Application Detail

Description of Medical Service

The proposed medical service is percutaneous reconstruction of an insufficient mitral valve, through tissue approximation using transvenous/transeptal techniques. The procedure is performed using a catheter-based device that enables physicians to perform percutaneous, transvenous/transseptal mitral valve repair in patients with mitral regurgitation (MR) while the heart is beating. It provides an alternative to ongoing medical management in patients not suitable for conventional open chest, arrested heart surgery; and in whom existing comorbidities would not preclude the expected benefit from correction of MR. The procedure is based on the principle of edge-to-edge repair, but a mechanical clip is used in place of a suture to allow permanent coaptation (‘approximation’) of the two mitral valve leaflets.

This application refers to the proposed medical service as transcatheter mitral valve repair (TMVr).

Description of Medical Condition

MR occurs when the leaflets (or flaps) of the heart’s mitral value do not close properly and leak. The mitral valve is a one-way valve that separates the left atrium (a chamber in the heart which collects blood from the lungs) from the left ventricle (a chamber in the heart which pumps blood to the rest of the body). During pumping, the leak in the mitral valve causes blood to flow backwards into the left atrium (also known as regurgitant volume), thereby decreasing blood flow to the body (resulting in lower cardiac output and stroke volume).

To maintain blood flow to the body and compensate for MR, the left ventricle must pump harder. Backflow due to MR places an extra burden on the left ventricle and lungs. Eventually, this burden can cause other problems, such as: stroke, sudden death, irregular heartbeat, increasing damage to the heart muscle (progressive myocardial injury); and/or inability to maintain adequate circulation of blood (congestive heart failure).

Reason for Application

Resubmission

Medical Service Type

Therapeutic

Previous Application Number

1192
1192.1
1192.2

Associated Documentation

Application Form

Application Form (PDF 2133 KB)
Application Form (Word 1115 KB)

Consultation Survey

Consultation Survey (PDF 561 KB)
Consultation Survey (Word 70 KB)

PICO Confirmation

PICO Confirmation (PDF 2153 KB)
PICO Confirmation (Word 949 KB)

Assessment Report

-

Public Summary Document

Public Summary Document (PDF 950 KB)
Public Summary Document (Word 464 KB)

Meetings for this Application

PASC

8 August 2019

ESC

13-14 February 2020

MSAC

3 April 2020
9 September 2020