Prasertwitayakij Narawudt, Yanyongmathe Jakkapun, Pongbangli Natnicha, Nantsupawat Teerapat, Gunaparn Siriluck, Pisespongsa Cheeranun, Tawaditap Chanya, Phrommintikul Arintaya, Wongcharoen Wanwarang
Division of Cardiology, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, 50200, Thailand.
Division of Cardiology, Department of Internal Medicine, Chiang Rai Prachanukroh Hospital, Chiang Rai, Thailand.
Sci Rep. 2025 Jan 25;15(1):3214. doi: 10.1038/s41598-025-87735-9.
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.
口袋血肿是心脏植入式电子设备（CIED）植入后常见且严重的并发症，会导致显著的发病率和死亡率。本研究旨在评估一种新型口袋压迫装置在减少口袋血肿发生方面的疗效。我们纳入了242例行CIED植入术的患者，将他们随机分为两组，分别接受带有压力袖带的新型压迫背心或传统沙袋压迫。口袋血肿分为1级（轻度）、2级（中度）或3级（重度，需要干预或延长住院时间）。主要终点为术后24小时口袋血肿的发生率，两组之间无显著差异（26.7%对19.7%，p = 0.224）。2级血肿的发生率同样较低且相当（2.5%对0.8%，p = 0.368），未观察到3级血肿。两组之间的皮肤反应和患者舒适度相似。血肿发生的唯一预测因素是当前使用口服抗凝药。总之，我们的研究发现临床上显著的口袋血肿发生率较低。新型口袋压迫装置显示出与传统方法相当的疗效，表明它是减少术后并发症且无额外不良反应的可行替代方法。试验注册号：该研究已在泰国临床试验注册中心（TCTR）（https://www.thaiclinicaltrials.org/）注册，识别号为TCTR20230913005，首次试验注册日期为2023年9月13日。
