Atrioesophageal fistula (AEF) is a severe complication of left atrial
radiofrequency (RF) ablation for the treatment of atrial fibrillation. Proactive cooling with a novel cooling device has been shown to significantly reduce thermal injury, with no AEFs yet encountered after thousands of treatments worldwide. Computer modeling suggested that lethal temperatures could be avoided with moderate-power and
moderate-duration RF ablation. We aimed to evaluate the effects of proactive cooling during high-power short-duration (HPSD) ablation, and compare the computed results to clinical data and recently published experimental data.
A computer model accounting for the left atrium and esophagus including the active cooling device was created. We used both the Arrhenius equation and 50ºC isotherm to estimate the esophageal thermal damage during 50 W, 10 second and 90 W, 4 second RF ablations.
Under control conditions, temperatures across the esophageal wall exceeded the lethal isotherm, in agreement with recent experimental data. With proactive esophageal cooling in place, temperatures in the esophageal tissue were significantly reduced, with the resulting fraction of esophageal damage reduced by 74% under 50 W
and 10 seconds of ablation, and by 82% under 90 W and 4 seconds of ablation.
Esophageal damage was restricted to the epi-esophageal region, sparing the remainder of the esophageal tissue, including the mucosal surface.
Proactive esophageal cooling significantly reduced temperatures and
the resulting fraction of damage in the esophagus during HPSD ablation. These findings offer a mechanistic rationale explaining the absence of AEF encountered to date using proactive esophageal cooling.
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March 2020
The purpose of this document is to provide a product development summary for an accessory device that joins an esophageal temperature probe and a mapping catheter together to be used during cardiac ablation. Catheter ablation therapy is performed in the left atrium, utilizing extremely hot or cold temperatures to create scar tissue and treat atrial fibrillation and other arrhythmias. The close
... [Show full abstract] positioning of the left atria adjacent to the esophagus presents a large risk as the extreme temperatures used during ablation can lead to esophageal damage or fistulas. This device is designed to integrate correlate data from the temperature probe with the esophageal mapping catheter position in order to monitor esophageal temperature and create a map for use in catheter ablation. This document contains an overview of the development for this product. The document comprises the following sections: Introduction, Background, Objectives, Customer Requirements, Design Specifications, Project Management, Prototype Manufacturing Plans, Test Plans, Discussion, and Conclusions. Read more May 2020 · Cardiovascular Engineering and Technology
Purpose:
Atrial fibrillation (AF) is the most common heart rhythm disorder in the world. Radiofrequency catheter ablation (RFCA) has become the preferred method of treatment for drug-refractory AF. One of the rare (< 0.2%) but deadly (≈ 80%) complications of RFCA is Atrioesophageal fistula (AEF). Although the exact pathophysiological events in developing AEF are not fully understood, one
... [Show full abstract] hypothesis is that the underlying cause may be thermal damage to the mucosa (the esophagus lumen).
Method:
The present study reports on a computer model of RFCA in the posterior wall of the left atrium (LA) which is in close proximity to the esophagus. A novel systematic approach was taken by considering a range of anatomical variations (obtained from clinical data) to study the spatial and temporal temperature data when RF energy was applied to cause a threshold temperature of 50 °C in the mucosa. The model is also used to investigate the spatial and temporal changes in mucosal temperature that may affect the reliability of the readings from esophageal temperature monitoring devices if they are not positioned accurately.
Results:
The results suggest evidence of transmural esophageal lesions in all the anatomies except one, if the 50 °C temperature threshold is the only criteria used for identification of thermal damage. However, by taking into consideration the effect of time (temperature-time integral), only some anatomies were identified as being partially damaged. Investigating the temperature and the temperature gradient data during the ablation revealed that the increases in both the temperature and the temperature gradient were time, location and anatomy dependent. This finding may have significance in the design and development of next-generation temperature monitoring devices that will provide a temperature map rather than single point measurements.
