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同一天内植入心脏起搏器并出院:这有可能吗?E-MOTION 试验(起搏器植入后早期活动)。

Same-day CIED implantation and discharge: Is it possible? The E-MOTION trial (Early MObilization after pacemaker implantaTION).

机构信息

Division of Cardiology, A.O.U. Città della Salute e della Scienza di Torino-Molinette, Department of Medical Sciences, University of Turin, Turin, Italy.

Division of Cardiology, A.O.U. Città della Salute e della Scienza di Torino-Molinette, Department of Medical Sciences, University of Turin, Turin, Italy.

出版信息

Int J Cardiol. 2019 Aug 1;288:82-86. doi: 10.1016/j.ijcard.2019.04.020. Epub 2019 Apr 8.

DOI:10.1016/j.ijcard.2019.04.020
PMID:31031076
Abstract

BACKGROUND

Despite the increasing number of cardiac implantable electronic devices (CIED) procedures worldwide, no guideline assessed postoperative mobilization protocols. Lacking evidences in literature, many centers require 24-hour immobilization and bed rest to minimize the risk of pacing lead (PL) dislodgement. Prolonged immobilization may futilely delay discharge, induce pain and reduced joint mobility especially in elderly patients. We examined whether early mobilization at 3-h after CIED surgery would result in higher complication rates, compared with standard 24-hour immobilization.

METHODS

Consecutive patients undergoing CIED implantation were randomized to early (3-h) mobilization protocol with an arm sling support (E-motion group, EMG) vs. standard (24-h) immobilization (control group, CG). The primary end-point was 24-month PL dislodgement. Secondary safety end-point was any major intra-procedural complication (cardiac perforation, pericardial tamponade, valve damage, haemothorax, pneumothorax, myocardial infarction, peripheral embolus, TIA/stroke or death).

RESULTS

Among 200 enrolled patients, 86% underwent pacemaker implantation (28% single-chamber, 72% dual-chamber device), 14% underwent ICD implantation (75% single-chamber, 25% dual-chamber device). PL fixation was mostly passive (97% atrial PL, 88% ventricular PL), without differences between EMG and CG (p = 0.99). No differences were observed in the incidence of 24-month PL dislodgement (3% in the EMG vs. 4% in the CG, p = 0.99). No major intra-procedural complications were observed.

CONCLUSIONS

Early mobilization at 3-h following CIED surgery is safe and feasible compared with standard immobilization and is not associated with an increased risk of intra-procedural complications or 24-month lead dislodgment. So, same-day implantation and discharge might be possible.

摘要

背景

尽管全球范围内心脏植入式电子设备(CIED)手术的数量不断增加,但没有指南评估术后活动方案。由于文献中缺乏证据,许多中心需要 24 小时的固定和卧床休息,以最大程度地降低起搏导线(PL)移位的风险。长时间的固定可能会徒劳地延迟出院,引起疼痛和关节活动度降低,尤其是在老年患者中。我们研究了与标准 24 小时固定相比,CIED 手术后 3 小时早期活动是否会导致更高的并发症发生率。

方法

连续接受 CIED 植入的患者被随机分为早期(3 小时)活动方案臂吊带支持(E-motion 组,EMG)与标准(24 小时)固定(对照组,CG)。主要终点是 24 个月时 PL 移位。次要安全性终点是任何主要的术中并发症(心脏穿孔、心包填塞、瓣膜损伤、血胸、气胸、心肌梗死、外周栓塞、TIA/中风或死亡)。

结果

在 200 名入组患者中,86%接受了起搏器植入(28%单腔,72%双腔装置),14%接受了 ICD 植入(75%单腔,25%双腔装置)。PL 固定大多是被动的(97%的心房 PL,88%的心室 PL),EMG 和 CG 之间没有差异(p=0.99)。24 个月时 PL 移位的发生率也没有差异(EMG 组为 3%,CG 组为 4%,p=0.99)。未观察到主要的术中并发症。

结论

与标准固定相比,CIED 手术后 3 小时的早期活动是安全可行的,并且与术中并发症或 24 个月时的导线移位风险增加无关。因此,当天植入和出院是可能的。

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