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

This study aims to determine the safety and effectiveness of the KronoSafe® permanent pacemaker adapter for temporary cardiac pacing (TCP) with active-fixation leads (TCPAFLs).

This was a multicentre, 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 h. Thirty patients (10 with atrioventricular block, nine TAVI, five alcohol septal ablations, two slow atrial fibrillations, two bradycardia–tachycardia syndrome, and two pacemaker infections) who required TCP were included. Two centres 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.

Temporary cardiac pacing with active-fixation leads using the KronoSafe® adapter is safe and effective, and its use can be extended outside the intensive care unit.