Chest Pain, Coronary Artery Disease, Heart Diseases, STEMI, Stenosis Coronary
Conditions
Keywords
Heart, Chest Pain, Artery, Stenosis, TEE, CABG, Bypass
Brief summary
This goal of this study is to better understand when and where intraoperative transesophageal echocardiography (TEE) should (or should not) be used during coronary artery bypass graft (CABG) surgeries.
Detailed description
This trial will look at benefits and harms to two different treatments strategies in order to improve clinical outcomes. Intraoperative TEE is an ultrasound-based, imaging device that uses sound waves to look at the heart continuously during a heart surgery.
Interventions
DEVICETEE probe
Transesophageal echocardiography, ultrasound probe
Sponsors
University of Pennsylvania
National Institutes of Health (NIH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
(1) Default TEE: Where the TEE probe is placed after going under general anesthesia and a breathing tube is placed. TEE issued to take pictures of your heart before and after the CABG surgery. The TEE probe will remain in place throughout the surgery. (2) As-Needed TEE: Where the TEE probe is placed only in situations where a surgeon requires information that can only be obtained by ultrasound imaging of the heart.
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
1. Scheduled to undergo isolated CABG surgery at a hospital within the UPenn Health System 2. Age ≥18 years 3. Ejection fraction ≥50% 4. Transthoracic echocardiography within one year of scheduled surgery date 5. Left heart catheterization within one year of scheduled surgery date 6. English language fluency or facilitated via language interpreter 7. Able to provide informed consent either in English or via a language interpreter 8. Willing to comply with all study procedures
Exclusion criteria
1. Documented valve (aortic, mitral, tricuspid, or pulmonic) disease (stenosis or regurgitation) moderate or greater. 2. Any CABG surgery with either "possible" or "definite" aortic intervention listed as a planned part of the procedure. plan for either definite or possible surgical intervention. 3. Any CABG surgery with either "possible" or "definite" valve repair/replacement listed as a planned part of the procedure. 4. Having undergone any previous cardiac surgeries (i.e. scheduled with a "REDO" modifier). 5. Proximal/critical left main coronary disease (e.g. greater than or equal to 90% stenosis). 6. Preexisting anomalous coronary arteries 7. Preexisting end-stage renal disease on hemodialysis 8. Preexisting chronic kidney disease (CKD) stage 3, 4, or 5 9. Stroke with residual focal neurological deficit(s) within 90 days of surgery 10. Any of the following presurgical, mechanical circulatory support devices: 1. Intraaortic balloon pump 2. Percutaneous right ventricular assist device (RVAD) 3. Impella 4. Extracorporeal membrane oxygenation (ECMO) 11. Absolute contraindication to echocardiography defined as one or more of the following documented conditions: 1. Esophagectomy 2. Esophagogastrectomy 3. Esophageal trauma 12. Any of these three relative contraindication to TEE: 1. Esophageal varies 2. Gastric bypass surgery 3. Descending thoracic aortic aneurysm 13. Severe pulmonary hypertension defined as: 1. Pulmonary arterial pressure ≥60 mmHg 2. Pulmonary vascular resistance (PVR) ≥3 Woods Units 14. Hemodynamic instability after induction and following placement of an endotracheal tube will be defined as one or more of the following events or scenarios: 1. Placement of an intraaortic balloon pump (IABP) 2. Initiation of venoarterial extracorporeal membrane oxygenation (VAECMO) 3. Placement of a right or left percutaneous mechanical circulatory support device 4. Initiation of epinephrine infusion at a dose ≥ 6 mcg/min for a duration ≥5 minutes 5. Initiation of norepinephrine at a dose ≥8 mcg/min for a duration ≥ minutes 6. Initiation of phenylephrine infusion at a dose ≥100 mcg/min for a duration ≥ minutes 7. Initiation of vasopressin infusion at a dose ≥0.04 units/min for a duration ≥ minutes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Enrollment and Randomization Feasibility | At time of enrollment and randomization (baseline) | Enrollment and randomization feasibility defined as the proportion of patients approached for enrollment who consented and were successfully randomized. Of 72 patients approached for enrollment, 40 were randomized. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Protocol Adherence | During index surgical procedure (from induction of anesthesia to completion of surgery; typical duration approximately 5-8 hours) | Protocol adherence defined as receipt of the intraoperative transesophageal echocardiography strategy corresponding to randomized assignment. |
| Rescue Echocardiography Use in the Backup TEE Arm | During index surgical procedure (from induction of anesthesia to completion of surgery; typical duration approximately 5-8 hours) | Use of rescue transesophageal echocardiography among participants randomized to the Backup TEE strategy, defined as intraoperative TEE performed in response to a clinical indication per protocol. Of 20 participants randomized to Backup TEE, 3 (15%) received rescue TEE. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATOREmily MacKay, DO, MS
University of Pennsylvania, Penn Medicine
Baseline characteristics
| Characteristic | — |
|---|---|
| 1-2 Bypass Grafts | 3 Participants |
| >3 Bypass Grafts | 7 Participants |
| 3 Bypass Grafts | 10 Participants |
| Age, Continuous | 65.42 years STANDARD_DEVIATION 9.3 |
| Body Mass Index (BMI) | 29.44 Kg/m2 STANDARD_DEVIATION 5.28 |
| Chronic Obstructive Pulmonary Disease (COPD) | 2 Participants |
| Ejection Fraction | 60.15 % STANDARD_DEVIATION 6.51 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Hypertension | 34 Participants |
| Non-ST-segment elevation myocardial infarction (NSTEMI) | 6 Participants |
| Preoperative Serum Creatinine (Cr) | 1.01 mg/dL STANDARD_DEVIATION 0.21 |
| Proximal Left Main Coronary Disease | 9 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 33 Participants |
| Region of Enrollment United States | 20 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 18 Participants |
| Society of Thoracic Surgeons (STS) Predicted Risk of Morbidity or Mortality | 6.14 % predicted risk of morbidity or mortali STANDARD_DEVIATION 6.47 |
| Society of Thoracic Surgeons (STS) Predicted Risk of Mortality | 1.20 % predicted risk of mortality STANDARD_DEVIATION 1.61 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 1 / 19 |
| other Total, other adverse events | 0 / 21 | 0 / 19 |
| serious Total, serious adverse events | 2 / 21 | 1 / 19 |
Outcome results
None listed