背景:阵发性心房颤动(PAF)的射频消融(RFA)主要集中在肺静脉隔离(PVI)上。然而,尽管最初取得了积极成果,已经发生了显著的复发,部分原因是肺静脉(PV)重新连接或非PV异位病灶,包括上腔静脉(SVC)。
目标:这个前瞻性,随机研究旨在研究在接受消融的有症状的PAF患者中额外使用SVCI联合PVI的疗效.
方法:从2011年11月至2013年5月,使用CARTO(®)3系统对随机接受有症状的药物难治性PAFPVI的患者进行RFA,伴(PVI+SVCI组)或不伴(单独PVI组)SVCI。在消融期间通过螺旋导管记录确认PVI和SVCI。程序数据,评估了并发症和无房性心动过速(AT)和心房颤动(AF).
结果:在18个月的时间里,100例连续患者(56±9岁;17例女性)有症状的PAF被纳入研究(PVI+SVCI,n=51;PVI,n=49);CHA2DS2-VASc评分为0.9±1。手术持续时间的中位数(±四分位数),2.5±1小时;X射线总照射量,13.3±8分钟;经房间隔穿刺和导管定位,8±5分钟;左心房电解剖重建术,3±2分钟;导管消融,3.7±3分钟。中位随访15±8个月后,经历了一个单一的程序,84%的患者无症状,而86%的人在接受两次手术后仍然无症状。使用Kaplan-Meier曲线解释房性心律失常(AT或AF)的累积风险,并使用对数秩检验进行比较。长期随访显示两组间无显著差异,PVI+SVCI组6例(12%)患者和单纯PVI组9例(18%)患者发生房性心律失常(P=0.6).PVI+SVCI组发生1例短暂性膈神经麻痹和1例膈神经损伤并部分恢复。
结论:SVCI联合PVI并没有降低房颤复发的风险,造成了两次膈神经损伤.因此,获益风险比与系统SVCI相反。
BACKGROUND: Radiofrequency ablation (RFA) of paroxysmal atrial fibrillation (PAF) has focused on pulmonary vein isolation (PVI). However, despite initial positive results, significant recurrences have occurred, partly because of pulmonary vein (PV) reconnection or non-PV ectopic foci, including the superior vena cava (SVC).
OBJECTIVE: This prospective, randomized study sought to investigate the efficacy of additional SVCI combined with PVI in symptomatic PAF patients referred for ablation.
METHODS: From November 2011 to May 2013, RFA was performed remotely using a CARTO(®) 3 System in patients randomized to undergo PVI for symptomatic drug-refractory PAF, with (PVI+SVCI group) or without (PVI alone group) SVCI. PVI and SVCI were confirmed by spiral catheter recording during ablation. Procedural data, complications and freedom from atrial tachycardia (AT) and atrial fibrillation (AF) were assessed.
RESULTS: Over an 18-month period, 100 consecutive patients (56±9years; 17 women) with symptomatic PAF were included in the study (PVI+SVCI, n=51; PVI, n=49); the CHA2DS2-VASc score was 0.9±1. Median duration of procedure (±interquartile), 2.5±1hours; total X-ray exposure, 13.3±8minutes; transseptal puncture and catheter positioning, 8±5minutes; left atrium electroanatomical reconstruction, 3±2minutes; and catheter ablation, 3.7±3minutes. After a median follow-up of 15±8months, and having undergone a single procedure, 84% of patients were symptom free, while 86% remained asymptomatic after undergoing two procedures. The cumulative risks of atrial arrhythmias (AT or AF) were interpreted using Kaplan-Meier curves and compared using the log-rank test. Long-term follow-up revealed no significant difference between groups, with atrial arrhythmias occurring in six (12%) patients in the PVI+SVCI group and nine (18%) patients in the PVI alone group (P=0.6). One transient phrenic nerve palsy and one phrenic nerve injury with partial recovery occurred in the PVI+SVCI group.
CONCLUSIONS: SVCI combined with PVI did not reduce the risk of subsequent AF recurrence, and was responsible for two phrenic nerve injuries. Accordingly, the benefit-to-risk ratio argues against systematic SVCI.