Background Active esophageal cooling during pulmonary vein isolation (PVI) with radiofrequency (RF) ablation for the treatment of atrial fibrillation (AF) is increasingly being utilized to reduce esophageal injury and atrioesophageal fistula formation. Randomized controlled data also show trends towards increased freedom from AF when using active cooling. This study aimed to compare 1-year arrhythmia recurrence rates between patients treated with luminal esophageal temperature (LET) monitoring versus active esophageal cooling during left atrial ablation. Method Data from two healthcare systems (including 3 hospitals and 4 electrophysiologists) were reviewed for patient rhythm status at 1-year follow-up after receiving PVI for the treatment of AF. Results were compared between patients receiving active esophageal cooling (ensoETM, Attune Medical, Chicago, IL) and those treated with traditional LET monitoring using Kaplan–Meier estimates. Results A total of 513 patients were reviewed; 253 received LET monitoring using either single or multi-sensor temperature probes; and 260 received active cooling. The mean age was 66.8 (SD ± 10) years, and 36.8% were female. Arrhythmias were 60.1% paroxysmal AF, 34.3% persistent AF, and 5.6% long-standing persistent AF, with no significant difference between groups. At 1-year follow-up, KM estimates for freedom from AF were 58.2% for LET-monitored patients and 72.2% for actively cooled patients, for an absolute increase in freedom from AF of 14% with active esophageal cooling (p = .03). Adjustment for the confounders of patient age, gender, type of AF, and operator with an inverse probability of treatment weighted Cox proportional hazards model yielded a hazard ratio of 0.6 for the effect of cooling on AF recurrence (p = 0.045). Conclusions In this first study to date of the association between esophageal protection strategy and long-term efficacy of left atrial RF ablation, a clinically and statistically significant improvement in freedom from atrial arrhythmia at 1 year was found in patients treated with active esophageal cooling when compared to patients who received LET monitoring. More rigorous prospective studies or randomized studies are required to validate the findings of the current study.
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 Various factors influence successful freedom from atrial arrhythmia after pulmonary vein isolation (PVI) with radiofrequency (RF) ablation for the treatment of atrial fibrillation (AF). Lesion transmurality and continuity (as measured by the Continuity Index) are two important factors, and these can be worsened by pauses in RF energy application due to esophageal overheating. Proactive esophageal cooling precludes the need for premature cessation of power, avoiding partially-formed lesions and the need to “hop-scotch” in the left atrium. The resulting improvement in lesion continuity may improve long-term freedom from atrial arrhythmia after PVI, particularly in patients with persistent AF, where more posterior wall ablation is often necessary. Purpose Determine differences in freedom from arrhythmia at one year between patients receiving LET monitoring and those receiving esophageal cooling during PVI for persistent AF. Methods We reviewed data from two healthcare systems for patient rhythm status at one-year follow up after PVI for the treatment of persistent or long-standing persistent AF. We then determined Kaplan-Meier estimates of freedom from arrhythmia (AF, atrial flutter, and atrial tachycardia), and compared these between patients receiving esophageal cooling and those treated with traditional LET monitoring. Results A total of 252 patients received PVI for persistent or long-standing persistent AF and had data available for review. Of these, 148 received LET monitoring (with either a single or multi-sensor temperature probe), and 104 received active cooling with a dedicated esophageal cooling device. Mean age and gender for each group was similar (67.2, range 21 to 88 years, 36% female for LET monitoring, and 67.8, range 32 to 89 years, 30% female for esophageal cooling). KM estimates for freedom from AF at the one-year follow-up were 44.2% for LET monitored patients and 79.3% for actively cooled patients (P=0.01). Conclusions Freedom from atrial arrhythmia at one-year after PVI for persistent AF is associated with significant improvement when using active esophageal cooling rather than LET monitoring. Funding Acknowledgement Type of funding sources: Private company. Main funding source(s): Attune Medical
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