Department of Cardiology, University of Virginia Health System, Charlottesville, Virginia, USA.
Department of Cardiology, William Beaumont Oakland University School of Medicine, Royal Oak, Michigan, USA.
Pacing Clin Electrophysiol. 2022 Apr;45(4):491-498. doi: 10.1111/pace.14454. Epub 2022 Mar 4.
An important complication of cardiac implantable electronic devices (CIED) implantation is the development of hematoma and device infection.
We aimed to evaluate a novel mechanical compression device for hematoma prevention and cosmetic outcomes following CIED implantation.
An open, prospective, randomized, single-center clinical trial was performed in patients undergoing CIED implantation. Patients were randomized to receive a novel mechanical compression device (PressRite, PR) or to receive the standard of care post device implantation. Skin pliability was measured with a calibrated durometer; the surgical site was evaluated using the Manchester Scar Scale (MSS) by a blinded plastic surgeon and the Patient and Observer Scar Scale (POSAS). Performance of PR was assessed through pressure measurements, standardized scar scales and tolerability.
From the total of 114 patients evaluated for enrollment, 105 patients were eligible for analysis. Fifty-one patients were randomized to management group (PR) and 54 to the control group. No patients required early removal or experienced adverse effects from PR application. There were 11 hematomas (14.8% vs. 5.9% in the control and PR group respectively, p = NS). The control group had higher post procedure durometer readings in the surgical site when compared with the PR group (7.50 ± 3.45 vs. 5.37 ± 2.78; p = < .01). There were lower MSS scores in the PR group after 2 weeks (p = .03).
We have demonstrated the safety of PR application and removal. In addition, PR appears to improve postoperative skin pliability, which could facilitate wound healing.
心脏植入式电子设备（CIED）植入后的一个重要并发症是血肿和设备感染的发生。
我们旨在评估一种新型机械压迫装置在预防 CIED 植入后血肿和改善美容效果方面的应用。
这是一项在接受 CIED 植入的患者中进行的开放性、前瞻性、随机、单中心临床试验。患者被随机分配接受新型机械压迫装置（PressRite，PR）或在设备植入后接受标准护理。使用校准的硬度计测量皮肤柔韧性；由一位盲法整形医生使用曼彻斯特瘢痕量表（MSS）和患者和观察者瘢痕量表（POSAS）对手术部位进行评估。通过压力测量、标准化瘢痕量表和可耐受性来评估 PR 的性能。
在总共评估了 114 名符合入组条件的患者中，有 105 名患者符合分析条件。51 名患者被随机分配到管理组（PR），54 名患者分到对照组。没有患者需要早期移除或因 PR 应用而出现不良反应。血肿发生率为 11 例（分别为 14.8%和 5.9%，对照组和 PR 组之间无统计学差异，p=NS）。与 PR 组相比，对照组在术后术区的硬度计读数更高（7.50 ± 3.45 与 5.37 ± 2.78；p <.01）。PR 组在 2 周后 MSS 评分较低（p =.03）。
我们已经证明了 PR 应用和移除的安全性。此外，PR 似乎可以改善术后皮肤柔韧性，这有助于伤口愈合。
