Early Insertion of Axillary Impella® With VA ECMO

NCT04084015 | Terminated Results FDA Device

• 1 other identifier: 2019P000668
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

Veno-arterial extra-corporeal membrane oxygenation (VA-ECMO) is used as a rescue strategy for patients in acute hemodynamic deterioration such as cardiogenic shock and cardiopulmonary arrest with severe pulmonary congestion. VA ECMO is the fastest way to stabilize a patient with cardiogenic shock and improve end-organ perfusion. However, one of the major disadvantages of peripheral VA-ECMO is that it provides no left ventricular unloading and increases left ventricular (LV) afterload secondary to the retrograde blood flow. Therefore, LV wall tension and myocardial oxygen demand may actually increase in the setting of VA ECMO. The Impella® device is a miniature rotary blood pump which can be inserted retrograde across the aortic valve. In this configuration, it withdraws blood from the LV and ejects it into the ascending aorta. It unloads the left ventricle, reducing LV wall tension and myocardial oxygen demand and increasing myocardial blood flow. The Impella® 5.0 is an FDA approved pump designed for intermediate support in patients with severe, cardiogenic shock. The axillary positioning allows for early extubation and ambulation and is more stable than groin placement. In present practice, the decision to place an Impella® pump in VA-ECMO patients is based on the perceived need for direct LV unloading or when a bridge device is required to transition off ECMO support. Patients with peripheral VA ECMO are managed with inotropic agents at the beginning and once patients develop pulmonary edema mechanical LV unloading is considered electively. The advantage of LV unloading with Impella® has been demonstrated in recent studies. We also reported that concomitant implantation of Impella® with VA ECMO for LV unloading resulted in improved survival and recovery of ventricular performance in patients with cardiogenic shock. Compared to delayed elective LV unloading, early LV unloading could lead to decreased pulmonary edema, improved oxygenation delivery to the myocardium, increased chance of LV recovery and improved survival. The objective of this prospective study is to assess whether the early direct ventricular unloading using axillary Impella® leads to higher rates of cardiac recovery, defined as survival free from mechanical circulatory support, heart transplantation or inotropic support at thirty days, compared with the conventional, elective placement of Impella® after developing significant pulmonary congestion.

Conditions

Cardiogenic Shock

Keywords

Extracorporeal membrane oxygenation; Left ventricular unloading; Impella®

Outcome Measures

Primary Outcomes (1)

• Survival

  Patient survival at 30-days post VA ECMO cannulation timepoint. Collected through patient chart review.

  30 days after cannulation of VA ECMO

Secondary Outcomes (4)

• Death From Cardiovascular Causes

  30 days after cannulation of VA ECMO or Discharge

• New York Heart Association Functional Status

  30 days after cannulation of VA ECMO or Discharge

• Number of Participants With a Neurological Event

  30 days after cannulation of VA ECMO or Discharge

• Left Ventricular Function

  30 days after cannulation of VA ECMO or Discharge

Other Outcomes (3)

• Number of Participants With Acute Kidney Injury

  Within 30 days after cannulation of VA ECMO

• Vascular Complication

  Within 30 days after cannulation of VA ECMO

• Number of Participants With Bleeding

  Within 30 days after cannulation of VA ECMO

Study Arms (1)

Early axillary Impella®

EXPERIMENTAL

Early placement of axillary Impella® for LV unloading and LV recovery in patients with VA ECMO

Device: Axillary Impella®

Interventions

Axillary Impella® DEVICE

All enrolled patients will undergo surgical placement of Impella® via axillary artery within 48 hours after peripheral VA ECMO initiation and be managed with early extubation and ambulation strategy

Early axillary Impella®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18
• Impaired LV systolic function with ≤35% of left ventricular ejection fraction (LVEF)
• Enlarged LV with ≥50mm of left ventricular diastolic diameter (LVEDD) on echocardiogram

You may not qualify if:

• Non-cardiac etiology
• Surgically correctable cardiac abnormality
• Recent significant pulmonary embolism
• Severe pulmonary hypertension
• Acute aortic dissection
• Presence of mechanical aortic valve prosthesis
• Presence of left ventricle thrombus
• Pre-existing Impella® 5.0
• Critical aortic stenosis
• Uncorrectable system malperfusion under ECMO support
• Significant cerebrovascular accident

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Results Point of Contact

• Title: Dr. David D'Alessandro
• Organization: Massachusetts General Hospital

DADALESSANDRO@MGH.HARVARD.EDU

617-726-8841

Study Officials

• David D'Alessandro, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Principal Investigator, Surgical Director, Heart Transplantation and Mechanical Circulatory Support

Model Details: This prospective, single-arm trial will include all consecutive patients undergoing cannulation of peripheral VA ECMO at the Massachusetts General Hospital from April 2019 to March 2020. Approximately 20 subjects are anticipated to be enrolled during this time.

Study Record Dates

• First Submitted: September 6, 2019
• First Posted: September 10, 2019
• Study Start: October 1, 2019
• Primary Completion: March 23, 2021
• Study Completion: March 23, 2021
• Last Updated: June 29, 2021
• Results First Posted: June 29, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)