1361 and 1361.1 - Transcatheter Aortic Valve Implantation via Transfemoral or Transapical Delivery

Medical Services Advisory Committee

Page last updated: 11 July 2016

Application Detail

Status

Closed

Description of Medical Service

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).

Description of Medical Condition

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.

Reason for Application

New MBS item

Medical Service Type

Therapeutic

Previous Application Number

Not Applicable

Associated Documentation

Application Form

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PICO Confirmation

27 June 2014 - 18 July 2014
Consultation Protocol (PDF 1350 KB)
Consultation Protocol (Word 1076 KB)

Survey and Feedback Form (PDF 42 KB)
Survey and Feedback Form (Word 109 KB)

Final Protocol (PDF 940 KB)
Final Protocol (Word 831 KB)

Assessment Report

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Public Summary Document

Public Summary Document - April 2015 (PDF 473 KB)
Public Summary Document - April 2015 (Word 274 KB)

Public Summary Document - July 2015 (PDF 502 KB)
Public Summary Document - July 2015 (Word 89 KB)

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.

Minutes of TAVI Stakeholder Meeting 30 October 2015 (PDF 77 KB)
Minutes of TAVI Stakeholder Meeting 30 October 2015 (Word 67 KB)

Meetings for this Application

PASC

16 to 17 April 2014

ESC

12 to 13 February 2015
11 to 12 June 2015

MSAC

1 to 2 April 2015
30 to 31 July 2015