Research published in JACC: Clinical Electrophysiology has found a significant reduction in the rate of atrioesophageal fistuals (AEFs) during cardiac ablation of the left atrium when with the use of the ensoETM (Attune Medical) system when compared luminal oesophageal temperature monitoring.
Oesophageal injury can occur during ablation procedures for the treatment of atrial fibrillation (AF), and an AEF is the most severe form of injury, resulting in death in most cases.
The study set out to compare the rate of AEFs before and after the adoption of proactive oesophageal cooling. It incorporated data from over 25,000 patients in over 30 hospitals across the US and found in 10,962 patients receiving luminal oesophageal temperature monitoring, 16 developed an AEF, and in 14,224 patients receiving the ensoETM to proactively cool the oesophagus, none were found to have an AEF.
The authors concluded that adoption of active esophageal cooling during radiofrequency (RF) ablation of the left atrium for the treatment of AF was associated with a significant reduction in AEF rate.
“This is the first study of the effectiveness of any technique to show a significant benefit in the reduction of AEFs. The ensoETM device has proven to be remarkably effective at protecting our patients and it has become our standard of care,” commented first author Javier (Texas Cardiac Arrhythmia, Dallas, USA).
The ensoETM has been used to treat over 50,000 patients since first becoming available in 2015, and recently received de novo marketing authorisation from the US Food and Drug Administration (FDA) to reduce the likelihood of ablation-related oesophageal injury resulting from radiofrequency cardiac ablation procedures.
“Because the ensoETM is visible on intracardiac echocardiography, we are able to perform our procedures without fluoroscopy, offering further benefits to patients and staff by reducing radiation exposure and eliminating the need to wear heavy lead protective shields throughout the case,” noted co-author Christopher Woods (Sutter Health, San Francisco, USA).
Senior author Mark Metzl (NorthShore University Health System, Chicago, USA), said, “I would like to thank all our co-authors and collaborators for their work on this important study. In addition to the substantial safety benefits, we have found significant improvements in procedure time, outcome, and cost in the years since adopting ensoETM in our healthcare system, and this study further underscores the value of this technology.”