Observational Hemodynamic Monitoring During LVAD Implantation Among Individuals With Advanced Heart Failure

Study Overview
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Brief Summary
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The overall objective of this pilot analysis is to characterize the hemodynamic changes that occur during implantation of a left ventricular assist device (LVAD) in patients with advanced heart failure - specifically, how right ventricular function is compromised as a result of LVAD implantation.

Official Title
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Observational Hemodynamic Monitoring During LVAD Implantation Among

Conditions
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Heart Failure, Circulatory Disorders Postprocedural Complication, Cardiomyopathy, Congestive, Surgery

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: individuals ≥ 18 years of age with severe heart failure (HF) and who have been approved by the advanced HF selection committee for LVAD implantation. Exclusion Criteria: Patients with pre-existing right ventricular (RV) dysfunction/failure, defined as: Imaging evidence of moderate-severe RV dysfunction on echocardiography Hemodynamic evidence of RV dysfunction with: a right-atrial pressure (RAP): pulmonary capillary wedge pressure (PCWP) ratio of ≥ 0.67 (note: this index compares pressures on the right [RAP] and left [PCWP] side of the heart; an RAP/PCWP ratio ≥ 0.67 provides hemodynamic evidence of RV dysfunction. Clinical evidence of preexisting RV dysfunction, as indicated by significant (3-4+ peripheral edema) and/or elevated jugular venous pressures on clinical examination. Patients with end-stage renal disease requiring hemodialysis Patients requiring temporary hemodynamic support prior to LVAD implantation with temporary LVADs, and/or veno-arterial extracorporeal membrane oxygenators (ECMO). Planned concurrent implantation of right ventricular assist device

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Advanced HF patients scheduled to undergo LVAD implantation<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Cardiovascular hemodynamics (invasive and noninvasive) | Cardiovascular hemodynamics will be measured both invasively and noninvasively as standard-of-care during LVAD implantation in the Operating Room (OR), and immediately afterwards in the CT-ICU unit prior to discharge. | During LVAD implant and for 12-24 hours during ICU admission | 
| Change in Heart Rate (HR) | Changes in HR will be evaluated during LVAD implantation in the OR, and immediately afterwards in the CT-ICU unit prior to discharge. | During LVAD implant and for 12-24 hours during ICU admission | 
| Change in Blood Pressure (BP) | Changes in BP will be evaluated during LVAD implantation in the OR, and immediately afterwards in the CT-ICU unit prior to discharge. | During LVAD implant and for 12-24 hours during ICU admission | 
| Change in Right Atrial (RA) pressure | Changes in RA pressure will be evaluated during LVAD implantation in the OR, and immediately afterwards in the CT-ICU unit prior to discharge. | During LVAD implant and for 12-24 hours during ICU admission | 
| Change in pulmonary pressure | Pulmonary pressure changes will be evaluated during LVAD implantation in the OR, and immediately afterwards in the CT-ICU unit prior to discharge. | During LVAD implant and for 12-24 hours during ICU admission | 
| Change in Cardiac output | Cardiac output changes will be evaluated during LVAD implantation in the OR, and immediately afterwards in the CT-ICU unit prior to discharge. | During LVAD implant and for 12-24 hours during ICU admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Right ventricular function | Right ventricular function will be evaluated during LVAD implantation in the OR, and immediately afterwards in the CT-ICU unit prior to discharge. | During LVAD implant and for 12-24 hours during ICU admission | 
| Change in Brain blood flow | Brain blood flow will be evaluated during LVAD implantation in the OR, and immediately afterwards in the CT-ICU unit prior to discharge. | During LVAD implant and for 12-24 hours during ICU admission |