Inappropriate noise detection in Tendril family pacing leads

Area of Science:

• Cardiology
• Biomedical Engineering
• Medical Device Technology

Background:

• Noise oversensing is a potential issue in cardiac implantable electronic devices.
• Abbott Tendril leads have been associated with oversensing events.

Purpose of the Study:

• To investigate the incidence and characteristics of noise oversensing in Abbott Tendril leads.
• To compare the performance of Tendril leads with Medtronic CapSureFix leads in Abbott generators.

Main Methods:

• Retrospective analysis of patients with Abbott Tendril leads (models 1688, 1788, 1888, 2088).
• Prospective enrollment of patients with Medtronic CapSureFix leads (models 4076, 5076) connected to Abbott generators.
• Evaluation of lead impedance, symptoms, interventions, and explanted lead analysis.

Main Results:

• Noise oversensing was detected in 6.2% of 1063 Tendril leads over 3.9 years.
• Most affected Tendril leads had normal impedance; 1.5% required replacement.
• Lead-to-device abrasion and insulation breach were found in explanted Tendril leads.
• No noise oversensing was observed in 145 Medtronic CapSureFix leads connected to Abbott generators over 3.6 years.

Conclusions:

• Noise oversensing is relatively common with Abbott Tendril leads.
• Medtronic leads did not exhibit noise oversensing when connected to Abbott generators.
• Conservative management is often feasible for asymptomatic patients with Tendril lead noise oversensing.