Observational Hemodynamic Monitoring During LVAD Implantation Among
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Change in pulmonary pressure
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Change in pulmonary pressure
Time Frame: During LVAD implant and for 12-24 hours during ICU admission
Pulmonary pressure changes will be evaluated during LVAD implantation in the OR, and immediately afterwards in the CT-ICU unit prior to discharge.
Change in Cardiac output
Time Frame: During LVAD implant and for 12-24 hours during ICU admission
Cardiac output changes will be evaluated during LVAD implantation in the OR, and immediately afterwards in the CT-ICU unit prior to discharge.
Change in Cardiovascular hemodynamics (invasive and noninvasive)
Time Frame: During LVAD implant and for 12-24 hours during ICU admission
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.
Change in Heart Rate (HR)
Time Frame: During LVAD implant and for 12-24 hours during ICU admission
Changes in HR will be evaluated during LVAD implantation in the OR, and immediately afterwards in the CT-ICU unit prior to discharge.
Change in Right Atrial (RA) pressure
Time Frame: During LVAD implant and for 12-24 hours during ICU admission
Changes in RA pressure will be evaluated during LVAD implantation in the OR, and immediately afterwards in the CT-ICU unit prior to discharge.
Change in Blood Pressure (BP)
Time Frame: During LVAD implant and for 12-24 hours during ICU admission
Changes in BP will be evaluated during LVAD implantation in the OR, and immediately afterwards in the CT-ICU unit prior to discharge.
Secondary Outcomes
- Change in Right ventricular function(During LVAD implant and for 12-24 hours during ICU admission)
- Change in Brain blood flow(During LVAD implant and for 12-24 hours during ICU admission)