ABSTRACT
Objectives
To investigate safety and effectiveness of left atrial appendage closure (LAAC) in atrial fibrillation patients with prior major bleeding.
Methods
A total of 377 consecutive patients scheduled for LAAC with Watchman device were divided into bleeding group (n = 137) and non-bleeding group (n = 240). Data were compared between groups.
Results
The bleeding group had more patients ≥75 years old (P = 0.044), higher CHA2DS2-VASc (P = 0.029) and HAS-BLED scores (P = 0.001) than the non-bleeding group. During the long-term follow-up, except for thromboembolism event (P = 0.031), the incidences of major bleeding , all-cause death , co-primary efficacy events , and the cumulative survival ratio after adjustment of confounding factors were comparable. The observed thromboembolism rate was reduced by 86.3% (P = 0.0002) and 55.1% (P = 0.0293) and the observed major bleeding rate was decreased by 61.9% (P = 0.0393) and 35.7% (P = 0.2426) compared with expected risks in bleeding and non-bleeding groups, respectively. The risk reduction in thromboembolism and major bleeding were significantly greater in bleeding group versus non-bleeding group (all P < 0.0001).
Conclusions
Among patients with prior bleeding, LAAC is a safe and effective alternative to anticoagulation therapy and seems to emerge as a higher efficacy in risk reduction of thromboembolism and major bleeding compared to those without prior bleeding.
Availability of data
The data supporting this article will be available on reasonable request to the corresponding author.
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 except for that disclosed.
Reviewer Disclosures
Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.
Supplementary Material
Supplemental data for this article can be accessed here.