Reduced Procedure Time and Variability with Active Esophageal Cooling During Radiofrequency Ablation for Atrial Fibrillation

This protocol is significant for demonstrating workflow analysis using contextual inquiry to identify and map data structures to the electronic health record and facilitate analyses of clinical outcomes. The main advantage of this technique is improved accuracy of data identification and facilitation of downstream data mapping. This technique can be applied to a wide range of therapies and diseases simply by changing the focus of the particular variables of clinical interest.

To begin, connect the esophageal cooling device to the external heat exchanger, then turn on the power and activate the water flow to provide adequate device stiffness and ensure the absence of any leaks. Apply a generous amount of lubrication to the distal 15 centimeter and place the device in a similar fashion to a standard orogastric tube. Determine proper esophageal cooling device placement using standard fluoroscopy demonstrating the device tip below the patient's diaphragm.

And if zero fluoroscopy techniques are used, visualize the device on intracardiac echocardiography. After identifying the data elements as described in the manuscript, map the data elements to database structures for bulk reporting using electronic health record database mapping tools to translate these structures from the operational structures, to relational database tables in the reporting database. Then extract the data into a tabular format for integration with the results of the manual chart review.

After identifying any necessary data that cannot be easily extracted via database structures, perform manual extraction in the data elements as described in the manuscript. Create a new project within the red cap database instrument to facilitate manual chart review by clicking the new project button. After naming the project, this will lead to a page titled as Project Setup.

Then navigate to the second section titled as Design Your Data Collection Instruments, and click the online designer button. In the online designer, click create a new instrument from scratch In the instrument, add all the fields as described in the manuscript in addition to a patient medical record number in order to correlate the manual data collected to the data that was collected via electronic health record database structure extraction. Once the instrument is finalized, click the move project to production button.

From the left panel, click add edit records to view the finalized data instruments for inputting the data during the chart review. Identify patients that fit within the study inclusion criteria, including all patients that received ablations for atrial fibrillation between January, 2020 and January, 2022. Perform a manual chart review of the included patients adding the data collected into the project created in REDCap for future analysis.

During the study period, 63 patients received luminal esophageal temperature monitoring for their pulmonary vein isolation, and 101 patients received active esophageal cooling for esophageal protection with similar proportions of atrial fibrillation type in both groups. The mean procedure time in patients that underwent luminal esophageal temperature monitoring was 176 minutes, while it was 156 minutes in the actively cooled group representing a 20 minute overall reduction in procedure duration. Similarly, the median procedure time was 172 minutes in the luminal esophageal temperature monitored group, and 151 minutes in the active esophageal cooling group with an overall median reduction of 21 minutes Accurately recording realtime field observations and identifying specific elements of interest related to outcomes to determine where these variables are recorded and located in the Epic Chronicles database is the most important step to remember when attempting this procedure.

This point of care, observation based approach to data identification can be applied to many other clinical scenarios.