- Status Complete
- Type New application
- Pre-PASC consultation -
- Pre-MSAC consultation -
- Outcome Deferred
Application details
Reason for application
New MBS item.
Service or technology in this application
Transcatheter aortic valve implantation (TAVI) aims to provide a less invasive alternative to open heart surgery to treat aortic stenosis. In this procedure the new aortic valve is inserted through a catheter into the heart, with the patient under general anaesthesia (or using local anaesthesia with sedation). The new valve is positioned within the existing diseased aortic valve and is immediately functional. The faulty valve is not cut or removed.
TAVI can be performed via the transfemoral approach (into the femoral artery) or the transapical approach (through the chest wall for patients where the transfemoral approach is not suitable).
Type: Therapeutic
Medical condition this application addresses
Aortic stenosis (AS) typically occurs in individuals greater than 65 years of age and involves progressive thickening and hardening of the leaflets (heart valve flaps) which become restricted in their opening when the heart contracts. This in turn causes a thickening of the heart muscle and a decrease of flow of blood to the body and coronary arteries.
Typically, patients with AS are free from cardiovascular symptoms (e.g. angina, syncope and/or heart failure) until late in the course of the disease. However, once symptoms manifest, the prognosis is poor, especially when associated with congestive heart failure. Death in general, including sudden death, occurs primarily in symptomatic patients.
Application documents
PICO confirmation
Public summary document – April 2015
Public summary document – July 2015
Minutes
Public summary document – July 2015
Minutes
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Meetings to consider this application
- PASC meeting: 16 - 17 April 2014
- ESC meeting:
- 12 - 13 February 2015
- 11 - 12 June 2015
- MSAC meeting: 1 - 2 April 2015
Stakeholder meeting: 30 to 31 July 2015
Friday 30 October 2015, members of MSAC, clinicians with experience in managing patients with severe aortic stenosis and expertise in treating the condition, representatives of Edwards Lifesciences, Boston Scientific, Medtronic Australia, St Jude Medical Australia and the Department of Health met to discuss Transcatheter Aortic Valve Implantation (TAVI). This was not an MSAC decision forum, but a meeting that would inform the issues considered by MSAC, following its July 2015 reconsideration of application 1361- TAVI. The key objective of the meeting was to meet with stakeholders to discuss concerns raised by MSAC in relation to the proposed clinical setting. Attached are the final minutes of this meeting.