Early Experience with the Biotronik Protego ICD Lead

Area of Science:

• Cardiology
• Biomedical Engineering
• Medical Devices

Background:

• Newer generation implantable cardioverter-defibrillator (ICD) leads are developed based on insights from previous lead failures.
• The Biotronik Protego ICD lead was introduced in 2013.

Purpose of the Study:

• To assess the long-term performance of the Biotronik Protego ICD lead.
• To evaluate the mechanisms of failure for this ICD lead in a real-world patient cohort.

Main Methods:

• Retrospective observational study of patients implanted with the Protego ICD lead between November 2013 and March 2017.
• Semi-annual device follow-up controls were performed.
• Primary endpoint was lead failure; secondary endpoints included all-cause death, appropriate/inappropriate shocks, and reintervention.

Main Results:

• 64 patients (mean age 66.7 years) were included, with 78% for primary prevention and high prevalence of ischemic heart disease (53%) and dilated cardiomyopathy (40.6%).
• Mean follow-up was 5.5 years. Two lead fractures occurred after 5.5 and 5.7 years.
• The calculated annual lead failure rate was 0.59% per patient.

Conclusions:

• The Biotronik Protego ICD lead demonstrates promising durability and long-term performance.
• The observed lead failure rate suggests a favorable safety profile for this device generation.