Atrial Fibrillation
Conditions
Brief summary
Evaluating contrast enhanced ECG-gated cardiac CT (CCT) as an alternative to transesophageal echocardiography (TEE) to expedite cardioversion of atrial fibrillation (AF), improve patient care and reduce hospital admissions for AF and atrial flutter.
Interventions
DIAGNOSTIC_TESTContrast enhanced ECG-gated cardiac CT (CCT)
Contrast enhanced ECG-gated cardiac CT (CCT) is a sensitive, noninvasive alternative method used to exclude of left atrial and LAA thrombus. CCT provides high spatial and good temporal resolution and its ability to detect thrombus has been evaluated. CCT, compared to TEE, for the exclusion of thrombus in the LAA had a sensitivity and specificity of 100% and 99.3%, respectively. A high sensitivity is needed to minimize risk of embolus, and if a thrombus is detected on CT, a confirmatory TEE may be performed or patients may receive anticoagulation. Some argue that the potential benefits of CT and its lower associated procedural risk, the risk:benefit ratio would still favour CT.
DIAGNOSTIC_TESTTransesophageal Echocardiography (TEE)
TEE is considered the reference standard to rule-out left atrial (LA) and left atrial appendage (LAA) thrombus prior to cardioversion. Several studies have examined the accuracy of TEE for detecting LAA thrombus. Compared to autopsy and intraoperative findings, TEE has a mean sensitivity of 100% and mean specificity of 99%. Although the gold standard, a TEE-guided therapy is still associated with an embolic rate of 0.8%.
Sponsors
Ottawa Heart Institute Research Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Admitted patients who require LA imaging prior to cardioversion 2. Age ≥18 years old 3. Able and willing to comply with the study procedures
Exclusion criteria
1. Indication for acute cardioversion (e.g. hemodynamic instability, acute coronary syndrome (ACS), or pulmonary edema) 2. Unwillingness or inability to provide informed consent 3. Contraindication to Cardiac CT * Severe renal insufficiency(GFR\< 45ml/min) * Allergy to intravenous contrast agents * Contraindications to radiation exposure (for example, pregnancy) * Inability to perform 20-second breath-hold 4. Contraindication to TEE * Unrepaired tracheoesophageal fistula * Esophageal obstruction or stricture * Perforated hollow viscus * Poor airway control * Severe respiratory depression * Uncooperative, unsedated patient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Imaging | From admission to imaging/spontaneous cardioversion, up to approximately 30 days. | This outcome was measured by calculating the time between admission and imaging. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Cardioversion | From admission to cardioversion, up to approximately 30 days | This outcome was measured by calculating the time between admission and cardioversion. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time to Hospital Discharge | From admission to hospital discharge, up to approximately 90 days. | This outcome was measured by calculating the time between admission and hospital discharge. |
| QoL | At hospital discharge | This outcome was calculated from the following QoLs: European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) and Atrial Fibrillation Impact (AFImpact). EQ-5D-5L health score is a continuous scale from 0 to 100 with 100 being the best outcome. AFImpact scores were calculated using a seven-point Likert Scale (1=none of the time, 7=all of the time). AFImpact-Vitality, Emotional Distress, Sleep score (AFImpact-VEDS) was calculated using all questions in the questionnaire. The difference between AFImpact-VEDS scores at hospital admission and discharge was calculated where minimum change in score is 0 and maximum change in score is 108. AFImpact-emotional distress subscale score was calculated using 8 questions about emotional distress. The difference between AFImpact emotional distress scores at hospital admission and discharge was calculated where minimum change in score is 0 and maximum change in score is 48. The higher change in AFImpact scores represented a better outcome. |
Countries
Canada
Participant flow
Recruitment details
Total of 102 participants, 52 were randomized to CCT and 50 to TEE
Participants by arm
| Arm | Count |
|---|---|
| TEE Arm TEE will be performed as per clinical routine using multiple standard tomographic planes to rule-out LA/LAA thrombus. Echocardiographic analysis will include: LAA-emptying velocity, and grading the severity of LAA spontaneous ECHO. The severity of the SEC will be graded on a 4 point scale with 1 = minor homogeneous contrast enhancement, 2 = significant homogeneous contrast enhancement, 3 = significant, dense, and inhomogeneous, slow-moving contrast, and 4 = dense slow-moving contrast.
