Background: Randomised trial evidence suggests that active control of local temperature can prevent thermal injury to the oesophagus; alternative methods of protection have been proposed, including the measurement of luminal temperature, and mechanical deviation away from the source of energy. Specific devices are available for each role.
Objective: To use multiple sources of real-world evidence to determine the safety and clinical efficacy of oesophageal protection devices in AF ablation in clinical practice.
Methods: We reviewed multiple databases, including regulatory and internal company registry data. The search encompassed the United States Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database, the FDA Medical and Radiation Emitting Device Recalls, the FDA Total Product Life Cycle (TPLC) database, the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) Medical Device Alerts and the SwissMedic records of Field Safety Corrective Actions (FSCA).
Results: Of more than 20,000 oesophageal temperature control devices used to the end of March 2022, the purpose was recorded as oesophageal protection during left atrial ablations in 10,300. A total of 5 events associated with the device were identified, all from the MAUDE database; 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 oesophageal injury was reported in a patient who had been protected by the oesophageal temperature control device. A search for all atrio-oesophageal fistulae revealed 307 cases; a review of the narrative of each case showed that 77 had occurred in association with the use of a temperature probe and 4 in association with a dedicated deviation device. No fistula had occurred with the use of an oesophageal temperature control device.
Conclusions: Real-world data from multiple sources support the hypothesis that oesophageal luminal temperature control is associated with a low rate of clinically significant oesophageal injury. Other methods of protection show less evidence of efficacy. ❑