Strain Analysis for Assessment of Myocardic Dysfunction During Orthotopic Liver Transplantation (STRAIN ETO)

Mycocardial systolic function (contractility) is an essential element of cardio-circulatory physiology during major visceral surgery, in particular during liver transplantation during which several factors are likely to be at the origin of a ventricular dysfunction: acute hemorrhage, major volume changes, acute pulmonary arterial hypertension and ischemia-reperfusion syndrome.

Ventricular dysfunction is an underestimated intraoperative liver transplantation phenomenon while it constitutes a risk factor for peroperative and postoperative morbidity and mortality established that graft function can be compromised through the phenomena of low cardiac output and hepatic congestion.

Also, better analyzing myocardial systolic function during liver transplantation could guide practitioners in the treatments to be undertaken, evaluate their effects and diagnose various complications.

In addition, the usual cardiac output measurement systems (transpulmonary thermodilution techniques and pulse wave contour analysis) are poorly suited to liver transplantation. Frequent variations in blood volume, vasomotor tone and temperature require regular recalibrations and prevent a continuous and reliable estimate of cardiac output.

Thus, the choice of hemodynamic monitoring during liver transplantation performed in our center is transesophageal ultrasound, a semi-invasive method with a favorable benefit-risk ratio in this category of the population. However, analysis of right ventricular systolic function by classical indices is difficult in transesophageal ultrasound for reasons of alignment of the ultrasound shot on the right ventricular. The analysis of left ventricular systolic function is complex due to the sudden variations in volume and the difficulty in carrying out planimetry measurements in real time.

Myocardial strain imaging has been developed in recent years and is widely validated for the assessment of left ventricular contractile function. It was subsequently applied to the exploration of the right ventricular. Its measurement can be performed from recordings on dedicated software.

Thus, the strain could make it possible to better assess myocardial systolic dysfunction in liver per-transplantation from the transesophageal echographic loops recorded in current practice at the different operating times. Strain measurements will be carried out a posteriori from the images which are acquired in a standard way during the operation.

Study Overview

• Status: Completed
• Conditions: Liver Transplant; Complications; Myocardial Dysfunction
• Intervention / Treatment: Procedure: Longitudinal strain obtained thanks to transesophageal ultrasound data recorded during liver transplantation

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• France
  • Rhone Alpes
    • Lyon, Rhone Alpes, France, 69004
      • Hôpital de la Croix Rousse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing a liver transplantation

Description

Inclusion Criteria:

• Age of 18 years old and more
• Patients undergoing a liver transplantation

Exclusion Criteria:

• Contraindication to transesophageal ultrasound
• Refusal to participate
• Age <18 years old

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient undergoing a liver transplantation; Patients undergoing a liver transplantation and able to have a transesopahageal ultrasound	Procedure: Longitudinal strain obtained thanks to transesophageal ultrasound data recorded during liver transplantation; Longitudinal strain of Left Ventricule and longitudinal strain of Right Ventricule free wall obtained thanks to TransEosophagal Ultrasound performed during the Liver Transplant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
variations of strain	Variations of left ventricular longitudinal strain and right ventricular free wall longitudinal strain obtained with transesophageal ultrasound data during each phase of orthotopic liver transplantation, The primary endpoint is to objective a myocardial dysfunction comparatively to baseline assessment.	The variations will be observed thanks to measurements done before incision, during the dissection phase, during the anhepatic period, during the reperfusion phase, during the biliary reconstruction and finally after the patient closure

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Actual): April 1, 2021
• Study Completion (Actual): May 30, 2021

Study Registration Dates

• First Submitted: August 31, 2021
• First Submitted That Met QC Criteria: August 31, 2021
• First Posted (Actual): September 8, 2021

Study Record Updates

• Last Update Posted (Actual): September 8, 2021
• Last Update Submitted That Met QC Criteria: August 31, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: CRC_GHN_2021_002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The individual participant data will not be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No