Trial Outcomes & Findings for Early Insertion of Axillary Impella® With VA ECMO (NCT NCT04084015)

Results Overview

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

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

2 participants

Primary outcome timeframe

30 days after cannulation of VA ECMO

Results posted on

2021-06-29

Participant Flow

Patients were recruited from inpatient medical units at Massachusetts General Hospital. The recruitment period was from August 2019-March 2021.

Participant milestones

Participant milestones
Measure	Early Axillary Impella® Early placement of axillary Impella® for LV unloading and LV recovery in patients with VA ECMO Axillary Impella®: 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
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Early Axillary Impella® n=2 Participants Early placement of axillary Impella® for LV unloading and LV recovery in patients with VA ECMO Axillary Impella®: 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
Age, Continuous	47 years STANDARD_DEVIATION 15.6 • n=2 Participants
Sex: Female, Male Female	0 Participants n=2 Participants
Sex: Female, Male Male	2 Participants n=2 Participants

PRIMARY outcome

Timeframe: 30 days after cannulation of VA ECMO

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

Outcome measures

Outcome measures
Measure	Early Axillary Impella® n=2 Participants Early placement of axillary Impella® for LV unloading and LV recovery in patients with VA ECMO Axillary Impella®: 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
Survival	1 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Early Axillary Impella® n=2 Participants Early placement of axillary Impella® for LV unloading and LV recovery in patients with VA ECMO Axillary Impella®: 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
Death From Cardiovascular Causes	1 Participants

SECONDARY outcome

Timeframe: 30 days after cannulation of VA ECMO or Discharge

Population: Data were not collected. NYHA Assessment was not done at 30-days post VA-ECMO cannulation per standard of care.

Retrospective review in a patient chart

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Early Axillary Impella® n=2 Participants Early placement of axillary Impella® for LV unloading and LV recovery in patients with VA ECMO Axillary Impella®: 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
Number of Participants With a Neurological Event	1 Participants

SECONDARY outcome

Timeframe: 30 days after cannulation of VA ECMO or Discharge

Population: Neither of the subjects who were enrolled had an echocardiogram done at the 30 day post VA-ECMO cannulation or Discharge timepoints so LVEF could not be collected.

Measured by Echocardiogram study.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Within 30 days after cannulation of VA ECMO

Retrospective review in a patient chart

Outcome measures

Outcome measures
Measure	Early Axillary Impella® n=2 Participants Early placement of axillary Impella® for LV unloading and LV recovery in patients with VA ECMO Axillary Impella®: 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
Number of Participants With Acute Kidney Injury	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Within 30 days after cannulation of VA ECMO

Population: Data not collected for either subject

Retrospective review in a patient chart

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Early Axillary Impella® n=2 Participants Early placement of axillary Impella® for LV unloading and LV recovery in patients with VA ECMO Axillary Impella®: 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
Number of Participants With Bleeding	1 Participants

Adverse Events

Early Axillary Impella®

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Early Axillary Impella® n=2 participants at risk Early placement of axillary Impella® for LV unloading and LV recovery in patients with VA ECMO Axillary Impella®: 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
Cardiac disorders Death	50.0% 1/2 • Adverse event data were collected up to 30-days post VA-ECMO cannulation/Impella Insertion, whichever came first. Each subject will be followed through 30 days post VA-ECMO cannulation/Impella Insertion. Adverse events data will be collected throughout this time period. Adverse events will be determined and assessed only through medical chart review.

Other adverse events

Adverse event data not reported

Additional Information

Dr. David D'Alessandro

Massachusetts General Hospital

Phone: 617-726-8841

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place