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

Not Applicable

Completed

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

• Registration Number: NCT04890860
• Lead Sponsor: CMC Ambroise Paré

Brief 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.

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 Timeline

• Study First Submitted: 2021-05-03
• Study First Submitted QC: 2021-05-12
• Study First Posted: 2021-05-18
• Status Verified: 2021-06
• Study Start: 2021-06-15
• Primary Completion: 2022-08-11
• Study Completion: 2022-08-11
• Last Update Submitted: 2023-03-01
• Last Update Posted: 2023-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Adults patients undergoing mitral and / or tricuspid valve surgery with cardiopulmonary bypass.	cardiac surgery involving mitral or tricuspid valve repair procedure, with cardiopulmonary bypass	-

Primary Outcome Measures

Name	Time	Method
Right ventricular failure	First 24 hours post cardiac surgery	1. systolic dysfunction (TAPSE below 16 mm or S wave below 9.5 cm/s); 2. RV fractional area change below 35%; 3. End-diastole diameter ratio between RV and left ventricle \> 0.6; 4. Ratio between S and D wave or inverse D wave in supra-hepatic veins
Portal flow measured by Doppler	First 24 hours post cardiac surgery	flow pulsatility is assessed with the formula = 100 x (Vmax-Vmin)/Vmax. Time frame: First 24 hours post cardiac surgery

Secondary Outcome Measures

Name	Time	Method
Echocardiographic acquisition	First 24 hours post cardiac surgery	Feasability of all measurements (RV failure with the portal flow with Doppler)
Concordance of pulsatile flow assessment	First 24 hours post cardiac surgery	Concordance of repeated measurements of the venous portal flow Time frame: First 24 hours post cardiac surgery
Concordance of RV dysfunction measurements	First 24 hours post cardiac surgery	Concordance of repeated measurements of : 1. systolic dysfunction (TAPSE below 16 mm or S wave below 9.5 cm/s); 2. RV fractional area change below 35%; 3. End-diastole diameter ratio between RV and left ventricle \> 0.6; 4. Ratio between S and D wave or inverse D wave in supra-hepatic veins
Preoperative RV dysfunction	30 days before cardiac surgery	As defined; 1. systolic dysfunction (TAPSE below 16 mm or S wave below 9.5 cm/s); 2. RV fractional area change below 35%; 3. End-diastole diameter ratio between RV and left ventricle \> 0.6; 4. Ratio between S and D wave or inverse D wave in supra-hepatic veins
Acute kidney injury	one week after surgery	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.
Cholestasis	one week after surgery	Conjugate bilirubin elevation above 12 mmol/L

Trial Locations

Locations (1)

CMC Ambroise Paré; 🇫🇷 Neuilly-sur-Seine, France