Safety and efficacy of a novel intercostal, extravascular temporary lead
E M Burke, A Faller, S Doshi, Z Jarisic, A Anic, W Crockett, J Poskin, G Chimera, M Husby, A Marcovecchio, R Sanghera, A Ebner, R E Knops, M C BurkeAbstract
Background
A novel intercostal extravascular pacing lead (EV-TP) iteratively designed to function with a market-released temporary pacemaker has been developed for pacing. Clinical data has been analyzed to characterize procedure success and acute/subacute pacing success for the final lead design.
Methods
From 2019-2025, six clinical studies (n=88) involving similar design iterations of the EV-TP lead were evaluated. The implant procedure and form factor of evaluated EV-TP leads were largely unchanged. Differences between devices were limited to minor changes, such as electrode sizes, position and spacing until the final iteration which utilizes a suspension heel rather than the previous flat heel. This final design was utilized in two studies (n=41;2 enrolled but no implant attempt), STEP V (n=27; patients with pacing indications) and PIONEER (n=12; patients with pacing indications during transcatheter aortic valve replacement (TAVR) implant with monitoring post-procedure). The EV-TP lead insertion procedure involved placement through an intercostal space along the left parasternal margin over the heart using a custom delivery tool. The distal end of the EV-TP lead was designed to bank off the pericardium. Procedure success was defined as placement of the EV-TP lead into the chest with pacing capture using 1.5 msec pulse width. The proportion of successful procedures was calculated pooling data across both studies. Pacing capture threshold (minimum current (milliamperes (mA)) required for capture) was determined with patients in the supine position.
Results
Procedure success occurred in all subjects attempted (n=39). Pacing capture threshold immediately post procedure was 5.7mA (SD=4.1) n=39. Pacing capture at 1-day follow-up (22:27hrs) was 9.8mA (SD=5.8) n=38. Pacing capture at 2-day follow-up (44:04hrs) was 8.9mA (SD=4.5) n=28. The post TAVR patients had less durable capture due to fixation occurring prior to TAVR making for procedure-related less consistent capture.
Conclusion
This novel EV-TP using a paddle suspension heel can be successfully implanted and is a durable temporary pacing solution. TAVR procedures need to fixate the EV-TP lead after the valve implant to allow for flexibility in dealing with preload changes and heart movement.