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

Recruiting
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
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
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Exclusion Criteria

Not provided

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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Mini-sternotomy aortic valve replacement3D TEE RVEFPatients who have mini-sternotomy aortic valve replacement
Transcatheter aortic valve replacement3D TEE RVEFPatients who have transcatheter aortic valve replacement
Surgical aortic valve replacement3D TEE RVEFPatients who have surgical aortic valve replacement
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
Postoperative course in daysPostoperative 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 stayFrom 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 stayFrom 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

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