NCT04084015

Early Insertion of Axillary Impella® With VA ECMO

Terminated NA Results posted Last updated 29 June 2021

What this trial tests

NA trial testing Axillary Impella® in Cardiogenic Shock in 2 participants. Terminated before completion.

Timeline

1 October 2019

Primary endpoint
23 March 2021

23 March 2021

Quick facts

Lead sponsor	Massachusetts General Hospital
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	2
Start date	1 October 2019
Primary completion	23 March 2021
Estimated completion	23 March 2021
Sites	1 location across United States

Drugs / interventions tested

• Axillary Impella®

Conditions studied

• Cardiogenic Shock — all drugs for Cardiogenic Shock →

Sponsor

Massachusetts General Hospital

Who can join

18 and older, any sex, with Cardiogenic Shock. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Survival Primary · 30 days after cannulation of VA ECMO

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

Group	Value	95% CI
Early Axillary Impella®	1

Death From Cardiovascular Causes Secondary · 30 days after cannulation of VA ECMO or Discharge

Death from cardiovascular cases at 30-days post VA ECMO cannulation timepoint. Collected from review of patient charts.

Group	Value	95% CI
Early Axillary Impella®	1

Number of Participants With a Neurological Event Secondary · 30 days after cannulation of VA ECMO or Discharge

Neurological event up to 30-days post VA-ECMO cannulation or Discharge. Includes hypoxic brain damage, intracerebral bleeding, hemorrhagic stroke, or ischemic stroke. Data collected through patient chart review.

Group	Value	95% CI
Early Axillary Impella®	1

Number of Participants With Acute Kidney Injury Secondary · Within 30 days after cannulation of VA ECMO

Retrospective review in a patient chart

Group	Value	95% CI
Early Axillary Impella®	2

Number of Participants With Bleeding Secondary · Within 30 days after cannulation of VA ECMO

Moderate bleeding in hospital. Defined by transfusion of red blood cells without hemodynamic impairment. Collected through review of patient chart.

Group	Value	95% CI
Early Axillary Impella®	1

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data were collected up to 30-days post VA-ECMO cannulation/Impella Insertion, whichever came first.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Early Axillary Impella®

Serious: 1/2 (50%)

Deaths: 1/2

Serious adverse events (1 terms)

Reaction	System	Early Axillary Impella®
Death	Cardiac disorders	—

Most-reported serious reactions: Death.

Data from ClinicalTrials.gov NCT04084015 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Extracorporeal membrane oxygenation and left ventricular unloading: What is the evidence?
   Lorusso R, Meani P, Raffa GM, Kowalewski M. · · 2022 · cited 28× · PMID 35711197 · DOI 10.1016/j.xjtc.2022.02.039