Development and validation of a novel algorithm based on the ECG magnet response for rapid identification of any unknown pacemaker.

ABSTRACT

BACKGROUND: Pacemaker (PM) interrogation requires correct manufacturer identification. However, an unidentified PM is a frequent occurrence, requiring time-consuming steps to identify the device. OBJECTIVE: The purpose of this study was to develop and validate a novel algorithm for PM manufacturer identification, using the ECG response to magnet application. METHODS: Data on the magnet responses of all recent PM models (≤15 years) from the 5 major manufacturers were collected. An algorithm based on the ECG response to magnet application to identify the PM manufacturer was subsequently developed. Patients undergoing ECG during magnet application in various clinical situations were prospectively recruited in 7 centers. The algorithm was applied in the analysis of every ECG by a cardiologist blinded to PM information. A second blinded cardiologist analyzed a sample of randomly selected ECGs in order to assess the reproducibility of the results. RESULTS: A total of 250 ECGs were analyzed during magnet application. The algorithm led to the correct single manufacturer choice in 242 ECGs (96.8%), whereas 7 (2.8%) could only be narrowed to either 1 of 2 manufacturer possibilities. Only 2 (0.4%) incorrect manufacturer identifications occurred. The algorithm identified Medtronic and Sorin Group PMs with 100% sensitivity and specificity, Biotronik PMs with 100% sensitivity and 99.5% specificity, and St. Jude and Boston Scientific PMs with 92% sensitivity and 100% specificity. The results were reproducible between the 2 blinded cardiologists with 92% concordant findings. CONCLUSION: Unknown PM manufacturers can be accurately identified by analyzing the ECG magnet response using this newly developed algorithm.