Right Ventricular Dysfunction
Conditions
Keywords
Right ventricular dysfunction, Three-dimensional transesophageal echocardiography, Surgical aortic valve replacement, Mini-sternotomy aortic valve replacement, Transcatheter aortic valve replacement
Brief summary
Three-dimensional echocardiography has become a gold standard to assess right ventricular (RV) function, and investigators plan to use 3D transesophageal echocardiography to assess RV function in 3 types of aortic valve replacement (AVR): full sternotomy surgical AVR (full-SAVR), mini-sternotomy surgical AVR (mini-SAVR), and transcatheter AVR (TAVR).
Detailed description
Objective: Right ventricular (RV) function is known to be a critical factor to determine postoperative outcome in cardiac surgery, and echocardiography plays an important role in RV function assessment. In the previous studies, RV function was reported to be more reduced in surgical aortic valve replacement (SAVR) than transcatheter aortic valve replacement (TAVR), but its assessment was performed by 2-dimensional echocardiography. On the other hand, three-dimensional (3D) echocardiography has been the gold standard to assess RV systolic function (EF: ejection fraction), and its intraoperative use is getting more useful in cardiac surgery given recent technological advance in echocardiography machines. However, realty is that RV function assessment is based on subjective information or traditional RV function indices, mostly due to unfamiliarity of 3D technique. In this study, the investigators plan to evaluate intraoperative RV function assessment by 3D transesophageal echocardiography (TEE). The investigators will compare 3D RV EF with other traditional RV function indices (RV fractional area change (FAC),, tricuspid annular plane systolic excursion (TAPSE) in full-SAVR, mini-SAVR, and TAVR.
Interventions
DIAGNOSTIC_TEST3D TEE RVEF
With TEE package software, the investigators measure and calculate 3D TEE RVEF using mid esophageal 4 chamber view
Sponsors
Thomas Jefferson University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients over 18 years old * Patients who had SAVR, mini AVR, or TAVR
Exclusion criteria
* Patients' refusal * Suboptimal echocardiography data for RVEF, RV size, RIMP, RVFAC, TAPSE, S', STE
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3D RVEF (Baseline) | For SAVR and mini AVR, baseline is post general anesthesia induction, and postop is after chest closure, up to the end of procedure. For TAVR, baseline is post general anesthesia induction, and postop is after valve deployment, up to the end of procedure. | RVEF assessed using 3D TEE at baseline |
| %Change in 3D RVEF (From Baseline to Postop) | For SAVR and mini AVR, baseline is post general anesthesia induction, and postop is after chest closure, up to the end of procedure. For TAVR, baseline is post general anesthesia induction, and postop is after valve deployment, up to the end of procedure. | (Postop 3D RVEF-baseline 3D RVEF)\*100/baseline 3D RVEF |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| TAPSE (Baseline) | For SAVR and mini AVR, baseline is post general anesthesia induction, and postop is after chest closure, up to the end of procedure. For TAVR, baseline is post general anesthesia induction, and postop is after valve deployment, up to the end of procedure. | TAPSE assessed using TEE at baseline |
| RV FAC (Baseline) | For SAVR and mini AVR, baseline is post general anesthesia induction, and postop is after chest closure, up to the end of procedure. For TAVR, baseline is post general anesthesia induction, and postop is after valve deployment, up to the end of procedure. | RV FAC assessed using TEE at baseline |
| %Change in RV FAC (From Baseline to Postop) | For SAVR and mini AVR, baseline is post general anesthesia induction, and postop is after chest closure, up to the end of procedure. For TAVR, baseline is post general anesthesia induction, and postop is after valve deployment, up to the end of procedure. | (Postop RV FAC-baseline 3D RV FAC)\*100/baseline RV FAC |
| %Change in TAPSE (From Baseline to Postop) | For SAVR and mini AVR, baseline is post general anesthesia induction, and postop is after chest closure, up to the end of procedure. For TAVR, baseline is post general anesthesia induction, and postop is after valve deployment, up to the end of procedure. | (Postop TAPSE-baseline TAPSE)\*100/baseline TAPSE |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORYoshihisa Morita, MD
Thomas Jefferson University
Participant flow
Recruitment details
The included patients were aged \> 18 years and underwent TAVR, mini-SAVR, and full-SAVR, or TAVR requiring intraoperative transesophageal echocardiography (TEE) between April 2023 and April 2025 at Thomas Jefferson University Hospital.
Pre-assignment details
Twenty-three (full-SAVR), 22 (mini-SAVR) and 24 (TAVR) patients were enrolled in the study. Two patients were excluded from the TAVR group owing to poor TEE image quality. Thus, there were 22 patients each in the TAVR and mini-SAVR groups and 23 patients in the full-SAVR group (a total of 67 patients)
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 67.57 years old STANDARD_DEVIATION 12.63 |
| Number of aortic stenosis valve disease patients aortic regurgitation | 4 Participants |
| Number of aortic stenosis valve disease patients aortic stenosis | 22 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 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 | 13 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 22 | 0 / 22 |
| other Total, other adverse events | 0 / 23 | 0 / 22 | 0 / 22 |
| serious Total, serious adverse events | 0 / 23 | 0 / 22 | 0 / 22 |
Outcome results
None listed