Application Detail

Description of Medical Service

Impella is a transluminal microaxial ventricular assist device that is inserted percutaneously or surgically.
The Impella devices have a small microaxial pump (at one end of a thin, flexible catheter) that pumps blood from the left ventricle through an inlet area near the tip and expels blood into the ascending aorta. The other end of the tube is connected to an automated control system outside the body (that controls the pump rate). The Impella technology is part of the latest generation of cardiac assist devices. The device stabilises haemodynamics, unloads the ventricle, augments peak coronary flow, perfuses the end organs, reduces myocardial oxygen demand and allows for recovery of the native heart. It is indicated for clinical use in interventional cardiology and cardiac surgery for supporting the native heart in patients with reduced ventricular function.

Description of Medical Condition

Cardiogenic shock is a complex clinical syndrome, a medical life-threatening emergency, with poor prognosis, which occurs when the heart suddenly cannot pump enough blood and oxygen to the brain and other vital organs. It is defined as a state of end-organ hypoperfusion caused by left ventricular, right ventricular, or biventricular myocardial injury resulting in systolic and/or diastolic myocardial pump failure (Kar 2011). It is characterised by a self-propagating cascade of acute, falling cardiac output and hypotension with ensuing compromised end-organ perfusion. Without appropriate intervention, the end result is multi-organ failure and death (National Heart Foundation of Australia and Cardiac Society of Australia and New Zealand 2018 guidelines for the prevention, detection, and management of heart failure in Australia (NHFA CSANZ 2018).

Reason for Application

New MBS item

Medical Service Type

Therapeutic technology

Previous Application Number/s

1523

Associated Documentation

Application Summary and PICO Set

Application Summary (PDF 228 KB)
Application Summary (Word 43 KB)

PICO Set (PDF 691 KB)
PICO Set (Word 631 KB)

Consultation Survey

Consultation Survey (PDF 187 KB)
Consultation Survey (Word 31 KB)

PASC Consultation
Not applicable

MSAC Consultation
MSAC consultation input must be received by no later than Friday, 16 February 2024 for it to be considered by MSAC at its April 2024 meeting.

For further information please refer to PASC, ESC, MSAC Key Dates
For further information on the consultation process please refer to MSAC Consultation Process

PICO Confirmation

-

Assessment Report

-

Public Summary Document

-

Meetings for this Application

PASC

Expedited - bypassed PASC

ESC

15-16 February 2024

MSAC

4-5 April 2024