Detection of Right Ventricular Dysfunction by Portal Vein Doppler After Cardiac Surgery (DVDDP)

Right ventricular (RV) failure after cardiac surgery is associated with morbidity and mortality, but is hard to diagnose with conventional echocardiographic means. RV dysfunction may be associated with hepatic congestion, which may have an effect on portal veinous flow, but this has not been extensively. The investigators aimed determine whether an increased pulsatility in the portal venous flow was associated with RV dysfunction, after cardiac surgery at risk of RV dysfunction: mitral and tricuspid valve procedures.

Study Overview

• Status: Completed
• Conditions: Heart Diseases; Heart Failure; Postoperative Complications; Heart Valve Diseases
• Intervention / Treatment: Other: cardiac surgery involving mitral or tricuspid valve repair procedure, with cardiopulmonary bypass

Detailed Description

In cardiac surgical patients, RV dysfunction is associated with organ hypoperfusion and venous congestion leading to increased morbidity and mortality.

Non-invasive methods used to assess RV function are 2D-echocardiographic measurement of tricuspid annular plane systolic excursion (TAPSE), RV ejection fraction (EF), RV fractional area change (FAC), 3D assessment of RV function, tissue Doppler assessment of velocities, and magnetic resonance imaging (MRI). Though MRI is the gold standard method to assess RV function, it cannot be used in the perioperative period.

In the present prospective observational study, The investigators investigated the association between the pattern of portal venous flow and RV function as assessed by echocardiography in the postoperative period.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Neuilly-sur-Seine, France, 92200
    • CMC Ambroise Paré

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• More than 18 years old
• Ability to provide an informed consent
• Planned mitral and / or tricuspid valve surgery under cardiopulmonary bypass.

Exclusion Criteria:

• Insufficient echogenicity

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adults patients undergoing mitral and / or tricuspid valve surgery with cardiopulmonary bypass.	Other: cardiac surgery involving mitral or tricuspid valve repair procedure, with cardiopulmonary bypass; cardiac surgery involving mitral or tricuspid valve repair procedure, with cardiopulmonary bypass

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Right ventricular failure	systolic dysfunction (TAPSE below 16 mm or S wave below 9.5 cm/s); RV fractional area change below 35%; End-diastole diameter ratio between RV and left ventricle > 0.6; Ratio between S and D wave or inverse D wave in supra-hepatic veins	First 24 hours post cardiac surgery
Portal flow measured by Doppler	flow pulsatility is assessed with the formula = 100 x (Vmax-Vmin)/Vmax. Time frame: First 24 hours post cardiac surgery	First 24 hours post cardiac surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Echocardiographic acquisition	Feasability of all measurements (RV failure with the 4 criteria: systolic dysfunction (TAPSE below 16 mm or S wave below 9.5 cm/s); RV fractional area change below 35%; End-diastole diameter ratio between RV and left ventricle > 0.6; Ratio between S and D wave or inverse D wave in supra-hepatic veins)	First 24 hours post cardiac surgery
Echocardiographic acquisition	Feasability of all measurements (RV failure with the portal flow with Doppler)	First 24 hours post cardiac surgery
Concordance of pulsatile flow assessment	Concordance of repeated measurements of the venous portal flow Time frame: First 24 hours post cardiac surgery	First 24 hours post cardiac surgery
Concordance of RV dysfunction measurements	Concordance of repeated measurements of : systolic dysfunction (TAPSE below 16 mm or S wave below 9.5 cm/s); RV fractional area change below 35%; End-diastole diameter ratio between RV and left ventricle > 0.6; Ratio between S and D wave or inverse D wave in supra-hepatic veins	First 24 hours post cardiac surgery
Preoperative RV dysfunction	As defined; systolic dysfunction (TAPSE below 16 mm or S wave below 9.5 cm/s); RV fractional area change below 35%; End-diastole diameter ratio between RV and left ventricle > 0.6; Ratio between S and D wave or inverse D wave in supra-hepatic veins	30 days before cardiac surgery
Acute kidney injury	defined by KDIGO criteria as creatininemia elevation above > 26 micromol/L during the first 48 hours or +50% during the first week, oliguria with urine output less than 0.5 mL/kg/h during 6 hours.	one week after surgery
Cholestasis	Conjugate bilirubin elevation above 12 mmol/L	one week after surgery

Collaborators and Investigators

• Sponsor: CMC Ambroise Paré

Publications and helpful links

General Publications

• Rudski LG, Lai WW, Afilalo J, Hua L, Handschumacher MD, Chandrasekaran K, Solomon SD, Louie EK, Schiller NB. Guidelines for the echocardiographic assessment of the right heart in adults: a report from the American Society of Echocardiography endorsed by the European Association of Echocardiography, a registered branch of the European Society of Cardiology, and the Canadian Society of Echocardiography. J Am Soc Echocardiogr. 2010 Jul;23(7):685-713; quiz 786-8. doi: 10.1016/j.echo.2010.05.010. No abstract available.
• Haddad F, Couture P, Tousignant C, Denault AY. The right ventricle in cardiac surgery, a perioperative perspective: II. Pathophysiology, clinical importance, and management. Anesth Analg. 2009 Feb;108(2):422-33. doi: 10.1213/ane.0b013e31818d8b92.
• Haddad F, Couture P, Tousignant C, Denault AY. The right ventricle in cardiac surgery, a perioperative perspective: I. Anatomy, physiology, and assessment. Anesth Analg. 2009 Feb;108(2):407-21. doi: 10.1213/ane.0b013e31818f8623.
• Denault AY, Beaubien-Souligny W, Elmi-Sarabi M, Eljaiek R, El-Hamamsy I, Lamarche Y, Chronopoulos A, Lambert J, Bouchard J, Desjardins G. Clinical Significance of Portal Hypertension Diagnosed With Bedside Ultrasound After Cardiac Surgery. Anesth Analg. 2017 Apr;124(4):1109-1115. doi: 10.1213/ANE.0000000000001812.

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2021
• Primary Completion (Actual): August 11, 2022
• Study Completion (Actual): August 11, 2022

Study Registration Dates

• First Submitted: May 3, 2021
• First Submitted That Met QC Criteria: May 12, 2021
• First Posted (Actual): May 18, 2021

Study Record Updates

• Last Update Posted (Actual): March 2, 2023
• Last Update Submitted That Met QC Criteria: March 1, 2023
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Echocardiography; Cardiac surgery; Doppler; Portal vein Doppler; Ventricular function; Right ventricular dysfunction
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Heart Diseases; Postoperative Complications; Heart Valve Diseases; Ventricular Dysfunction; Ventricular Dysfunction, Right
• Other Study ID Numbers: 2020/08

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