Relationship Between the Posterior Atrial Wall and the Esophagus: Esophageal Position and Temperature MEasurement During Atrial Fibrillation Ablation.

Atrial Arrhythmia Clinical Trial

— AWESOME-AF  

Official title:

Impact of Pulmonary Vein Isolation (PVI) Line Modification Based on the Multidetector Computed Tomography (MDCT)-Derived Fingerprinted Esophageal Distance to the Posterior Wall of the Left Atrium, on the Esophageal Temperature Raise Measured With an Intraluminal Esophageal Temperature Monitoring Lead. A Randomized Controlled Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04394923
• Other study ID #: AWESOME-AF
• Status: Completed
• Phase: N/A
• Start date: June 22, 2020
• Est. completion date: January 15, 2022

Study information

• Verified date: January 2022
• Source: Centro Medico Teknon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A multimodal strategy integrating esophageal visualization with the multidetector computed tomography (MDCT) and simultaneous temperature monitoring has never been put into practice. We have developed an isodistance map (esophageal print) to depict the atrio-esophageal relationship and to analyze the esophageal position peri procedurally. The present randomized study intends to analyze the usefulness of the esophageal print in predicting local thermal heating of the esophagus.

Description:

Primary objective: to validate the usefulness of the esophageal print in avoiding temperature rises caused by radiofrequency (RF) application at the left atrial (LA) posterior wall during atrial fibrillation ablation

Secondary objectives:

1. to establish if there is a linear relationship between intraesophageal temperature rise and atrio-esophageal distance as calculated by the MDCT-derived esophageal print.

2. to analyze the need for ablation line modification.

3. to analyze the need for energy (power settings, ablation index, ablation time, etc.) modification.

4. to develop a new multimodal approach to esophageal monitoring during AF/AT ablation.

Interventions

1. Pre-procedural scan and Esophageal Isodistance Print

The methods for the acquisition of the cardiac MDCT and the image processing have been described in Part 1. During the segmentation process, the epicardial layer of the posterior atrial wall and the esophageal wall have been defined. The distance between these two structures is computed at each epicardial point, allowing to create an esophageal print on top of the epicardial layer. The isodistance color map uses a color scale to depict a range of distance; red being the closest (< 1 mm) and purple being the most distant (> 4 mm). Yellow, green and blue will be considered the intermediate values.

2. Luminal esophageal temperature (LET) monitoring

A multi-thermocouple temperature probe (SensiTherm, St. Jude Medical, Inc., St. Paul, MN, USA) will be advanced via transnasal or transoral access into the esophagus once the patient is under general anesthesia. When the esophageal print is close to the ablation line, the temperature probe position will be adjusted under fluoroscopic guidance before application at each pair of pulmonary veins to ensure that it overlaps the ablation line. All esophageal temperature rises above 39 °C will be documented and RF application will be stopped.

3. Pulmonary vein ablation lines regarding Esophageal Isodistance Print

Before randomization, an investigator blinded to the esophageal position will draw the PVI ablation line around both pairs of veins based on the type of AF (closer to the ostium for paroxysmal AF and wider for persistent AF).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: January 15, 2022
• Est. primary completion date: March 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18 years.

• Indication for any atrial fibrillation or left atrial flutter ablation procedure.

• Documented episodes of atrial arrhythmia (AF/AT/AFL)

• Signed informed consent.

Exclusion Criteria:

• Age < 18 years.

• Pregnancy.

• Impossibility to perform CT Scan.

• Impossibility to perform transesophageal echocardiography or to insert esophageal temperature monitoring probe.

• Concomitant investigation treatments.

• Medical, geographical and social factors that make study participation impractical

• Inability to give written informed consent.

• Patient's refusal to participate in the study.

Related Conditions & MeSH terms

• Atrial Arrhythmia
• Atrial Fibrillation

Intervention

Procedure:
• Modification of the pulmonary vein ablation line
The ablation line previously drawn will be modified regarding the esophageal print position in order to avoid RF application within the red layer of the esophageal print.
• Regular PVI ablation
Blinded to the esophageal position based on the type of AF, closer to the ostium for paroxysmal AF and wider for persistent AF

Locations

Country	Name	City	State
Spain	Teknon Medical Center	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Centro Medico Teknon

Country where clinical trial is conducted

Spain, 

References & Publications (15)

Barbhaiya CR, Kumar S, Guo Y, Zhong J, John RM, Tedrow UB, Koplan BA, Epstein LM, Stevenson WG, Michaud GF. Global Survey of Esophageal Injury in Atrial Fibrillation Ablation: Characteristics and Outcomes of Esophageal Perforation and Fistula. JACC Clin Electrophysiol. 2016 Apr;2(2):143-150. doi: 10.1016/j.jacep.2015.10.013. Epub 2015 Dec 23. — View Citation

Halbfass P, Pavlov B, Müller P, Nentwich K, Sonne K, Barth S, Hamm K, Fochler F, Mügge A, Lüsebrink U, Kuhn R, Deneke T. Progression From Esophageal Thermal Asymptomatic Lesion to Perforation Complicating Atrial Fibrillation Ablation: A Single-Center Registry. Circ Arrhythm Electrophysiol. 2017 Aug;10(8). pii: e005233. doi: 10.1161/CIRCEP.117.005233. — View Citation

Kadado AJ, Akar JG, Hummel JP. Luminal esophageal temperature monitoring to reduce esophageal thermal injury during catheter ablation for atrial fibrillation: A review. Trends Cardiovasc Med. 2019 Jul;29(5):264-271. doi: 10.1016/j.tcm.2018.09.010. Epub 2018 Sep 19. Review. — View Citation

