A novel device for temporary cardiac stimulation using permanent pacemaker generators and active-fixation leads: the TEMPACE multicentre prospective study

Abstract

To determine the safety and effectiveness of the KronoSafe® permanent pacemaker adapter for temporary cardiac pacing (TCP) with active-fixation leads (TCPAFL). Methods: This was a multicenter, prospective, descriptive clinical investigation involving a medical device (ClinicalTrials.gov Identifier: NCT05351658). Between January 2023 and December 2024, all consecutive patients who underwent implantation of a temporary active-fixation pacemaker were included. The devices were secured using the KronoSafe® adapter throughout the period of use. Complications during TCPAFL were recorded, and R-wave sensing, lead impedance, and pacing threshold were determined every 48 hours. Results: Thirty patients (10 with atrioventricular block, 9 TAVI, 5 alcohol septal ablations, 2 slow atrial fibrillations, 2 bradycardia-tachycardia syndrome, and 2 pacemaker infections) who required TCP were included. Two centers participated in the study. The mean duration of TCP was 7.8 days (maximum 22 days), with 79.2% of the time spent in the cardiology ward. One complication (3%) was recorded, due to accidental traction of the system associated with an episode of agitation. Conclusions: TCPAFL using the KronoSafe® adapter is safe and effective, and its use can be extended outside the Intensive Care Unit.