Proactive esophageal cooling protects against thermal insults during high-power short-duration radiofrequency cardiac ablation

Montoya, Marcela; Bustamante, Tatiana Gomez; Berjano, Enrique; Mickelsen, Steven; Daniels, James; Arango, Pablo Hernandez; Schieber, Jay D.; Kulstad, Erik

doi:10.1080/02656736.2022.2121860

Cited by 14 publications

(22 citation statements)

References 51 publications

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“…Preclinical data as well as mathematical modeling support the findings of a significant effect size, with a dose-response effect of coolant temperature shown in a large animal model,[24] and a significant reduction of lethal isotherm formation in the esophagus shown with mathematical models. [33, 36] Although randomized clinical studies have shown reductions in severe esophageal lesions with active esophageal cooling,[31, 37, 38] the effect sizes seen were not such that the findings of no AEF in our large population sample would be expected. Downstream effects on inflammatory markers (which are well-described in the burn literature) [39-41] may be another mechanism involved in reducing the likelihood of fistula formation with cooling.…”

Section: Discussionmentioning

confidence: 75%

“…Downstream effects on inflammatory markers (which are well-described in the burn literature) [39-41] may be another mechanism involved in reducing the likelihood of fistula formation with cooling. Insulating effects from the pericardial fat, fibrous pericardium, and serous layers minimize cooling in the atrial myocardium so that effective lesions can still be placed,[33] with long-term follow up data confirming no decrease in freedom from atrial arrhythmias at one year with active esophageal cooling compared with LET monitoring. [32] A larger volume of retrospective data further suggests improvement in freedom from arrhythmias with cooling,[42] which may be due to differences in lesion placement sequence with the catheter, enabled by having cooling in place.…”

Section: Discussionmentioning

confidence: 99%

“…[46] Analysis of this event suggests higher total energy was deposited over the esophagus than is typical, with higher ablation index targets on the posterior wall than the commonly used 380-400 units, and lesions stacked near the esophagus, which has recently been suggested to increase risk of injury. [33,[47][48][49][50][51] This may serve to emphasize that, like most technologies employed for safety, there may be limitations in the protective capabilities of cooling. Complications from the esophageal cooling device itself have been infrequent, with most occurring during long-term use for critical care patients (where durations of use extend well beyond 24 hours).…”

Section: Discussionmentioning

confidence: 99%

“…[21][22][23] Active esophageal cooling using a dedicated esophageal cooling device is a newer technique that has shown benefits in preclinical studies, mathematical modeling, and clinical studies. [24][25][26][27][28][29][30][31][32][33][34] An international multicenter randomized controlled trial is currently underway (NCT04577859), but this study relies on the surrogate endpoint of endoscopically detected esophageal lesion (EDEL) reduction. Because an event rate of <1% requires an extremely large sample size, no study to date has evaluated the effectiveness of any strategy in reducing AEFs.…”

Section: Introductionmentioning

confidence: 99%

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Multicenter analysis of atrioesophageal fistula rates before and after adoption of active esophageal cooling during atrial fibrillation ablation

Sánchez

Woods²,

Zagrodzky³

et al. 2023

Preprint

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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.

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Section: Discussionmentioning

confidence: 75%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Multicenter analysis of atrioesophageal fistula rates before and after adoption of active esophageal cooling during atrial fibrillation ablation

Sánchez

Woods²,

Zagrodzky³

et al. 2023

Preprint

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“…where ρ bl is blood density, C p,bl is blood heat capacity, ω bl is the perfusion rate, taken from the IT'IS database for each tissue, 13 T bl is blood temperature (37°C), and β is a nondimensional parameter to simulate that blood perfusion ceases once tissue is completely destroyed by thermal necrosis (β = 1 while fraction of thermal damage remains less than 99% and β = 0 for 100% damage). 10 A radiation boundary condition was considered on the atrial wall exterior surface to account for the heat dissipation from the tissue, as follows:…”

Section: Casesmentioning

confidence: 99%

Proactive esophageal cooling during laser cardiac ablation: A computer modeling study

Gomez Bustamante,

Mercado Montoya,

Berjano

et al. 2024

Lasers Surg Med

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Background and ObjectivesLaser ablation is increasingly used to treat atrial fibrillation (AF). However, atrioesophageal injury remains a potentially serious complication. While proactive esophageal cooling (PEC) reduces esophageal injury during radiofrequency ablation, the effects of PEC during laser ablation have not previously been determined. We aimed to evaluate the protective effects of PEC during laser ablation of AF by means of a theoretical study based on computer modeling.MethodsThree‐dimensional mathematical models were built for 20 different cases including a fragment of atrial wall (myocardium), epicardial fat (adipose tissue), connective tissue, and esophageal wall. The esophagus was considered with and without PEC. Laser‐tissue interaction was modeled using Beer–Lambert's law, Pennes' Bioheat equation was used to compute the resultant heating, and the Arrhenius equation was used to estimate the fraction of tissue damage (FOD), assuming a threshold of 63% to assess induced necrosis. We modeled laser irradiation power of 8.5 W over 20 s. Thermal simulations extended up to 250 s to account for thermal latency.ResultsPEC significantly altered the temperature distribution around the cooling device, resulting in lower temperatures (around 22°C less in the esophagus and 9°C in the atrial wall) compared to the case without PEC. This thermal reduction translated into the absence of transmural lesions in the esophagus. The esophagus was thermally damaged only in the cases without PEC and with a distance equal to or shorter than 3.5 mm between the esophagus and endocardium (inner boundary of the atrial wall). Furthermore, PEC demonstrated minimal impact on the lesion created across the atrial wall, either in terms of maximum temperature or FOD.ConclusionsPEC reduces the potential for esophageal injury without degrading the intended cardiac lesions for a variety of different tissue thicknesses. Thermal latency may influence lesion formation during laser ablation and may play a part in any collateral damage.

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Improved 1-year outcomes after active cooling during left atrial radiofrequency ablation

Joseph

Nazari

Zagrodzky

et al. 2023

J Interv Card Electrophysiol

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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.

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Proactive esophageal cooling protects against thermal insults during high-power short-duration radiofrequency cardiac ablation

Cited by 14 publications

References 51 publications

Multicenter analysis of atrioesophageal fistula rates before and after adoption of active esophageal cooling during atrial fibrillation ablation

Multicenter analysis of atrioesophageal fistula rates before and after adoption of active esophageal cooling during atrial fibrillation ablation

Proactive esophageal cooling during laser cardiac ablation: A computer modeling study

Improved 1-year outcomes after active cooling during left atrial radiofrequency ablation

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