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Randomized Controlled Trial
. 2025 Jan 25;15(1):3214.
doi: 10.1038/s41598-025-87735-9.

Effect of pocket compression device on pocket hematoma after cardiac implantable electronic device implantation

Narawudt Prasertwitayakij  1 , Jakkapun Yanyongmathe  1 , Natnicha Pongbangli  2 , Teerapat Nantsupawat  1 , Siriluck Gunaparn  1 , Cheeranun Pisespongsa  3 , Chanya Tawaditap  3 , Arintaya Phrommintikul  1 , Wanwarang Wongcharoen  4
Affiliations
Randomized Controlled Trial

Effect of pocket compression device on pocket hematoma after cardiac implantable electronic device implantation

Narawudt Prasertwitayakij et al. Sci Rep. .

Abstract

Pocket hematoma is a common and serious complication following cardiac implantable electronic device (CIED) implantation, contributing to significant morbidity and mortality. This study aimed to evaluate the efficacy of a novel pocket compression device in reducing pocket hematoma occurrence. We enrolled 242 patients undergoing CIED implantation, randomly assigning them to receive either the novel compression vest with a pressure cuff or conventional sandbag compression. Pocket hematomas were categorized as grade 1 (mild), grade 2 (moderate), or grade 3 (severe, requiring intervention or prolonged hospitalization). The primary endpoint, incidence of pocket hematoma 24 h post-procedure, did not significantly differ between the two groups (26.7% vs. 19.7%, p = 0.224). Rates of grade 2 hematoma were similarly low and comparable (2.5% vs. 0.8%, p = 0.368), with no grade 3 hematomas observed. Skin reactions and patient comfort were similar between groups. The sole predictor for hematoma occurrence was current oral anticoagulation use. In conclusion, our study found a low incidence of clinically significant pocket hematomas. The novel pocket compression device showed comparable efficacy to conventional methods, suggesting it as a viable alternative for reducing post-procedural complications without additional adverse effects.Trial registration number: The study was registered in the Thai Clinical Trials Registry (TCTR) at https://www.thaiclinicaltrials.org/ , with the identification number TCTR20230913005, date of first trial registration 13/09/2023.

Keywords: Cardiac implantable electronic devices; Defibrillator; Pacemaker; Pocket compression; Pocket hematoma..

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Conflict of interest statement

Declarations. Competing interests: The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Consort flow diagram.
Fig. 2
Fig. 2
Pocket compression method. (A) Novel pocket compression device. (B) Conventional 1-kg sandbag compression with adhesive tape.
Fig. 3
Fig. 3
Efficacy outcome according to prespecified antithrombotic status. (A) Patients taking oral anticoagulant or dual antiplatelet therapy (B) Patients not taking oral anticoagulant or dual antiplatelet therapy.
See this image and copyright information in PMC

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