Percutaneous RVAD to Preemptively Treat Right Heart Failure Post-LVAD

Prior studies have shown that left ventricular assist device (LVAD) implantation commonly results in right ventricular failure (RVF). Right ventricular dysfunction and failure after LVAD implantation is known to increase morbidity and mortality and contribute to longer post-implant hospital length of stay. Since RVF is difficult to predict and can have harmful effects such as increased ICU stay, adverse outcomes, and mortality, it could be beneficial to preemptively treat patients through preoperative or intraoperative percutaneous right ventricular assist device (RVAD) placement to prevent RVF.

This trial will include both a prospective interventional cohort and a retrospective control cohort. The prospective interventional cohort will consist of patients undergoing LVAD implantation at Massachusetts General Hospital. These patients will preemptively receive an RVAD (either the ProtekDuo or Impella RP) surrounding LVAD implantation. The historical control cohort will consist of retrospective data collection on patients who have undergone LVAD implantation in the past. This group will be matched with the enrolled prospective interventional patients. The purpose of this study is to compare clinical outcomes of standard of care treatment versus percutaneous RVAD placement perioperatively to LVAD implantation. The investigators hypothesize that the use of the RVAD will mitigate need for inotropic support, reducing the vasoactive-inotrope score (VIS) by 50%, and will improve end organ function in patients compared to standard of care.

Subjects who consent to the study will undergo peri-operative placement of an RVAD, which will be left in up to 72 hours postoperatively. The type of RVAD (Impella RP or ProtekDuo) inserted will be determined by patient needs and venous access and will be up to the discretion of the treating physician. 25 subjects will be enrolled in the prospective interventional cohort and compared to 25 subjects in the matched retrospective control cohort.

Study Overview

• Status: Active, not recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Device: Percutaneous RVAD

Detailed Description

Prior studies have shown that left ventricular assist device (LVAD) implantation commonly results in right ventricular failure (RVF). Right ventricular dysfunction and failure after LVAD implantation is known to increase morbidity and mortality and contribute to longer post-implant hospital length of stay. More severe right ventricular failure is highly correlated with poor prognosis and death post-LVAD implantation. In current practice, patients who receive LVADs require right heart support, provided in the form of inotropes. Vasoactive inotrope score (VIS) is a measure that quantifies the amount of right heart support required post-operatively, including dopamine, dobutamine, milrinone, epinephrine, norepinephrine, and vasopressin. It has been used in other studies as a surrogate marker for hemodynamic cardiovascular derangement.

In some cases, right ventricular failure post-LVAD also requires mechanical circulatory support during the perioperative period. Since RVF is difficult to predict and can have harmful effects such as increased ICU stay, adverse outcomes, and mortality, it could be beneficial to preemptively treat patients through preoperative or intraoperative percutaneous right ventricular assist device (RVAD) placement to prevent RVF. The purpose of this study is to test the hypothesis that preemptive use of percutaneous RVADs will mitigate the need for inotropic support in LVAD patients, reducing associated adverse outcomes.

This trial will include both a prospective interventional cohort and a retrospective control cohort. The prospective interventional cohort will consist of patients undergoing LVAD implantation at Massachusetts General Hospital. These patients will receive an RVAD (either the ProtekDuo or Impella RP) prior to or during LVAD implantation. The historical control cohort will consist of retrospective data collection on patients who have undergone LVAD implantation in the past. This group will be matched with the enrolled prospective interventional patients. The purpose of this study is to compare clinical outcomes of standard of care treatment versus preemptive percutaneous RVAD placement surrounding LVAD implantation. The investigators hypothesize that the use of the RVAD will mitigate need for inotropic support, reducing the vasoactive-inotrope score (VIS) by 50%, and will improve end organ function in patients compared to standard of care.

There are two types of percutaneous RVADs that will be used in the study: the Impella RP and the ProtekDuo. These devices allow for early intervention in RVF without the need for invasive surgical procedures requiring placement of durable RVADs via thoracotomy or sternotomy. The Impella RP, manufactured by Abiomed, is a heart pump that delivers blood from the inferior vena cava (IVC) to the pulmonary artery (PA). Its insertion is done percutaneously via catheterization through the femoral vein. ProtekDuo, manufactured by TandemLife, is another device placed percutaneously for right heart support via the right internal jugular (RIJ) vein.

Subjects who consent to the study will undergo pre-operative or intra-operative placement of an RVAD, which will be left in up to 72 hours postoperatively. The type of RVAD (Impella RP or ProtekDuo) inserted will be determined by patient needs and venous access and will be up to the discretion of the treating physician. 25 subjects will be enrolled in the prospective interventional cohort and compared to 25 subjects in the matched retrospective control cohort.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kamila Drezek; Phone Number: 617-724-2610; Email: KDREZEK@mgh.harvard.edu
• Study Contact Backup: Name: David D'Alessandro, MD; Phone Number: 617-726-8841; Email: DADALESSANDRO@MGH.HARVARD.EDU

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Ages 18-75
• Accepted for LVAD implantation by MGH multidisciplinary team

Exclusion Criteria:

• Disorders of the pulmonary artery wall that would preclude placement or correct positioning of RVAD
• Presence of mechanical valves
• Mural thrombosis of the right atrium or vena cava
• Anatomic conditions precluding insertion of the RVAD
• Complicated venous access precluding or complicating device placement (i.e. femoral and jugular thrombosis)
• No evidence of right ventricular dysfunction by echocardiogram

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: prospective interventional cohort; The prospective interventional cohort will consist of patients undergoing LVAD implantation at Massachusetts General Hospital. These patients will receive an RVAD (either the ProtekDuo or Impella RP) prior to or during LVAD implantation.	Device: Percutaneous RVAD; ProtekDuo or Impella RP
No Intervention: retrospective control cohort; The historical control cohort will consist of retrospective data collection on patients who have undergone LVAD implantation in the past. This group will be age and sex matched with the enrolled prospective interventional patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vasoactive Inotropic Score	Retrospective review in a patient chart. Score calculated based on dosages of vasopressors and inotropes within first 24-hours post-LVAD implant. It is hypothesized that a higher score will correspond with worse outcomes.	first 24 hours post-LVAD implantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Vasoactive Inotropic Score	Retrospective review in a patient chart. Calculated based on dosages of inotropes and vasopressors from time of LVAD implantation to hospital discharge.	up to date of hospital discharge (estimated average = 3 weeks)
Intensive Care Unit length of stay	Retrospective review in a patient chart	up to date of discharge from intensive care unit (estimated average = 1 week)
Total post-operative length of stay after LVAD implantation	Retrospective review in a patient chart	up to date of hospital discharge (estimated average = 3 weeks)
Survival at discharge after LVAD placement	Retrospective review in a patient chart	up to date of hospital discharge (estimated average = 3 weeks)
Survival at 1 year after LVAD placement or heart transplant	Retrospective review in a patient chart	up to 1 year post-LVAD implantation
End organ dysfunction	end organ dysfunction including 1) Development of acute kidney injury (AKI) - defined as increase in serum creatinine (sCr) to 4mg/dl or greater, a 150 percent or greater increase in sCr over the baseline preoperative value, or a new requirement for renal replacement therapy; 2) Liver dysfunction	up to 1 year post-LVAD implantation
LVAD Device Speed	Retrospective review in a patient chart	measured up to 1 year post-LVAD implantation

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2020
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: June 16, 2020
• First Submitted That Met QC Criteria: June 30, 2020
• First Posted (Actual): July 7, 2020

Study Record Updates

• Last Update Posted (Actual): October 19, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 2020P000422

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes