Application Detail

Status

Closed

Description of Medical Service

The WATCHMAN™ Left Atrial Appendage (LAA) Closure Device is intended for patients with non-valvular Atrial Fibrillation who require treatment for potential thrombus formation and are eligible for long-term oral anticoagulation therapy, or who have a contraindication to anticoagulation therapy. The procedure aims to prevent ischemic stroke and systemic thromboembolism by closing off the LAA permanently to avoid the migration of emboli (clots) to the brain.

The LAA Closure Device is a self-expanding nitinol frame structure with fixation anchors and a permeable polyester fabric that covers the atrial facing surface of the device. The access sheath and delivery catheter permit device placement in the LAA via femoral venous access and inter-atrial septum crossing into the left atrium.

The procedure takes up to approximately 60 minutes, and is performed under general anaesthesia by an interventional cardiologist or electrophysiologist in a catheterisation lab under fluoroscopy and transoesophageal echocardiogram (TOE).

Description of Medical Condition

Atrial Fibrillation (AF) is the most common sustained cardiac arrhythmia and a key risk factor for ischaemic strokes. A thrombus can form when blood becomes trapped in the LAA due to fibrillation. When the thrombus becomes dislodged it migrates through the arterial system towards the brain, resulting in vascular occlusion from the thromboembolism which may cause an ischemic stroke. Ischemic strokes can lead to a large number of complications including hemi-paralysis, speech deficits, dysphasia, and even death.

Reason for Application

New MBS item

Medical Service Type

Therapeutic

Previous Application Number

Not Applicable

Associated Documentation

Application Form

-

PICO Confirmation

Final Protocol (PDF 700 KB)
Final Protocol (Word 1568 KB)

Assessment Report

-

Public Summary Document

Public Summary Document (PDF 154 KB)
Public Summary Document (Word 271 KB)

Meetings for this Application

PASC

12 to 13 December 2013

ESC

8 to 10 October 2014

MSAC

26 to 28 November 2014

Stakeholder Meeting

Friday 5 June 2015, members of the MSAC, clinicians with experience in managing patients with non-valvular atrial fibrillation (NVAF) and expertise in treating the condition, representatives of Boston Scientific and St Jude Medical Australia, and the Department of Health met to discuss transcatheter occlusion of the left atrial appendage for patients with non-valvular atrial fibrillation. This was not an MSAC decision making forum, but a meeting that would inform the issues considered by MSAC following its November 2014 consideration of application 1347 (transcatheter occlusion of the left atrial appendage for patients with non-valvular atrial fibrillation). The key objective of the meeting was to ensure that those with knowledge of these devices could be involved in discussing the issues raised by the November 2014 MSAC meeting, particularly the appropriate patient population and comparator, to provide a basis for any re-application of a public funding proposal. Attached are the final minutes from this meeting.

Minutes of the Stakeholder Meeting - 5 June 2015 (PDF 94 KB)
Minutes of the Stakeholder Meeting - 5 June 2015 (Word 67 KB)