Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Change in right atrial pressure (RAP) pre-LVAD implantation to post-operative day 3 |
RAP measured by pulmonary artery catheter |
Baseline, Day 3 |
|
Primary |
Change in right atrial pressure (RAP) pre-LVAD implantation to post-operative day 7 |
RAP measured by pulmonary artery catheter |
Baseline, Day 7 |
|
Primary |
Change in right atrial pressure (RAP) pre-LVAD implantation to end of hemodynamic monitoring post-LVAD implantation |
RAP measured by pulmonary artery catheter |
Baseline, end of hemodynamic monitoring (about Day 10) |
|
Primary |
Change in right atrial pressure/pulmonary capillary wedge pressure (RAP/PCWP) pre-LVAD implantation to post-operative day 3 |
RAP/PCWP measured by pulmonary artery catheter |
Baseline, Day 3 |
|
Primary |
Change in right atrial pressure/pulmonary capillary wedge pressure (RAP/PCWP) pre-LVAD implantation to post-operative day 7 |
RAP/PCWP measured by pulmonary artery catheter |
Baseline, Day 7 |
|
Primary |
Change in right atrial pressure/pulmonary capillary wedge pressure (RAP/PCWP) pre-LVAD implantation to end of hemodynamic monitoring post-LVAD implantation |
RAP/PCWP measured by pulmonary artery catheter |
Baseline, end of hemodynamic monitoring (about Day 10) |
|
Primary |
Change in pulmonary artery pulsatility index (PAPI) pre-LVAD implantation to post-operative day 3 |
PAPI measured by pulmonary artery catheter |
Baseline, Day 3 |
|
Primary |
Change in pulmonary artery pulsatility index (PAPI) pre-LVAD implantation to post-operative day 7 |
PAPI measured by pulmonary artery catheter |
Baseline, Day 7 |
|
Primary |
Change in pulmonary artery pulsatility index (PAPI) pre-LVAD implantation to end of hemodynamic monitoring post-LVAD implantation |
PAPI measured by pulmonary artery catheter |
Baseline, end of hemodynamic monitoring (about Day 10) |
|
Primary |
Change in right ventricle stroke work index (RVSWI) pre-LVAD implantation to post-operative day 3 |
RVSWI measured by pulmonary artery catheter |
Baseline, Day 3 |
|
Primary |
Change in right ventricle stroke work index (RVSWI) pre-LVAD implantation to post-operative day 7 |
RVSWI measured by pulmonary artery catheter |
Baseline, Day 7 |
|
Primary |
Change in right ventricle stroke work index (RVSWI) pre-LVAD implantation to end of hemodynamic monitoring post-LVAD implantation |
RVSWI measured by pulmonary artery catheter |
Baseline, end of hemodynamic monitoring (about Day 10) |
|
Primary |
Change in cardiac power output (CPO) pre-LVAD implantation to post-operative day 3 |
CPO measured by pulmonary artery catheter |
Baseline, Day 3 |
|
Primary |
Change in cardiac power output (CPO) pre-LVAD implantation to post-operative day 7 |
CPO measured by pulmonary artery catheter |
Baseline, Day 7 |
|
Primary |
Change in cardiac power output (CPO) pre-LVAD implantation to end of hemodynamic monitoring post-LVAD implantation |
CPO measured by pulmonary artery catheter |
Baseline, end of hemodynamic monitoring (about Day 10) |
|
Secondary |
RV failure defined by the 2014 Interagency Registry for Mechanical Circulatory Support (INTERMACS) |
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 |
Through duration of hospitalization, up to 30 days following LVAD implantation |
|
Secondary |
RV failure defined by the 2020 Academic Research Consortium (ARC) |
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 |
Through duration of hospitalization, up to 30 days following LVAD implantation |
|
Secondary |
Inotropic therapy |
Total number of inotropes used |
Through duration of hospitalization, up to 30 days following LVAD implantation |
|
Secondary |
Vasopressor therapy |
Total number of vasopressors used |
Through duration of hospitalization, up to 30 days following LVAD implantation |
|
Secondary |
Total time on inhaled nitric oxide |
Measured in days |
Through duration of hospitalization, up to 30 days following LVAD implantation |
|
Secondary |
Number of individuals who experience all-cause mortality |
All-cause mortality |
Through duration of hospitalization, up to 30 days following LVAD implantation |
|
Secondary |
ICU length of stay |
Measured in days |
Through duration of hospitalization, up to 30 days following LVAD implantation |
|
Secondary |
Hospital length of stay |
Measured in days |
Through duration of hospitalization, up to 30 days following LVAD implantation |
|
Secondary |
Number of individuals with acute kidney injuries requiring renal replacement therapy |
Acute kidney injury requiring renal replacement therapy (intermittent hemodialysis or continuous renal replacement therapy) |
Through duration of hospitalization, up to 30 days following LVAD implantation |
|
Secondary |
Number of individuals with transient ischemic attacks [TIA] or cerebrovascular accidents [CVA] |
Transient ischemic attack or cerebrovascular accident as diagnosed by a Neurologist either clinically and/or radiographically |
Through duration of hospitalization, up to 30 days following LVAD implantation |
|
Secondary |
Number of individuals with an arrhythmia requiring medical team intervention |
Arrhythmia requiring medical team intervention, either through electrical or chemical cardioversion or any intravenous anti-arrhythmia medication administration |
Through duration of hospitalization, up to 30 days following LVAD implantation |
|
Secondary |
Number of individuals who need tracheostomy |
Need for tracheostomy |
Through duration of hospitalization, up to 30 days following LVAD implantation |
|
Secondary |
Number of individuals needing percutaneous endoscopic gastrostomy tube |
Need for percutaneous endoscopic gastrostomy tube |
Through duration of hospitalization, up to 30 days following LVAD implantation |
|