Viewing Study NCT05855148



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Last Modification Date: 2024-10-26 @ 2:58 PM
Study NCT ID: NCT05855148
Status: COMPLETED
Last Update Posted: 2023-05-11
First Post: 2023-03-30

Brief Title: Right Ventricle Dysfunction in Patients Undergoing Lung Transplant
Sponsor: Policlinico Hospital
Organization: Policlinico Hospital

Study Overview

Official Title: Right Ventricle Dysfunction in Patients Undergoing Lung Transplant
Status: COMPLETED
Status Verified Date: 2023-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: LUTX_strain
Brief Summary: Patients enlisted for bilateral lung transplantation LUTX have subclinical right ventricle RV dysfunction1 which is usually clinically silent until LUTX During LUTX several reasons ie sequential pulmonary arteries cross-clamp hypoxia hypercapnia lead to de-compensation of RV function cardiac failure and shock2 In this clinical scenario extracorporeal life support ECLS with cardiopulmonary bypass CBP or extracorporeal membrane oxygenation ECMO is emergently implemented

ECLS is associated with prolonged mechanical ventilation primary graft dysfunction PGD bleeding and graft rejection3 This may be due to 1 the activation of pro-inflammatory cascade due to blood-circuit contact 2 the increased need for allogenic blood components which per se has been associated to an increased risk of PGD4

Avoiding intraoperative ECLS may thus have significant positive clinical outcomes In the general cohort of patients undergoing LUTX pulmonary hypertension and right ventricular dysfunction have been identified as risk factors for intraoperative ECLS5

At enlistment for LUTX patients undergo a comprehensive evaluation of right cardiac function comprising transthoracic echocardiography pulmonary artery catheterization and calculation of RV ejection fraction RVEF by multiple gated radionuclide ventriculography Echocardiography is non-invasive can be performed repeatedly and at the bedside

The free-wall RV longitudinal strain RVLS is a novel echocardiographic method for quantification of myocardial deformation6 with high diagnostic accuracy to predict depressed RV ejection fraction RVLS may be used for non-invasive repeated and bedside assessment of RV function before LUTX We envision the employment of RVLS to document subclinical RV dysfunction before LUTX
Detailed Description: This study is a prospective observational cohort analysis of echocardiographic studies and medical records of consecutive patients who underwent LUTX at our Institution from January 2021 to March 2023 All patients enlisted for LUTX during the study period were considered for inclusion Exclusion criteria were 1 single LUTX 2 re-transplantation 3 patients bridged to LUTX with veno-venous ECLS 4 missing medical records At our Institution at enlistment for LUTX patients undergo a comprehensive cardiac evaluation comprising 1 invasive right heart catheterization 2 multi-gated radionuclide ventriculography 3 trans-thoracic echocardiography performed by a specialized cardiologist For further details on the management of LUTX at our Institution see Online Supplement Additional Methods

To conduct this study following enlistment the research team contacted the patients and a specialized sonographer SS and a specialized cardiologist PM blinded to the results of the enlistment echocardiography carried out a further echocardiographic examination for the measurement of RV strain Specifically a GE Vivid IQ machine GE Healthcare Milwaukee WI was used Images were acquired during breath holds with stable electrocardiographic recordings and digitally stored for subsequent offline analysis using EchoPAC Clinical Workstation Software GE Healthcare Milwaukee WI RV global longitudinal strain RVGLS and RV free wall strain RVFWS were calculated ex-post using conventional the two-dimensional echocardiographic apical 4-chamber 1718 or - when inaccessible - subcostal view

Thus according to the most recent data available patients were classified as having and abnormal -169 borderline between -169 and -192 and normal -192 RVFWLS

We obtained the following measurement following international guidelines right atrium RA area RV end-diastolic area RV EDA RV free wall thickness fractional area change FAC M-mode measured tricuspid annular plane excursion TAPSE pulsed-wave tissue Doppler imaging TDI tricuspid peak annulus systolic velocity S and pulmonary artery systolic pressure PAPs

The following data at the time of enlisting for LUTX were prospectively collected demographics weight height the indication to LUTX further aggregated in pulmonary fibrosis vs not pulmonary fibrosis comorbidities lung allocation score LAS oxygen requirement at rest spirometry arterial blood gas analyses diffusing capacity of carbon monoxide DLCO six-minute walking test 6MWT pulmonary arterial pressures and cardiac output by invasive cardiac catheterization pulmonary scintigraphy right ventricle ejection fraction RVEF measured by multi-gated radionuclide ventriculography

Statistical analysis Data were reported as the median first-third quartile and number of events percentage of the subgroup for continuous and categorical variables respectively Patients without an available echocardiographic window for RV evaluation were not considered for the echocardiographic analysis The Z-test was utilized to compare the patients population with standard normality values122122 The correlation between continuous variables was tested with the R2 linear regression Sensitivity specificity positive predictive value PPV and negative predictive values NPV and associated confidence intervals CI of RVFWS vs TAPSE FAC S multi-gated radionuclide ventriculography were computed Comparison between patients cohorts ie normal RVLS vs compromised RVLS was performed with Chi2 or Fisher Exact Test and logistic regressions as appropriate The odds ratios OR and associated 95 likelihood ratio-based confidence intervals were calculated Statistical significance was accepted at P 005 The JMP pro 160 SAS Cary NC was utilized

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None