DOES LEFT ATRIAL APPENDAGE CLOSURE IMPROVE THE SUCCESS OF PULMONARY VEIN ISOLATION? RESULTS OF A RANDOMIZED CLINICAL TRIAL

Background: The combination of left atrial appendage (LAA) occlusion with pulmonary vein isolation (PVI) potentially represents a comprehensive treatment for 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. Methods: 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 implantation (n=45). All patients were followed 24‐months to assess maintenance of sinus rhythm and AF burden (by implantable loop recorder (ILR)), and safety. Results: By intention‐to‐treat, at the 24‐month follow‐up examination, 29 (66%) of the 44 PVI only group patients and 27 (60%) of the 45 PVI with LAA closure device implantation group were AF/AT‐free on no antiarrhythmic drugs (p=0.49)Six patients in PVI + LAA closure group crossed over to PVI only group due to failure of LAA closure device implantation. In regard to on‐treatment comparisons at the 24‐month follow‐up, 33 (66%) of the 50 PVI only group patients and 23 (59%) of the 39 PVI with LAA closure device implantation group were AF/AT‐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). After the blanking period, the AF% during the follow‐up was similar in both groups. At the end follow‐up, there were no serious complications in both groups. No strokes or thromboembolic events were observed in either group. Conclusion: The combination of LAA closure device implantation with PVI is safe but does not have any impact on success of PVI in patients with symptomatic refractory AF. Early AF after ablation however is increased by LAA closure.