Mechanisms of action behind the protective effects of proactive esophageal cooling during radiofrequency catheter ablation in the left atrium.

Proactive esophageal cooling for the purpose of reducing the likelihood of ablation-related esophageal injury resulting from radiofrequency (RF) cardiac ablation procedures is increasingly being used and has been Food and Drug Administration cleared as a protective strategy during left atrial RF ablation for the treatment of atrial fibrillation. In this review, we examine the evidence supporting the use of proactive esophageal cooling and the potential mechanisms of action that reduce the likelihood of atrioesophageal fistula (AEF) formation. Although the pathophysiology behind AEF formation after thermal injury from RF ablation is not well studied, a robust literature on fistula formation in other conditions (eg, Crohn disease, cancer, and trauma) exists and the relationship to AEF formation is investigated in this review. Likewise, we examine the abundant data in the surgical literature on burn and thermal injury progression as well as the acute and chronic mitigating effects of cooling. We discuss the relationship of these data and maladaptive healing mechanisms to the well-recognized postablation pathophysiological effects after RF ablation. Finally, we review additional important considerations such as patient selection, clinical workflow, and implementation strategies for proactive esophageal cooling.

Assessment of Esophageal Shifts during Catheter Ablation of Atrial Fibrillation Using Intracardiac Ultrasound Integrated with 3-Dimensional Electroanatomical Mapping System.

Purpose: Atrioesophageal fistula is one of the most feared complications of radiofrequency catheter ablation (RFCA) of atrial fibrillation (AF) as it is associated with high mortality. Determining the esophagus location during RFCA might reduce the risk of esophageal injury. The present study aims to evaluate the feasibility of using intracardiac echocardiography integrated into a 3-dimensional electroanatomical mapping system (ICE/3D EAM) for the assessment of esophageal position and shifts in response to ablation. Methods: We prospectively enrolled 20 patients that underwent RFCA of AF under conscious analgosedation. The virtual anatomy of the left atrium, the pulmonary vein (PV) ostia, and the esophagus was created with ICE/3D EAM. The esophageal positions were obtained at the beginning of the procedure and then after left and right PV isolation (PVI). Esophageal shifts were measured offline after the procedure using the tools available in the 3D EAM system. Results: Most esophagi moved away from the ablated PV ostia. After the left PVI, the median of the shifts was 2.8 mm (IQR 1.0-6.3). In 25% of patients, the esophagus shifted by >5.0 mm (max. 13.4 mm). After right PVI, the median of shifts was 2.0 mm (IQR 0.7-4.9). In 10% of patients, the esophageal shift was >5.0 mm (max. 7.8 mm). Conclusions: ICE/3D EAM enables the intraprocedural visualization of baseline esophageal position and its shifts after PVI. The shifts are variable, but they tend to be small and directed away from the ablation site. Repeated intraprocedural visualization of the esophagus may be needed to reduce the risk of esophageal injury.

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

BACKGROUND AND OBJECTIVES: Laser 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. METHODS: Three-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. RESULTS: PEC 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. CONCLUSIONS: PEC 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.

EsophAguS Deviation During RadiofrequencY Ablation of Atrial Fibrillation: The EASY AF Trial.

BACKGROUND: Injury to the esophagus has been reported in a high percentage of patients undergoing ablation of atrial fibrillation (AF). OBJECTIVES: This study assessed the incidence of esophageal injury in patients undergoing ablation of AF with and without an esophageal deviating device. METHODS: This prospective, randomized, multicenter, double-blinded, controlled Food and Drug Administration investigational device exemption trial compared the incidence of ablation-related esophageal lesions, as assessed by endoscopy, in patients undergoing AF ablation assigned to a control group (luminal esophageal temperature [LET] monitoring alone) compared with patients randomized to a deviation group (esophagus deviation device + LET). This novel deviating device uses vacuum suction and mechanical deflection to deviate a segment of the esophagus, including the trailing edge. RESULTS: The data safety and monitoring board recommended stopping the study early after randomizing 120 patients due to deviating device efficacy. The primary study endpoint, ablation injury to the esophageal mucosa, was significantly less in the deviation group (5.7%) in comparison to the control group (35.4%; P < 0.0001). Control patients had a significantly higher severity and greater number of ablation lesions per patient. There was no adverse event assigned to the device. By multivariable analysis, the only feature associated with reduced esophageal lesions was randomization to deviating device (OR: 0.13; 95% CI: 0.04-0.46; P = 0.001). Among control subjects, there was no difference in esophageal lesions with high power/short duration (31.8%) vs other radiofrequency techniques (37.2%; P = 0.79). CONCLUSIONS: The use of an esophageal deviating device resulted in a significant reduction in ablation-related esophageal lesions without any adverse events.

