CA-528-03 A REGISTRY REVIEW UPDATE OF 7120 CATHETER ABLATIONS FOR ATRIAL FIBRILLATION USING A DEDICATED ESOPHAGEAL TEMPERATURE CONTROL DEVICE FOR PROTECTION

Abstract

Esophageal protection using a dedicated device to provide controlled active thermal protection of the esophagus during atrial fibrillation ablation has been shown to be effective. Randomized evidence from the IMPACT trial showed an 83.4% reduction in endoscopically detected esophageal lesions compared to standard care. Real world registry data of this device has been under review. To determine the safety of an esophageal temperature control device by an updated review of real-world registry data on its clinical use and any reported device-related adverse events. The following databases were reviewed for any reported esophageal temperature control device-related complications: The United States Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE), FDA Medical and Radiation Emitting Device Recalls, the Medicines and Healthcare products Regulatory Agency (MHRA) Medical Device Alerts and SwissMedic records of Field Safety Corrective Actions (FSCA). An internal registry (post-marketing follow up) database maintained by the manufacturer of the device was used to quantify the number used for each indication. Reported events underwent an updated review including any instances of device-related adverse events when used during catheter ablations. Of the 20,000 oesophageal temperature control devices used, 7120 were recorded as having been used for the purpose of esophageal protection during left atrial catheter ablations. A total of 5 events associated with the device were identified, all from the MAUDE database. Three were from 2017, one from 2018, and one from 2019. All involved its use in critical care or trauma patients and were related to user error or contraindicated patient selection; none resulted in serious harm to the patient. No adverse events occurred related to its use during left atrial catheter ablations. No case of clinically significant esophageal injury was reported in a patient who had been protected by the esophageal temperature control device. Real world registry data has shown no adverse events reported to date in 7120 uses of an esophageal temperature control device during left atrial catheter ablations, for the purpose of active thermal protection.