Application Detail

Description of Medical Service

The proposed medical service is the fixation of aortic endografts using helical anchors adjunctive to aortic endovascular aneurysm repair (EVAR) or thoracic endovascular aneurysm repair (TEVAR). Type IA endoleaks at the proximal attachment site and loss of fixation with endograft migration continue to pose a challenge in aortic aneurysm (AA) management. Current management of hostile aneurysm neck anatomy involve more complex EVAR/TEVAR procedures including fenestrated, chimney and branched endografts. The introduction of the helical anchors used adjunct to EVAR/TEVAR represents an alternate treatment option for patients with complex aneurysms that have hostile neck anatomy, have experienced or are at risk of a type IA endoleak or device migration or late graft failure. Helical anchors adjunct to EVAR/TEVAR is intended specifically to aid in the sealing and fixation of endografts potentially reducing revision procedures and re-hospitalisations; and potentially introducing costs savings when compared with complex AAA/TAA stent graft systems.

Description of Medical Condition

An aneurysm is defined as an artery that has localised dilatation more than 1.5 times greater than the usual diameter of that artery (Johnson et al 1991). When the aneurysm occurs in the aorta it is referred to as an aortic abdominal or thoracic aneurysm dependent on its location. Most aortic aneurysms occur in the abdomen (referred to as AAA) with thoracic aortic aneurysm (TAA) occurring less frequently. Aortic aneurysms (AAs) are often asymptomatic and are often identified incidentally through imaging for symptoms unrelated to the AA. The natural history is ongoing expansion of the aneurysm, with the risk of rupture increasing with increasing size. Patients with a ruptured aneurysm have more than 50% risk of death before hospitalisation or treatment (Chaikof et al 2018). Whilst AA is rare in people < 50 years old, the prevalence increases sharply with increasing age with more men than women affected.

Reason for Application

New MBS item/s

Medical Service Type

Therapeutic

Previous Application Number

Not Applicable

Associated Documentation

Application Form

Application Form (Word 1492 KB)
Application Form (PDF 1376 KB)

Consultation Survey

Consultation Survey (PDF 304 KB)
Consultation Survey (Word 508 KB)

PICO Confirmation

PICO Confirmation (PDF 1110 KB)
PICO Confirmation (Word 259 KB)

Assessment Report

-

Public Summary Document

Public Summary Document (PDF 642 KB)
Public Summary Document (Word 175 KB)

Meetings for this Application

PASC

6-7 December 2018

ESC

13-14 February 2020

MSAC

3 April 2020