Esophageal injury, perforation, and fistula formation following atrial fibrillation ablation.

BACKGROUND: Esophageal perforation and fistula formation are rare but serious complications following atrial fibrillation ablation. In this review article, we outline the incidence, pathophysiology, predictors, and preventative strategies of this dreaded complication. METHODS: We conducted an electronic search in 10 databases/electronic search engines to access relevant publications. All articles reporting complications following atrial fibrillation ablation, including esophageal injury and fistula formation, were included for systematic review. RESULTS: A total of 130 manuscripts were identified for the final review process. The overall incidence of esophageal injury following atrial fibrillation ablation was significantly higher with thermal ablation modalities (radiofrequency 5-40%, cryoballoon 3-25%, high-intensity focused ultrasound < 10%) as opposed to non-thermal ablation modalities (no cases reported to date). The incidence of esophageal perforation and fistula formation with the use of thermal ablation modalities is estimated to occur in less than 0.25% of all atrial fibrillation ablation procedures. The use of luminal esophageal temperature monitoring probe and mechanical esophageal deviation showed protective effect toward reducing the incidence of this complication. The prognosis is very poor for patients who develop atrioesophageal fistula, and the condition is rapidly fatal without surgical intervention. CONCLUSIONS: Esophageal perforation and fistula formation following atrial fibrillation ablation are rare complications with poor prognosis. Various strategies have been proposed to protect the esophagus and reduce the incidence of this fearful complication. Pulsed field ablation is a promising new ablation technology that may be the future answer toward reducing the incidence of esophageal complications.

Catheter ablation of atrial fibrillation: anticipating and avoiding complications.

INTRODUCTION: Atrial fibrillation (AF) ablation is being performed more frequently and more widely at more centers. This stems from several factors including 1) demographic forces leading to an increased prevalence of the arrhythmia; 2) greater availability of ambulatory monitoring making diagnosis more frequent; 3) relative inefficacy of medications; and 4) improved safety and efficacy of the procedure. Ablation has become much more streamlined and reproducible than a decade ago, but life-threatening complications may still arise. AREAS COVERED: This review will focus on awareness, avoidance, and early recognition and management of complications of AF ablation. This literature review is challenged by differing approaches to ablation of AF both within a center and between centers, the rapid improvement of technology making the outcomes associated with a therapeutic strategy begun a few years prior relatively obsolete, as well as the heterogeneity of the population being studied. EXPERT OPINION: Newer technologies are on the horizon which will allow us to ablate AF with increasing efficacy, efficiency, and hopefully safety. Such new technology and changing usage mandate vigilance to avoid complications.

Atrioesophageal Fistula Rates Before and After Adoption of Active Esophageal Cooling During Atrial Fibrillation Ablation.

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. A formal analysis of the atrioesophageal fistula (AEF) rate with active esophageal cooling has not previously been performed. OBJECTIVES: The authors aimed to compare AEF rates before and after the adoption of active esophageal cooling. METHODS: This institutional review board (IRB)-approved study was a prospective analysis of retrospective data, designed before collecting and analyzing the real-world data. The number of AEFs occurring in equivalent time frames before and after adoption of cooling using a dedicated esophageal cooling device (ensoETM, Attune Medical) were quantified across 25 prespecified hospital systems. AEF rates were then compared using generalized estimating equations robust to cluster correlation. RESULTS: A total of 14,224 patients received active esophageal cooling during RF ablation across the 25 hospital systems, which included a total of 30 separate hospitals. In the time frames before adoption of active cooling, a total of 10,962 patients received primarily luminal esophageal temperature (LET) monitoring during their RF ablations. In the preadoption cohort, a total of 16 AEFs occurred, for an AEF rate of 0.146%, in line with other published estimates for procedures using LET monitoring. In the postadoption cohort, no AEFs were found in the prespecified sites, yielding an AEF rate of 0% (P < 0.0001). CONCLUSIONS: 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.

A novel esophageal retractor with eccentric balloon during atrial fibrillation ablation.

