Feasibility, safety, and efficacy of a novel preshaped nitinol esophageal deviator to successfully deflect the esophagus and ablate left atrium without esophageal temperature rise during atrial fibrillation ablation: The DEFLECT GUT study

Valay Parikh, Vijay Swarup, Jacob Hantla, Venkat Vuddanda, Tawseef Dar, Bharath Yarlagadda, Luigi Di Biase, Amin Al-Ahmad, Andrea Natale, Dhanunjaya Lakkireddy

Research output: Contribution to journalArticle

11 Citations (Scopus)

Abstract

Background: Esophageal thermal injury is a feared complication of radiofrequency ablation for atrial fibrillation (AF). Rise in luminal esophageal temperature (LET) limits the ability to deliver radiofrequency energy on the posterior wall of the left atrium. Objective: The purpose of this study was to evaluate the feasibility, safety, and efficacy of a mechanical esophageal deviation (ED) tool during AF ablation. Methods: We evaluated 687 patients who underwent radiofrequency ablation for AF. In 209 patients, the EsoSure (Northeast Scientific) was used to deflect the esophagus away from the ablation site. Propensity score matching was performed to obtain 180 patients each in the ED and non-ED arms. ED was used for LET rise seen in 61.7% of patients (111/180) and was used if the esophagus was in the line of ablation on fluoroscopy in 38.3% of patients (69/180). Results: Mean deviation of trailing edge of esophagus with EsoSure was 2.45 ± 0.9 cm (range 1–4.5). LET rise >1°C was significantly lower in the ED than non-ED group (3% vs 79.4%; P <.001). Mean LET rise was also lower in the ED arm (ED 0.34 ± 0.59 vs non-ED 1.66 ± 0.54; P <.001). Intraprocedural success of pulmonary vein antral isolation, was slightly improved in the ED arm than in the non-ED arm without statistical significance. AF recurrence was lower in the ED arm at 3-month, 6-month, and 1-year follow-up than in the non-ED arm. No ED-related complications were noted. Conclusion: Mechanical displacement of the esophagus with EsoSure seems to be feasible, safe, and efficacious in enabling adequate radiofrequency energy delivery to the posterior wall of the left atrium without significant LET rise and obvious clinical signs of esophageal injury.

Original languageEnglish (US)
JournalHeart Rhythm
DOIs
StateAccepted/In press - Jan 1 2018

Fingerprint

Heart Atria
Atrial Fibrillation
Esophagus
Safety
Temperature
Propensity Score
Pulmonary Veins
Fluoroscopy
Wounds and Injuries
Hot Temperature
nitinol
Recurrence

Keywords

  • Atrial fibrillation
  • Atrio-esophageal fistula
  • Catheter ablation
  • Esophageal deviation
  • Esophageal injury

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)

Cite this

Feasibility, safety, and efficacy of a novel preshaped nitinol esophageal deviator to successfully deflect the esophagus and ablate left atrium without esophageal temperature rise during atrial fibrillation ablation : The DEFLECT GUT study. / Parikh, Valay; Swarup, Vijay; Hantla, Jacob; Vuddanda, Venkat; Dar, Tawseef; Yarlagadda, Bharath; Di Biase, Luigi; Al-Ahmad, Amin; Natale, Andrea; Lakkireddy, Dhanunjaya.

In: Heart Rhythm, 01.01.2018.

Research output: Contribution to journalArticle

@article{f056b3c421e54835bbfb5e6f215fceb9,
title = "Feasibility, safety, and efficacy of a novel preshaped nitinol esophageal deviator to successfully deflect the esophagus and ablate left atrium without esophageal temperature rise during atrial fibrillation ablation: The DEFLECT GUT study",
abstract = "Background: Esophageal thermal injury is a feared complication of radiofrequency ablation for atrial fibrillation (AF). Rise in luminal esophageal temperature (LET) limits the ability to deliver radiofrequency energy on the posterior wall of the left atrium. Objective: The purpose of this study was to evaluate the feasibility, safety, and efficacy of a mechanical esophageal deviation (ED) tool during AF ablation. Methods: We evaluated 687 patients who underwent radiofrequency ablation for AF. In 209 patients, the EsoSure (Northeast Scientific) was used to deflect the esophagus away from the ablation site. Propensity score matching was performed to obtain 180 patients each in the ED and non-ED arms. ED was used for LET rise seen in 61.7{\%} of patients (111/180) and was used if the esophagus was in the line of ablation on fluoroscopy in 38.3{\%} of patients (69/180). Results: Mean deviation of trailing edge of esophagus with EsoSure was 2.45 ± 0.9 cm (range 1–4.5). LET rise >1°C was significantly lower in the ED than non-ED group (3{\%} vs 79.4{\%}; P <.001). Mean LET rise was also lower in the ED arm (ED 0.34 ± 0.59 vs non-ED 1.66 ± 0.54; P <.001). Intraprocedural success of pulmonary vein antral isolation, was slightly improved in the ED arm than in the non-ED arm without statistical significance. AF recurrence was lower in the ED arm at 3-month, 6-month, and 1-year follow-up than in the non-ED arm. No ED-related complications were noted. Conclusion: Mechanical displacement of the esophagus with EsoSure seems to be feasible, safe, and efficacious in enabling adequate radiofrequency energy delivery to the posterior wall of the left atrium without significant LET rise and obvious clinical signs of esophageal injury.",
keywords = "Atrial fibrillation, Atrio-esophageal fistula, Catheter ablation, Esophageal deviation, Esophageal injury",
author = "Valay Parikh and Vijay Swarup and Jacob Hantla and Venkat Vuddanda and Tawseef Dar and Bharath Yarlagadda and {Di Biase}, Luigi and Amin Al-Ahmad and Andrea Natale and Dhanunjaya Lakkireddy",
year = "2018",
month = "1",
day = "1",
doi = "10.1016/j.hrthm.2018.04.017",
language = "English (US)",
journal = "Heart Rhythm",
issn = "1547-5271",
publisher = "Elsevier",

