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

University of Colorado Denver (CU Denver)

Status: Completed

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

Study type: Observational

Funder types: Other

Identifiers

NCT03464981

17-2119

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

20 participants in 1 patient group

Advanced HF patients scheduled to undergo LVAD implantation