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

Heart Failure Clinical Trial

— DVDDP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04890860
• Other study ID #: 2020/08
• Status: Completed
• Phase: N/A
• Start date: June 15, 2021
• Est. completion date: August 11, 2022

Study information

• Verified date: June 2021
• Source: CMC Ambroise Paré
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: August 11, 2022
• Est. primary completion date: August 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Diseases
• Heart Failure
• Heart Valve Diseases
• Postoperative Complications
• Ventricular Dysfunction
• Ventricular Dysfunction, Right

Intervention

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

Locations

Country	Name	City	State
France	CMC Ambroise Paré	Neuilly-sur-Seine

Sponsors (1)

Lead Sponsor	Collaborator
CMC Ambroise Paré

Country where clinical trial is conducted

France, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Echocardiographic acquisition	Feasability of all measurements (RV failure with the portal flow with Doppler)	First 24 hours post cardiac surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Cholestasis	Conjugate bilirubin elevation above 12 mmol/L	one week after surgery