ABSTRACT
Objectives: To report long-term safety and efficacy of combined percutaneous LAA and PFO/ASD closure.
Methods: A retrospective study of 370 consecutive patients undergoing LAAC procedures using the Watchman (WM) device. Data were compared between 330 cases only with LAAC procedure (Group I) and 25/5 (PFO/ASD) cases with sequential procedures of LAAC and PFO/ASD closure (Group II).
Results: Compared to Group I, Group II had more males (86.7% vs. 65.8%, p < 0.05) and a higher rate of stroke (33.3% vs. 10.6%, p < 0.01), but there were no statistical differences in the remaining patient characteristics. During the follow-up period, there were no significant differences between the two groups in embolism events (6.1% vs. 0%, p = 0.39), device related thrombus (5.8% vs 3.3%, p = 1.0), major bleeding (9.4% vs. 6.7%, p = 1.0) and cardiac death (3.6% vs. 0%, p = 0.61). The observed rate of all thromboembolic events by Kaplan–Meier analysis was decreased by 39.9% and 100% and the observed annual rate of bleeding was reduced by 32.9% and 57.6% in Group I and Group II, respectively.
Conclusions: LAAC combined with PFO/ASD closure might be an ideal choice to prevent stroke and other thrombotic complications in patients with both NVAF and PFO/ASD.
Declaration of interest
J Yu is a consultant to Boston Scientific The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
Reviewer disclosures
One peer reviewer has received speaker fees from Abbott. Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.
Author contributions
J Yu: Study design, acquisition of data, interpretation of data analysis, and implementation of the study.
S Tang, X Liu, Z Meng: Study design, acquisition of data,interpretation of data analysis, and writing of the manuscript.
J Zhou, X Xue, M Muenzel, PC Schulze, S Moebiu-Winkler, T Keil: Study design, acquisition of data, interpretation of data analysis, and critical revision of the manuscript.