Chapter 5 76 2. Methods 2.1. Study cohort We retrospectively evaluated all consecutive adult patients who underwent an elective pacemaker or defibrillator surgery between January 2016 and June 2019. This population did not include patients with a recent (<3 months) transvenous lead extraction, patients who received a device during unplanned hospitalization, and patients who received a leadless pacemaker. The only inclusion criterion was a history of AF. Exclusion criteria were the use of concomitant antiplatelet therapy (i.e., aspirin, clopidogrel, ticagrelor or prasugrel) and any other regimen than continued VKA or interrupted DOAC. Thus, patients with bridging therapy, interrupted VKA or no oral anticoagulation use were excluded. No patient in our center continued DOAC during an elective CIED procedure. Data were collected from the electronic medical records. 2.2. Anticoagulation regimen and discharge Patients using DOAC discontinued their drug 24–48 h before surgery depending on their renal function. All DOACs were restarted 24 h after end of surgery, unless stated otherwise by the operator. In patients using acenocoumarol or fenprocoumon, the target international normalized ratio (INR) was 2.0 to 2.5 in the morning of the procedure. Patients with continued VKA usually attained to their regular dosing schedule. Patients undergoing a device implantation were discharged the day after the procedure. At the day of discharge, these patients underwent a physical examination of their device pocket, had a device interrogation and a chest X-ray. Patients undergoing a generator replacement only were discharged on the same day of the procedure after clinically significant pocket hematoma had been ruled out. 2.3. Study endpoints The primary endpoint was clinically significant device pocket hematoma < 30 days after surgery. A clinically significant hematoma was defined as a hematoma resulting in either re-operation, prolongation of hospitalization (>24 h after index surgery) or interruption of oral anticoagulation. This definition of clinically significant hematoma is
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