Application Detail

Description of Medical Service

TAVI involving the SAPIEN 3 BEV system involves minimally-invasive transfemoral insertion of a prosthetic heart valve, positioned within the native 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, under general or local anaesthesia.

Description of Medical Condition

Severe aortic stenosis is characterised by narrowing of the aortic valve, leading to restriction of blood flow. Aortic stenosis 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 the resulting excessive workload causes the left ventricle to hypertrophy (leading to further 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 aortic stenosis, classified as being at intermediate risk for surgery. Intermediate risk is historically defined by a predicted 30-day risk of surgical mortality of 4-8%, based on the Society of Thoracic Surgeons Predicted Risk of Mortality score.

Reason for Application

New MBS item

Medical Service Type

Therapeutic

Previous Application Number/s

Not Applicable

Associated Documentation

Application Form

Application Form (PDF 1502 KB)
Application Form (Word 339 KB)

Consultation Survey

Consultation Survey (PDF 490 KB)
Consultation Survey (Word 70 KB)

PICO Confirmation

PICO Confirmation (PDF 1210 KB)
PICO Confirmation (Word 246 KB)

Assessment Report

-

Public Summary Document

Public Summary Document (PDF 815 KB)
Public Summary Document (Word 423 KB)

Meetings for this Application

PASC

5-6 December 2019

ESC

8-9 October 2020

MSAC

26-27 November 2020