Study Design and Setting
This was a sub-study of a larger retrospective review of prospectively collected data (Advarra IRB #Pro00066277). All patients undergoing left atrial ablation for the treatment of AF with PVI over the specified time frame were included in the study. Data from three EP labs in hospital systems were collected over equal time frames before (pre-adoption) and after the adoption (post-adoption) of cooling. In the pre-adoption time frame, LET monitoring (with esophageal deviation when selected by the operator) was used as a means of esophageal protection. In the post-adoption time frame, proactive esophageal cooling (ensoETM®, Attune Medical, Chicago, IL) was adopted in September 2021, November 2021, and March 2022 at each respective site in place of LET monitoring or deviation.
The analysis period was divided into two separate time frames with equivalent duration: pre-adoption of proactive esophageal cooling, and post-adoption of proactive esophageal cooling. Despite the loss of two operators in the post-adoption phase of the study, this design enabled comparison of procedural volumes between the two time frames while keeping location and patient demographics consistent throughout the study.