Application Detail

Status

Closed

Description of Medical Service

CRT-D therapy requires the insertion of a cardiac resynchronisation therapy pulse generator and three leads. All three leads are inserted into the heart via the subclavian vein (or the cephalic or internal jugular vein in some cases), and the generator is positioned adjacent to the subclavian vein. The defibrillation lead is attached to the right ventricle and the pacing lead is attached to the right atrium. The third lead, which is required to coordinate ventricular contractions, is attached to the coronary venous system of the left ventricle. This lead also enters the heart via the subclavian vein, but it is then threaded through the coronary sinus and into the coronary vein.

Description of Medical Condition

Patients with heart failure not only suffer from shortness of breath with or without exercise, shortness of breath at night, fatigue and weakness, and possibly dizzy spells and palpitations, but they are also at increased risk of sudden cardiac arrest (SCA). For this reason, some patients are provided with an implantable cardioverter defibrillator (ICD), which in the event of a SCA may generate a shock to the heart thus restoring normal cardiac rhythm.

Clinical problems in patients suffering from heart failure, namely symptoms of shortness of breath and the risk of sudden death, led to the development of a device that combines the cardiac resynchronisation function with that of an ICD (i.e. a CRT-D).

Reason for Application

-

Medical Service Type

-

Previous Application Number

Not Applicable

Associated Documentation

Application Form

-

PICO Confirmation

Final Protocol (PDF 1745 KB)
Final Protocol (Word 586 KB)
Final Protocol released 6 June 2013

Assessment Report

Assessment Report (PDF 4695 KB)
Assessment Report (Word 32441 KB)

Public Summary Document

28 November 2013
Final Public Summary Document (PDF 211 KB)
Final Public Summary Document (Word 138 KB)

Predicted versus Actual

24-25 November 2016
Public Summary Document - November 2016 (Word 316 KB)
Public Summary Document - November 2016 (PDF 976 KB)

Meetings for this Application

PASC

13 – 14 December 2012

ESC

10 - 11 October 2013

MSAC

28 November 2013
24-25 November 2016