1635 – Transcatheter aortic valve implantation via transfemoral delivery using the balloon-expandable valve system for patients at low risk for surgery

New MBS item.

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.

Type: Therapeutic

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.

• PASC meeting: 13 August 2020
• ESC meeting: 11 to 12 February 2021
• MSAC meeting: 
  • 31 March to 1 April 2021
  • 29 to 30 July 2021