Clinical trial NCT05804240: TEE 3D RV Assessment for SAVR, 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Right Ventricular Dysfunction
Keywords: Right ventricular dysfunction
Three-dimensional transesophageal echocardiography
Surgical aortic valve replacement
Mini-sternotomy aortic valve replacement
Transcatheter aortic valve replacement
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2023-04-07
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients who had SAVR, mini AVR, and TAVR at Thomas Jefferson University Hospital

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.

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

Primary outcomes:
measure: RV function assessment indices with TEE (3D RV EF)
timeFrame: 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.
measure: RV function assessment indices with TEE (RV size)
timeFrame: 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.
measure: RV function assessment indices with TEE (RIMP)
timeFrame: 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.
measure: RV function assessment indices with TEE (RV FAC)
timeFrame: 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.
measure: RV function assessment indices with TEE (S')
timeFrame: 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.
measure: RV function assessment indices with TEE (TAPSE)
timeFrame: 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.
measure: RV function assessment indices with TEE (STE)
timeFrame: 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 outcomes:
measure: Postoperative course in days
timeFrame: 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
measure: ICU stay
timeFrame: 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
measure: Hospital stay
timeFrame: 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
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Yoshihisa Morita, MD
role: PRINCIPAL_INVESTIGATOR
References:
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