Application Detail

Description of Medical Service

Transcatheter aortic valve implantation involving the SAPIEN 3 balloon expandable device involves minimally invasive transfemoral insertion of a prosthetic heart valve that is positioned within the aortic annulus using the SAPIEN 3 system. Once in-situ, the valve is expanded while the heart is rapidly paced. The procedure is performed using fluoroscopic and transoesophageal guidance and under general or local anaesthesia.

Description of Medical Condition

Severe aortic stenosis (AS) is characterised by narrowing of the aortic valve leading to restriction of blood flow. AS is often caused by a build-up of calcium on the valve leaflets, causing them to become stiff and reducing their ability to open and close efficiently. It is associated with high pressure inside the left ventricle and as a result of the excessive workload, the left ventricle hypertrophies, which further leads to inefficiency in blood circulation. Symptoms include angina, dyspnoea and syncope. Left untreated, heart failure develops, and the risk of death is increased.

This application is relevant to patients with severe, symptomatic AS classified as being at low risk for surgery (low surgical risk), defined by a predicted 30-day risk of surgical mortality of less than 4%, based on the Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) score.

Reason for Application

New MBS item

Medical Service Type

Therapeutic

Previous Application Number/s

Not Applicable

Associated Documentation

Application Form

Application Form (PDF 1366 KB)
Application Form (Word 281 KB)

Consultation Survey

Consultation Survey (PDF 563 KB)
Consultation Survey (Word 70 KB)

PICO Confirmation

PICO Confirmation (PDF 1471 KB)
PICO Confirmation (Word 396 KB)

Assessment Report

-

Public Summary Document

Public Summary Document (PDF 1228 KB)
Public Summary Document (Word 708 KB)

Meetings for this Application

PASC

13 August 2020

ESC

11-12 February 2021

MSAC

31 March - 1 April 2021
29-30 July 2021