TEE 3D RV Assessment for SAVR, Mini AVR, and TAVR

Study Overview
=================
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.

Official Title
-----------------
Utility of Three-dimensional Transesophageal Echocardiography in Right Ventricular Function Assessment in Surgical Aortic Valve Replacement, Mini-sternotomy Aortic Valve Replacement, and Transcatheter Aortic Valve Replacement

Conditions
-----------------
Right Ventricular Dysfunction

Intervention / Treatment
-----------------
* Diagnostic Test: 3D TEE RVEF


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Surgical aortic valve replacement<br>Patients who have surgical aortic valve replacement | Diagnostic Test: 3D TEE RVEF<br>* With TEE package software, the investigators measure and calculate 3D TEE RVEF using mid esophageal 4 chamber view<br>|
| Mini-sternotomy aortic valve replacement<br>Patients who have mini-sternotomy aortic valve replacement | Diagnostic Test: 3D TEE RVEF<br>* With TEE package software, the investigators measure and calculate 3D TEE RVEF using mid esophageal 4 chamber view<br>|
| Transcatheter aortic valve replacement<br>Patients who have transcatheter aortic valve replacement | Diagnostic Test: 3D TEE RVEF<br>* With TEE package software, the investigators measure and calculate 3D TEE RVEF using mid esophageal 4 chamber view<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RV function assessment indices with TEE (3D RV EF) | 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. | 
| RV function assessment indices with TEE (RV size) | 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 function assessment indices with TEE (RIMP) | 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. | 
| RV function assessment indices with TEE (RV FAC) | 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 function assessment indices with TEE (S') | 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. | 
| RV function assessment indices with TEE (TAPSE) | 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. | 
| RV function assessment indices with TEE (STE) | 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative course in days | Intubation time (if extubated in OR, it will be 0 day) | 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 | 
| ICU stay | Postoperative course in days | 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 | 
| Hospital stay | Postoperative course in days. | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Right ventricular dysfunction, Three-dimensional transesophageal echocardiography, Surgical aortic valve replacement, Mini-sternotomy aortic valve replacement, Transcatheter aortic valve replacement