Conclusion:
Studies such as the present work may provide more convenient platforms for investigating the effect of the many factors involved in the RF procedure and how they may link to the development of AEF. Read more June 2015 · Journal of Cardiothoracic and Vascular Anesthesia
Read more January 2008 · Journal of Cardiovascular Electrophysiology
Introduction:
Esophageal temperature rise (ETR) during ablation inside left atrium has been reported as a marker for esophageal thermal injury. We sought to investigate the possible relationships between chest pain and ETR during radiofrequency (RF) ablation, and ETR and locations of RF application, in patients undergoing pulmonary vein (PV) isolation under moderate sedation.
Methods and
... [Show full abstract] results:
We analyzed anatomical locations of each RF application and its association with esophageal temperature and presence/absence of pain. Data from 40 consecutive patients (mean age: 56 +/- 10 years) were analyzed. There were a total of 4,071 RF applications resulting in 291 episodes of pain (7.1%) and 223 ETRs (5.5%). Thirty-five patients (87.5%) experienced at least one pain episode and 32 (80.0%) had at least one ETR. While 77.4% of posterior wall applications that caused pain also corresponded to an ETR (P < 0.0001), only 0.8% of pain-free posterior wall applications were associated with ETRs (P < 0.0001). The sensitivity and specificity of pain during ablation for ETR were 94% and 98%, respectively. No ETRs were observed during anterior wall applications. ETRs occurred more frequently during ablation on the left (86.1%) versus the right (13.9%), and in inferior (70.4%) versus superior (29.6%) segments.
Conclusion:
In patients undergoing PV isolation, ETR was encountered when ablating in the posterior left atrium with the distribution left > right and inferior > superior. Pain during ablation was associated with ETR, and lack of pain was strongly associated with absence of ETR. Pain during RF ablation may thus serve as a predictor of esophageal heating and potential injury. Read more July 2005 · Circulation
Left atrioesophageal fistula is a devastating complication of atrial fibrillation ablation. There is no standard approach for avoiding this complication, which is caused by thermal injury during ablation. The objectives of this study were to evaluate the course of the esophagus and the temperature within the esophagus during pulmonary vein antrum isolation (PVAI) and correlate these data with
... [Show full abstract] esophagus tissue damage.
Eight-one patients presenting for PVAI underwent esophagus evaluation that included temperature probe placement. Esophagus course was obtained with computed tomography, 3D imaging (NAVX), or intracardiac echocardiography. For each lesion, the power, catheter and esophagus temperature, location, and presence of microbubbles were recorded. Lesion location and esophagus course were defined with 6 predetermined left atrial anatomic segments. Endoscopy evaluated tissue changes during and after PVAI. Of 81 patients, the esophagus coursed near the right pulmonary veins in 23 (28.4%), left pulmonary veins in 31 (38.3%), and mid-posterior wall in 27 (33%). Esophagus temperature was significantly higher during left atrial lesions along its course than with lesions elsewhere (38.9+/-1.4 degrees C, 36.8+/-0.5 degrees C, P<0.01). Lesions that generated microbubbles had higher esophagus temperatures than those without (39.3+/-1.5 degrees C, 38.5+/-0.9 degrees C, P<0.01). Power was not predictive of esophagus temperatures. Distance between the esophagus and left atrium was 4.4+/-1.2 mm.
Lesions near the course of the esophagus that generated microbubbles significantly increased esophagus temperature compared with lesions that did not. Power did not correlate with esophagus temperatures. Esophagus variability makes the avoidance of lesions along its course difficult. Rather than avoiding posterior lesions, emphasis could be placed on better esophagus monitoring for creation of safer lesions. Read more April 2018 · Heart rhythm: the official journal of the Heart Rhythm Society
Background:
Esophageal thermal injury is a feared complication of radiofrequency ablation (RFA) for atrial fibrillation (AF). Rise in luminal esophageal temperature (LET) limits the ability to deliver RF energy on posterior wall of LA.
Objective:
The aim of this registry was to evaluate feasibility, safety and efficacy of a mechanical esophageal deviation (ED) tool during AF
... [Show full abstract] ablation.
Methods:
We evaluated 687 patients who underwent RFA for AF. In 209 patients, EsoSure® was used to deflect esophagus away from ablation site. Propensity-score matching was performed to obtain 180 patients each in ED and non-ED arms. ED was used for LET rise seen in 61.7% (111/180) patients and was used if esophagus was in the line of ablation on fluoroscopy in 38.3% (69/180) patients.
