Alexander Limkakeng, Jr., MD, MHSc
Disclosure Relationship(s): Abbott Diagnostics: Research Grant; astra zeneca: Research Grant; Bristol Myers: Research Grant; GE: Research Grant; Ischemia Care, LTD: Research Grant; Roche Diagnostics: Research Grant; Siemens Healthcare Diagnostics : Research Grant
Background: Concern exists that interrogating pacemakers and internal cardioverter defibrillators (ICDs), also known as cardiac implantable electronic devices (CIEDs), with the wrong or “mismatched” read-only interrogator may cause device malfunction. Our objective was to determine if intentionally mismatching a specific company’s interrogator to the mismatched manufacturer’s CIED could result in CIED malfunction.
Methods: We performed interrogations of non-implanted CIEDs from each of the 3 major device manufacturers: Abbott Laboratories (Lake Bluff IL), Boston Scientific (Marlboro MA), and Medtronic Plc (Minneapolis MN). We attempted to reproduce the cohort of devices that an emergency physician might encounter by requesting a mix of new and older pacemaker and ICD models. Devices were interrogated for 2 minutes with a mismatched read-only interrogator, then evaluated with the correct programmer to identify any induced malfunction. This cycle was repeated with the other mismatched interrogator. Evaluation of implanted CIEDs followed. Consenting patients at an elective electrophysiology clinic evaluation were evaluated by a single mismatched interrogator (randomized as to which mismatch was used) for two minutes. CIED function was then evaluated by clinic staff, blinded to mismatched interrogator used.
Results: The non-implanted phase evaluated 75 donated devices (25 from each company), providing 150 mismatched interrogations. The implanted phase involved 30 patients (10 from each company), with 30 mismatched interrogations. Average patients age was 71.6 (35-92, 14.7). 16 (53%) patients were male. 24 (80%) patients were implanted with pacemakers, 4 (13%) were implanted with combo pacemaker/ICDs, and 2 (7%) were implanted with ICDs only. In total, we performed 180 mismatched interrogations. No device settings were changed and no malfunctions were reported as a result of manufacturer-mismatched interrogation (0/180, 8%, 97.5% CI 0-2%).
Conclusion: We found no evidence of device malfunction following CIED interrogation with intentionally mismatched read-only interrogators. This suggests that emergency physician use of read-only CIED interrogators, even if the device type is unknown, is very unlikely to result in patient harm.