2348

(Affix identification label here)

URN:

Princess Alexandra Hospital

XXXXXXXXXXXXXXXXXXXXXX Family name:

Given name(s):
Leadless Pacemaker Consent
Address:
Townsville University Hospital
Date of birth: Sex: M F
A. Interpreter / Cultural Needs
Significant risks and procedure options:

Is an Interpreter required? Yes No • Bruising at the groin puncture site (5%)

If Yes, is a qualified Interpreter present? Yes No • Failure to implant the pacemaker inside the heart
(2%)
Is a Cultural Support Person required? Yes No
• Dislodgement of the pacemaker inside the
If Yes, is a Cultural Support Person present? Yes No
circulation (0.5%)
• A hole is accidentally made in the heart or heart
B. Condition and Treatment valve (1%). This may need surgery to repair.
• Death is possible (1/1,000) due to the procedure
The doctor has explained that you have: or other heart problems.
Slow heart rate requiring Pacemaker
Risks of not having this procedure:
This condition requires the following procedure:
• Slow heart rate continues and deteriorates
Implantation of Leadless Pacemaker
Inability to add other treatments for heart
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•
The following will be performed: conditions

Both groins and the front of the chest will be washed with
D. Anaesthetic
antiseptic solution. You will have an injection of Local
Anaesthetic into the groin. The vein in the groin will be
This procedure may require an anaesthetic.
punctured to allow entry of a steerable tube containing the
pacemaker. The tube and pacemaker are steered together into (Doctor to document type of anaesthetic discussed)
the heart, using X-ray for guidance. Once the pacemaker is
……………………………………………………………………
positioned in the heart, it is tested to make sure it is working
properly and is stable. The steering tube is then removed and ……………………………………………………………………
the puncture in the groin is closed with a stitch.
……………………………………………………………………
C. Risks of the Procedure

In recommending this procedure you and your doctor have

balanced the benefits and risks of the procedure against the
benefits and risks of not proceeding. Your doctor believes
there is a net benefit to you going ahead. This is a complicated
assessment.

The risks and complications with this procedure can include

but are not limited to the following.
v1.0 03/2017

Uncommon risks and complications (1-5%) include:

• Bad bruising especially if you are taking blood
thinning drugs such as Warfarin, Dabigatran,
Apixaban, Rivaroxaban, Aspirin, Clopidogrel (Plavix
or Iscover), Ticagrelor (Brilinta), or Dipyridamole
(Persantin or Asasantin).

Rare risks and complications (less than 1%) include:

• Unexpected pacemaker failure. This would require
00011:2348

replacement of the leadless pacemaker or

implantation of a traditional pacemaker.
• Blood clot in the leg vein used to insert the leadless
pacemaker
• A stroke. This can cause long term disability

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 (Affix identification label here)
URN:

Family name:
Princess Alexandra Hospital
xxxxxxxxxxxxxxxxxxxxxxxxxxxxx
Given name(s):
Leadless Pacemaker Consent Address:
Townsville University Hospital
Date of birth: Sex: M F

E. Patient Consent Patients who lack capacity to provide consent

Consent must be obtained from a substitute decision
I acknowledge that the doctor/doctor delegate has explained maker/s in the order below.
the proposed procedure.
Does the patient have an Advance Health Directive (AHD)?
I understand:
Yes Location of the original or certified copy of the AHD:
• My medical condition and the proposed procedure,
.............................................................................................
including additional treatment if the doctor finds
something unexpected. I understand the risks and No Name of Substitute Decision Maker/s:
complications, including the risks that are specific to me.
............................................................................................
• The anaesthetic required for this procedure. I
Signature:...........................................................................
understand the risks, including the risks that are specific
to me. Relationship to Patient:.......................................................
• Other relevant procedure/treatment options and their Date:............................ Ph No.:..........................................
associated risks.
Source of decision making authority (tick one):
• My prognosis and the risks of not having the procedure.
Tribunal-appointed Guardian
That no guarantee has been made that the procedure

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•
will improve my condition even though it has been Attorney/s for health matters under Enduring Power
carried out with due professional care. of Attorney or AHD

• The procedure may include a blood transfusion. Statutory Health Attorney

• Tissues and blood may be removed and could be used If none of these, the Adult Guardian has provided
for diagnosis or management of my condition, stored consent. Ph 1300 QLD OAG (753 624)
and disposed of sensitively by the hospital.
• If immediate life-threatening events happen during the F. Doctor/Delegate Statement
procedure they will be treated based on my discussions
with the doctor/doctor delegate or my Acute
Resuscitation Plan. I have explained to the patient all the above points under
the Patient Consent section (E ) and I am of the opinion that
• A doctor/doctor delegate undergoing further training the patient/substitute decision maker has understood the
may conduct this procedure. information.
I have been given the following Patient Information Name of Doctor/doctor delegate:
Sheet/s:
...............................................................................................
Local Anaesthetic and Sedation for your
Procedure Designation: ........................................................................
Pacemaker
Signature: ...........................................Date: .......................

