Application Detail

Description of Medical Service

The proposed medical service involves the implantation of an acute coronary syndrome event detector (ACSED) in patients who have had prior acute coronary syndrome (ACS) events and who remain at high risk for recurrent ACS events. The ACSED is implanted in a left pectoral subcutaneous pocket, similar to a permanent pacemaker, and connects to a transvenous active-fixation endocardial bipolar pacing lead which is placed in the right ventricular apex. Using a can-tip vector, the ACSED monitors the intracardiac electrograms gathered in real time to assess for ST segment changes, including ST depression and elevation. If the device detects an excessive ST shift relative to the baseline ST segment, and if the ST shift exceeds a pre-programmed threshold, the ACSED vibrates to warn the patient and simultaneously signals the patient’s external device to provide redundant audible and visual external warning. The ACSED also stores electrograms for subsequent retrieval by the Programmer via wireless telemetry.

Description of Medical Condition

Acute coronary syndrome describes a range of conditions associated with sudden, reduced blood flow to the heart. The blockage can be sudden and occur in one instant, or it may come and go over a period of time. The condition occurs due to the build-up of fatty deposits in and on the walls of the coronary arteries. These arteries are responsible for delivering oxygen and nutrients to heart muscles. Acute coronary syndrome is used to describe three types of coronary artery disease: Unstable angina; Non-ST-segment elevation myocardial infarction or heart attack (NSTEMI); ST-segment elevation myocardial infarction or heart attack (STEMI). The lack of blood supply to any tissue is called ischemia. The death of the cells results in damage to muscle tissue, and this is a heart attack or myocardial infarction.Unstable angina is the term used to describe the condition when acute coronary syndrome does not lead to cell death.

Reason for Application

New MBS item

Medical Service Type

Investigative

Previous Application Number/s

Not Applicable

Associated Documentation

Application Form

Application Form (PDF 1260 KB)
Application Form (Word 194 KB)

Consultation Survey

Consultation Survey (PDF 558 KB)
Consultation Survey (Word 70 KB)

PASC Consultation
PASC consultation closed

MSAC Consultation

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

PICO Confirmation (PDF 1226 KB)
PICO Confirmation (Word 209 KB)

Assessment Report

-

Public Summary Document

-

Meetings for this Application

PASC

17 April 2020

ESC

7 October 2021

MSAC

-