Background: Active esophageal cooling reduces the incidence of endoscopically identified severe esophageal lesions during radiofrequency (RF) catheter ablation of the left atrium for the treatment of atrial fibrillation. No atrioesophageal fistula (AEF) has been reported to date with active esophageal cooling, and only one pericardio-esophageal fistula has been reported; however, a formal analysis of the AEF rate with active esophageal cooling has not previously been performed. Methods: Atrial fibrillation ablation procedure volumes before and after adoption of active cooling using a dedicated esophageal cooling device (ensoETM, Attune Medical) were determined across 25 hospital systems with the highest total use of esophageal cooling during RF ablation. The number of AEFs occurring in equivalent time frames before and after adoption of cooling were then determined, and AEF rates were compared using generalized estimating equations robust to cluster correlation. Results: Throughout the 25 hospital systems, which included a total of 30 separate hospitals, 14,224 patients received active esophageal cooling during RF ablation, with the earliest adoption beginning in March 2019 and the most recent beginning in March 2022. In the time frames prior to adoption of active cooling, a total of 10,962 patients received primarily luminal esophageal temperature (LET) monitoring during their RF ablations. In this pre-adoption cohort a total of 16 AEFs occurred, for an AEF rate of 0.146%, in line with other published estimates of <0.1% to 0.25%. No AEFs were found in the cohort treated after adoption of active esophageal cooling, yielding an AEF rate of 0% (P<0.0001). Conclusion: Adoption of active esophageal cooling during RF ablation of the left atrium for the treatment of atrial fibrillation was associated with a significant reduction in AEF rate.
Background Active esophageal cooling is increasingly being utilized during radiofrequency (RF) ablation to achieve pulmonary vein isolation (PVI) for the treatment of atrial fibrillation (AF). In addition to data showing decreases in severe esophageal injury with active esophageal cooling, placement of a commercially available cooling device can be identified on intracardiac echocardiography (ICE), allowing implementation in zero-fluoroscopy settings. In the case of procedures that do not have ICE available, an alternative method to determine proper placement of an esophageal cooling device is needed in zero-fluoroscopy settings.. Purpose To describe a large single-center approach to visualizing an active esophageal cooling device into a 3D mapping system. Methods We reviewed data on patients treated with RF ablation for PVI procedures over the time frame 1/1/2020 to 12/31/21. Active esophageal cooling was phased in towards the end of 2020. For all cases, transseptal puncture was performed with the use of transesophageal echocardiography (TEE). After successful transseptal puncture, the TEE probe was removed, and either a single-sensor LET probe or an active esophageal cooling device was placed. For the active cooling device, the distal tip was cut, and an SL-1 (0.032 inch, 150 cm length) guidewire was placed through the central lumen of the cooling device (used for gastric suctioning and enteral feeding). The guidewire was pinned via a pin block to the 3D mapping system (EnSite, Abbott). Unipolar configuration was used to generate a 3D map, which was then visualized during device placement. Placement was confirmed after visualizing the guidewire tip on the 3D map passing below the coronary sinus (Figure 1). Results A total of 417 cases were performed over the study timeframe. The mean age of patients was 65±10 years, and 40% were female. A total of 5 complications were recorded (3 pericardial effusions, 1 pseudoaneurysm, and 1 air embolism). A total of 156 patients received LET monitoring, and 261 received active esophageal cooling. The mean procedure length was 109±24 minutes for cases utilizing LET monitoring, and 93±11 minutes for cases utilizing active esophageal cooling. Visualization of the active esophageal cooling device on the cardiac mapping system was possible in all cases. Conclusions We describe here the largest series to date utilizing active esophageal cooling in a zero-fluoroscopy, zero-ICE setting. With increasing efforts to reduce fluoroscopy, this approach allows pursuit of zero-fluoroscopy even in systems without the availability of ICE, while maintaining procedural speed and safety. Funding Acknowledgement Type of funding sources: Private company. Main funding source(s): Attune Medical
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