Fabien Squara1, William W Chik2, Daniel Benhayon2, Shingo Maeda2, Decebal Gabriel Latcu3, Jonathan Lacaze-Gadonneix4, Thierry Tibi5, Olivier Thomas6, Joshua M Cooper2, Guillaume Duthoit7. 1. Department of Cardiology, Pasteur University Hospital, Nice, France. Electronic address: fabiensquara@gmail.com. 2. Electrophysiology Section, Cardiovascular division, Hospital of the University of Pennsylvania, Philadelphia. 3. Service de Cardiologie, Centre Hospitalier Princesse Grace, Avenue Pasteur, Monaco. 4. Department of Cardiology, Georges Pompidou University Hospital, Paris, France. 5. Service de Cardiologie, Centre Hospitalier Pierre Nouveau, Cannes, France. 6. Clinique Ambroise Paré, Neuily sur Seine, France. 7. Unité de Rythmologie, Institut de Cardiologie, GHU Pitié-Salpêtrière, Paris, France.
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.
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.