Influence of peri-procedural management of direct oral anticoagulants on the incidence of pocket hematoma in patients undergoing cardiac rhythm device implantation – The StimAOD study

Abstract

Direct oral anticoagulants (DOAC) are commonly used in patients undergoing rhythm device implantation, exposing to an increased risk of pocket hematoma. However, the optimal perioperative strategy for DOAC management remains unclear. We performed a multicentre prospective observational study of patients receiving DOAC and undergoing pacemaker or defibrillator implantation. The primary endpoint was clinically relevant hematoma (CRH) within 30 ± 5 days after implantation. Any hematoma included CRH and non-clinically relevant hematoma. We aimed to describe practices, assess the impact of DOAC interruption before and after the procedure and identify predictors of CRH. In total, 789 patients were included, median age 80 [30–102], 36.4% women. CHA 2 DS 2 -VASc score was 4 [0–8] and 16.5% had a history of stroke. Defibrillators were implanted in one fifth. Antiplatelet therapy accounted for 18.5%. Overall DOAC were interrupted 40.8 ± 45.3 h prior the procedure and resumed 38.8 ± 40.3 h later. Pre- and post-procedural heparin bridging were observed in 8.2% and 3.9%, and shortened anticoagulation interruption (32.1 ± 48.8 vs. 55.8 ± 45.5 h, P < 0.001 and 22 ± 26.2 vs. 39.5 ± 40.6 h, P < 0.001, respectively). Postoperative bridging increased by 4.1 the risk of any hematoma up to 5.9 when associated with preoperative bridging. CRH occurred in 3.3%. In multivariate analysis dual antiplatelet therapy, defibrillator implantation and CHA 2 DS 2 -VASc score 0-1 were strong predictors of CRH ( Table 1 ). Among CHA 2 DS 2 -VASc score 0-1, postoperative anticoagulation was resumed earlier in those with a hematoma (29.6 ± 15.1 vs. 65.7 ± 70.5 hours, P = 0.007). Finally, thromboembolic events were low (0.63%). Dual antiplatelet therapy, defibrillator and CHA 2 DS 2 -VASc score 0-1 majored the risk of CRH. Timing of DOAC interruption and resumption were not predictive of CHR, however postoperative period seemed to be at high-risk of hematoma especially when bridging is performed. These findings have strong impact for clinical practice.