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

University of Colorado, Denver20 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Heart Failure Circulatory Disorders Postprocedural Complication Cardiomyopathy, Congestive Surgery

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Colorado Hospital

Aurora, Colorado, United States

Outcomes

Primary Outcomes

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.