• I was able to ask questions and raise concerns with the

doctor/doctor delegate about the proposed procedure
G. Interpreter’s Statement
and its risks. My questions and concerns have been
discussed and answered to my satisfaction.
• I understand I have the right to change my mind at any I have given a sight translation in :
time including after I have signed this form but, ................................................................................................
preferably, following a discussion with my doctor/doctor
delegate. (State the patient’s language here) of the consent form and
assisted in the provision of any verbal and written
• I understand that image/s or video footage may be
information given to the patient/parent or guardian/substitute
recorded as part of and during my procedure and that
decision-maker by the Doctor.
these image/s or video/s will assist the doctor to provide
appropriate treatment. Name of Interpreter:
On the basis of the above statements I request to have
...............................................................................................
the procedure:
Signature: ............................................................................
Name of Patient:
................................................................................................... Date: ............................................................
Signature: ................................................................................
Date: ...................................................
 Consent Information – Patient Copy
Leadless Pacemaker

1. What is a pacemaker? 2. My anaesthetic

A pacemaker will treat a slow heart beat.
This procedure will require an anaesthetic. See Local
There are four types of pacemakers. The doctor will Anaesthetic and Sedation for Your Procedure
decide which pacemaker suits your condition. Information Sheet for information about the
anaesthetic and the risks involved. If you have any
i. Single Chamber: one lead to the lower chamber
concerns, discuss these with your doctor.
of the heart.
If you have not been given an information sheet, please
ii. Single Chamber: Leadless Pacemaker to the
ask for one
lower chamber of the heart.
iii. Dual Chamber: two leads. One to the upper and
one to the lower chamber of the heart 3. What are the risks of this procedure?
iv. Biventricular: three leads. One to the upper and
two to the lower chambers of the heart. There are risks and complications with this procedure.
They include but are not limited to the following.
Uncommon risks and complications (1-5%) include:
A Standard Pacemaker is made up of two parts, a pulse
generator, which gives off impulses and a lead(s), which • Bad bruising especially if you are taking blood
sends impulses to and from the heart. thinning drugs such as Warfarin, Dabigatran,
A leadless Pacemaker is made up of one part: a pulse Apixaban, Rivaroxaban, Aspirin, Clopidogrel
generator, which gives off impulses directly to the heart (Plavix or Iscover), Ticagrelor (Brilinta), or
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without requiring a lead. Dipyridamole (Persantin or Asasantin).

The pacemaker is ‘programmed’ to your needs by the Rare risks and complications (less than 1%)
doctor who puts the device in. An external machine is include:
used to check the pacemaker. The rate of the
pacemaker can be set using this machine. As part of the • Unexpected pacemaker failure. This would
clinic test, the pacing speed of your pacemaker may be require replacement of the leadless pacemaker
temporarily increased and decreased. Then it will be or implantation of a traditional pacemaker.
reset to its normal setting. • Blood clot in the leg vein used to insert the
Pacemakers ‘stand by’ until the heart rate falls below leadless pacemaker
the set rate of the pacemaker. It will then step in and • A stroke. This can cause long term disability
‘pace’ your heart rate.
Significant risks and procedure options:
You will have the following procedure:
• Bruising at the groin puncture site (5%)
Before the procedure, you may be given antibiotics.
These are given to prevent an infection from occurring. • Failure to implant the pacemaker inside the
heart (2%)
A needle with a tube connected to it will be put in your
arm. This is called an intravenous line or IV. • Dislodgement of the pacemaker inside the
circulation (0.5%)
Both groins and the front of the chest will be washed
with antiseptic solution. You will have an injection of • A hole is accidentally made in the heart or heart
Local Anaesthetic into the groin. The vein in the groin valve (1%). This may need surgery to repair.
will be punctured to allow entry of a steerable tube
• Death is possible (1/1,000) due to the
containing the pacemaker. The tube and pacemaker are
procedure or other heart problems.
steered together into the heart, using X-ray for
guidance. Once the pacemaker is positioned in the Risks of not having this procedure:
heart, it is tested to make sure it is working properly and
is stable. The steering tube is then removed and the • Slow heart rate continues and deteriorates.
puncture in the groin is closed with a stitch.
• Inability to add other treatments for heart
conditions.
Pacemaker Device

The battery is checked each time you come to your

clinic appointment. The battery lasts between 6 and 12
years and cannot be recharged. When the battery
needs changing, it will require a procedure similar to
this.

You cannot drive for 2 weeks after a Pacemaker.