Association Between Portal Flow Pulsatility and Right Ventricular Dysfunction in the Postoperative Period of Cardiac Surgery (LIFESAVE)

Liver Infusion Flow Evaluation With ultraSound for Assessment of Right Ventricular Function: a Single cEnter Cohort Study (LIFESAVE)

Right ventricular dysfunction (RVD) after cardiac surgery is associated with ischemia and myocardial injury. While echocardiographic measures like Tricuspid Annular Plane Systolic Excursion (TAPSE) are frequently used to assess ventricular function, they have limitations in terms of accuracy. The pulmonary artery catheter remains the gold standard for assessing RVD.

This dysfunction is associated with an increased risk of both renal and hepatic failure, complications that significantly affect patient outcomes. Doppler ultrasound has emerged as a valuable tool in predicting these complications, particularly in monitoring portal circulation and hepatic perfusion.

This study aims to explore the association between portal flow pulsatility and RVD after cardiac surgery.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Postoperative Complications
• Intervention / Treatment: Other: Transthoracic and Transesophageal echography within 24 hours post cardiac surgery

Detailed Description

The postoperative right ventricular dysfunction (RVD) after cardiac surgery has been described since the 1990s. It is associated to various pathophysiological mechanisms, including ischemia from prolonged aortic clamping, cardioplegia defects, myocardial injury, and ischemia-reperfusion phenomena.

Many studies have observed reduced right ventricular function intraoperatively through transthoracic echocardiographic parameters like TAPSE, fractional area change, and longitudinal strain. However, accurately assessing RVD is challenging, as these parameters can be affected post-surgery without indicating true ventricular failure.

In this context, obtaining reliable and robust invasive hemodynamic measurements is crucial for accurate assessment of RVD.

The pulmonary artery catheter (PAC), or Swan-Ganz catheter remains the gold standard, providing precise information on right ventricular systolic and diastolic function, pulmonary artery pressures, left ventricular end-diastolic pressure, venous oxygen saturation, and cardiac output.

In cardiac surgery, venous congestion resulting from right ventricular dysfunction is closely associated with increased mortality, leading to renal and hepatic failure. Tools like Doppler ultrasound (of renal, portal, and hepatic veins) can predict renal failure risk.

Researchers developed the VEXUS score in 2020 to assess this risk, and recent research found an association between 50% portal flow pulsatility and RVD.

However, some aspects remain to be clarified, such as the significant association between portal venous flow pulsatility and altered TAPSE.

This prospective study aims to examine the association between portal flow pulsatility and right ventricular dysfunction after cardiac surgery.

• Study Type: Observational
• Enrollment (Actual): 32

Contacts and Locations

Study Locations

• France
  • Île-de-France Region
    • Neuilly-sur-Seine, Île-de-France Region, France, 92200
      • CMC Ambroise Paré Hartmann

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing cardiac surgery with cardiopulmonary bypass, presenting a risk factor for complicated postoperative management due to hemodynamic instability:

• Patients over 60 years old
• Preoperative left ventricular ejection fraction (LVEF) < 50%
• Surgery involving coronary artery bypass grafting and valve surgery
• Mitral valve surgery
• Preoperative creatinine clearance less than 30 ml/min

Description

Inclusion Criteria:

• Patient aged at least 18 years

• Patients undergoing cardiac surgery with cardiopulmonary bypass and presenting at least one risk factor for postoperative complications, including:

  • Patient over 60 years old
  • Preoperative left ventricular ejection fraction (LVEF) < 50%
  • Surgery involving both coronary artery bypass grafting and valve procedures
  • Mitral valve surgery
  • Preoperative creatinine clearance less than 30 ml/min
• Patient having signed the informed consent form in accordance with regulations
• Patient covered by social security or an equivalent healthcare system

Exclusion Criteria:

• Patient presenting a confounding factor for altered portal flow:

  • Tricuspid regurgitation greater than grade 2
  • Known cirrhosis
• Patient with intrahepatic arteriovenous malformations

• Patient at risk for pulmonary artery catheter insertion:

