Percutaneous RVAD to Preemptively Treat Right Heart Failure Post-LVAD

Heart Failure Clinical Trial

Official title:

Percutaneous RVAD to Preemptively Treat Right Heart Failure Post-LVAD

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04458103
• Other study ID #: 2020P000422
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 12, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Percutaneous RVAD
ProtekDuo or Impella RP

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	Survival at discharge after LVAD placement	Retrospective review in a patient chart	up to date of hospital discharge (estimated average = 3 weeks)
Secondary	Survival at 1 year after LVAD placement or heart transplant	Retrospective review in a patient chart	up to 1 year post-LVAD implantation
Secondary	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
Secondary	LVAD Device Speed	Retrospective review in a patient chart	measured up to 1 year post-LVAD implantation