Chapter 5 80 2.5% in patients using continued VKA and 0% in patients with interrupted DOAC. Our results are in line with both BRUISE CONTROL trials, which showed an incidence of 3.5% and 2.1% in the continued VKA arm and interrupted DOAC arm, respectively (3,4). Using patient level data from both BRUISE CONTROL trials, Essebag et al. also showed no difference in clinically significant pocket hematoma between DOAC use (either continued or interrupted) and continued VKA after adjusting for concomitant antiplatelet use (odds ratio 0.86, 95% CI 0.38–1.96, P = 0.72) (23). 4.2. Trend in DOAC use In the Netherlands, there was initially a conservative policy with regard to DOAC use, mainly due to concerns about the lack of an antidote, patient adherence, lack of monitoring and increased health care cost (26). Therefore, there was a slower uptake of DOAC use in the Netherlands in comparison to other Western European countries (27). Since 2016 there has been a steady increase in the use of DOAC in the Netherlands. This is reflected by the steady increase in the relative proportion of patients with periprocedural DOAC in our study population, from 15% in 2016 to 42% in 2019. This also explains why patients in the DOAC group were more likely to undergo a de novo implantation and less likely to undergo a device replacement in comparison to the VKA group. Because a device replacement is associated with a higher likelihood of pocket hematoma (21), this may result in bias towards a more favourable outcome for the DOAC group in comparison to the VKA group in the present study. It is expected that in the future the majority of patients will undergo CIED surgery with periprocedural DOACs as these are the preferred agents for stroke prevention in patients with AF (1). Also, the potential treatment of device-detected AF with DOAC, depending on the outcome of NOAH-AFNET 6 and ARTESiA (28,29), will result in more CIED patients being treated with a DOAC. Our real-world data is reassuring that an interrupted DOAC regimen is associated with a low risk of clinically significant pocket hematoma and no thromboembolic events in patients undergoing elective CIED surgery.
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