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Risk factors for hematoma in patients undergoing cardiac device procedures: A WRAP-IT trial analysis
Khaldoun G Tarakji1, Panagiotis Korantzopoulos2, Francois Philippon3
1Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.
Insights
Hematoma risk after cardiac device procedures is linked to anticoagulant and antiplatelet medications. Understanding these factors can help manage antithrombotic therapy and reduce complications.
Area of Science:
- Cardiology
- Medical Devices
- Pharmacology
Background:
- Implant site hematoma is a recognized complication following cardiac device implantation.
- These hematomas can lead to significant adverse outcomes for patients.
Purpose of the Study:
- To identify risk factors associated with hematoma development after cardiac device procedures.
- To clarify the relationship between anticoagulant (AC) and antiplatelet (AP) medication use and hematoma occurrence.
Main Methods:
- Analysis of 6800 patients from the WRAP-IT trial.
- Utilized stepwise Cox regression to identify baseline and procedural characteristics linked to hematoma within 30 days.
- Evaluated the impact of AC/AP use on hematoma risk.
Main Results:
- The overall hematoma rate was 2.2%.
- Key risk factors included anticoagulant use (HR: 2.44), lower BMI (HR: 1.06), and prior valve surgery (HR: 2.11).
- Antiplatelet use nearly doubled hematoma risk (HR: 1.85). Heparin bridging showed the highest risk (HR: 4.98).
Conclusions:
- Identified significant risk factors for hematoma in cardiac device procedures.
- Findings can guide antithrombotic management strategies to mitigate hematoma risk.
Background:
Implant site hematoma is a known complication of cardiac device procedures and can lead to major consequences.
Objectives:
To evaluate risk factors for hematoma and further understand the relationship between anticoagulant (AC), antiplatelet (AP) use, and hematoma development.
Methods:
We included 6800 patients from the WRAP-IT trial. To assess baseline and procedural characteristics associated with hematoma within the first 30 days postprocedure, a stepwise Cox regression model was implemented with minimal Akaike information criterion. Cox regressions were also used to evaluate AC/AP use and hematoma risk.
Results:
The overall rate of hematoma was 2.2%. The model identified 11 baseline and procedural characteristics associated with hematoma risk. AC use (hazard ratio [HR]: 2.44, P < .001), lower body mass index (HR: 1.06, P < .001), and history of valve surgery (HR: 2.11, P < .001) were associated with the highest risk. AP use, male sex, history of coronary artery disease, existing pocket, history of nonischemic cardiomyopathy, number of previous cardiac implantable electronic device (CIED) procedures, procedure time, and lead revision were associated with moderate risk. Antithrombotic use was high overall (86%) and AC+AP use was highly predictive of hematoma risk. Regardless of AC status, AP use was associated with an almost doubling of risk vs no AP (HR = 1.85, P = .0006) in the general cohort. Interruption of AC was associated with the lowest hematoma risk (HR = 2.35) while heparin bridging (HR = 4.98) and AP use vs no AP use (HR = 1.85) was associated with the highest hematoma risk.
Conclusion:
The results of this analysis highlight risk factors associated with the development of hematoma in patients undergoing CIED procedures and can inform antithrombotic management.
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