Implantation of permanent pacemakers (PPMs) or implantable cardiac defibrillators (ICDs) may be complicated by the development of pocket hematomas.

To evaluate bleeding complications in patients taking apixaban and undergoing a pacemaker or ICD implantation in everyday clinical practice.

It is a multicenter, observational, prospective study of patients with non-valvular atrial fibrillation (AF) undergoing a pacemaker or implantable cardioverter defibrillator [ICD]. Eligible patients had been taking apixaban (2.5 or 5mg twice daily) for ≥3 weeks before the procedure, and were followed for 30 days afterwards.

A total of 115 patients (80 [72,85] years, 63% male, mean CHA2DS2-VASc score 3, mean HAS BLED score 3) were enrolled at 25 academic/non-academic centres in France; 68 patients (59%) were receiving apixaban 10mg/day and 47 (41%) 5mg/day. The most prevalent concomitant disorders were hypertension (55% of patients), diabetes (15%), vascular disease (10%) and a history of stroke (6%). Mean creatinine value was 93±25μmol/L, median weight was 83±18kg and mean creatinine clearance (Cockroft−Gault) was 82±34mL/min. The implantation was a planned procedure in 102 (89%) of cases. The mean duration of procedure was 51min. The management of apixaban in the periprocedural period was let to the investigators preference. Median withdrawal time was 25h. Bleeding events were detected in 4 (3.5%) cases. One of them was a pocket hematoma with infection treated by the extraction of the device. Three patients presented minor bleedings according to ISTH classification without prolongation of hospitalization.

These observational data of patients on apixaban undergoing pacemaker/ICD implantation in everyday practice show a management of apixaban according to guidelines with a low rate of bleeding events.