Results:
The mean deviation of trailing edge of esophagus with EsoSure® was 2.45 ± 0.9 cm (range: 1-4.5 cm). LET rise >1°C was significantly lower in ED than non-ED group (3% vs 79.4%, p<0.001). Mean LET rise (ED 0.34 ± 0.59 vs non-ED 1.66 ± 0.54, p<0.001). Intra-procedural success of PVAI, was slightly improved in ED arm than in non-ED arm without statistical significance. AF recurrence was lower in ED arm at 3-month, 6-month and 1-year follow-up than non-ED arm. No ED-related complications were noted.
Conclusions:
Mechanical displacement of esophagus with EsoSure® appears to be feasible, safe and efficacious in enabling adequate RF energy delivery to posterior wall of LA without significant LET rise and obvious clinical signs of esophageal injury. Read more February 2018 · Circulation Arrhythmia and Electrophysiology
Background:
Catheter ablation for atrial fibrillation has potential to cause esophageal thermal injury. Esophageal temperature monitoring during ablation is commonly used; however, it has not eliminated thermal injuries, possibly because conventional sensors have poor spatial sampling and response characteristics. To enhance understanding of temperature dynamics that may underlie esophageal
... [Show full abstract] injury, we tested a high-resolution, intrabody, infrared thermography catheter to continuously image esophageal temperatures during ablation.
Methods and results:
Atrial fibrillation ablation patients were instrumented with a flexible, 9F infrared temperature catheter inserted nasally (n=8) or orally (n=8) into the esophagus adjacent to the left atrium. Ablation was performed while the infrared catheter continuously recorded surface temperatures from 7680 points per second circumferentially over a 6-cm length of esophagus. Physicians were blinded to temperature data. Endoscopy was performed within 24 hours to document esophageal injury. Thermal imaging showed that most patients (10/16) experienced ≥1 events where peak esophageal temperature was >40°C. Three patients experienced temperatures >50°C; and 1 experienced >60°C. Analysis of temperature data for each subject's maximum thermal event revealed high gradients (2.3±1.4°C/mm) and rates of change (1.5±1.3°C/s) with an average length of esophageal involvement of 11.0±5.4 mm. Endoscopy identified 3 distinct thermal lesions, all in patients with temperatures >50°C; all resolved within 2 weeks.
Conclusions:
Infrared thermography provided dynamic, high-resolution mapping of esophageal temperatures during cardiac ablation. Esophageal thermal injury occurred with temperatures >50°C and was associated with large spatiotemporal gradients. Additional studies are warranted to determine the relationships between thermal parameters and esophageal injury. Read more June 2008 · Journal of Cardiovascular Electrophysiology
Introduction: Evaluation of luminal temperature during left atrial ablation is used clinically; however, luminal temperature does not necessarily reflect temperature within the esophageal wall and poses a risk of atrioesophageal fistula. This animal study evaluates luminal esophageal temperature and its relation to the temperature of the external esophageal tissue during left atrial lesions using
... [Show full abstract] the 8 mm solid tip and the open irrigated tip catheters (OIC).
Methods and Results: A thermocouple was secured to the external surface of the esophagus at the level of the left atrium of the dogs. Luminal esophageal temperature was measured using a standard temperature probe. In four randomized dogs, lesions were placed using an 8 mm solid tip ablation catheter. In six randomized dogs, lesions were placed using the 3.5 mm OIC. The average peak esophageal tissue temperature when using the OIC was significantly higher than that of the 8 mm tip catheter (88.6°C ± 15.0°C vs. 62.3°C ± 12.5°C, P < 0.05). Both OIC and 8 mm tip catheter had significantly higher peak tissue temperatures than luminal temperatures (OIC: 88.6°C ± 15.0°C vs 39.7°C ± 0.82°C, P < 0.05) (8 mm: 62.3°C ± 12.5°C vs 39.0 ± 0.5°C, P < 0.05). Both catheters achieved peak temperatures faster in the tissue as compared to the lumen of the esophagus, although the tissue temperature peaked significantly faster for the OIC (OIC: 25 seconds vs 90 seconds, P < 0.05) (8 mm: 63 seconds vs 105 seconds, P < 0.05).
