DOACs in pacemaker or defibrillator surgery 75 1. Introduction In patients with atrial fibrillation (AF) direct oral anticoagulants (DOACs) are currently the preferred choice of oral anticoagulation for long-term stroke prevention (1,2). A cardiac implantable electronic device (CIED) procedure is generally considered a procedure with a low bleeding risk (2). However, device-pocket hematoma is a common complication with an incidence ranging from 0.2% up to 16%, depending on definition and antithrombotic regimen (3-7). A pocket hematoma is associated with local discomfort, increased risk of infection, prolongation of hospitalization and may require surgical intervention in some cases (8-11). Previous studies have shown that periprocedural oral anticoagulation is associated with a higher likelihood for pocket hematoma (5,12,13). The current guidelines recommend continuation of vitamin K antagonists (VKAs) during CIED procedures as bridging therapy with heparin is associated with a five-fold higher risk of bleeding compared with continued VKA (2,4,7). With regard to periprocedural DOAC use, the BRUISE CONTROL-2 trial, published in 2018, demonstrated that continued and interrupted DOAC had a similar low incidence of clinically significant pocket hematoma.(3) However, a meta-analysis in 2020 demonstrated a numerically higher incidence of bleeding complications in patients who continued DOAC (14). Furthermore, a large European survey demonstrated that in the majority of patients (89%) an interrupted DOAC strategy was used (15). The ESC guidelines and a EHRA expert consensus statement did not suggest a preference for either continued or interrupted DOAC during CIED surgery (6,7). Currently, there is little real-world data comparing the safety and efficacy of continued VKA versus interrupted DOAC in patients undergoing CIED surgery. The aim of the present study is to evaluate the incidence of clinically significant device pocket hematoma between both periprocedural anticoagulation regimens in patients with AF undergoing an elective CIED procedure in an academic center. 5
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