Cardiomyopathy, Congestive, Circulatory Disorders Postprocedural Complication, Heart Failure, Surgery
Conditions
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.
Interventions
None listed
Sponsors
University of Colorado, Denver
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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: 1. Imaging evidence of moderate-severe RV dysfunction on echocardiography 2. 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. 3. Clinical evidence of preexisting RV dysfunction, as indicated by significant (3-4+ peripheral edema) and/or elevated jugular venous pressures on clinical examination. 4. Patients with end-stage renal disease requiring hemodialysis 5. Patients requiring temporary hemodynamic support prior to LVAD implantation with temporary LVADs, and/or veno-arterial extracorporeal membrane oxygenators (ECMO). 6. Planned concurrent implantation of right ventricular assist device
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cardiac output | 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 Right Atrial (RA) pressure | 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 pulmonary pressure | 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 Cardiovascular hemodynamics (invasive and noninvasive) | 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) | 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 Blood Pressure (BP) | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Brain blood flow | During LVAD implant and for 12-24 hours during ICU admission | Brain blood flow will be evaluated during LVAD implantation in the OR, and immediately afterwards in the CT-ICU unit prior to discharge. |
| Change in Right ventricular function | During LVAD implant and for 12-24 hours during ICU admission | Right ventricular function will be evaluated during LVAD implantation in the OR, and immediately afterwards in the CT-ICU unit prior to discharge. |
Countries
United States
Outcome results
None listed