Does left atrial appendage closure improve the success of pulmonary vein isolation? Results of a randomized clinical trial.

Abstract

The combination of left atrial appendage (LAA) occlusion with pulmonary vein isolation (PVI) potentially represents a comprehensive treatment for atrial fibrillation (AF), controlling symptoms while at the same time reducing the risk of stroke and the need for chronic anticoagulation. The aim of this randomized clinical trial was to assess the impact of LAA closure added to PVI in patients with high-risk AF. Patients with a history of symptomatic paroxysmal or persistent AF refractory to ≥ 2 antiarrhythmic drugs, CHA2DS2-VASc score ≥ 2, and HAS-BLED score ≥ 3 were randomized to PVI-only (n = 44) or PVI with LAA closure (n = 45). Six patients in PVI + LAA closure group crossed over to PVI-only group due to failure of LAA closure device implantation. On-treatment comparisons at the 24 month follow-up revealed that 33 (66%) of the 50 PVI group and 23 (59%) of the 39 PVI with LAA closure group were AF-free on no antiarrhythmic drugs (p = 0.34). The PVI + LAA closure treatment was significantly associated with a higher AF burden during the blanking period: 9.7 ± 10.8 vs 4.2 ± 4.1% (p = 0.004). At the end follow-up, there were no serious complications and no strokes or thromboembolic events in either group. The combination of LAA closure device implantation with PVI was safe but was not observed to influence the success of PVI in patients with symptomatic refractory AF. Early AF after ablation, however, is increased by LAA closure. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01695824.