BACKGROUND: There are no international guidelines indicating how long a patient should stay strictly in bed after pacemaker implantation. In the present study, we tested a new protocol concerning the mobilization of patients 3 h after receiving a single or a dual-chamber pacemaker. METHODS:Consecutive patients who underwent single or dual-chamber pacemaker implantation were randomized to a 3 or 24 h immobilization protocol. Only bipolar passive fixation leads were computed. After the implant, an elastic bandage was put on the homolateral shoulder of all patients for 24 h. A complete clinical and electronic follow-up was performed before discharge and repeated 2 months later. End-points considered were the displacement of the lead, high pacing thresholds (> 3.5 V/0.4 ms at the discharge or > 2.5 V/0.4 ms at the 2-month follow-up), sensing defects not corrigible by programming and clinical complications of the pocket RESULTS:One hundred and thirty-four patients were included in the study: 57 in group A (mobilization after 3 h) and 77 in group B (24 h). In group A, one haematoma and two displacements occurred in three patients. In group B, we registered one haematoma, one subclavian vein thrombosis, three displacements and three high stimulation thresholds. No statistical differences were observed between the end-points of group A versus B. CONCLUSIONS: The present study shows that an early mobilization protocol is feasible because no statistical differences resulted from the two groups of study as regards clinical outcome, complications and electronic measurements of the implanted devices, which have been followed up for 2 months.
RCT Entities:
BACKGROUND: There are no international guidelines indicating how long a patient should stay strictly in bed after pacemaker implantation. In the present study, we tested a new protocol concerning the mobilization of patients 3 h after receiving a single or a dual-chamber pacemaker. METHODS: Consecutive patients who underwent single or dual-chamber pacemaker implantation were randomized to a 3 or 24 h immobilization protocol. Only bipolar passive fixation leads were computed. After the implant, an elastic bandage was put on the homolateral shoulder of all patients for 24 h. A complete clinical and electronic follow-up was performed before discharge and repeated 2 months later. End-points considered were the displacement of the lead, high pacing thresholds (> 3.5 V/0.4 ms at the discharge or > 2.5 V/0.4 ms at the 2-month follow-up), sensing defects not corrigible by programming and clinical complications of the pocket RESULTS: One hundred and thirty-four patients were included in the study: 57 in group A (mobilization after 3 h) and 77 in group B (24 h). In group A, one haematoma and two displacements occurred in three patients. In group B, we registered one haematoma, one subclavian vein thrombosis, three displacements and three high stimulation thresholds. No statistical differences were observed between the end-points of group A versus B. CONCLUSIONS: The present study shows that an early mobilization protocol is feasible because no statistical differences resulted from the two groups of study as regards clinical outcome, complications and electronic measurements of the implanted devices, which have been followed up for 2 months.