Mitigating Post-Op RV Dysfunction After LVAD Implantation

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

Detailed Description
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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).

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

Conditions
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Heart Failure, Right Ventricular Dysfunction, Right Ventricular Failure

Intervention / Treatment
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* Other: Standardized RV Management
* Other: Usual Care RV Management


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standardized RV Management<br>Physicians will follow prespecified parameters for RV management (consistent with SOC) | Other: Standardized RV Management<br>* Standardized parameters for post-operative management (i.e., Rhythm Management, Ventilation Management, RV Ischemia Management, RV Preload, RV Afterload, RV Contractility, and RV Geometry)<br>|
| Active Comparator: Usual Care RV Management<br>Physicians will use their own clinical judgement with no prespecified goals for RV management parameters (consistent with SOC) | Other: Usual Care RV Management<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in right atrial pressure (RAP) pre-LVAD implantation to post-operative day 3 | RAP measured by pulmonary artery catheter | Baseline, Day 3 | 
| Change in right atrial pressure (RAP) pre-LVAD implantation to post-operative day 7 | RAP measured by pulmonary artery catheter | Baseline, Day 7 | 
| 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) | 
| 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 | 
| 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 | 
| 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) | 
| Change in pulmonary artery pulsatility index (PAPI) pre-LVAD implantation to post-operative day 3 | PAPI measured by pulmonary artery catheter | Baseline, Day 3 | 
| Change in pulmonary artery pulsatility index (PAPI) pre-LVAD implantation to post-operative day 7 | PAPI measured by pulmonary artery catheter | Baseline, Day 7 | 
| 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) | 
| 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 | 
| 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 | 
| 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) | 
| Change in cardiac power output (CPO) pre-LVAD implantation to post-operative day 3 | CPO measured by pulmonary artery catheter | Baseline, Day 3 | 
| Change in cardiac power output (CPO) pre-LVAD implantation to post-operative day 7 | CPO measured by pulmonary artery catheter | Baseline, Day 7 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Inotropic therapy | Total number of inotropes used | Through duration of hospitalization, up to 30 days following LVAD implantation | 
| Vasopressor therapy | Total number of vasopressors used | Through duration of hospitalization, up to 30 days following LVAD implantation | 
| Total time on inhaled nitric oxide | Measured in days | Through duration of hospitalization, up to 30 days following LVAD implantation | 
| Number of individuals who experience all-cause mortality | All-cause mortality | Through duration of hospitalization, up to 30 days following LVAD implantation | 
| ICU length of stay | Measured in days | Through duration of hospitalization, up to 30 days following LVAD implantation | 
| Hospital length of stay | Measured in days | Through duration of hospitalization, up to 30 days following LVAD implantation | 
| 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 | 
| 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 | 
| 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 | 
| Number of individuals who need tracheostomy | Need for tracheostomy | Through duration of hospitalization, up to 30 days following LVAD implantation | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LVAD, LVAD-related complications, right ventricular dysfunction, hemocompatibility-related adverse events, hemodynamic-related events, post-operative right ventricular management, right ventricular failure