BACKGROUND: Due to the anatomically adjacent relationship between the left atrium (LA) and esophagus, energy delivery on the posterior wall of LA is limited. The aim of this study was to evaluate the feasibility of a novel esophageal retractor (SAFER) with an inflatable C-curve balloon during atrial fibrillation (AF) ablation. METHOD: Nine patients underwent AF ablation assisted with the SAFER. After inflation, the esophagus was deviated laterally away from the intended ablation site of the posterior wall under local anesthesia. The extent of mechanical esophageal deviation (MED) was evaluated under fluoroscopy, defined as the shortest distance from the trailing esophageal edge to the closest point of the ablation line. Gastroscopy was performed before and after ablation. The target ablation index used in all LA sites including the posterior wall was 400-450 after effective MED. All adverse events during the periprocedural period were recorded. RESULTS: The mean deviation distance achieved 16.2 ± 9.6 mm away from the closest ablation point of the pulmonary vein lesion set. With respect to the individual left and right pulmonary vein lesion sets, the deviation distance was 19.7 ± 11.5 and 12.7 ± 6.8 mm, respectively. The extent of deviation was 0 to 5 mm, 5.1 to 10 mm, or >10 mm in 0(0%), 7(38.9%), and 11(61.1%), respectively. Procedural success was achieved in all patients without acute reconnection. There was only one esophageal complication which manifested as esophageal erosion and this patient experienced throat pain possibly related to the SAFER retractor with no clinical sequelae. CONCLUSION: Esophageal deviation with the novel eccentric balloon is a novel feasible choice during AF ablation, enabling adequate energy delivery to the posterior wall of LA. Additional prospective randomized controlled studies are required for further validation.

Successful non-operative management of atrioesophageal fistula after combined therapy of catheter ablation and left atrial appendage closure for atrial fibrillation: A case report.

Atrioesophageal fistula (AEF) is a rare but devastating complication of radiofrequency ablation (RFCA) for atrial fibrillation (AF) and is associated with high mortality rates. Whereas most cases of AEF are treated by emergency surgical interventions, we report a case of paroxysmal AF with AEF after combined therapy of catheter ablation and percutaneous left atrial appendage closure (LAAC), which was treated successfuly without major surgery or esophageal stenting. He was presented 18 days after the procedure, suffering chest pain, fever, and a transient loss of consciousness. Computed tomography (CT) of the chest disclosed a small accumulation of air in the region of the left atrium adjacent to the esophagus, suggesting AEF. Supported by early aggressive antibiotic therapy, pericardial drainage and a fasting state with adequate parenteral nutrition, resulted in improvement of his condition with no recurrence of symptoms. Subsequent chest CT scans confirmed disappearance of the leaked air and the patient was discharged home 28 days after admission with no neurological compromise. Early detection, rapid treatment and constant awareness of potential fatal consequences are prerequisites for successful treatment of this complication and prevention of fatal outcome.

Improved hospital discharge and cost savings with esophageal cooling during left atrial ablation.

BACKGROUND: Left atrial ablation to obtain pulmonary vein isolation (PVI) for the treatment of atrial fibrillation (AF) is a technologically intensive procedure utilizing innovative and continually improving technology. Changes in the technology utilized for PVI can in turn lead to changes in procedure costs. Because of the proximity of the esophagus to the posterior wall of the left atrium, various technologies have been utilized to protect against thermal injury during ablation. The impact on hospital costs during PVI ablation from utilization of different technologies for esophageal protection during ablation has not previously been evaluated. OBJECTIVE: To compare the costs of active esophageal cooling to luminal esophageal temperature (LET) monitoring during left atrial ablation. METHODS: We performed a time-driven activity-based costing (TDABC) analysis to determine costs for PVI procedures. Published data and literature review were utilized to determine differences in procedure time and same-day discharge rates using different esophageal protection technologies and to determine the cost impacts of same-day discharge versus overnight hospitalization after PVI procedures. The total costs were then compared between cases using active esophageal cooling to those using LET monitoring. RESULTS: The effect of implementing active esophageal cooling was associated with up to a 24.7% reduction in mean total procedure time, and an 18% increase in same-day discharge rate. TDABC analysis identified a $681 reduction in procedure costs associated with the use of active esophageal cooling after including the cost of the esophageal cooling device. Factoring in the 18% increase in same-day discharge resulted in an increased cost savings of $2,135 per procedure. CONCLUSIONS: The use of active esophageal cooling is associated with significant cost-savings when compared to traditional LET monitoring, even after accounting for the additional cost of the cooling device. These savings originate from a per-patient procedural time savings and a per-population improvement in same-day discharge rate.

Acquired atrioesophageal fistula: Need it be lethal? Sizing up the problem, diagnostic modalities, and best management.

