A novel device to reduce the incidence of pocket hematoma

The incidence of pocket hematoma following cardiac device implantation varies widely, ranging from 0.2% to 16%. Pocket hematomas are clinically significant, as they are associated with a ninefold increased risk of infection. Preventing pocket hematomas requires optimal perioperative management of anticoagulation and antiplatelet therapy. In addition, meticulous surgical technique and careful attention to hemostasis are essential. Mechanical compression using sandbags or other tools can also help reduce the risk of hematoma formation. However, there are no standardized guidelines for preventing or treating hematomas postoperatively.

A prospective cohort study was conducted, enrolling 205 patients who underwent cardiac implantable electronic device (CIED) implantation or replacement. Of these, since August 2023 to February 2024, 108 patients received standard compressive bandages, while, since February 2024 to September 2024, 95 were treated with Premofix PM/ICD Set® (Andanza), a novel compression system. Compression was applied for six hours after the procedure in both groups. Pocket hematomas were evaluated during the hospital stay, before discharge, and at a one-month follow-up visit. Patients were also instructed to report any post-discharge symptoms. Pocket hematoma was defined as an hematoma requiring reoperation (due to failure of nonoperative measures or actual wound breakdown or necrosis), prolonging hospitalization (24 hours or more), or necessitating interruption of oral anticoagulation (OAC) for at least 24 hours. To minimize confounding factors, patient and procedural characteristics, including age, gender, body mass index, diabetes, heart failure, chronic kidney disease, platelet count, peri-procedural use of antiplatelets or anticoagulants, and procedure type were compared between groups.

No significant differences were found, as shown in Figure 1. In the control group, five (4.7%) developed pocket hematomas, while none in the Premofix group experienced this complication (p = 0.03). In two out of five cases in the control group, anticoagulation therapy was discontinued, and in three, hospitalization was prolonged. Importantly, none required surgical intervention. Considering the five cases, four were on OAC and one was on dual antiplatelet therapy. Among those taking OAC, three were using VKAs, while one was on a DOAC. The last one was on dual antiplatelet therapy.

The significant reduction in hematomas observed in the Premofix group can be attributed to more effective compression compared to traditional bandages. Premofix enhances hemostasis, ensuring consistent pressure over the surgical site, reducing swelling, and minimizing hematoma formation. Its use may decrease patient morbidity, shorten hospital stays, and improve procedural outcomes. While these results are promising, further research is needed.