Cardiovascular Implantable Electronic Devices -> Bradycardia Devices: -> Device Technology D-PO01 - Featured Poster Session (ID 11) Poster

D-PO01-222 - Electrical Performance Of A Novel Entirely Extravascular Temporary Pacing System: Initial Pilot Study Experience (ID 974)


Background: A completely extravascular cardiac temporary pacing system has been developed that includes a lead positioned within the anterior mediastinum, through a parasternal skin incision using a custom delivery tool (Figure 1, top). This novel system may provide clinical advantages over existing device alternatives that require intravascular, endocardial, or epicardial contact.
Objective: The purpose of this study was to evaluate the electrical performance of a novel, human prototype extravascular lead system for temporary pacing.
Methods: In this single-center study, patients who underwent a transvenous (TV) permanent pacemaker implant or replacement were simultaneously implanted with the temporary extravascular lead. Electrical performance was evaluated through analysis of capture thresholds, impedance, and R-wave amplitudes at implant, 1 and 2 days post implant.
Results: Lead insertions with acute capture were successful in all 11 patients (36% female, 67.7 ± 9.4 years, BMI 25.9 ± 3.5 kg/m2). Mean acute measurements, including threshold @ 1.5 ms, impedance and R-wave amplitude were 3.9 V, 580 Ω, 4.3 mV, respectively. A trend in rising thresholds with decreasing impedance and R-waves was observed, although capture remained possible over the follow-up period. (Figure)
Conclusion: A completely extravascular pacing lead can facilitate effective temporary bradycardia pacing. Although capture generally remained possible over time, further investigations to minimize threshold increases and impedance changes are warranted.