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. 2025 Aug 28:zuaf111.
doi: 10.1093/ehjacc/zuaf111. Online ahead of print.

A Novel Device for Temporary Cardiac Stimulation Using Permanent Pacemaker Generators and Active-Fixation Leads: The TEMPACE Multi-Center Prospective Study

Raimundo Vicente-Miralles  1   2 , Nuria Rivas-Gándara  3   4 , Pablo Jordán Marchite  3   4 , Raquel Adeliño  3   4 , María Ángeles Carmona  3   4   5 , Mónica Díaz Barranco  1   2 , Alicia Ascensión Ibañez Criado  6   2 , Juan Miguel Ruiz Nodar  6   2   7 , María Ajo Ferrer  6   2 , Amaya García-Fernández  6   2 , Vicente Bertomeu-Gonzalez  7   8 , Juan Gabriel Martínez Martínez  6   2
Affiliations

A Novel Device for Temporary Cardiac Stimulation Using Permanent Pacemaker Generators and Active-Fixation Leads: The TEMPACE Multi-Center Prospective Study

Raimundo Vicente-Miralles et al. Eur Heart J Acute Cardiovasc Care. .

Abstract

Aims: 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.

Keywords: External Permanent Pacemaker; Temporary Pacemaker; Temporary Pacemaker with Active-Fixation Leads; Temporary-Permanent Pacemaker.

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