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

Recruiting

• Conditions: Postoperative Complications; Heart Failure

• Registration Number: NCT06777355
• Lead Sponsor: CMC Ambroise Paré

Brief Summary

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.

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 Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-03
• Study First Submitted QC: 2025-01-10
• Study First Posted: 2025-01-15
• Study Start: 2025-02-24
• Last Update Submitted: 2025-04-10
• Last Update Posted: 2025-04-11
• Primary Completion: 2026-09-24
• Study Completion: 2026-10-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
RV dysfunction	Maximum 30 days post cardiac surgery	Will be evaluated with echocardiographic parameters: 1. 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.; 2. 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.
Venous congestion	Maximum 30 days post cardiac surgery	Venous congestion is measured via central venous catheter, or by echocardiographic findings
Renal failure	Maximum 30 days post cardiac surgery	Acute kidney injury (AKI) will be defined according to the KDIGO classification.
Liver failure	Maximum 30 days post cardiac surgery	As defined; 1. Hyperbilirubinemia \> 2 mg/dL; 2. Elevated liver enzymes (AST \> 110 U/L and ALT \> 190 U/L)
Association Between Portal Flow and Postoperative Complications, Including Cardiac Tamponade	Maximum 30 days post cardiac surgery	Evaluation of the occurrence of cardiac tamponade.
Association between Portal Flow and Postoperative complications, Including Cardiac arrhythmias	Maximum 30 days post cardiac surgery	Evaluation of the occurrence of ventricular arrhythmias.
Association between Portal Flow and Postoperative complications, Including initiation of extracorporeal renal replacement therapy	Maximum 30 days post cardiac surgery	Evaluation of the occurrence of the need for initiation of extracorporeal renal replacement therapy (RRT)
Association between Portal Flow and Postoperative complications, Including mechanical ventilation	Maximum 30 days post cardiac surgery	Use of ventilatory support through mechanical ventilation
Association between Portal Flow and Postoperative complications, Including catecholamine administration	Maximum 30 days post cardiac surgery	Evaluation of the occurrence of catecholamine administration
Association between Portal Flow and Postoperative complications, Including mortality	Maximum 30 days post cardiac surgery	Mortality in the ICU and in the hospital

Trial Locations

Locations (1)

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