High-impedance alerts with pulse generator-Lead mismatch.

Area of Science:

• Cardiology
• Biomedical Engineering
• Medical Device Technology

Background:

• Cardiac Implantable Electronic Devices (CIEDs) include pulse generators and leads.
• Combining devices and leads from different manufacturers is common practice in some centers.
• Previous reports suggest high-impedance issues with Boston Scientific CIEDs paired with competitor leads.

Purpose of the Study:

• To investigate the incidence of high-impedance abnormalities in matched versus mismatched Boston Scientific Accolade pacemakers.
• To determine if lead-device compatibility impacts CIED performance.

Main Methods:

• Retrospective chart review of Boston Scientific Accolade pacemakers implanted between January 2017 and June 2019.
• Primary outcome: transient high-impedance changes leading to unipolar pacing/sensing switch without other lead issues.
• Fisher exact tests used to compare matched versus mismatched lead-device systems.

Main Results:

• 514 pacemakers and 882 leads analyzed; 21 leads showed high-impedance abnormalities.
• Mismatched lead-device pairs were significantly associated with CIED malfunction (3.3% vs. 0%, p=0.0019).
• Median time to unipolar safety switch was 12.4 months, with a median follow-up of 21.6 months.

Conclusions:

• Mismatched leads with Boston Scientific Accolade devices increase the risk of undesirable sensing polarity changes and pacing inhibition.
• Awareness of this interaction can guide programming adjustments and scrutiny of mismatched CIED systems.
• This finding emphasizes the importance of lead-device compatibility in CIEDs.