Bipolar tined polyurethane ventricular lead: a four-year experience.

Area of Science:

• Biomedical Engineering
• Cardiovascular Devices
• Materials Science

Background:

• Polyurethane insulation is increasingly used in permanent pacemaker leads.
• Concerns exist regarding the long-term durability and integrity of these polyurethane-insulated leads.
• Specific attention is drawn to bipolar tined polyurethane ventricular leads due to potential failure risks.

Purpose of the Study:

• To assess the 4-year performance and failure rates of specific bipolar tined polyurethane ventricular pacemaker leads.
• To compare lead integrity between two manufacturing groups: those produced before and after a specified date.
• To evaluate the need for improved lead design, failure rate determination, and registry mechanisms.

Main Methods:

• Retrospective analysis of a 4-year patient experience with polyurethane-insulated pacemaker leads.
• Categorization of patients into two groups based on lead manufacturing date (pre- and post-specified date).
• Calculation of lead failure rates and average time to failure for each group; actuarial analysis for survivorship.

Main Results:

• The failure rate was 8.8% in the earlier manufactured group (at increased risk) versus 3.9% in the later manufactured group (not at increased risk).
• Lead failures in the first group occurred at an average of 17.5 months.
• Actuarial analysis indicated potentially non-significant differences in lead failure-free survivorship between the two groups, pending longer follow-up for the second group.

Conclusions:

• The study underscores the importance of monitoring polyurethane pacemaker lead integrity and failure rates.
• Identifying optimal lead designs and configurations is crucial for improving long-term device performance.
• Establishing a lead registry is recommended for evaluating the ongoing integrity of various pacemaker leads.