Carlo Budano1, Paolo Garrone1, Davide Castagno1, Arianna Bissolino1, Alessandro Andreis2, Laura Bertolo1, Diana Mazzini1, Laura Bergamasco3, Sebastiano Marra1, Fiorenzo Gaita1. 1. Division of Cardiology, A.O.U. Città della Salute e della Scienza di Torino-Molinette, Department of Medical Sciences, University of Turin, Turin, Italy. 2. Division of Cardiology, A.O.U. Città della Salute e della Scienza di Torino-Molinette, Department of Medical Sciences, University of Turin, Turin, Italy. Electronic address: alessandro.andreis@unito.it. 3. Department of Surgical Sciences, University of Turin, Turin, Italy.
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% underwentpacemaker 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.
RCT Entities:
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.