Ablation, Atrial Fibrillation, Esophageal Deviation
Conditions
Keywords
Atrial Fibrillation ablation, Esophageal Deviation, AF
Brief summary
In this randomized double-blind study, the investigators would like to compare standard practice (i.e., use of luminal esophageal temperature monitoring) to that of esophageal deviation during AF ablation. The investigators hypothesize that the strategy of esophageal deviation will result in safer ablation strategy with a reduction in the incidence of esophageal injury as assessed by endoscopy.
Detailed description
Catheter ablation is a commonly performed strategy employed for the treatment of atrial fibrillation. However ablation in the posterior wall of the left atrium can cause thermal injury to the esophagus. When significant thermal injury to the esophagus occurs, two significant complications can occur: 1) the formation of an atrio-esophageal fistula, and 2) gastrointestinal dysmotility. While the former is rate, it is an important complication since it can be fatal. The frequency of the latter complication is less well appreciated, but probably occurs in the range of 1:100 to 1:500. Currently luminal esophageal temperature monitoring is the most commonly employed modality to prevent such injury. However, there are limitations to its use, and atrio-esophageal fistulas have been reported even when using esophageal temperature monitoring. Esophageal deviation using either a TEE or EGD probe has been described in the literature, but the effectiveness and practicality of these techniques are suboptimal, and have therefore precluded their use in routine clinical practice. Recently, we have demonstrated that esophageal deviation is indeed possible using off-the-shelf equipment (a soft thoracic tube and endotracheal stylet) in patients undergoing AF ablation. In this randomized double-blind study, we will compare standard practice (i.e., use of luminal esophageal temperature monitoring) to esophageal deviation during AF ablation. We hypothesize that the strategy of esophageal deviation will result in safer ablation strategy with a reduction in the incidence of esophageal injury as assessed by endoscopy.
Interventions
DEVICEesophageal deviation with IDE device
esophageal deviation during AF ablation
Sponsors
Boston Scientific Corporation
Vivek Reddy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age \>18 - Age \< 80 yr * Documentation of atrial fibrillation (AF) * Referred for a first ever ablation procedure for AF (prior ablation of right-sided Typical flutter, or limited left-sided of an accessory pathway are permitted) * General anesthesia * All patients must understand and adhere to the requirements of the study and be willing to comply with the post study follow-up requirements.
Exclusion criteria
* Any reversible cause of AF (post-surgery, thyroid disorder, etc.) * INR \> 4.0 at the time of the procedure * H/o of severe esophageal ulcers, strictures, esophagitis or GERD * H/o Esophageal Surgery * Prior surgical or catheter ablation procedure for AF (except right atrial flutter ablation) * Any evidence of esophageal diverticulum or other structural abnormalities of the esophagus seen during baseline barium esophagogram * Significant abnormality on Swallowing Impairment Score * Mental impairment precluding signing consent or completing follow up * Patients with any other significant uncontrolled or unstable medical condition * Women who are known to be pregnant or have had a positive β-HCG test 7 days prior to procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Presence of Esophageal Injury | within 1 week of AF ablation procedure | The presence of esophageal injury as assessed by upper gastrointestinal endoscopy that is performed within 1 week of the procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedure Time | day 1, duration ofAF ablation procedure | Procedure time and fluoroscopic imaging with barium contrast time |
| Temperature | during AF ablation procedure (intraoperative) | Extent of temperature rise on the temperature monitoring probe |
| Swallowing Impairment Score | during AF ablation procedure (intraoperative) | Swallowing impairment during procedure - Scale from 0 (no impairment) to 4 (severe impairment). |
Countries
United States
Participant flow
Recruitment details
Recruitment began in November 2011, with enrollment beginning February 2012
Pre-assignment details
88 participants were consented, but 2 withdrew prior to randomization
Participants by arm
| Arm | Count |
|---|---|
| Esophageal Deviation esophageal deviation with IDE device during AF ablation | 36 |
| Temperature Monitoring luminal esophageal standing temperature monitoring alone | 33 |
| Total | 69 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | ineligible after signing consent | 2 | 0 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Temperature Monitoring | Total | Esophageal Deviation |
|---|---|---|---|
| Age, Continuous | 62.6 years STANDARD_DEVIATION 8.6 | 61.7 years STANDARD_DEVIATION 8.4 | 60.8 years STANDARD_DEVIATION 8.3 |
| CHADS Score | 1 units on a scale STANDARD_DEVIATION 0.9 | 0.83 units on a scale STANDARD_DEVIATION 0.9 | 0.7 units on a scale STANDARD_DEVIATION 0.8 |
| History of GERD | 4 Participants | 9 Participants | 5 Participants |
| Paroxysmal AF | 18 Participants | 38 Participants | 20 Participants |
| Persistent AF | 15 Participants | 31 Participants | 16 Participants |
| Sex: Female, Male Female | 6 Participants | 18 Participants | 12 Participants |
| Sex: Female, Male Male | 27 Participants | 51 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 36 | 0 / 33 |
| other Total, other adverse events | 7 / 36 | 4 / 33 |
| serious Total, serious adverse events | 2 / 36 | 3 / 33 |
Outcome results
Primary
Number of Participants With Presence of Esophageal Injury
The presence of esophageal injury as assessed by upper gastrointestinal endoscopy that is performed within 1 week of the procedure.
Time frame: within 1 week of AF ablation procedure
Population: 17 roll-in patients and two pre-procedure withdrawals are removed from the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Esophageal Deviation | Number of Participants With Presence of Esophageal Injury | 5 Participants |
| Temperature Monitoring | Number of Participants With Presence of Esophageal Injury | 4 Participants |
Secondary
Procedure Time
Procedure time and fluoroscopic imaging with barium contrast time
Time frame: day 1, duration ofAF ablation procedure
Population: 17 roll-in patients and two pre-procedure withdrawals are removed from the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Esophageal Deviation | Procedure Time | Fluoroscopy time | 21.1 minutes | Standard Deviation 9.9 |
| Esophageal Deviation | Procedure Time | Procedure duration | 3.39 minutes | Standard Deviation 1 |
| Temperature Monitoring | Procedure Time | Fluoroscopy time | 20.9 minutes | Standard Deviation 18.3 |
| Temperature Monitoring | Procedure Time | Procedure duration | 4.11 minutes | Standard Deviation 1.07 |
Secondary
Swallowing Impairment Score
Swallowing impairment during procedure - Scale from 0 (no impairment) to 4 (severe impairment).
Time frame: during AF ablation procedure (intraoperative)
Population: 17 roll-in patients and two pre-procedure withdrawals are removed from the analysis.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Esophageal Deviation | Swallowing Impairment Score | 0.67 units on a scale |
| Temperature Monitoring | Swallowing Impairment Score | 0.27 units on a scale |
Secondary
Temperature
Extent of temperature rise on the temperature monitoring probe
Time frame: during AF ablation procedure (intraoperative)
Population: 17 roll-in patients and two pre-procedure withdrawals are removed from the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Esophageal Deviation | Temperature | 0.26 Celsius | Standard Deviation 0.2 |
| Temperature Monitoring | Temperature | 1.1 Celsius | Standard Deviation 0.7 |