Abstract 13553: Left Atrial Appendage Closure Does Not Improve the Success of Pulmonary Vein Isolation: First Randomized Study
Introduction: The combination of left atrial appendage (LAA) occlusion with pulmonary vein isolation (PVI) might be an elegant way to comprehensively treat AF, suppressing arrhythmia, reducing the risk of stroke and abolishing the need for chronic oral anticoagulant. The aim of this randomized clinical trial was to assess the impact of LAA closure when added to PVI in patients with AF and stroke risk.
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 device (n=45). All patients were followed during 24 months to assess maintenance of sinus rhythm, AF burden (by implantable loop recorder (ILR)), stroke/TIA events and safety. Patients were analyzed by intent-to-treat assignment.
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 were crossovers to PVI-only group due to inability to complete LAA closure device implantation. 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).
Based on ILR data at the first month follow-up, AF% was significantly higher in the PVI with LAA closure device group than PVI-only group, 9.7±10.8% and 4.2±4.1%, respectively (p=0.004). The PVI + LAA closure treatment was significantly associated with a higher AF burden during the blanking period [5.5, 95% Cl: 2.2 - 8.8, p<0.01]. After the 3-month blanking period, the AF% during the follow-up was similar in both groups (p=0.46). At the end follow-up, there were no serious complications in both groups.
Conclusions: The combination of LAA closure device implantation with PVI was safe but did not have any impact on success of PVI in patients with symptomatic refractory AF. Early AF events were increased by adding LAA closure to PVI.
Author Disclosures: E. Pokushalov: None. A. Romanov: None. S. Artyomenko: None. A. Yakubov: None. I. Stenin: None. E. Kretov: None. O. Krestianinov: None. I. Grazhdankin: None. D. Risteski: None. A. Karaskov: None. J.S. Steinberg: None.
- © 2014 by American Heart Association, Inc.