Long-term thresholds of nonsteroidal permanent pacing leads: a 5-year study

Area of Science:

• Cardiology
• Biomedical Engineering
• Medical Device Technology

Background:

• The market offers various nonsteroidal endocardial pacing leads.
• Understanding long-term performance differences is crucial for clinical decision-making.

Purpose of the Study:

• To compare the long-term pacing and sensing performance of three representative nonsteroidal endocardial lead types.
• To evaluate lead performance over a 5-year follow-up period in patients with VVI implants.

Main Methods:

• A randomized clinical trial involving 99 patients undergoing VVI implantation.
• Three lead types were used: sintered platinum, activated pyrolytic carbon, and vitreous carbon.
• Noninvasive voltage thresholds and acute sensing parameters were monitored for 5 years.

Main Results:

• No significant differences in pacing or sensing capabilities were found at implantation among the three lead types.
• All leads showed similar threshold increases, peaking at 1 month and plateauing by 6 months.
• No significant differences in thresholds were observed between leads during the 5-year follow-up, with a mean threshold of 0.93 V at 0.5 ms at 5 years.

Conclusions:

• All tested lead types perform well without distinct clinical advantages over each other.
• Early threshold peaking necessitates delayed output reduction, while later stable thresholds allow for pacing output adjustments.
• Safe low-energy pacing requires careful consideration of lead-generator combinations.
• Annual follow-up beyond 1 year provided limited additional clinical information.
• Cost becomes a primary factor in lead selection when performance is comparable.