内科,杭州 310016
- 折叠
摘要
目的 评估国产脉冲电场消融(PFA)系统在活体猪心脏模型中的消融有效性和安全性.方法 实验使用14头成年健康猪,体重(56.0±2.7)kg,按顺序分为急性期组(8头)和长期组(6头),消融靶点包括左心房的肺静脉和右心房的上腔静脉.使用微秒级的双极双相脉冲波(输出电压范围1 500～1 800 V,单次消融时间＜0.2 s)进行PFA,并在术后立即评估电隔离效果.长期组90 d后再次进行电生理测试.实验猪在处死后进行大体解剖,观察心脏目标靶点的损伤和心脏周边组织的损伤.结果 急性期组术后100％的肺静脉和上腔静脉成功实现了电隔离,长期组93％肺静脉和100％上腔静脉在90 d时保持持续的隔离状态.急性期组和长期组中均未观察到显著的不良反应或并发症发生,93％消融仅引起少量微气泡,未见大量微气泡产生的现象.结论 新型国产PFA系统在活体猪心房消融中具有良好的效果和安全性.
Abstract
Objective To evaluate the effectiveness and safety of a domestically developed pulsed field ablation(PFA)system in a live porcine heart model.Methods Fourteen healthy adult pigs[mean weight(56.0±2.7)kg]were divided into an acute group(n=8)and a long-term group(n=6).Target ablation sites included the pulmonary veins(PV)in the left atrium and the superior vena cava(SVC)in the right atrium.Microsecond bipolar biphasic pulse waves(output voltage range:1 500-1 800 V,single ablation duration＜0.2 s)were used for PFA.Electrical isolation was assessed immediately post-procedure in all pigs,with follow-up electrophysiological testing performed at 90 days in the long-term group.Gross anatomical examination was conducted after sacrifice to assess damage to cardiac target sites and surrounding tissues,verifying the safety and efficacy of the ablation.Results Immediate electrical isolation of all PV and the SVC was achieved in 100％of pigs in the acute group.At 90 days,sustained isolation was observed in 93％of PV and 100％of the SVC in the long-term group.No significant adverse events or complications were noted in either group.Microbubble formation was minimal,with 93％of ablation procedures generating a small number of microbubbles;no cases of extensive microbubble formation were observed.Conclusion The novel Chinese PFA system demonstrated excellent safety and effectiveness in atrial ablation within a porcine model,achieving reliable electrical isolation of PVs and the SVC without significant adverse effects.
关键词
导管消融术/脉冲电场消融/猪模型/肺静脉隔离Key words
Catheter ablation/Pulsed field ablation/Porcine model/Pulmonary vein isolation引用本文复制引用
出版年
2024
NETL
NSTL
万方数据