Intraoperative Global Longitudinal Strain and Global Longitudinal Strain Rate as Predictors of Unfavorable Outcome in On-Pump Mitral Surgery

Mitral Valve Disease Clinical Trial

— Mit-GO  

Official title:

Intraoperative Transesophageal Echocardiography in On-pump Mitral Surgery: A Single Center Prospective Observational Study of Global Longitudinal Strain and Global Longitudinal Strain Rate as Predictors of Unfavorable Outcome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04045340
• Other study ID #: MIT-GO-2019
• Status: Completed
• Start date: October 28, 2019
• Est. completion date: November 26, 2021

Study information

• Verified date: October 2020
• Source: Scientific Institute San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of the present study is to assess the best echocardiographic parameters (GLS, GLS rate and standard echocardiographic parameters) predicting LCOS in on-pump mitral surgery.

Description:

Low cardiac output syndrome (LCOS) is a common complication in cardiac surgery after weaning from cardiopulmonary bypass (CPB) associated with high morbidity and mortality. Its prompt recognition and management may mitigate the effect of LCOS on the outcome. To date, advanced age, prolonged CPB, urgent surgery and impaired left ventricular function assessed by left ventricular ejection fraction (LVEF) are commonly considered strong predictors of postoperative LCOS. Nevertheless, LVEF has several limitations including image quality, operator experience, limited reproducibility, inter- and intra-observer discrepancy and load/volume dependency. Global Longitudinal Strain (GLS), with automated speckle-tracking echocardiography (STE) may overcome several of the LVEF limitations. In fact, while the LVEF detects changes in left ventricular chamber volume, GLS reflects myocardial longitudinal deformation due to contraction. The rate of myocardial deformation over time (expressed as 1/s) is called GLS Rate. Global Longitudinal Strain, mostly evaluated from transthoracic echocardiography (TTE), has shown lower inter- and intra-observer variability, a better reproducibility and prognostic value compared to LVEF in a generic cardiac population. In addition the results of the GLS with TTE (GLS-TTE) may not be shifted in cardiac surgery due to the effect of the general anesthesia (GA) and positive pressure ventilation. Thus, these factors should be considered when the global longitudinal strain, evaluated from transesophageal echocardiography (GLS-TEE) is used as predictor of early outcome. Amabili et al. have shown that GLS-TEE is better than LVEF in predicting LCOS in a general cardiac surgery population. Similarly Sonny et al. in patients undergoing aortic valve surgery for stenosis have reported that a GLS-TEE and GLS-TEE Rate are superior to standard echocardiographic parameters in predicting a complicated course. To the best of our knowledge, there are no studies investigating the role of intraoperative evaluation of GLS-TEE and GLS-TEE Rate as predictors of LCOS in mitral valve surgery. In this setting LVEF is not a reliable marker of cardiac function due to a systematic overestimation of the ejection fraction. Moreover these patients are at high risk of postoperative cardiac dysfunction and LCOS owing to the afterload mismatch after mitral surgery. For the reasons mentioned above, more effective predictors are advocated. In the present study we try to fill the gap. Thus, aim of present study is to assess the role of GLS-TEE, GLS-TEE Rate and standard echocardiographic parameters in predicting LCOS in on-pump mitral surgery. In doing so, the best cut-off for each echocardiographic parameter will be provided. Finally to detect the effect of the GA, the echocardiographic parameters calculated after the induction of GA will be compared with those collected preoperatively. A telephonic follow-up will be performed at 30 days and 12-months investigating mortality and rehospitalization due to heart failure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: November 26, 2021
• Est. primary completion date: April 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients undergoing elective or urgent open mitral valve repair or mitral valve replacement over 18 years
• Ability to sign informed consent
• Availability of pre-CBP and after-CPB intraoperative transesophageal echocardiography which include a 4-chambers, 2-chambers and a long axis view at a minimum frame rate of 50 Hz
• Good quality echocardiographic images with a optimal endocardial definition
• Good quality ECG tracing

Exclusion Criteria:

• All patients undergoing emergent open mitral valve repair or mitral valve replacement
• Unavailability of pre-CBP and after-CPB intraoperative transesophageal echocardiography which include a 4-chambers, 2-chambers and a long axis view at a minimum frame rate of 50 Hz
• Poor quality echocardiographic images
• ECG artefacts

Related Conditions & MeSH terms

• Cardiac Output, Low
• Low Cardiac Output Syndrome
• Mitral Valve Disease

Intervention

Device:
• Philips QLAB Ultrasound Quantification Software
Offline processing of intraoperative transesophageal echocardiography would be performed with Global Longitudinal Strain on apical 4 chamber, apical 2 chamber and long axis views in order to analyze left ventricle and left atrium contractility and right ventricle free wall motion

Locations

Country	Name	City	State
Italy	Scientific Institute San Raffaele	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Scientific Institute San Raffaele

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Amabili P, Benbouchta S, Roediger L, Senard M, Hubert MB, Donneau AF, Brichant JF, Hans GA. Low Cardiac Output Syndrome After Adult Cardiac Surgery: Predictive Value of Peak Systolic Global Longitudinal Strain. Anesth Analg. 2018 May;126(5):1476-1483. doi — View Citation

Sonny A, Alfirevic A, Sale S, Zimmerman NM, You J, Gillinov AM, Sessler DI, Duncan AE. Reduced Left Ventricular Global Longitudinal Strain Predicts Prolonged Hospitalization: A Cohort Analysis of Patients Having Aortic Valve Replacement Surgery. Anesth An — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global longitudinal strain of myocardium in mitral valve surgery	Offline processing of GLS, GLS Rate	Intraoperative 6 hours
Primary	Number of patients with low cardiac output syndrome after mitral valve surgery		30 days
Primary	Global longitudinal strain threshold associated with LCOS after mitral valve surgery		Intraoperative 6 hours
Secondary	Effect of general anesthesia on systole and diastole		Intraoperative 6 hours
Secondary	All-cause mortality during the follow-up		30 days and 1years
Secondary	Length of intensive care unit stay		30 days
Secondary	Length of hospital stay		30 days
Secondary	30-day or in hospital mortality		30 days
Secondary	Duration of post-operative mechanical ventilation		30 days
Secondary	Post-operative rate of acute kidney injury		30 days
Secondary	Post-operative rate of hepatic dysfunction		30 days
Secondary	Readmission rate in intensive care		30 days