NCT05804240

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 78 (estimated)
• Sponsor: Thomas Jefferson University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Right Ventricular Dysfunction

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	3D TEE RVEF	With TEE package software, the investigators measure and calculate 3D TEE RVEF using mid esophageal 4 chamber view

Timeline

• Start date: 2023-04-01
• Primary completion: 2025-06-30
• Completion: 2025-06-30
• First posted: 2023-04-07
• Last updated: 2024-11-22

Locations

1 site across 1 country: United States