Objective. This randomized clinical trial was designed to assess the impact of pulmonary vein isolation (PVI) combined with LAA occlusion on patients with high-risk AF.
Methods. Patients with a history of symptomatic paroxysmal (P) AF and/or persistent (Pers) AF and CHA2DS2-VASc score ≥2 and HAS-BLED score ≥3 were randomized in groups with PVI only (n = 44) and PVI combined with LAA occlusion (n = 45). All patients were followed during 24 months in order to evaluate the safety of thromboembolic complications and to monitor the heart rhythm conducted by means of an implantable cardiac monitor.
Results. 6 patients from the PVI with LAA occlusion group were transferred to the PVI only group because of a failure to implant a LAA closure device. Based on ILR data, by the end of the follow-up 33 (66%) out of 50 patients in the PVI only group and 23 (59%) out of 39 patients in the PVI with LAA closure device implantation group were free from atrial fibrillation and flutter without antiarrhythmic drugs (p = 0.34). In the blanking period, AF% was significantly higher in the PVI with LAA closure group than that in the PVI-only group, 9.7±10.8 and 4.2±4.1% respectively (p = 0.004). After the blanking period, the AF% was similar in both groups. During the entire follow-up, no AF/intervention-related complications were observed.
Conclusion. The combination of LAA closure device implantation with PVI seems to be a safe procedure. However, it does not improve the efficacy of PVI in patients with symptomatic refractory AF. But in the blanking period LAA occlusion increases AF %.