The "SPEM" (Studio Policentrico Elettrocateteri Membrane): a multicenter study on membrane leads

Area of Science:

• Cardiovascular Medicine
• Biomedical Engineering
• Electrophysiology

Background:

• Ventricular leads are crucial for cardiac pacing.
• Steroid elution and specialized lead designs aim to improve pacing performance and reduce inflammation.
• Understanding lead behavior is essential for optimizing patient outcomes.

Purpose of the Study:

• To evaluate the acute and chronic electrophysiological behavior of three different ventricular leads.
• To compare a steroid-eluting lead with a non-steroid lead and a control group.
• To assess the impact of an ion exchange membrane and steroid elution on pacing parameters.

Main Methods:

• A multicenter, randomized, double-blind study (SPEM) involving 81 patients.
• Three ventricular lead types were tested: steroid-eluting, non-steroid, and control.
• Electrophysiological parameters were measured at implant and up to 360 days post-implantation.

Main Results:

• No significant differences in acute pacing parameters (threshold, amplitude, slew rate) were observed at implant.
• Steroid-eluting leads showed a lower chronic pacing threshold increase compared to non-steroid and control leads.
• The ion exchange membrane alone did not prevent an acute increase in pacing threshold within the first month.

Conclusions:

• Steroid elution is effective in reducing chronic pacing thresholds.
• The ion exchange membrane contributes to reducing chronic thresholds but does not mitigate acute increases.
• Lead design and steroid elution play a role in managing chronic pacing performance.