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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04045340
Acronym
Mit-GO
Enrollment
140
Registered
2019-08-05
Start date
2019-10-28
Completion date
2021-11-26
Last updated
2026-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Cardiac Output Syndrome, Mitral Valve Disease

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.

Interventions

DEVICEPhilips 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

Sponsors

Scientific Institute San Raffaele
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Global longitudinal strain of myocardium in mitral valve surgeryIntraoperative 6 hoursOffline processing of GLS, GLS Rate
Number of patients with low cardiac output syndrome after mitral valve surgery30 days
Global longitudinal strain threshold associated with LCOS after mitral valve surgeryIntraoperative 6 hours

Secondary

MeasureTime frame
Effect of general anesthesia on systole and diastoleIntraoperative 6 hours
All-cause mortality during the follow-up30 days and 1years
Length of intensive care unit stay30 days
Length of hospital stay30 days
30-day or in hospital mortality30 days
Duration of post-operative mechanical ventilation30 days
Post-operative rate of acute kidney injury30 days
Post-operative rate of hepatic dysfunction30 days
Readmission rate in intensive care30 days

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 6, 2026