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

Completed

• Conditions: Low Cardiac Output Syndrome; Mitral Valve Disease

• Registration Number: NCT04045340
• Lead Sponsor: Scientific Institute San Raffaele

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2019-07-26
• Study First Submitted QC: 2019-08-02
• Study First Posted: 2019-08-05
• Study Start: 2019-10-28
• Status Verified: 2020-10
• Primary Completion: 2021-04-28
• Study Completion: 2021-11-26
• Last Update Submitted: 2022-12-02
• Last Update Posted: 2022-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients with low cardiac output syndrome after mitral valve surgery	30 days
Global longitudinal strain threshold associated with LCOS after mitral valve surgery	Intraoperative 6 hours
Global longitudinal strain of myocardium in mitral valve surgery	Intraoperative 6 hours	Offline processing of GLS, GLS Rate

Secondary Outcome Measures

Name	Time	Method
Length of hospital stay	30 days
30-day or in hospital mortality	30 days
Effect of general anesthesia on systole and diastole	Intraoperative 6 hours
Length of intensive care unit stay	30 days
Post-operative rate of acute kidney injury	30 days
All-cause mortality during the follow-up	30 days and 1years
Duration of post-operative mechanical ventilation	30 days
Post-operative rate of hepatic dysfunction	30 days
Readmission rate in intensive care	30 days

Trial Locations

Locations (1)

Scientific Institute San Raffaele; 🇮🇹 Milan, Italy