Dataset Information

Safety of an esophageal deviator for atrial fibrillation catheter ablation.

ABSTRACT:

Background

Esophageal thermal injury is a complication of atrial fibrillation (AF) ablation, and it can be avoided by esophageal deviation during left atrial posterior wall radiofrequency catheter ablation.

Objective

This study aimed to evaluate the safety of a nitinol-based mechanical esophageal displacement device (MEDD) and its performance.

Methods

This preclinical safety study was conducted on 20 pigs, with 10 undergoing radiofrequency AF ablation using the MEDD and 10 serving as a control group under anticoagulation but without radiofrequency application. Esophageal traumatic injuries were classified from 0 to 4 and were grouped as absent (grade 0), minor (grade 1 or 2), moderate (grade 3), or major risk lesions (grade 4) by anatomopathological study. Grades 1 and 2 were considered acceptable. Fluoroscopy was used to measure displacement.

Results

Five (25%) pigs developed traumatic lesions, 4 with grade 1 and 1 with grade 2 (2-mm superficial ulcer). There was no difference in lesion occurrence between the radiofrequency and control groups (30% and 20%, respectively; P = .43). Under rightward displacement, the right edge moved 23.9 (interquartile range [IQR] 21.3-26.3) mm and the left edge moved 16.3 (IQR 13.8-18.4) mm (P < .001) from baseline. Under leftward displacement, the right edge moved 13.5 (IQR 10.9-15.3) mm and the left edge moved 16.5 (IQR 12.3-18.5) mm (P = .07). A perforation to the pharyngeal diverticulum occurred in 1 pig, related to an accidental extubation.

Conclusion

In pigs, the MEDD demonstrated safety in relation to esophageal tissue, and successful deviation. Esophageal traumatic injuries were acceptable, but improper manipulation led to pharyngeal lesion.

SUBMITTER: Pereira R

PROVIDER: S-EPMC10513920 | biostudies-literature | 2023 Sep

REPOSITORIES: biostudies-literature

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Publications

Safety of an esophageal deviator for atrial fibrillation catheter ablation.

Pereira Renner R Pisani Cristiano C Aiello Vera V Cestari Idágene I Oyama Helena H Santos Osmar O Otubo Jorge J Moura Daniel D Scanavacca Mauricio M

Heart rhythm O2 20230809 9

<h4>Background</h4>Esophageal thermal injury is a complication of atrial fibrillation (AF) ablation, and it can be avoided by esophageal deviation during left atrial posterior wall radiofrequency catheter ablation.<h4>Objective</h4>This study aimed to evaluate the safety of a nitinol-based mechanical esophageal displacement device (MEDD) and its performance.<h4>Methods</h4>This preclinical safety study was conducted on 20 pigs, with 10 undergoing radiofrequency AF ablation using the MEDD and 10 ...[more]

PMID: 37744938

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Project description:AF is a heterogeneous rhythm disorder that is related to a wide spectrum of etiologies and has broad clinical presentations. Mechanisms underlying AF are complex and remain incompletely understood despite extensive research. They associate interactions between triggers, substrate and modulators including ionic and anatomic remodeling, genetic predisposition and neuro-humoral contributors. The pulmonary veins play a key role in the pathogenesis of AF and their isolation is associated to high rates of AF freedom in patients with paroxysmal AF. However, ablation of persistent AF remains less effective, mainly limited by the difficulty to identify the sources sustaining AF. Many theories were advanced to explain the perpetuation of this form of AF, ranging from a single localized focal and reentrant source to diffuse bi-atrial multiple wavelets. Translating these mechanisms to the clinical practice remains challenging and limited by the spatio-temporal resolution of the mapping techniques. AF is driven by focal or reentrant activities that are initially clustered in a relatively limited atrial surface then disseminate everywhere in both atria. Evidence for structural remodeling, mainly represented by atrial fibrosis suggests that reentrant activities using anatomical substrate are the key mechanism sustaining AF. These reentries can be endocardial, epicardial, and intramural which makes them less accessible for mapping and for ablation. Subsequently, early interventions before irreversible remodeling are of major importance. Circumferential pulmonary vein isolation remains the cornerstone of the treatment of AF, regardless of the AF form and of the AF duration. No ablation strategy consistently demonstrated superiority to pulmonary vein isolation in preventing long term recurrences of atrial arrhythmias. Further research that allows accurate identification of the mechanisms underlying AF and efficient ablation should improve the results of PsAF ablation.

Dataset Information

Safety of an esophageal deviator for atrial fibrillation catheter ablation.

Background

Objective

Methods

Results

Conclusion

Publications

Safety of an esophageal deviator for atrial fibrillation catheter ablation.

Similar Datasets

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