Abstract
Background
Traditional cardiac pacemakers commonly have a range of complications related to the presence of intracardiac leads. A new class of extravascular and leadless pacemakers has recently emerged with the potential to mitigate these complications and expand access to cardiac pacing. The objective of this study is to evaluate the implantation, short-term chronic safety, and performance of a novel subxiphoidal extracardiac pacemaker.
Methods
Normal Yorkshire Cross swine (n = 16) were implanted with the subxiphoidal pacemaker. The pacemaker was inserted through a midline chest incision and clipped to the underside of the sternum, with the stimulation electrode placed on the anterior pericardium. Animals were chronically paced and followed for 90 days post-implant, with periodic measurement of pacing capture threshold (PCT) and electrode impedance.
Results
All 16 animals were successfully implanted with the study device. At implant, a consistent average PCT of 2.2 ± 0.4 V at a pulse width of 1.0 ms was observed in all animals, with an average implant impedance of 648 ± 44 Ω. Chronic pacing was programmed at a rate of 60 bpm, an amplitude of 3.4 ± 0.7 V, and a pulse width of 1.0 ms. PCT rose to 4.6 ± 0.8 V at 14 days and stabilized; at 90 days, PCT was 3.8 ± 1.2 V and electrode impedance was 533 ± 105 Ω. All implanted animals completed the study with no clinically significant findings, no clinically significant abnormalities, and with no adverse events that affected animal welfare.
Conclusions
This study demonstrated the safety and feasibility of a novel subxiphoidal extracardiac pacemaker to deliver short-term chronic extravascular therapy. Further studies are required to assess the safety, feasibility, and long-term chronic pacing performance in human subjects.
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The study was approved by the Institutional Animal Care and Use Committee and conformed to the Food and Drug Administration “Principles of Good Laboratory Practice (GLP)” and the National Institute of Health “Guide and Care for Use of Laboratory Animals.”
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Drs. Libbus, Tholakanahalli, Roukoz, and Knoper are consultants to Calyan Technologies. Mr. Verma, Ms. Isac, and Dr. Manicka are employees of Calyan Technologies.
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Libbus, I., Tholakanahalli, V., Roukoz, H. et al. Safety and performance of a novel subxiphoidal pacemaker system. J Interv Card Electrophysiol (2024). https://doi.org/10.1007/s10840-024-01778-y
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DOI: https://doi.org/10.1007/s10840-024-01778-y