A novel device for temporary cardiac stimulation using permanent pacemaker generators and active-fixation leads: the...

Area of Science:

• Cardiology
• Medical Devices
• Clinical Investigation

Background:

• Temporary cardiac pacing (TCP) is crucial for managing various cardiac conditions.
• Active-fixation leads offer advantages but require secure adaptation for temporary use.
• The KronoSafe® adapter is a novel device for securing these leads during TCP.

Purpose of the Study:

• To evaluate the safety and effectiveness of the KronoSafe® permanent pacemaker adapter for temporary cardiac pacing with active-fixation leads (TCPAFL).
• To assess the feasibility of using this adapter outside of intensive care settings.

Main Methods:

• A multicenter, prospective, descriptive clinical investigation (NCT05351658) was conducted.
• Thirty patients requiring TCP with active-fixation leads secured by the KronoSafe® adapter were enrolled.
• Complications, R-wave sensing, lead impedance, and pacing thresholds were monitored throughout the pacing period.

Main Results:

• Thirty patients with diverse indications for TCP were included.
• The mean duration of pacing was 7.8 days, with most patients managed on the cardiology ward.
• A single complication (3%) occurred due to accidental system traction.

Conclusions:

• Temporary cardiac pacing with active-fixation leads using the KronoSafe® adapter is safe and effective.
• The KronoSafe® adapter facilitates the extension of TCPAFL use outside the Intensive Care Unit.
• This device enhances the management of patients requiring temporary cardiac pacing in broader clinical settings.