Risk factors for hematoma in patients undergoing cardiac device procedures: A WRAP-IT trial analysis

Khaldoun G Tarakji; Panagiotis Korantzopoulos; Francois Philippon; Mauro Biffi; Suneet Mittal; Jeanne E Poole; Charles Kennergren; Daniel R Lexcen; Jeff D Lande; Gregory Hilleren; Swathi Seshadri; Bruce L Wilkoff

doi:10.1016/j.hroo.2022.05.012

Risk factors for hematoma in patients undergoing cardiac device procedures: A WRAP-IT trial analysis

Heart Rhythm O2. 2022 Jun 16;3(5):466-473. doi: 10.1016/j.hroo.2022.05.012. eCollection 2022 Oct.

Authors

Affiliations

¹ Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.
² First Department of Cardiology, University Hospital of Ioannina, Ioannina, Greece.
³ Cardiology Department, Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ), Quebec, Canada.
⁴ Cardiology, Policlinico Sant' Orsola, Malpighi, Italy.
⁵ Electrophysiology, Valley Health System, Ridgewood, New Jersey.
⁶ Division of Cardiology, University of Washington School of Medicine, Seattle, Washington.
⁷ Cardiothoracic Surgery, Sahlgrenska University Hospital, Göteborg, Sweden.
⁸ Cardiac Rhythm Management, Medtronic, Inc, Mounds View, Minnesota.

Abstract

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.

Keywords: Anticoagulation; Antiplatelet; Antithrombotic management; CIED; Complication; Hematoma; Risk factor.