Heart Failure, Right Ventricular Dysfunction, Right Ventricular Failure
Conditions
Keywords
LVAD, LVAD-related complications, right ventricular dysfunction, hemocompatibility-related adverse events, hemodynamic-related events, post-operative right ventricular management, right ventricular failure
Brief summary
This project evaluates right ventricle (RV) protective strategies after left ventricular assist device (LVAD) implantation.
Detailed description
The main purpose of this study is to learn more about protecting against RV dysfunction and RV failure (RVF) in patients receiving LVAD implantations. This is a prospective, randomized controlled study that will include 20 patients with heart failure undergoing LVAD implantation. Patients will receive their LVAD implantation as part of routine care. Patients will be randomized 1:1 to one of two arms, 1) standardized RV management arm, and 2) usual care RV management arm, which are both consistent with standard of care (SOC).
Interventions
OTHERStandardized RV Management
Standardized parameters for post-operative management (i.e., Rhythm Management, Ventilation Management, RV Ischemia Management, RV Preload, RV Afterload, RV Contractility, and RV Geometry)
OTHERUsual Care RV Management
No standardized parameters for post-operative management (i.e., Rhythm Management, Ventilation Management, RV Ischemia Management, RV Preload, RV Afterload, RV Contractility, and RV Geometry)
Sponsors
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Undergoing durable LVAD implantation without plan for perioperative right ventricular mechanical circulatory support
Exclusion criteria
* Patients with pre-operative right ventricular mechanical circulatory support or having high likelihood of requiring right ventricular mechanical circulatory support. * Patients with RV implantable cardiac device (ICD)/pacemaker lead who are pacemaker-dependent * Pregnant patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in cardiac power output (CPO) pre-LVAD implantation to end of hemodynamic monitoring post-LVAD implantation | Baseline, end of hemodynamic monitoring (about Day 10) | CPO measured by pulmonary artery catheter |
| Change in right atrial pressure (RAP) pre-LVAD implantation to post-operative day 7 | Baseline, Day 7 | RAP measured by pulmonary artery catheter |
| Change in right atrial pressure (RAP) pre-LVAD implantation to end of hemodynamic monitoring post-LVAD implantation | Baseline, end of hemodynamic monitoring (about Day 10) | RAP measured by pulmonary artery catheter |
| Change in right atrial pressure/pulmonary capillary wedge pressure (RAP/PCWP) pre-LVAD implantation to post-operative day 3 | Baseline, Day 3 | RAP/PCWP measured by pulmonary artery catheter |
| Change in right atrial pressure/pulmonary capillary wedge pressure (RAP/PCWP) pre-LVAD implantation to post-operative day 7 | Baseline, Day 7 | RAP/PCWP measured by pulmonary artery catheter |
| Change in right atrial pressure/pulmonary capillary wedge pressure (RAP/PCWP) pre-LVAD implantation to end of hemodynamic monitoring post-LVAD implantation | Baseline, end of hemodynamic monitoring (about Day 10) | RAP/PCWP measured by pulmonary artery catheter |
| Change in pulmonary artery pulsatility index (PAPI) pre-LVAD implantation to post-operative day 3 | Baseline, Day 3 | PAPI measured by pulmonary artery catheter |
| Change in pulmonary artery pulsatility index (PAPI) pre-LVAD implantation to post-operative day 7 | Baseline, Day 7 | PAPI measured by pulmonary artery catheter |
| Change in pulmonary artery pulsatility index (PAPI) pre-LVAD implantation to end of hemodynamic monitoring post-LVAD implantation | Baseline, end of hemodynamic monitoring (about Day 10) | PAPI measured by pulmonary artery catheter |
| Change in right ventricle stroke work index (RVSWI) pre-LVAD implantation to post-operative day 3 | Baseline, Day 3 | RVSWI measured by pulmonary artery catheter |
| Change in right ventricle stroke work index (RVSWI) pre-LVAD implantation to post-operative day 7 | Baseline, Day 7 | RVSWI measured by pulmonary artery catheter |
| Change in right ventricle stroke work index (RVSWI) pre-LVAD implantation to end of hemodynamic monitoring post-LVAD implantation | Baseline, end of hemodynamic monitoring (about Day 10) | RVSWI measured by pulmonary artery catheter |
| Change in cardiac power output (CPO) pre-LVAD implantation to post-operative day 3 | Baseline, Day 3 | CPO measured by pulmonary artery catheter |
| Change in cardiac power output (CPO) pre-LVAD implantation to post-operative day 7 | Baseline, Day 7 | CPO measured by pulmonary artery catheter |
| Change in right atrial pressure (RAP) pre-LVAD implantation to post-operative day 3 | Baseline, Day 3 | RAP measured by pulmonary artery catheter |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| RV failure defined by the 2020 Academic Research Consortium (ARC) | Through duration of hospitalization, up to 30 days following LVAD implantation | The ARC definition of RVF stratifies patients based on the onset of RVF (e.g. early acute right heart failure, early post-implant right heart failure, or late right heart failure) requiring inotropic therapy or RVAD implantation during LVAD implantation, \<30 days post-operatively, or \>30 days post-operatively, respectively |
| Inotropic therapy | Through duration of hospitalization, up to 30 days following LVAD implantation | Total number of inotropes used |
| Vasopressor therapy | Through duration of hospitalization, up to 30 days following LVAD implantation | Total number of vasopressors used |
| Total time on inhaled nitric oxide | Through duration of hospitalization, up to 30 days following LVAD implantation | Measured in days |
| Number of individuals who experience all-cause mortality | Through duration of hospitalization, up to 30 days following LVAD implantation | All-cause mortality |
| ICU length of stay | Through duration of hospitalization, up to 30 days following LVAD implantation | Measured in days |
| Hospital length of stay | Through duration of hospitalization, up to 30 days following LVAD implantation | Measured in days |
| Number of individuals with acute kidney injuries requiring renal replacement therapy | Through duration of hospitalization, up to 30 days following LVAD implantation | Acute kidney injury requiring renal replacement therapy (intermittent hemodialysis or continuous renal replacement therapy) |
| Number of individuals with transient ischemic attacks [TIA] or cerebrovascular accidents [CVA] | Through duration of hospitalization, up to 30 days following LVAD implantation | Transient ischemic attack or cerebrovascular accident as diagnosed by a Neurologist either clinically and/or radiographically |
| Number of individuals with an arrhythmia requiring medical team intervention | Through duration of hospitalization, up to 30 days following LVAD implantation | Arrhythmia requiring medical team intervention, either through electrical or chemical cardioversion or any intravenous anti-arrhythmia medication administration |
| Number of individuals who need tracheostomy | Through duration of hospitalization, up to 30 days following LVAD implantation | Need for tracheostomy |
| Number of individuals needing percutaneous endoscopic gastrostomy tube | Through duration of hospitalization, up to 30 days following LVAD implantation | Need for percutaneous endoscopic gastrostomy tube |
| RV failure defined by the 2014 Interagency Registry for Mechanical Circulatory Support (INTERMACS) | Through duration of hospitalization, up to 30 days following LVAD implantation | The INTERMACS definition of RVF stratifies patients based on duration of inotropic therapy, inhaled nitric oxide therapy, vasodilator therapy or RVAD implantation. RVF is described as mild, moderate, severe, or severe acute based on ≤7, 8-14, \>14 days of the above therapies or RVAD implantation, respectively |
Countries
United States
Outcome results
None listed