Conclusion: Despite the significant difference in actual tissue temperatures, no significant difference was observed in luminal temperatures between the OIC and 8 mm tip catheter. Read more October 2015 · Journal of Cardiovascular Electrophysiology
Cardioesophageal fistulas (CEFs) are uncommon but life-threatening complications of radiofrequency (RF) catheter ablation of atrial fibrillation (AF). They are usually, but not exclusively, related to ablation of the left atrial posterior wall. We report a case of a 73-year-old man that presented with CEF following RF ablation in the coronary sinus, highlighting the importance of esophageal
... [Show full abstract] temperature monitoring whenever ablating in the posterior heart. This article is protected by copyright. All rights reserved Read more July 2009 · Journal of Cardiovascular Electrophysiology
Introduction: Atrioesophageal fistula is an uncommon but often lethal complication of atrial fibrillation (AF) ablation. The purpose of our study was to prospectively investigate the incidence of esophageal ulcerations (ESUL) as well as the impact of energy settings, radiofrequency lesion sets, and direct visualization of the esophagus on esophageal wall injury.
Methods and Results: One hundred
... [Show full abstract] seventy-five patients, 57.1% paroxysmal AF, 78.5% male, underwent AF ablation and esophagoscopy 24 hours thereafter. We performed a 2:1:1-randomization as follows:
Control group: Ablation without visualization of the esophagus using 25 Watt (W) power limit on the posterior wall, n = 70.
Visualization and 15 W maximum: Ablation guided by barium visualization of the esophageal course using a limit of 15 W, n = 35.
Visualization and 25 W “short burns”: Ablation guided by barium visualization using 25 W and “short burns” (max. 5 sec), n = 35.
Patients performed under general anesthesia (n = 35) were separated as a nasogastric tube for visualization of the esophagus was used.
In total, we found 2.9% of patients (5/175) presenting ESUL. Parameters discriminating the development of ESUL in a specific patient were type of AF, maximum energy delivered, usage of a nasogastric tube, and additional left atrial lines. Visualization of the esophageal course by barium contrast was not able to prevent ESUL.
Conclusion: ESUL is a rare finding when using a reasonable energy maximum of 25 W with open-irrigated tip catheters at the posterior wall. Lower energy settings may increase safety without losing efficacy. Additional linear radiofrequency lesions increase the risk of ESUL development. Read more May 2013 · Journal of Cardiovascular Electrophysiology
Background:
Radiofrequency (RF) ablation in the posterior left atrium has risk of thermal injury to the adjacent esophagus. Increased intraluminal esophageal temperature has been correlated with risk of esophageal injury. The objective of this study was to compare esophageal temperature monitoring (ETM) using a multi-sensor temperature probe with 12 sensors to a single-sensor probe during
... [Show full abstract] catheter ablation for atrial fibrillation (AF).
Methods and results:
We compared the detection of intraluminal esophageal temperature rises in 543 patients undergoing RF ablation for AF with ETM. Esophageal endoscopy (EGD) was performed on all patients with maximum esophageal temperature ≥ 39°C. Esophageal lesions were classified by severity as mild or severe ulcerations. Four hundred fifty-five patients underwent RF ablation with single-sensor ETM and 88 patients with multi-sensor ETM. Thirty-nine percent of patients with single-sensor versus 75% with multi-sensor ETM reached a maximum detected esophageal temperature ≥ 39°C (P < 0.0001). Esophageal injury was detected by EGD in 29% of patients with maximum temperature ≥ 39°C by single-sensor versus 46% of patients with multi-sensor ETM (P = 0.021). Thirty-nine percent of patients with lesions in the single-sensor probe group had severe ulcerations compared to 33% of patients in the multi-sensor probe group (P = 0.641).
Conclusions:
Intraluminal esophageal temperature ≥ 39°C is detected more frequently by the multi-sensor temperature probe versus the single-sensor probe, with more frequent esophageal injury and with comparable severity of injury. Despite detecting esophageal temperature rises in more patients, the multi-sensor probe may not have any measurable benefit compared to a single-sensor probe. Read more Last Updated: 22 Feb 2022
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