Safety and performance of a novel subxiphoidal pacemaker system.

Area of Science:

• Cardiology
• Biomedical Engineering
• Medical Devices

Background:

• Traditional pacemakers carry risks due to intracardiac leads.
• Leadless and extravascular pacemakers offer potential to reduce complications and improve access.
• Novel pacing technologies are crucial for advancing cardiac care.

Purpose of the Study:

• To evaluate the implantation, short-term safety, and performance of a new subxiphoidal extracardiac pacemaker.
• To assess the feasibility of a leadless pacing solution placed beneath the sternum.
• To investigate the potential of extravascular pacing for cardiac rhythm management.

Main Methods:

• 16 Yorkshire Cross swine underwent implantation of the subxiphoidal pacemaker.
• The device was placed under the sternum with the electrode on the anterior pericardium.
• Animals were monitored for 90 days, with regular measurements of pacing capture threshold and impedance.

Main Results:

• Successful implantation was achieved in all 16 animals.
• Consistent initial pacing capture threshold (PCT) and impedance were recorded.
• PCT showed a slight increase and stabilized, with stable impedance over 90 days.
• No adverse events affecting animal welfare were observed.

Conclusions:

• The novel subxiphoidal extracardiac pacemaker demonstrated safety and feasibility for short-term extravascular pacing.
• This leadless device shows promise as an alternative to traditional pacemakers.
• Further human studies are necessary to confirm long-term safety and efficacy.