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Pocket hematoma after pacemaker or defibrillator surgery: Direct oral anticoagulants versus vitamin K antagonists
John de Heide1, Marisa van der Graaf1, Marijn J Holl1
1Department of Cardiology, Erasmus MC, University Medical Center Rotterdam, Rotterdam, the Netherlands. All authors take responsibility for all aspects of the reliability and freedom from bias of the data presented and their discussed interpretation.
Insights
Direct oral anticoagulants (DOACs) and vitamin K antagonists (VKAs) show similar low risks for pocket hematoma and thromboembolic events in atrial fibrillation (AF) patients undergoing cardiac implantable electronic device (CIED) procedures. Interrupted DOAC or continued VKA regimens are safe options.
Area of Science:
- Cardiology
- Pharmacology
- Medical Devices
Background:
- Direct oral anticoagulants (DOACs) are preferred for atrial fibrillation (AF) anticoagulation.
- Real-world data on DOACs in patients undergoing cardiac implantable electronic device (CIED) procedures is limited.
- Previous randomized trials suggest DOACs are safe and effective in this setting.
Purpose of the Study:
- To compare outcomes of interrupted DOAC versus continued vitamin K antagonist (VKA) regimens in AF patients undergoing elective CIED procedures.
- To evaluate the incidence of pocket hematoma and thromboembolic complications.
- To provide real-world evidence on anticoagulation management during CIED procedures.
Main Methods:
- Retrospective single-center study of 283 AF patients undergoing elective CIED procedures (January 2016 - June 2019).
- Patients were on either interrupted DOAC (N=81) or continued VKA (N=202) oral anticoagulation.
- Primary endpoint: clinically significant pocket hematoma within 30 days. Secondary endpoint: systemic thromboembolic complications within 30 days.
Main Results:
- No significant difference in pocket hematoma rates between VKA (2.5%) and DOAC (0%) groups (P=0.33).
- No thromboembolic events were reported in either group.
- DOAC group was younger, had less renal disease, more paroxysmal AF, and lower HAS-BLED scores.
Conclusions:
- Interrupted DOAC and continued VKA regimens are associated with comparably low risks of pocket hematoma and systemic thromboembolic events in AF patients undergoing elective CIED procedures.
- This real-world data supports the safety of both anticoagulation strategies.
- Further research may explore optimal management in specific patient subgroups.
Background:
Direct oral anticoagulants (DOACs) are the preferred choice of oral anticoagulation in patients with atrial fibrillation (AF). Randomized trials have demonstrated the efficacy and safety of DOAC in patients undergoing a cardiac implantable electronic device procedure (CIED); however, there is limited real-world data.
Objective:
To evaluate the outcome of patients undergoing an elective CIED procedure in a tertiary referral center with an interrupted DOAC or continued vitamin K antagonist (VKA) regimen.
Methods:
This was a retrospective single-center study of consecutive patients with AF undergoing an elective CIED procedure between January 2016 and June 2019. The primary endpoint was a clinically significant pocket hematoma < 30 days after surgery. The secondary endpoint was any systemic thromboembolic complication < 30 days after surgery.
Results:
Of a total of 1,033 elective CIED procedures, 283 procedures were performed in patients with AF using oral anticoagulation. One-third of the procedures were performed under DOAC (N = 81, 29%) and the remainder under VKA (N = 202, 71%). The DOAC group was younger, had less chronic renal disease, more paroxysmal AF and a lower HAS-BLED score. The VKA group more often underwent a generator change only in comparison to the DOAC group. Clinically significant pocket hematoma occurred in 5 patients (2.5%) in the VKA group and did not occur in the DOAC group (P = 0.33). There were no thromboembolic events reported.
Conclusion:
In patients with AF undergoing an elective CIED procedure, the risk of a pocket hematoma and a systemic thromboembolic event is comparably low when using either continued VKA or interrupted DOAC.
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