Cardiovascular Implantable Electronic Devices -> Leads & Electrodes: -> Clinical Trials D-PO03 - Poster Session III (ID 48) Poster

D-PO03-094 - Safety Analysis Of A Novel Entirely Extracardiac Temporary Pacing System: Results Of A Pilot Study (ID 1101)


Background: Recently, a temporary extracardiac pacing system has been developed. This system uses a uniquely designed lead and delivery tool to place an electrode within the anterior mediastinum through an intercostal space. This may provide clinical advantages over existing devices that require intravascular, endocardial or epicardial contact.
Objective: In this pilot study, we aimed to evaluate the initial safety of this extracardiac pacing system.
Methods: Patients, who underwent a permanent pacemaker implant or replacement, simultaneously received a temporary extracardiac pacing system. Implants were performed during two separate weeks on 6 and then 5 subjects, facilitating learning curve analyses. Safety was evaluated by analyzing all adverse device effects (ADE) through 30 days post-removal.
Results: The extracardiac pacing system was successfully inserted in all 11 patients (64% male, age 67.7 ± 9.4 years, BMI 25.9 ± 3.5 kg/m2). First attempt success rate improved from 17% to 60% between the two implant dates. Similarly, the mean time from first incision to pacing improved from 15.8 to 9.2 min. One patient experienced failure to capture and discomfort one day post-implant, possibly related to lead dislodgement. Another patient experienced pacing-induced discomfort starting one day post-implant. The lead was successfully removed from all 11 patients without ADE through 30 days post-removal.
Conclusion: An entirely extracardiac pacing system can be safely implanted to provide temporary pacing. ADEs were limited to lead dislodgement and chest discomfort with pacing. Results from this pilot study will guide further improvements that can be validated in subsequent studies.