Effect of a pocket compression device on hematomas, skin reactions, and comfort in patients receiving a cardiovascular implantable electronic device: a randomized controlled trial.

ABSTRACT

AIM/OBJECTIVE: Aim to evaluate the safety and effectiveness of a pocket compression device in patients undergoing cardiovascular implantable electronic device (CIED) implantation. MATERIAL AND METHODS: This randomized controlled trial included 54 patients in the control group (elastic adhesive tape) and 54 patients in the experimental group (pocket compression device). A sandbag was positioned over the pocket after CIED implantation, using elastic adhesive tape in the control group and a novel pocket compression device in the experimental group. The primary outcome was the incidence of pocket hematomas, and the secondary outcomes were adverse skin reactions, the need for sandbag positional adjustments, and patient comfort. RESULTS: The distributions of age, sex, and clinical and procedure characteristics was not significantly different between the two groups (P>0.05). The occurrence of hematomas was lower when using the pocket compression device than in the control group (13.0% vs. 44.4%, P<0.001). The incidence rates of hematomas of grades 1 and the grade 2 hematomas were significantly lower in the experimental group than in the control group (13.0% vs. 31.5%, 0% vs. 11.1% respectively, [all P<0.05]). The incidence rates of adverse skin reactions and sandbag positional adjustments were much lower and the patient comfort score was significantly higher in the experimental group than in the control group (all P<0.001). CONCLUSION: A pocket compression device can significantly decrease the incidence of pocket hematomas, adverse skin reactions, and positional adjustments when patients are undergoing CIED, which can improve patient comfort and decrease the nursing workload. CLINICALTRIALS GOV NCT04389398.