Fei Ye-Ping, Wang Lei, Zhu Chun-Yan, Sun Jing-Chao, Hu Hui-Lin, Zhai Chang-Lin, He Chao-Jie
Department of Cardiology, The Affiliated Hospital of Jiaxing University, Jiaxing, China.
Department of General Practice, The Affiliated Hospital of Jiaxing University, Jiaxing, China.
Front Cardiovasc Med. 2022 Feb 24;9:817453. doi: 10.3389/fcvm.2022.817453. eCollection 2022.
A pocket hematoma is a well-recognized complication that occurs after pacemaker or defibrillator implantation. It is associated with increased pocket infection and hospital stay. Patients suffering from atrial fibrillation and undergoing cardiovascular electronic implantable device (CIED) surgery are widely prescribed and treated with direct oral anticoagulants (DOACs). In this study, the use of a novel compression device was evaluated to examine its ability to decrease the incidence of pocket hematomas following device implantation with uninterrupted DOACs.
A total of 204 participants who received DOACs and underwent CIED implantation were randomized into an experimental group (novel compression device) and a control group (elastic adhesive tape with a sandbag). The primary outcome was pocket hematoma, and the secondary outcomes were skin erosions and patient comfort score. Grade 3 hematoma was defined as a hematoma that required anticoagulation therapy interruption, re-operation, or prolonged hospital stay.
The baseline characteristics of both groups had no significant differences. The incidence of grades 1 and 2 hematomas was significantly lower in the compression device group than in the conventional pressure dressing group (7.8 vs. 23.5 and 2.0 vs. 5.9%, respectively; < 0.01). Grade 3 hematoma occurred in 2 of 102 patients in the experimental group and 7 of 102 patients in the control group (2.0 vs. 6.9%; = 0.03). The incidence rates of skin erosion were significantly lower, and the patient comfort score was much higher in the compression device group than in the control group ( < 0.01). Multivariable logistic regression analysis showed that the use of novel compression device was a significant protective factor for pocket hematoma (OR = 0.42; 95% CI, 0.29-0.69, = 0.01).
The incidence of pocket hematomas and skin erosions significantly decreases when the proposed compression device is used for patients undergoing device implantation with uninterrupted DOACs. Thus, the length of hospital stay and re-operation rate can be reduced, and patient comfort can be improved.
http://www.chictr.org.cn, identifier: ChiCTR2100049430.
起搏器或除颤器植入术后，囊袋血肿是一种公认的并发症。它与囊袋感染增加和住院时间延长有关。患有心房颤动且正在接受心血管植入式电子设备（CIED）手术的患者广泛使用直接口服抗凝剂（DOACs）进行治疗。在本研究中，对一种新型压迫装置的使用进行了评估，以检验其在不间断使用DOACs的情况下降低设备植入后囊袋血肿发生率的能力。
总共204名接受DOACs并接受CIED植入的参与者被随机分为实验组（新型压迫装置）和对照组（带沙袋的弹性胶带）。主要结局是囊袋血肿，次要结局是皮肤糜烂和患者舒适度评分。3级血肿定义为需要中断抗凝治疗、再次手术或延长住院时间的血肿。
两组的基线特征无显著差异。压迫装置组1级和2级血肿的发生率显著低于传统加压包扎组（分别为7.8%对23.5%和2.0%对5.9%；<0.01）。实验组102例患者中有2例发生3级血肿，对照组102例患者中有7例发生3级血肿（2.0%对6.9%；=0.03）。压迫装置组的皮肤糜烂发生率显著更低，患者舒适度评分显著高于对照组（<0.01）。多变量逻辑回归分析表明，使用新型压迫装置是囊袋血肿的显著保护因素（OR=0.42；95%CI，0.29-0.69，=0.01）。
对于在不间断使用DOACs的情况下接受设备植入的患者，使用所提出的压迫装置时，囊袋血肿和皮肤糜烂的发生率显著降低。因此，可以缩短住院时间，降低再次手术率，并提高患者舒适度。