BACKGROUND AND AIM OF THE STUDY: An atrioesophageal fistula is a devastating complication of ablation for atrial fibrillation. For the surgeon facing this dreaded complication, it may be a 'once in a lifetime' case. This review aims to describe the clinical problem and evaluate the outcome of different surgical techniques to start guiding cardiothoracic surgeons toward those which offer the best chance of survival. METHODS: An electronic search retrieved 125 articles containing 195 cases of atrioesophageal fistula secondary to atrial fibrillation ablation. Reports of pericardio-esophageal or mediastino-esophageal fistula were excluded. RESULTS: The median age was 61 and 143 (73%) cases occurred in males. Fever (n = 147; 75%) and neurological dysfunction (n = 151; 77%) were the most common symptoms. The median time from ablation to symptom onset was 21 days (interquartile range: 12-28). The most sensitive thoracic imaging modality was computed tomography (n = 135/153; 90%). Immediate deterioration occurred during 11/58 (19%) oesophago-gastro-duodenoscopies. Mortality was lower in patients who had surgery (39%) compared with endoscopic intervention (94%) or conservative management (97%). Patients who had atrial repair combined with esophageal repair or oesophagectomy were more likely to survive than those who had atrial repair alone (OR 6.97; p < .001). Isolation of the esophageal aspect of the fistula conferred an additional survival benefit (OR 5.85; p = .02). CONCLUSIONS: Fever, neurological symptoms, and chest pain in the context of recent ablation should prompt immediate evaluation. Urgent CT thorax should be arranged and repeated if initially unremarkable. Esophageal instrumentation should be avoided due to the risk of catastrophic air embolism or massive hemorrhage. The best way forward is emergency surgical repair; the combination which offers the best survival benefit is atrial repair combined with esophageal surgery and isolation of the esophageal aspect of the fistula.

Active esophageal cooling during radiofrequency ablation of the left atrium: data review and update.

INTRODUCTION: Radiofrequency (RF) ablation of the left atrium of the heart is increasingly used to treat atrial fibrillation (AF). Unfortunately, inadvertent thermal injury to the esophagus can occur during this procedure, potentially creating an atrioesophageal fistula (AEF) which is 80% fatal. The ensoETM (Attune Medical, Chicago, IL), is an esophageal cooling device that has been shown to reduce thermal injury to the esophagus during RF ablation. AREAS COVERED: This review summarizes growing evidence related to active esophageal cooling during RF ablation for the treatment of AF. The review presents data demonstrating improved outcomes related to patient safety and procedural efficiency and suggests directions for future research. EXPERT OPINION: The use of active esophageal cooling during RF ablation reduces esophageal injury, reduces or eliminates fluoroscopy requirements, reduces procedure duration and post-operative pain, and increases long-term freedom from arrhythmia. These effects in turn increase patient same-day discharge rates, decrease operator cognitive load, and reduce cost. These findings are likely to further accelerate the adoption of active esophageal cooling.

Atrial fibrillation is a condition in which the heart beats irregularly, causing symptoms such as palpitations, dizziness, shortness of breath, and chest pain. Atrial fibrillation increases the risk of stroke, heart failure, dementia, and death. One treatment for atrial fibrillation is a procedure called a catheter ablation. This procedure is minimally invasive and is performed by a specialized cardiologist, called an electrophysiologist. The electrophysiologist, or operator, uses an energy source, such as radiofrequency energy (radio waves), to stop erratic electrical signals from traveling through the heart. One complication of the catheter ablation is an inadvertent injury to the esophagus, the organ that passes food from the mouth to the stomach. If the injury is severe, it may develop into an atrioesophageal fistula, which often results in death. In this review, a new technology is described that helps prevent this type of injury and can provide additional benefits for the patient, operator, and hospital.

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

BACKGROUND: Proactive cooling with a novel cooling device has been shown to reduce endoscopically identified thermal injury during radiofrequency (RF) ablation for the treatment of atrial fibrillation using medium power settings. We aimed to evaluate the effects of proactive cooling during high-power short-duration (HPSD) ablation. METHODS: A computer model accounting for the left atrium (1.5 mm thickness) and esophagus including the active cooling device was created. We used the Arrhenius equation to estimate the esophageal thermal damage during 50 W/ 10 s and 90 W/ 4 s RF ablations. RESULTS: With proactive esophageal cooling in place, temperatures in the esophageal tissue were significantly reduced from control conditions without cooling, and the resulting percentage of damage to the esophageal wall was reduced around 50%, restricting damage to the epi-esophageal region and consequently sparing the remainder of the esophageal tissue, including the mucosal surface. Lesions in the atrial wall remained transmural despite cooling, and maximum width barely changed (<0.8 mm). CONCLUSIONS: Proactive esophageal cooling significantly reduces temperatures and the resulting fraction of damage in the esophagus during HPSD ablation. These findings offer a mechanistic rationale explaining the high degree of safety encountered to date using proactive esophageal cooling, and further underscore the fact that temperature monitoring is inadequate to avoid thermal damage to the esophagus.

Two-stage hybrid repair with over-the-scope clip for atrioesophageal fistula after catheter-based ablation.

In this report, we present a case in which we successfully performed two-stage hybrid repair of heart surgery and endoscopic treatment with over-the-scope-clip system for atrio-esophageal fistula after catheter based ablation.