Efficacy of Hypothermic Compression Bandages in Cardiac Device Surgical Wounds: A Randomized Controlled Trial.

Background: Pocket hematoma is the most prevalent complication with cardiac implantable electronic devices (CIEDs), especially in patients who are undergoing oral anticoagulation and/or antiplatelet therapy.

Objective: To evaluate the efficacy of hypothermic compression bandaging versus conventional compression bandaging for the prevention of surgical wound hematoma of CIEDs in patients who are undergoing chronic anticoagulant drug use and/or antiplatelet therapy.

Methods: This was a single-center randomized prospective study. The intervention group received a hypothermic compression bandage, and the control group received a conventional compression bandage. The primary endpoint was the appearance of hematoma 10 days after the intervention.

Results: A total of 310 patients participated in the study. The mean age of the participants was 73.77 ± 10.68 years, and 74.8% were men. In the intervention group, 5.88% (n = 18) of patients developed ecchymosis, and 1.3% (n = 4) developed mild hematoma. In the control group, 5.88% (n = 18) of patients developed ecchymosis, and 2.9% (n = 9) developed mild hematoma. No patient in either group had a severe hematoma. No significant differences were observed between the two types of dressing in any of the three degrees of hematoma.

Conclusions: This study demonstrated that compression bandaging with or without hypothermic therapy effectively prevents pocket hematoma of CIEDs in patients at high risk of bleeding.