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Observational Study
. 2023 May 19;25(5):euad057.
doi: 10.1093/europace/euad057.

Impact of peri-procedural management of direct oral anticoagulants on pocket haematoma after cardiac electronic device implantation: the StimAOD multicentre prospective study

Anne-Céline Martin  1   2 , Orianne Weizman  1   3 , Jean-Marc Sellal  4   5 , Vincent Algalarrondo  6   7 , Walid Amara  8 , Abdeslam Bouzeman  9 , Estelle Gandjbakhch  10   11 , Nicolas Lellouche  12 , Jules Louembe  13 , Aymeric Menet  14 , Pierre Roumegou  15 , Frederic Treguer  16 , Anne Godier  2   17 , Serge Boveda  3   18   19 , Rodrigue Garcia  15   20 , Eloi Marijon  1   3
Affiliations
Observational Study

Impact of peri-procedural management of direct oral anticoagulants on pocket haematoma after cardiac electronic device implantation: the StimAOD multicentre prospective study

Anne-Céline Martin et al. Europace. .

Abstract

Aims: The study aims to investigate the impact of direct oral anticoagulant (DOAC) management on the incidence of pocket haematoma in patients undergoing pacemaker or implantable cardioverter-defibrillator implantation.

Methods and results: All consecutive patients receiving DOAC and undergoing cardiac electronic device implantation were included in a large multicentre prospective observational study (NCT03879473). The primary endpoint was clinically relevant haematoma within 30 days after implantation. Overall, 789 patients were enrolled [median age 80 (IQR 72-85) years old, 36.4% women, median CHA2DS2-VASc score 4 (IQR 0-8)], of which 632 (80.1%) received a pacemaker implantation. Antiplatelet therapy was combined with DOAC in 146 patients (18.5%). Direct oral anticoagulants (DOACs) were interrupted 52 (IQR 37-62) h before the procedure and resumed 31 (IQR 21-47) h later. Ninety-six percent of the patients had at least 12 h DOAC interruption before the procedure, and 78% had at least 12 h DOAC interruption after the procedure. Overall, anticoagulation was interrupted for 72 (IQR 48-96) h. Pre- or post-procedural heparin bridging was used in 8.2% and 3.9%, respectively. Timing of DOAC interruption of resumption was not associated with clinically relevant haematoma. Clinically relevant haematoma occurred in 26 patients (3.3%), and thromboembolic events occurred in 5 patients (0.6%).

Conclusion: In this large real-life registry where most patients had DOAC interruption, clinically relevant haematoma was rare. Despite DOAC interruption and high CHA2DS2-VASc score, thromboembolic events occurred seldomly, highlighting that bleeding exceeds thromboembolic risk in this peri-procedural period. Future research is needed to identify risk factors for clinically relevant haematoma and meaningfully guide clinicians in optimizing DOAC management.

Keywords: Direct oral anticoagulant; Implantable cardioverter–defibrillators; Pacemaker; Pocket haematoma.

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Conflict of interest statement

Conflict of interest: A.C.M. declares fees from Alliance BMS–Pfizer, Bayer, Boehringer Ingelheim, Abbott, and Novartis. J.M.S. declares fees from BMS–Pfizer, Bayer, and Boehringer Ingelheim. V.A. declares fees from Pfizer and Alnylam. W.A. served as a speaker or a member of a speaker’s bureau for Abbott, Bayer HealthCare Pharmaceuticals, Biotronik, Boston Scientific, Bristol-Myers Squibb, MicroPort, and Medtronic, Inc. E.G. declares consulting fees from MicroPort and Medtronic. N.L. declares fees from BMS–Pfizer and Bayer. S.B. is consultant for Medtronic, Boston Scientific, MicroPort, and Zoll. R.G. received research grants from Abbott, Medtronic, Boston Scientific, and MicroPort and consulting fees from Abbott and Boston Scientific. A.G. reports personal fees from Aguettant, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb/Pfizer, LFB, and Sanofi, outside the submitted work. E.M. received research grants from Abbott, Medtronic, Boston Scientific, Biotronik, and MicroPort and declares consulting fees from Abbott, Boston Scientific, Medtronic, Zoll, and Bayer. O.W., A.B., J.L., A.M., P.R., and F.T. declare no conflict of interest.

Figures

Graphical abstract
Graphical abstract
Figure 1
Figure 1
Distribution of pre- and post-procedural anticoagulation interruption duration.
See this image and copyright information in PMC

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