Chapter 5 78 were more likely to have paroxysmal AF and to use class I antiarrhythmic drugs, but less likely to have chronic renal disease and to use digoxin and diuretics. Patients with mechanical heart valves were only present in the VKA group. In the VKA group, the median INR at the day of surgery was 2.1 (IQR 1.8–2.4). In the DOAC group, the rhythm at the day of the procedure was sinus rhythm (57%), AF (38%), atrial flutter (3%) and atrioventricular sequential pacing (3%). Besides differences in patient characteristics, there were also differences in surgical characteristics (Table 2). The DOAC group more often underwent a de novo dual chamber device implantation, while the VKA group more often had a pulse generator replacement procedure only. The median procedure duration was longer in the DOAC group in comparison to the VKA group. 3.2. Study endpoints The primary endpoint occurred only in the VKA group. Although, there was a numerically higher incidence of clinically significant pocket hematoma in the VKA group (2.5%, 95% confidence interval [CI] 0.8%–5.7%) in comparison to the DOAC group (0%, 95% CI 0%–4.5%), this was not statistically different (P = 0.33) (Fig. 4). Of the 5 patients with clinically significant pocket hematoma, 4 patients (80%) had a device replacement or revision as the index procedure, 3 patients (60%) had an impaired renal function (eGFR < 60 mL/min) at baseline and 3 of 5 patients (60%) were > 70 years of age at the time of surgery (Table 3). Only 1 patient with a clinically significant pocket hematoma required a reoperation. Regarding the secondary endpoint, no systemic thrombotic event occurred (Fig. 4). 4. Discussion The present study demonstrates that continued VKA and interrupted DOAC were associated with a comparable low risk of clinically significant pocket hematoma in patients with AF undergoing CIED surgery in a tertiary referral center. Furthermore, no systemic thromboembolic events were observed in both groups in the first month after surgery.
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