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.