Clinical experience with a new lead combining active fixation with steroid elution

Area of Science:

• Cardiovascular Engineering
• Medical Device Design
• Electrophysiology

Background:

• Pacemaker leads are crucial for cardiac rhythm management.
• Traditional leads face challenges with chronic thresholds and stability.
• Novel designs aim to improve lead performance and patient outcomes.

Purpose of the Study:

• To evaluate the performance of the Medtronic 10335A lead, combining active fixation and steroid elution.
• To assess acute and chronic pacing thresholds, sensing amplitudes, and lead impedance.
• To identify any mechanical or sensing-related complications.

Main Methods:

• Implantation of 21 Medtronic 10335A leads (9 atrial, 12 ventricular) in 13 patients.
• Monitoring of pacing thresholds, P and R wave amplitudes, and lead impedance over 6 months.
• Analysis of acute and chronic performance data.

Main Results:

• Low chronic thresholds were observed for both atrial and ventricular leads, suggesting potential for battery savings.
• Ventricular leads showed a transient increase in thresholds at 1 week, which stabilized thereafter.
• No significant changes in sensing amplitudes or atrial lead impedance were noted; ventricular lead impedance decreased initially.
• Despite favorable pacing characteristics, a high rate of mechanical complications (helix deformations) led to study suspension.

Conclusions:

• The Medtronic 10335A lead demonstrated favorable electrical performance and low chronic thresholds.
• Significant mechanical complications, specifically helix deformations, necessitate a redesign of the lead.
• Further development is required to address mechanical issues while retaining the benefits of active fixation and steroid elution.