Mitigating Post-Op RV Dysfunction After LVAD Implantation

Protective Strategies to Mitigate Post-Operative Right Ventricular (PV) Dysfunction After Centrifugal Flow Durable Left Ventricular Assist Device (LVAD) Implantation

This project evaluates right ventricle (RV) protective strategies after left ventricular assist device (LVAD) implantation.

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).

LVAD, LVAD-related complications, right ventricular dysfunction, hemocompatibility-related adverse events, hemodynamic-related events, post-operative right ventricular management, right ventricular failure

Physicians will use their own clinical judgement with no prespecified goals for RV management parameters (consistent with SOC)

Standardized parameters for post-operative management (i.e., Rhythm Management, Ventilation Management, RV Ischemia Management, RV Preload, RV Afterload, RV Contractility, and RV Geometry)

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)

Change in right atrial pressure (RAP) pre-LVAD implantation to end of hemodynamic monitoring post-LVAD implantation

Change in right atrial pressure/pulmonary capillary wedge pressure (RAP/PCWP) pre-LVAD implantation to post-operative day 3

Change in right atrial pressure/pulmonary capillary wedge pressure (RAP/PCWP) pre-LVAD implantation to post-operative day 7

Change in right atrial pressure/pulmonary capillary wedge pressure (RAP/PCWP) pre-LVAD implantation to end of hemodynamic monitoring post-LVAD implantation

Change in pulmonary artery pulsatility index (PAPI) pre-LVAD implantation to end of hemodynamic monitoring post-LVAD implantation

Change in right ventricle stroke work index (RVSWI) pre-LVAD implantation to end of hemodynamic monitoring post-LVAD implantation

Change in cardiac power output (CPO) pre-LVAD implantation to end of hemodynamic monitoring post-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

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

Acute kidney injury requiring renal replacement therapy (intermittent hemodialysis or continuous renal replacement therapy)

Transient ischemic attack or cerebrovascular accident as diagnosed by a Neurologist either clinically and/or radiographically

Arrhythmia requiring medical team intervention, either through electrical or chemical cardioversion or any intravenous anti-arrhythmia medication administration

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