TEE 3D RV Assessment for SAVR, Mini AVR, and TAVR
- Conditions
- Right Ventricular Dysfunction
- Interventions
- Diagnostic Test: 3D TEE RVEF
- Registration Number
- NCT05804240
- Lead Sponsor
- Thomas Jefferson University
- 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): surgical AVR (SAVR), mini-sternotomy AVR (mini AVR), 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 size, Right Ventricular Index of Myocardial Performance (RIMP), RV fractional area change (FAC), peak systolic velocity of the lateral tricuspid annulus (S'), tricuspid annular plane systolic excursion (TAPSE), speckle tracking echocardiography (STE) in SAVR, mini-sternotomy AVR (mini AVR), and TAVR.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 78
- 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
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Mini-sternotomy aortic valve replacement 3D TEE RVEF Patients who have mini-sternotomy aortic valve replacement Transcatheter aortic valve replacement 3D TEE RVEF Patients who have transcatheter aortic valve replacement Surgical aortic valve replacement 3D TEE RVEF Patients who have surgical aortic valve replacement
- Primary Outcome Measures
Name Time Method RV function assessment indices with TEE (RV FAC) For SAVR and mini AVR, post general anesthesia induction, post cardiopulmonary bypass, and after chest closure, up to the end of procedure. For TAVR, post general anesthesia induction and after valve deployment, up to the end of procedure. RV FAC
RV function assessment indices with TEE (RV size) For SAVR and mini AVR, post general anesthesia induction, post cardiopulmonary bypass, and after chest closure, up to the end of procedure. For TAVR, post general anesthesia induction and after valve deployment, up to the end of procedure. RV size
RV function assessment indices with TEE (3D RV EF) For SAVR and mini AVR, post general anesthesia induction, post cardiopulmonary bypass, and after chest closure, up to the end of procedure. For TAVR, post general anesthesia induction and after valve deployment, up to the end of procedure. 3D RV EF
RV function assessment indices with TEE (RIMP) For SAVR and mini AVR, post general anesthesia induction, post cardiopulmonary bypass, and after chest closure, up to the end of procedure. For TAVR, post general anesthesia induction and after valve deployment, up to the end of procedure. RIMP
RV function assessment indices with TEE (TAPSE) For SAVR and mini AVR, post general anesthesia induction, post cardiopulmonary bypass, and after chest closure, up to the end of procedure. For TAVR, post general anesthesia induction and after valve deployment, up to the end of procedure. TAPSE
RV function assessment indices with TEE (STE) For SAVR and mini AVR, post general anesthesia induction, post cardiopulmonary bypass, and after chest closure, up to the end of procedure. For TAVR, post general anesthesia induction and after valve deployment, up to the end of procedure. STE
RV function assessment indices with TEE (S') For SAVR and mini AVR, post general anesthesia induction, post cardiopulmonary bypass, and after chest closure, up to the end of procedure. For TAVR, post general anesthesia induction and after valve deployment, up to the end of procedure. S'
- Secondary Outcome Measures
Name Time Method Postoperative course in days Postoperative course till patient is discharged from hospital. From date of surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months Intubation time (if extubated in OR, it will be 0 day)
Hospital stay From date of surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months Postoperative course in days.
ICU stay From date of surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months Postoperative course in days
Trial Locations
- Locations (1)
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States