3D Assessment of RV Function in Patients Undergoing LVAD Implantation

Study Overview
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Brief Summary
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This goal of this study is to analyze images of the right ventricle taken via 3D transesophageal echocardiography (TEE) during left ventricular assist device (LVAD) implantation.

Detailed Description
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There are two chambers in the heart known as ventricles which are responsible for pumping blood to both the lungs and the rest of the body. The right ventricle pumps blood to the lungs for oxygenation. The left ventricle then delivers this oxygenated blood to the organs in the body. When the left ventricle is damaged enough that it is not able to effectively pump blood then it may be necessary to assist it with a mechanical pump. This pump is called left ventricular assist device (LVAD). Left ventricular assist devices (LVADs) improve quality of life and survival in patients with end stage heart failure. However, right ventricular (RV) failure is common in 20-50% of LVAD recipients and is associated with perioperative complications. Traditional two-dimensional ultrasound views of the right ventricle may not accurately depict how well or poorly the right ventricle is working. Three-dimensional (3D) images can overcome the limitations of two-dimensional images and are becoming more commonplace. This goal of this study is to analyze images of the right ventricle taken via 3D transesophageal echocardiography (TEE) during the LVAD implantation to help predict which patients are at higher risk of right ventricular failure within 14 days of the procedure.

Official Title
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Three-Dimensional Assessment of Right Ventricular Function in Patients Undergoing Left Ventricular Assist Device Implantation

Conditions
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Heart Failure

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients will be eligible to be included in the study if they receive either a left-sided: HeartMate III (Thoratec, Pleasanton, CA) HeartWare HVAD (HeartWare, Oakville CA) Levitronix CentriMag (Levitronix LLC, Waltham, MA) LVAD. Exclusion Criteria: Patients will be excluded if:: hemodynamic data needed to calculate PAPi or comprehensive echocardiographic images are missing additional procedures affecting cardiac geometry and/or hemodynamic measurements, such as tricuspid, mitral, and/or aortic valve repair/replacement, were performed at the time of LVAD implantation sternal closure at the end of the procedure is not possible RV mechanical support was introduced concurrently with LVAD implantation inadequate image quality required to obtain a 3D protocol known contraindication to TEE unexpected inability to advance probe into the mid-esophagus

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular strain | Prognostic indicator of hypertensive heart failure | 24 hours | 
| Right ventricular fractional area of change | Percentage change in the RV chamber area between end-diastole to end-systole | 24 hours | 
| Right ventricular free wall strain | Prognostic indicator of pulmonary arterial hypertension | 24 hours | 
| Right ventricular end diastolic volume | Amount of blood in the heart's right ventricle just before the heart contracts | 24 hours | 
| Light ventricular end diastolic volume | Amount of blood in the heart's left ventricle just before the heart contracts | 24 hours | 
| Right ventricular end systolic volume | Amount of blood in the heart's right ventricle just after the heart contracts | 24 hours | 
| Left ventricular end systolic volume | Amount of blood in the heart's left ventricle just after the heart contracts | 24 hours | 
| Right ventricular ejection fraction | Amount of blood being pumped out of the right ventricle each time it contracts. | 24 hours | 
| Left ventricular ejection fraction | Amount of blood being pumped out of the left ventricle each time it contracts. | 24 hours | 
| Tricuspid annular plane systolic excursion | Parameter of global right ventricular function | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Age | Demographic measure | 1 day | 
| Gender | Demographic measure | 1 day | 
| Body Surface Area | Demographic measure | 1 day | 
| Central venous pressure | Pressure in the thoracic vena cava near the right atrium | 14 days | 
| Pulmonary artery pulsatility index | Hemodynamic index | 14 days | 
| Need for right ventricular mechanical support | Circulatory support | 14 days | 
| Need for pulmonary vasodilators | Supportive medication | 14 days | 
| Need for vasopressors | Supportive medications | 14 days | 
| Aspartate aminotransferase | Lab test (> or qual to 80 IU/L) | 14 days | 
| Bilirubin | Lab test (> 2.0 mg/dL) | 14 days | 
| Creatinine | Lab test (> or equal to 2.3 mg/dL) | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Right Ventricular Function, Left Ventricular Assist Device, 3D transesophageal echocardiography