2 Methods
2.1 Data Collection
After IRB review (Advarra #Pro00067967), patient data from a community
hospital registry containing all patients treated by a single provider
were obtained for the 12 months before (pre-adoption) and 12 months
after the adoption of active esophageal cooling (post-adoption) during
RF ablation. The data collected included the extent of ablation, whether
it involved only pulmonary vein isolation (PVI) or if additional
posterior wall isolation (PWI) was performed, patients’ post-ablation
symptoms, and the type of prophylactic treatment utilized. Post-ablation
chest pain was broadly considered to include thoracic discomfort,
whether or not a formal diagnosis of pericarditis was made.
2.2 Luminal Esophageal Temperature Monitoring
Prior to the adoption of esophageal cooling in December 2021,
multi-sensor luminal esophageal temperature (LET) monitoring (CIRCA
Scientific, S-cath, Englewood, CO) was utilized. Settings for the
multi-sensor LET monitoring system were such that alarms were triggered
for any increase of 1°C over baseline temperature.
2.3 Active Esophageal Cooling
In the post-adoption cohort, active esophageal cooling was performed
using a dedicated cooling device (ensoETM, Attune Medical, Chicago, IL)
which is FDA cleared to reduce the likelihood of ablation-related
esophageal injury resulting from RF cardiac ablation procedures. The
device is a closed-loop multi-lumen silicone tube placed in the
esophagus similar to a standard orogastric tube, and connected to a
standard water blanket heat exchanger commonly available in the hospital(Figure 1). Distilled water circulates through the device at
2.4 L/minute and at a temperature of 4°C. Due to the nature of the
device, there is no temperature sensor to monitor the temperature of the
esophagus. As such, there are no temperature alarms and therefore no
need to interrupt RF delivery.