Abstract 13046: Bleeding Complications During Cardiac Electronic Device Implantation With Novel Oral Anticoagulants versus Vitamin K Antagonist : A Systematic Review and Meta-Analysis

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Introduction: Pocket hematoma is a feared complication of cardiac implantable electronic device (CIED) placement. About half the patients undergoing the procedure are on anticoagulation with consequent increased frequency of device-pocket hematoma. The risk of hematoma is variable based on the type of anticoagulation therapy. The purpose of this study was to compare the risk of device-hematoma in patients on interrupted novel oral anticoagulants (NOAC) versus uninterrupted vitamin K antagonists (VKA) during the peri-operative period. Methods: We performed a meta-analysis using electronic literature search to retrieve studies with CIED surgery on uninterrupted VKA versus interrupted NOAC (range 12-96 hours). Primary outcome of interest was pocket-hematoma. Outcomes were pooled under random-effects meta-analyses and reported as risk ratios (RRs) and 95% CIs. 5 studies with low heterogeneity (I 2 =14%), 4 observational and 1 post-hoc analysis of a randomized trial, were included. 1002 patients NOAC group=376 and VKA group=626 were followed for 4-6 weeks. Results: Baseline characteristics were similar, mean age 71 years and 71% male across both groups. There was no significant difference in endpoints: pocket hematoma (major and minor) {RR 0.74 (0.43-1.29), P=0.29}; major hematoma {RR 0.53 (0.24-1.19), P=0.13}; hematomas with new implants {RR 0.82 (0.46-1.48), P=0.51}; hematomas with generator changes {RR 1.90 (0.84-4.31), P=0.12}; hematomas with device-upgrade {RR 0.41 (0.15-1.07), P=0.07}; major bleed {RR 0.18 (0.03-1.09), P=0.06}; pericardial effusion {RR 1.01 (0.13-8.19), P=0.67}(Fig 1). One study reported peri-implantation infection (n=4/311 NOAC, n=2/467 VKA). One patient out of all 5 studies had systemic thromboembolism in each group (1/837 NOAC, 1/1000 VKA). Conclusion: Interrupted NOAC use is not associated with a higher risk of pocket hematoma compared to uninterrupted VKA after CIED placement.