二代冷冻球囊消融作为阵发性心房颤动起始治疗的可行性研究

Feasibility study of second-generation cryoballoon ablation as initial treatment for paroxysmal atrial fibrillation

目的比较二代冷冻球囊消融与常规药物分别作为阵发性心房颤动(简称房颤)患者起始治疗的有效性与安全性。方法选取以二代冷冻球囊消融作为起始治疗的44例阵发性房颤患者作为消融组,观察手术时间、消融时间、X线透视时间、肺静脉隔离率、手术并发症等情况;选择同期住院且起始接受药物治疗的44例阵发性房颤患者作为药物组。两组均于出院后第1、3、6、12个月进行门诊随访,观察房颤复发率及并发症等情况,比较两组治疗的有效性与安全性。结果消融组手术时间、消融时间、X线透视时间分别为(108.0±39.0)min、(35.0±11.7)min、(10.0±6.9)min;肺静脉即刻隔离率为100%;手术相关并发症3例(6.8%),其中迷走神经反射1例、一过性膈神经损伤2例。药物组发生药物性窦性心动过缓2例,QTc延长1例,甲状腺功能降低1例。平均随访(12.0±5.9)个月后,消融组房颤复发率为11.4%,药物组房颤复发率为20.5%,消融组复发率显著低于药物组(P=0.033)。两组的并发症或不良反应发生率比较,差异无统计学意义(6.8%vs.9.1%,P=0.108)。结论与药物治疗相比,二代冷冻球囊消融治疗阵发性房颤成功率高,未增加并发症风险,可作为阵发性房颤的起始治疗策略之一。

Objective To compare the effectiveness and safety of second-generation cryoballoon ablation and conventional drug therapy separately as the initial treatment for patients with paroxysmal atrial fibrillation(AF).Methods We selected 44 patients with paroxysmal AF who had been initially treated by second-generation cryoballoon ablation as the ablation group.The operation time,ablation time,X-ray fluoroscopy time,pulmonary vein isolation rate,and surgical complications were observed.We selected another 44 inpatients with paroxysmal AF who had been initially treated by drug therapy during the same period as the medication group.The two groups were followed up separately one month,and 3,6 and 12 months after discharge to observe the recurrence rate and complications of AF.The efficacy and safety of treatment were further compared between the two groups.Results The operation time,ablation time and X-ray fluoroscopy time of the ablation group were(108.0±39.0)minutes,(35.0±11.7)minutes and(10.0±6.9)minutes,respectively;the immediate isolation rate of pulmonary vein was 100%;there were 3 cases(6.8%)of operation-related complications,including one case of vagus reflex and 2 cases of transient phrenic nerve injury.In the medication group,drug-induced sinus bradycardia occurred in 2 cases,QTc was prolonged in one case,and thyroid function was decreased in one case.After a mean follow-up of(12.0±5.9)months,the recurrence rate of AF was 11.4%in the ablation group while the rate was 20.5%in the medication group.The recurrence rate in the ablation group was significantly lower than that in the medication group(P=0.033).The incidence of complications or adverse reactions did not vary significantly from the ablation group to the medication group(6.8%vs 9.1%,P=0.108).Conclusion Compared with drug therapy,the second-generation cryoballoon ablation has a higher success rate for paroxysmal AF without increased risk of complications.The second-generation cryoballoon ablation can be considered as one of the initial treatment strategies for paroxysmal AF.