DOACs in pacemaker or defibrillator surgery 85 Table 2. Operative details. Characteristic VKA group (n=202) DOAC group (n=81) P-value New implant of a pacemaker - Single 6 (3.0) 4 (4.9) 0.42 - Dual 16 (7.9) 19 (23.5) <0.001 - Cardiac resynchronization 9 (4.5) 4 (4.9) 0.86 New implant of an ICD - Single 9 (4.5) 6 (7.4) 0.32 - Dual 3 (1.5) 5 (6.2) 0.03 - Cardiac resynchronization 11 (5.4) 3 (3.7) 0.54 - Subcutaneous ICD 4 (2.0) 4 (4.9) 0.17 Device replacement or revision - Pulse generator change only 115 (56.9) 21 (25.9) <0.001 - Pulse generator change with additional 25 (12.4) 12 (14.8) 0.58 - Other 4 (2.0) 3 (3.7) 0.40 Subpectoral pocket 15 (7.4) 5 (6.2) 0.71 Participation of fellow in procedure 123 (60.9) 57 (70.4) 0.13 INR at day of procedure 2.1 (1.8-2.4) - Duration of procedure (min) 50 (32-75) 69 (45-91) 0.003 Data are presented as n (%) or as median (25th, 75th percentile). Abbreviations: DOAC= direct oral anticoagulant; ICD= implantable cardioverter-defibrillator; INR= international normalized ratio; VKA = vitamin K antagonist. Table 3. Detailed overview of clinically significant hematoma. Case no. Type VKA Sex Age Cardiomyopathy eGFR (mL/min) Type of procedure HASBLED Intervention 1 Acenocoumarol M 64 Ischemic 67 Generator change and RV shock lead implantation 2 Prolongation of hospital stay & interruption of VKA 2 Acenocoumarol M 66 Non-ischemic 5 CRT-D implantation 3 Interruption of VKA 3 Acenocoumarol F 72 none 60 RV pacing lead change 2 Prolongation of hospital stay 4 Acenocoumarol M 81 Ischemic 56 ICD generator change 3 Prolongation of hospital stay 5 Acenocoumarol M 88 none 34 ICD generator change 2 Interruption of VKA & reoperation Data are presented as n (%). Abbreviations: CRT-D= cardiac resynchronization therapy defibrillator; eGFR= estimated glomerular filtration rate; F= female; ICD= implantable cardioverter-defibrillator; M= male; RV= Right Ventricle; VKA= vitamin K antagonist. 5
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