Cardiovascular Implantable Electronic Devices -> Monitoring & Outcomes: -> Quality Measures & Complications D-PO01 - Featured Poster Session (ID 11) Poster

D-PO01-221 - Cardiac Implantable Electronic Device Pulse Generator-Lead Mismatch & Complication Rates (ID 148)


Background: Cardiac Implantable Electronic Devices (CIED) include pulse generators and leads. In many implanting centres, it is common practice to match devices with leads from different companies. Case series have reported episodic high-impedance changes in Boston Scientific CIEDs with competitor leads. We investigated the incidence of high-impedance abnormalities in matched vs. mismatched Boston Scientific CIEDs.
Objective: To determine whether there are differences in failure rates between matched vs mis-matched CIED systems.
Methods: Retrospective chart review identified all consecutive Boston Scientific Accolade or Autogen implantations between January 2017 and June 2019 at a Canadian tertiary care cardiac centre. The primary outcome was the occurrence of transient, high-impedance changes which resulted in a switch to unipolar pacing / sensing in the absence of any other identifiable lead issue. Fisher exact tests (two-tailed, α = 0.05) were used to compare the incidence of outcomes in matched vs. mis-matched systems.
Results: 564 implantations were identified (514 Accolade, 50 Autogen), associated with 970 total leads (322 Boston Scientific, 333 Medtronic, 315 other). The primary outcome occurred with 14 leads, all of which were Medtronic (4.2%), and associated with occasional pacing inhibition, syncope, and early surgical revision. Medtronic leads were more likely to malfunction compared to Boston Scientific leads (P = 0.0001). Mean time from implant to unipolar safety switch was 10.7 months.
Conclusion: Use of Medtronic leads with a Boston Scientific Accolade or Autogen was associated with increased system malfunction associated with adverse clinical outcomes. Awareness of this interaction can allow for institution of appropriate programming remedies, and may increase scrutiny of the use of mis-matched CIED systems.