  • Tricuspid valve surgery
  • Pacemaker or implantable cardioverter-defibrillator in place
• Patient with an esophageal tract abnormalities contraindicating transesophageal echocardiography (TEE)
• Pregnant or breastfeeding women
• Patient unable to understand the information provided
• Patient under guardianship, curatorship, or legal protection
• Patients deprived of liberty

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Transthoracic and Transesophageal echography within 24 hours post cardiac surgery; Measurement of portal flow velocity using transthoracic echography, as well as measurement of the superior vena cava via transesophageal echography for predicting right ventricular dysfunction.	Other: Transthoracic and Transesophageal echography within 24 hours post cardiac surgery; Transthoracic and Transesophageal echography within 24 hours post cardiac surgery in patients at risk for postoperative complications

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure of Portal Vein Flow Pulsality	Measured by pulsed Doppler and calculated by the following formula: FP = (Vmax - Vmin) / Vmax × 100.	First 24 hours post cardiac surgery
Right ventricular (RV) function assessement	Right ventricular (RV) function will be assessed through invasive hemodynamic parameters measured by a pulmonary artery catheter.	First 24 hours post cardiac surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RV dysfunction	Will be evaluated with echocardiographic parameters: The systolic function is defined by the systolic excursion of the tricuspid annulus (TAPSE) < 17 mm and/or the systolic velocity of the tricuspid annulus (S' wave) < 9 cm/s.; Diastolic function is assessed by analyzing the tricuspid flow with pulsed tissue Doppler, where the E/A ratio is < 0.8, or an E/A ratio between 0.8 and 2 associated with an E/E' ratio > 6, or an E/A ratio > 2 with a Tei index (TDE) < 120 ms.	Maximum 30 days post cardiac surgery
Venous congestion	Venous congestion is measured via central venous catheter, or by echocardiographic findings	Maximum 30 days post cardiac surgery
Renal failure	Acute kidney injury (AKI) will be defined according to the KDIGO classification.	Maximum 30 days post cardiac surgery
Liver failure	As defined; Hyperbilirubinemia > 2 mg/dL; Elevated liver enzymes (AST > 110 U/L and ALT > 190 U/L)	Maximum 30 days post cardiac surgery
Association Between Portal Flow and Postoperative Complications, Including Cardiac Tamponade	Evaluation of the occurrence of cardiac tamponade.	Maximum 30 days post cardiac surgery
Association between Portal Flow and Postoperative complications, Including Cardiac arrhythmias	Evaluation of the occurrence of ventricular arrhythmias.	Maximum 30 days post cardiac surgery
Association between Portal Flow and Postoperative complications, Including initiation of extracorporeal renal replacement therapy	Evaluation of the occurrence of the need for initiation of extracorporeal renal replacement therapy (RRT)	Maximum 30 days post cardiac surgery
Association between Portal Flow and Postoperative complications, Including mechanical ventilation	Use of ventilatory support through mechanical ventilation	Maximum 30 days post cardiac surgery
Association between Portal Flow and Postoperative complications, Including catecholamine administration	Evaluation of the occurrence of catecholamine administration	Maximum 30 days post cardiac surgery
Association between Portal Flow and Postoperative complications, Including mortality	Mortality in the ICU and in the hospital	Maximum 30 days post cardiac surgery

Collaborators and Investigators

• Sponsor: CMC Ambroise Paré

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2025
• Primary Completion (Actual): July 4, 2025
• Study Completion (Actual): July 4, 2025

Study Registration Dates

• First Submitted: January 3, 2025
• First Submitted That Met QC Criteria: January 10, 2025
• First Posted (Actual): January 15, 2025

Study Record Updates

• Last Update Posted (Actual): December 1, 2025
• Last Update Submitted That Met QC Criteria: November 27, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: postoperative complication; transthoracic echocardiography; Swan-Ganz catheter; Right Ventricular Dysfunction; portal vein flow; Liver Infusion Flow; transesophageal echography
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Ventricular Dysfunction; Pathological Conditions, Signs and Symptoms; Heart Failure; Postoperative Complications; Ventricular Dysfunction, Right
• Other Study ID Numbers: 2024/04

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