Risk Factors of Haematoma Formation Following Cardiac Implantable Electronic Device Procedures.

Area of Science:

• Cardiology
• Medical Devices
• Pharmacology

Background:

• Pocket hematoma is a complication following cardiac implantable electronic device (CIED) procedures.
• Identifying risk factors is crucial for patient safety and procedural outcomes.

Purpose of the Study:

• To identify and quantify risk factors for perioperative pocket hematoma formation in adults undergoing CIED procedures.
• To compare the risk of hematoma formation between dual antiplatelet therapy (DAPT) and oral anticoagulation (OAC).

Main Methods:

• Retrospective analysis of 2,100 adult patients undergoing CIED procedures.
• Multivariate binomial logistic regression analysis to identify significant risk factors.
• Quantification of odds ratios (OR) for various antiplatelet and anticoagulant agents.

Main Results:

• DAPT, particularly with aspirin and prasugrel, showed a significantly higher odds of hematoma formation (OR 104) compared to OAC.
• Aspirin monotherapy (OR 3.02) and OACs (apixaban OR 2.59, dabigatran OR 3.81) were also associated with increased bleeding risk.
• Higher platelet counts were associated with a reduced bleeding risk (8% reduction per 10x10^3/μL increase).

Conclusions:

• DAPT significantly increases the risk of pocket hematoma post-CIED procedures, exceeding the risk associated with OAC.
• Medication reconciliation for P2Y12 inhibitors and perioperative policies considering anticoagulant half-lives are essential to mitigate bleeding risks.
• Understanding these risks can guide clinical practice and improve patient safety during CIED implantation.