Published Online
on September 14, 2009

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Original Article

Pulmonary Vein Isolation for the Maintenance of Sinus Rhythm in Patients with Atrial Fibrillation: a Meta-Analysis of Randomized Controlled Trials

Jonathan P. Piccini; Renato D. Lopes; Melissa H. Kong; Vic Hasselblad; Kevin Jackson and Sana M. Al-Khatib¹

Duke University Medical Center, Durham, NC

^* Corresponding author; email: alkha001{at}mc.duke.edu

Background—Catheter ablation is an established, yet evolving non-pharmacologic 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.

Methods and Results—We conducted a meta-analysis of all randomized controlled trials comparing PVI and medical therapy for the maintenance of sinus rhythm. The primary endpoint in this analysis was freedom from recurrent AF at 12 months. The relative efficacy of PVI was estimated using random-effects modeling according to the intention-to-treat. We identified six 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%] vs n=102/346 [29%]; OR 9.74 [95%CI 3.98-23.87]). When we excluded the one 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 -24.73]). PVI was associated with a decreased hospitalization for cardiovascular causes (14 vs. 93 per 100 person-years; Rate Ratio 0.15 [95% CI 0.10-0.23]). Among those randomized 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.

Conclusion—Compared with a non-ablation treatment strategy, PVI results in dramatically increased freedom from AF at one year. While the procedure can be associated with major complications, the risk of these complications is comparable to other interventional procedures.

Key Words: antiarrhythmia agents • meta-analysis • atrial fibrillation • catheter ablation • clinical trials • pulmonary vein isolation