}

TY - JOUR

T1 - Feasibility, safety, and efficacy of a novel preshaped nitinol esophageal deviator to successfully deflect the esophagus and ablate left atrium without esophageal temperature rise during atrial fibrillation ablation

T2 - The DEFLECT GUT study

AU - Parikh, Valay

AU - Swarup, Vijay

AU - Hantla, Jacob

AU - Vuddanda, Venkat

AU - Dar, Tawseef

AU - Yarlagadda, Bharath

AU - Di Biase, Luigi

AU - Al-Ahmad, Amin

AU - Natale, Andrea

AU - Lakkireddy, Dhanunjaya

PY - 2018/1/1

Y1 - 2018/1/1

N2 - Background: Esophageal thermal injury is a feared complication of radiofrequency ablation for atrial fibrillation (AF). Rise in luminal esophageal temperature (LET) limits the ability to deliver radiofrequency energy on the posterior wall of the left atrium. Objective: The purpose of this study was to evaluate the feasibility, safety, and efficacy of a mechanical esophageal deviation (ED) tool during AF ablation. Methods: We evaluated 687 patients who underwent radiofrequency ablation for AF. In 209 patients, the EsoSure (Northeast Scientific) was used to deflect the esophagus away from the ablation site. Propensity score matching was performed to obtain 180 patients each in the ED and non-ED arms. ED was used for LET rise seen in 61.7% of patients (111/180) and was used if the esophagus was in the line of ablation on fluoroscopy in 38.3% of patients (69/180). Results: Mean deviation of trailing edge of esophagus with EsoSure was 2.45 ± 0.9 cm (range 1–4.5). LET rise >1°C was significantly lower in the ED than non-ED group (3% vs 79.4%; P <.001). Mean LET rise was also lower in the ED arm (ED 0.34 ± 0.59 vs non-ED 1.66 ± 0.54; P <.001). Intraprocedural success of pulmonary vein antral isolation, was slightly improved in the ED arm than in the non-ED arm without statistical significance. AF recurrence was lower in the ED arm at 3-month, 6-month, and 1-year follow-up than in the non-ED arm. No ED-related complications were noted. Conclusion: Mechanical displacement of the esophagus with EsoSure seems to be feasible, safe, and efficacious in enabling adequate radiofrequency energy delivery to the posterior wall of the left atrium without significant LET rise and obvious clinical signs of esophageal injury.

AB - Background: Esophageal thermal injury is a feared complication of radiofrequency ablation for atrial fibrillation (AF). Rise in luminal esophageal temperature (LET) limits the ability to deliver radiofrequency energy on the posterior wall of the left atrium. Objective: The purpose of this study was to evaluate the feasibility, safety, and efficacy of a mechanical esophageal deviation (ED) tool during AF ablation. Methods: We evaluated 687 patients who underwent radiofrequency ablation for AF. In 209 patients, the EsoSure (Northeast Scientific) was used to deflect the esophagus away from the ablation site. Propensity score matching was performed to obtain 180 patients each in the ED and non-ED arms. ED was used for LET rise seen in 61.7% of patients (111/180) and was used if the esophagus was in the line of ablation on fluoroscopy in 38.3% of patients (69/180). Results: Mean deviation of trailing edge of esophagus with EsoSure was 2.45 ± 0.9 cm (range 1–4.5). LET rise >1°C was significantly lower in the ED than non-ED group (3% vs 79.4%; P <.001). Mean LET rise was also lower in the ED arm (ED 0.34 ± 0.59 vs non-ED 1.66 ± 0.54; P <.001). Intraprocedural success of pulmonary vein antral isolation, was slightly improved in the ED arm than in the non-ED arm without statistical significance. AF recurrence was lower in the ED arm at 3-month, 6-month, and 1-year follow-up than in the non-ED arm. No ED-related complications were noted. Conclusion: Mechanical displacement of the esophagus with EsoSure seems to be feasible, safe, and efficacious in enabling adequate radiofrequency energy delivery to the posterior wall of the left atrium without significant LET rise and obvious clinical signs of esophageal injury.

KW - Atrial fibrillation

KW - Atrio-esophageal fistula

KW - Catheter ablation

KW - Esophageal deviation

KW - Esophageal injury

UR - http://www.scopus.com/inward/record.url?scp=85050284707&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85050284707&partnerID=8YFLogxK

U2 - 10.1016/j.hrthm.2018.04.017

DO - 10.1016/j.hrthm.2018.04.017

M3 - Article

C2 - 29678784

AN - SCOPUS:85050284707

JO - Heart Rhythm

JF - Heart Rhythm

SN - 1547-5271

ER -