Dataset Information

Effect of esophageal cooling on ablation lesion formation in the left atrium: Insights from Ablation Index data in the IMPACT trial and clinical outcomes.

ABSTRACT:

Introduction

The IMPACT study established the role of controlled esophageal cooling in preventing esophageal thermal injury during radiofrequency (RF) ablation for atrial fibrillation (AF). The effect of esophageal cooling on ablation lesion delivery and procedural and patient outcomes had not been previously studied. The objective was to determine the effect of esophageal cooling on the formation of RF lesions, the ability to achieve procedural endpoints, and clinical outcomes.

Methods

Participants in the IMPACT trial underwent AF ablation guided by Ablation Index (30 W at 350-400 AI posteriorly, 40 W at ≥450 AI anteriorly). A blinded 1:1 randomization assigned patients to the use of the ensoETM® device to keep esophageal temperature at 4°C during ablation or standard practice using a single-sensor temperature probe. Ablation parameters and clinical outcomes were analyzed.

Results

Procedural data from 188 patients were analyzed. Procedure and fluoroscopy times were similar, and all pulmonary veins were isolated. First-pass pulmonary vein isolation and reconnection at the end of the waiting period were similar in both randomized groups (51/64 vs. 51/68; p = 0.54 and 5/64 vs. 7/68; p = 0.76, respectively). Posterior wall isolation was also similar: 24/33 versus 27/38; p = 0.88. Ablation effect on tissue, measured in impedance drop, was no different between the two randomized groups: 8.6Ω (IQR: 6-11.8) versus 8.76Ω (IQR: 6-12.2; p = 0.25). Arrhythmia recurrence was similar after 12 months (21.1% vs. 24.1%; 95% CI: 0.38-1.84; HR: 0.83; p = 0.66).

Conclusions

Esophageal cooling has been shown to be effective in reducing ablation-related thermal injury during RF ablation. This protection does not compromise standard procedural endpoints or clinical success at 12 months.

SUBMITTER: Leung LWM

PROVIDER: S-EPMC10091801 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature

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Publications

Effect of esophageal cooling on ablation lesion formation in the left atrium: Insights from Ablation Index data in the IMPACT trial and clinical outcomes.

Leung Lisa W M LWM Akhtar Zaki Z Elbatran Ahmed I AI Bajpai Abhay A Li Anthony A Norman Mark M Kaba Riyaz R Sohal Manav M Zuberi Zia Z Gallagher Mark M MM

Journal of cardiovascular electrophysiology 20221102 12

<h4>Introduction</h4>The IMPACT study established the role of controlled esophageal cooling in preventing esophageal thermal injury during radiofrequency (RF) ablation for atrial fibrillation (AF). The effect of esophageal cooling on ablation lesion delivery and procedural and patient outcomes had not been previously studied. The objective was to determine the effect of esophageal cooling on the formation of RF lesions, the ability to achieve procedural endpoints, and clinical outcomes.<h4>Metho ...[more]

PMID: 36284450

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Project description:Esophageal thermal injury is one of the most feared risks of ablation of the posterior left atrium despite the various devices used to monitor esophageal temperature or deviate the esophagus. Reactive cooling, in which cold water is manually instilled into the esophagus via an orogastric tube in response to rises in luminal esophageal temperature (LET), has been used by operators, but the availability of a dedicated esophageal cooling device offers the ability to provide proactive esophageal cooling without having to react to individual temperature rises in the esophagus. The objective of this study was to evaluate the feasibility of using a commercially available esophageal cooling device to provide esophageal protection during left atrial catheter ablation, then to compare this approach to standard LET monitoring with reactive cooling via manual cold-water instillation. In this study, we randomized 6 patients undergoing catheter ablation for atrial fibrillation. Three patients received the standard of care for our site (use of a single-sensor temperature probe, with adjunct ice-water instillation for any temperature increases of >1°C). Three patients underwent standard ablation after placement of the esophageal cooling device at a circulating water temperature of 4°C, without the use of any esophageal temperature monitoring. All patients underwent transesophageal echocardiography and esophagogastroduodenoscopy on the day prior to the ablation, followed by a second esophagogastroduodenoscopy the day after. The 6 patients in this study were enrolled between March and August 2018. In the 3 control patients, 1 had no evidence of esophageal mucosal damage, 1 had diffuse sloughing of the esophageal mucosa and multiple ulcerations, and 1 had a superficial ulcer with a large clot. Both patients with lesions were classified as 2a cases using the Zargar grading scheme for caustic injury. In the 3 patients treated with the cooling device, 1 had no evidence of esophageal mucosal damage, 1 had esophageal erythema (Zargar grade 1), and 1 had a solitary Zargar grade 2a lesion. At 3 months of follow-up, 1 patient in each group had recurrence of atrial fibrillation. Although a number of subsequent studies have confirmed the reduction of esophageal injury with the use of proactive esophageal cooling, this study is the only one to date to compare reactive cooling (via manual cold-water instillation) and proactive cooling (via a dedicated esophageal cooling device). Moreover, this is the first study to support the feasibility of using a dedicated cooling device for this purpose and provides the basis for further investigation.

Project description:Pulmonary vein isolation (PVI) with radiofrequency ablation (RFA) is the cornerstone of atrial fibrillation (AF) therapy, but few strategies exist for when it fails. To guide RFA, phase singularity (PS) mapping locates reentrant electrical waves (rotors) that perpetuate AF. The goal of this study was to test existing and develop new RFA strategies for terminating rotors identified with PS mapping. It is unsafe to test experimental RFA strategies in patients, so they were evaluated in silico using a bilayer computer model of the human atria with persistent AF (pAF) electrical (ionic) and structural (fibrosis) remodeling. pAF was initiated by rapidly pacing the right (RSPV) and left (LSPV) superior pulmonary veins during sinus rhythm, and rotor dynamics quantified by PS analysis. Three RFA strategies were studied: (i) PVI, roof, and mitral lines; (ii) circles, perforated circles, lines, and crosses 0.5-1.5 cm in diameter/length administered near rotor locations/pathways identified by PS mapping; and (iii) 4-8 lines streamlining the sequence of electrical activation during sinus rhythm. As in pAF patients, 2 ± 1 rotors with cycle length 185 ± 4 ms and short PS duration 452 ± 401 ms perpetuated simulated pAF. Spatially, PS density had weak to moderate positive correlations with fibrosis density (RSPV: r = 0.38, p = 0.35, LSPV: r = 0.77, p = 0.02). RFA PVI, mitral, and roof lines failed to terminate pAF, but RFA perforated circles and lines 1.5 cm in diameter/length terminated meandering rotors from RSPV pacing when placed at locations with high PS density. Similarly, RFA circles, perforated circles, and crosses 1.5 cm in diameter/length terminated stationary rotors from LSPV pacing. The most effective strategy for terminating pAF was to streamline the sequence of activation during sinus rhythm with >4 RFA lines. These results demonstrate that co-localizing 1.5 cm RFA lesions with locations of high PS density is a promising strategy for terminating pAF rotors. For patients immune to PVI, roof, mitral, and PS guided RFA strategies, streamlining patient-specific activation sequences during sinus rhythm is a robust but challenging alternative.

Dataset Information

Effect of esophageal cooling on ablation lesion formation in the left atrium: Insights from Ablation Index data in the IMPACT trial and clinical outcomes.

Introduction

Methods

Results

Conclusions

Publications

Effect of esophageal cooling on ablation lesion formation in the left atrium: Insights from Ablation Index data in the IMPACT trial and clinical outcomes.

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