Transesophageal Echocardiography (TEE): TEE is considered the reference standard to rule-out left atrial (LA) and left atrial appendage (LAA) thrombus prior to cardioversion. Several studies have examined the accuracy of TEE for detecting LAA thrombus. Compared to autopsy and intraoperative findings, TEE has a mean sensitivity of 100% and mean specificity of 99%. Although the gold standard, a TEE-guided therapy is still associated with an embolic rate of 0.8%. | 50 |
| CCT Arm A non-contrast enhanced prospective ECG-triggered image acquisition will be acquired. This will be followed by a contrast-enhanced prospective ECG-triggered will be acquired using tri-phasic contrast protocols. Delayed CT images will be acquired 60 seconds after initial contrast-enhanced CT scan.Cardiac CT image interpretation will be performed as per clinical routine. The LA and LAA will be assess for filling defects and characterized based upon attenuation values. If LA/LAA thrombus cannot be excluded, filling defects will be assessed on the delay images. Increases in attenuation would be consistent with pseudo-thrombus from 'slow flow' and 'incomplete opacification'. Areas where attenuation does not change significantly (persistent filling defect) will be diagnosed as thrombus. It will be recommended that patients with thrombus will undergo TEE.
Contrast enhanced ECG-gated cardiac CT (CCT): Contrast enhanced ECG-gated cardiac CT (CCT) is a sensitive, noninvasive alternative method used to exclude left atrial and LAA thrombus. CCT provides high spatial and good temporal resolution and its ability to detect thrombus has been evaluated. | 52 |
| Total | 102 |
Baseline characteristics
| Characteristic | TEE Arm | Total | CCT Arm |
|---|---|---|---|
| Age, Continuous | 67.2 years STANDARD_DEVIATION 11.8 | 66.76 years STANDARD_DEVIATION 11.52 | 66.3 years STANDARD_DEVIATION 11.3 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Canada | 50 participants | 102 participants | 52 participants |
| Sex: Female, Male Female | 14 Participants | 28 Participants | 14 Participants |
| Sex: Female, Male Male | 36 Participants | 74 Participants | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 50 | 1 / 52 |
| other Total, other adverse events | 14 / 50 | 17 / 52 |
| serious Total, serious adverse events | 0 / 50 | 0 / 52 |
Outcome results
Primary
Time to Imaging
This outcome was measured by calculating the time between admission and imaging.
Time frame: From admission to imaging/spontaneous cardioversion, up to approximately 30 days.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TEE Arm | Time to Imaging | 28.1 hours | Standard Deviation 34.9 |
| CCT Arm | Time to Imaging | 7.1 hours | Standard Deviation 12.5 |
Secondary
Time to Cardioversion
This outcome was measured by calculating the time between admission and cardioversion.
Time frame: From admission to cardioversion, up to approximately 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TEE Arm | Time to Cardioversion | 4.6 days | Standard Deviation 11.1 |
| CCT Arm | Time to Cardioversion | 1.7 days | Standard Deviation 1.8 |
Other Pre-specified
QoL
This outcome was calculated from the following QoLs: European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) and Atrial Fibrillation Impact (AFImpact). EQ-5D-5L health score is a continuous scale from 0 to 100 with 100 being the best outcome. AFImpact scores were calculated using a seven-point Likert Scale (1=none of the time, 7=all of the time). AFImpact-Vitality, Emotional Distress, Sleep score (AFImpact-VEDS) was calculated using all questions in the questionnaire. The difference between AFImpact-VEDS scores at hospital admission and discharge was calculated where minimum change in score is 0 and maximum change in score is 108. AFImpact-emotional distress subscale score was calculated using 8 questions about emotional distress. The difference between AFImpact emotional distress scores at hospital admission and discharge was calculated where minimum change in score is 0 and maximum change in score is 48. The higher change in AFImpact scores represented a better outcome.
Time frame: At hospital discharge
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TEE Arm | QoL | European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) | 68.1 score | Standard Deviation 18.2 |
| TEE Arm | QoL | AFImpact-Vitality, Emotional Distress, Sleep score (AFImpact-VEDS) | 8.5 score | Standard Deviation 4.2 |
| TEE Arm | QoL | Atrial Fibrillation Impact (AFImpact)-emotional distress | 3.0 score | Standard Deviation 1.8 |
| CCT Arm | QoL | European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) | 75.3 score | Standard Deviation 15.5 |
| CCT Arm | QoL | AFImpact-Vitality, Emotional Distress, Sleep score (AFImpact-VEDS) | 7.5 score | Standard Deviation 3.5 |
| CCT Arm | QoL | Atrial Fibrillation Impact (AFImpact)-emotional distress | 2.4 score | Standard Deviation 1.2 |
Other Pre-specified
Time to Hospital Discharge
This outcome was measured by calculating the time between admission and hospital discharge.
Time frame: From admission to hospital discharge, up to approximately 90 days.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TEE Arm | Time to Hospital Discharge | 6.7 days | Standard Deviation 6.9 |
| CCT Arm | Time to Hospital Discharge | 7.0 days | Standard Deviation 10.8 |