Division of Cardiology, Duke Clinical Research Institute, Duke University Medical Center, Durham, NC 27715, USA.
Circ Arrhythm Electrophysiol. 2009 Dec;2(6):626-33. doi: 10.1161/CIRCEP.109.856633.
Catheter ablation is an established yet evolving nonpharmacologic intervention for the maintenance of sinus rhythm in patients with atrial fibrillation (AF). The efficacy and safety of pulmonary vein isolation (PVI) compared with medical therapy remain in question.
We conducted a meta-analysis of all randomized, controlled trials comparing PVI and medical therapy for the maintenance of sinus rhythm. The primary end point in this analysis was freedom from recurrent AF at 12 months. The relative efficacy of PVI was estimated using random-effects modeling according to intention to treat. We identified 6 trials that randomized a total of 693 patients with AF to PVI or control. PVI was associated with markedly increased odds of freedom from AF at 12 months of follow-up (n=266/344 [77%] versus n=102/346 [29%]; odds ratio, 9.74; 95% CI, 3.98 to 23.87). When we excluded the trial that only enrolled patients with persistent AF (Q-statistic, 2.485; P=0.647 after exclusion), PVI was associated with even greater odds of AF-free survival (15.78; 95% CI, 10.07 to 24.73). PVI was associated with a decreased hospitalization for cardiovascular causes (14 versus 93 per 100 person-years; rate ratio, 0.15; 95% CI, 0.10 to 0.23). Among those randomly assigned to PVI, 17% required a repeat PVI ablation before 12 months. The rate of major complications was 2.6% (n=9/344) in the catheter ablation group.
Compared with a nonablation treatment strategy, PVI results in dramatically increased freedom from AF at 1 year. Although the procedure can be associated with major complications, the risk of these complications is comparable to other interventional procedures.
导管消融术是一种已确立但仍在不断发展的非药物干预手段，可用于维持心房颤动（房颤）患者的窦性心律。肺静脉隔离（PVI）与药物治疗相比的疗效和安全性仍存在争议。
我们对所有比较 PVI 与药物治疗以维持窦性心律的随机对照试验进行了荟萃分析。本分析的主要终点是 12 个月时无复发性房颤。根据意向治疗，使用随机效应模型估计 PVI 的相对疗效。我们确定了 6 项共纳入 693 例房颤患者的随机对照试验，将其分为 PVI 组或对照组。12 个月随访时，PVI 组无房颤的可能性明显增加（n=266/344[77%]与 n=102/346[29%]；优势比，9.74；95%CI，3.98 至 23.87）。当我们排除仅纳入持续性房颤患者的试验（Q 统计量，2.485；排除后 P=0.647）时，PVI 与更高的无房颤生存率相关（15.78；95%CI，10.07 至 24.73）。PVI 与心血管原因住院治疗的发生率降低相关（14 例/100 人年与 93 例/100 人年；发生率比，0.15；95%CI，0.10 至 0.23）。在随机分配至 PVI 的患者中，17%的患者在 12 个月前需要再次行 PVI 消融。导管消融组主要并发症的发生率为 2.6%（n=9/344）。
与非消融治疗策略相比，PVI 可显著提高 1 年时的无房颤率。尽管该操作可能与主要并发症相关，但这些并发症的风险与其他介入性操作相当。