Kaneshiro T, Matsumoto Y, Nodera M, Kamioka M, Kamiyama Y, Yoshihisa A, Ohkawara H, Suzuki H, Takeishi Y. Anatomical predisposing factors of transmural thermal injury after pulmonary vein isolation. Europace. 2018 Jul 1;20(7):1122-1128. doi: 10.1093/europace/eux185. — View Citation

Kapur S, Barbhaiya C, Deneke T, Michaud GF. Esophageal Injury and Atrioesophageal Fistula Caused by Ablation for Atrial Fibrillation. Circulation. 2017 Sep 26;136(13):1247-1255. doi: 10.1161/CIRCULATIONAHA.117.025827. Review. — View Citation

Kennedy R, Good E, Oral H, Huether E, Bogun F, Pelosi F, Morady F, Chugh A. Temporal stability of the location of the esophagus in patients undergoing a repeat left atrial ablation procedure for atrial fibrillation or flutter. J Cardiovasc Electrophysiol. 2008 Apr;19(4):351-5. Epub 2007 Dec 12. — View Citation

Kirchhof P, Benussi S, Kotecha D, Ahlsson A, Atar D, Casadei B, Castella M, Diener HC, Heidbuchel H, Hendriks J, Hindricks G, Manolis AS, Oldgren J, Popescu BA, Schotten U, Van Putte B, Vardas P; ESC Scientific Document Group. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Eur Heart J. 2016 Oct 7;37(38):2893-2962. doi: 10.1093/eurheartj/ehw210. Epub 2016 Aug 27. — View Citation

Kottkamp H, Piorkowski C, Tanner H, Kobza R, Dorszewski A, Schirdewahn P, Gerds-Li JH, Hindricks G. Topographic variability of the esophageal left atrial relation influencing ablation lines in patients with atrial fibrillation. J Cardiovasc Electrophysiol. 2005 Feb;16(2):146-50. — View Citation

Lakkireddy D, Reddy YM, Atkins D, Rajasingh J, Kanmanthareddy A, Olyaee M, Dusing R, Pimentel R, Bommana S, Dawn B. Effect of atrial fibrillation ablation on gastric motility: the atrial fibrillation gut study. Circ Arrhythm Electrophysiol. 2015 Jun;8(3):531-6. doi: 10.1161/CIRCEP.114.002508. Epub 2015 Mar 14. — View Citation

Lemola K, Sneider M, Desjardins B, Case I, Han J, Good E, Tamirisa K, Tsemo A, Chugh A, Bogun F, Pelosi F Jr, Kazerooni E, Morady F, Oral H. Computed tomographic analysis of the anatomy of the left atrium and the esophagus: implications for left atrial catheter ablation. Circulation. 2004 Dec 14;110(24):3655-60. Epub 2004 Nov 29. — View Citation

Sánchez-Quintana D, Cabrera JA, Climent V, Farré J, Mendonça MC, Ho SY. Anatomic relations between the esophagus and left atrium and relevance for ablation of atrial fibrillation. Circulation. 2005 Sep 6;112(10):1400-5. Epub 2005 Aug 29. — View Citation

Starek Z, Lehar F, Jez J, Scurek M, Wolf J, Kulik T, Zbankova A. Esophageal positions relative to the left atrium; data from 293 patients before catheter ablation of atrial fibrillation. Indian Heart J. 2018 Jan - Feb;70(1):37-44. doi: 10.1016/j.ihj.2017.06.013. Epub 2017 Jun 29. — View Citation

Suenari K, Nakano Y, Hirai Y, Ogi H, Oda N, Makita Y, Ueda S, Kajihara K, Tokuyama T, Motoda C, Fujiwara M, Chayama K, Kihara Y. Left atrial thickness under the catheter ablation lines in patients with paroxysmal atrial fibrillation: insights from 64-slice multidetector computed tomography. Heart Vessels. 2013 May;28(3):360-8. doi: 10.1007/s00380-012-0253-6. Epub 2012 Apr 22. — View Citation

Tsao HM, Wu MH, Higa S, Lee KT, Tai CT, Hsu NW, Chang CY, Chen SA. Anatomic relationship of the esophagus and left atrium: implication for catheter ablation of atrial fibrillation. Chest. 2005 Oct;128(4):2581-7. — View Citation

Zellerhoff S, Ullerich H, Lenze F, Meister T, Wasmer K, Mönnig G, Köbe J, Milberg P, Bittner A, Domschke W, Breithardt G, Eckardt L. Damage to the esophagus after atrial fibrillation ablation: Just the tip of the iceberg? High prevalence of mediastinal changes diagnosed by endosonography. Circ Arrhythm Electrophysiol. 2010 Apr;3(2):155-9. doi: 10.1161/CIRCEP.109.915918. Epub 2010 Mar 1. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants presenting a temperature rise as measured with a luminal esophageal temperature probe during radiofrequency delivery. The temperature is measured in Celsius degrees.	Number of intraesophageal temperature rises above 39°C or absolute temperature raises of 2°C degrees. The chosen probe is St Jude	1 day
Secondary	Proportion of patients needing ablation power or ablation time modification owing to esophageal presence in the immediate posterior wall .	Modification of the ablation parameters.Power is measured in Watts during radiofrequency application. Ablation time is measured in seconds of radiofrequency application. Both measures are provided by the electroanatomical navigation system.	1 day