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

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): full sternotomy surgical AVR (full-SAVR), mini-sternotomy surgical AVR (mini-SAVR), and transcatheter AVR (TAVR).

Study Overview

• Status: Completed
• Conditions: Right Ventricular Dysfunction
• Intervention / Treatment: Diagnostic test: 3D TEE RVEF

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 fractional area change (FAC),, tricuspid annular plane systolic excursion (TAPSE) in full-SAVR, mini-SAVR, and TAVR.

• Study Type: Observational
• Enrollment (Actual): 67

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adult patients who had SAVR, mini AVR, and TAVR at Thomas Jefferson University Hospital

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Surgical aortic valve replacement; Patients who have surgical aortic valve replacement	Diagnostic test: 3D TEE RVEF; With TEE package software, the investigators measure and calculate 3D TEE RVEF using mid esophageal 4 chamber view
Mini-sternotomy aortic valve replacement; Patients who have mini-sternotomy aortic valve replacement	Diagnostic test: 3D TEE RVEF; With TEE package software, the investigators measure and calculate 3D TEE RVEF using mid esophageal 4 chamber view
Transcatheter aortic valve replacement; Patients who have transcatheter aortic valve replacement	Diagnostic test: 3D TEE RVEF; With TEE package software, the investigators measure and calculate 3D TEE RVEF using mid esophageal 4 chamber view

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3D RVEF (Baseline)	RVEF assessed using 3D TEE at baseline	For SAVR and mini AVR, baseline is post general anesthesia induction, and postop is after chest closure, up to the end of procedure. For TAVR, baseline is post general anesthesia induction, and postop is after valve deployment, up to the end of procedure.
%Change in 3D RVEF (From Baseline to Postop)	(Postop 3D RVEF-baseline 3D RVEF)*100/baseline 3D RVEF	For SAVR and mini AVR, baseline is post general anesthesia induction, and postop is after chest closure, up to the end of procedure. For TAVR, baseline is post general anesthesia induction, and postop is after valve deployment, up to the end of procedure.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TAPSE (Baseline)	TAPSE assessed using TEE at baseline	For SAVR and mini AVR, baseline is post general anesthesia induction, and postop is after chest closure, up to the end of procedure. For TAVR, baseline is post general anesthesia induction, and postop is after valve deployment, up to the end of procedure.
RV FAC (Baseline)	RV FAC assessed using TEE at baseline	For SAVR and mini AVR, baseline is post general anesthesia induction, and postop is after chest closure, up to the end of procedure. For TAVR, baseline is post general anesthesia induction, and postop is after valve deployment, up to the end of procedure.
%Change in RV FAC (From Baseline to Postop)	(Postop RV FAC-baseline 3D RV FAC)*100/baseline RV FAC	For SAVR and mini AVR, baseline is post general anesthesia induction, and postop is after chest closure, up to the end of procedure. For TAVR, baseline is post general anesthesia induction, and postop is after valve deployment, up to the end of procedure.
%Change in TAPSE (From Baseline to Postop)	(Postop TAPSE-baseline TAPSE)*100/baseline TAPSE	For SAVR and mini AVR, baseline is post general anesthesia induction, and postop is after chest closure, up to the end of procedure. For TAVR, baseline is post general anesthesia induction, and postop is after valve deployment, up to the end of procedure.

Collaborators and Investigators

• Sponsor: Thomas Jefferson University
• Investigators: Principal Investigator: Yoshihisa Morita, MD, Thomas Jefferson University

Publications and helpful links

General Publications

• Lang RM, Badano LP, Mor-Avi V, Afilalo J, Armstrong A, Ernande L, Flachskampf FA, Foster E, Goldstein SA, Kuznetsova T, Lancellotti P, Muraru D, Picard MH, Rietzschel ER, Rudski L, Spencer KT, Tsang W, Voigt JU. Recommendations for cardiac chamber quantification by echocardiography in adults: an update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. J Am Soc Echocardiogr. 2015 Jan;28(1):1-39.e14. doi: 10.1016/j.echo.2014.10.003.
• Ternacle J, Berry M, Cognet T, Kloeckner M, Damy T, Monin JL, Couetil JP, Dubois-Rande JL, Gueret P, Lim P. Prognostic value of right ventricular two-dimensional global strain in patients referred for cardiac surgery. J Am Soc Echocardiogr. 2013 Jul;26(7):721-6. doi: 10.1016/j.echo.2013.03.021. Epub 2013 Apr 25.
• Cremer PC, Zhang Y, Alu M, Rodriguez LL, Lindman BR, Zajarias A, Hahn RT, Lerakis S, Malaisrie SC, Douglas PS, Pibarot P, Svensson LG, Leon MB, Jaber WA. The incidence and prognostic implications of worsening right ventricular function after surgical or transcatheter aortic valve replacement: insights from PARTNER IIA. Eur Heart J. 2018 Jul 21;39(28):2659-2667. doi: 10.1093/eurheartj/ehy251.
• Kempny A, Diller GP, Kaleschke G, Orwat S, Funke A, Schmidt R, Kerckhoff G, Ghezelbash F, Rukosujew A, Reinecke H, Scheld HH, Baumgartner H. Impact of transcatheter aortic valve implantation or surgical aortic valve replacement on right ventricular function. Heart. 2012 Sep;98(17):1299-304. doi: 10.1136/heartjnl-2011-301203. Epub 2012 Jun 11.
• Koo TK, Li MY. A Guideline of Selecting and Reporting Intraclass Correlation Coefficients for Reliability Research. J Chiropr Med. 2016 Jun;15(2):155-63. doi: 10.1016/j.jcm.2016.02.012. Epub 2016 Mar 31.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Actual): June 30, 2025
• Study Completion (Actual): June 30, 2025

Study Registration Dates

• First Submitted: March 7, 2023
• First Submitted That Met QC Criteria: April 6, 2023
• First Posted (Actual): April 7, 2023

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Transcatheter aortic valve replacement; Surgical aortic valve replacement; Right ventricular dysfunction; Three-dimensional transesophageal echocardiography; Mini-sternotomy aortic valve replacement
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Ventricular Dysfunction; Ventricular Dysfunction, Right
• Other Study ID Numbers: iRISID-2022-0802

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No