1603 – Transcatheter aortic valve implantation (TAVI) via transfemoral delivery, using the SAPIEN 3 balloon-expandable valve (BEV) system, for patients at intermediate risk for surgery

New MBS item.

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.

Type: Therapeutic

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.

• PASC meeting: 5 to 6 December 2019
• ESC meeting: 8 to 9 October 2020
• MSAC meeting: 26 to 27 November 2020