Cardiac Arrhythmia Center, Montefiore-Einstein Center for Heart and Vascular Care, Division of Cardiology, Department of Medicine, Albert Einstein College of Medicine, New York, New York.
Clinica Las Americas, Medellin, Colombia.
Heart Rhythm. 2021 Aug;18(8):1326-1335. doi: 10.1016/j.hrthm.2021.03.008. Epub 2021 Mar 5.
Subcutaneous implantable cardioverter-defibrillator (S-ICD) is an effective alternative to transvenous implantable cardioverter-defibrillator. General anesthesia (GA) is considered the standard sedation approach because of the pain caused by the manipulation of subcutaneous tissue with S-ICD implantation. However, GA carries several limitations, including additional risk of adverse events, prolonged in-room times, and increased costs.
The purpose of this study was to define the effectiveness and safety of tumescent local anesthesia (TLA) in comparison to GA in patients undergoing S-ICD implantation.
We performed a prospective, nonrandomized, controlled, multicenter study of patients referred for S-ICD implantation between 2019 and 2020. Patients were allocated to either TLA or GA on the basis of patient's preferences and/or anesthesia service availability. TLA was prepared using lidocaine, epinephrine, sodium bicarbonate, and sodium chloride. All patients provided written informed consent, and the institutional review board at each site provided approval for the study.
Sixty patients underwent successful S-ICD implantation from July 2019 to November 2020. Thirty patients (50%) received TLA, and the rest GA. There were no differences between groups with regard to baseline characteristics. In-room and procedural times were significantly shorter with TLA (107.6 minutes vs 186 minutes; P < .0001 and 53.2 minutes vs 153.7 minutes; P < .0001, respectively). Pain was reported less frequently by patients who received TLA. The use of opioids was significantly reduced in patients who received TLA (23% vs 62%; P = .002).
TLA is an effective and safe alternative to GA in S-ICD implantation. The use of TLA is associated with shorter in-room and procedural times, less postprocedural pain, and reduced usage of opioids and acetaminophen for analgesia.
皮下植入式心律转复除颤器（S-ICD）是经静脉植入式心律转复除颤器的有效替代方法。由于 S-ICD 植入时皮下组织的操作会引起疼痛，全身麻醉（GA）被认为是标准镇静方法。然而，GA 存在多种局限性，包括不良事件的风险增加、在房间内停留时间延长和成本增加。
本研究旨在确定肿胀局部麻醉（TLA）与 GA 在接受 S-ICD 植入的患者中的有效性和安全性。
我们进行了一项前瞻性、非随机、对照、多中心研究，研究对象为 2019 年至 2020 年间因 S-ICD 植入而转诊的患者。根据患者的偏好和/或麻醉服务的可用性，将患者分配至 TLA 或 GA。TLA 采用利多卡因、肾上腺素、碳酸氢钠和氯化钠制备。所有患者均提供书面知情同意，每个研究地点的机构审查委员会均批准了该研究。
2019 年 7 月至 2020 年 11 月，60 例患者成功接受 S-ICD 植入。30 例（50%）患者接受 TLA，其余患者接受 GA。两组患者的基线特征无差异。TLA 组的室内和手术时间明显缩短（107.6 分钟比 186 分钟；P <.0001 和 53.2 分钟比 153.7 分钟；P <.0001）。接受 TLA 的患者报告疼痛的频率较低。接受 TLA 的患者使用阿片类药物的比例显著降低（23%比 62%；P =.002）。
TLA 是 S-ICD 植入的有效且安全的 GA 替代方法。TLA 的使用与室内和手术时间更短、术后疼痛减轻以及阿片类药物和对乙酰氨基酚使用减少相关。
