Generator replacement

What is a generator replacement?

You would be very familiar with your cardiac device (pacemaker / defibrillator). Your device has two main highly sophisticated components: the lead(s) and the generator (which is also the battery unit). The battery cannot be removed from the generator or recharged. The generator unit which houses the electrical circuitry and battery will have to be replaced altogether. This also ensures that you have the most advanced technology and system helping your heart.

 What are the risks of having a generator replacement?

 They include but are not limited to the following.

Common risks and complications (more than 5%) include:

• Bruising / bleeding at the pacemaker site
• Large collection of blood (Haematoma) – this can take several weeks to settle
• Pain at the pacemaker site

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

• The pacemaker / device lead(s) can move. The lead will need to be put back into place by repeating this procedure
• Bad bruising if you are taking blood thinning drugs such as Warfarin, Xarelto, Eliquis, Dabigatran Aspirin, Clopidogrel (Plavix or Iscover) or Dipyridamole (Persantin or Asasantin)
• Unexpected device failure. There is a risk of battery (generator) or lead failure. This is uncommon but means the battery or lead will need to be removed and a new one put in
• Infection of the pacemaker site. This will need treatment with antibiotics and/or removal of the pacemaker
• Infection of heart valve and other infections

Rare risks and complications (less than 1%) (Only applicable if you need a new lead implanted) include:

• A punctured lung (pneumothorax). This may require a tube to be inserted into the chest to reinflate the lung
• Blood clot in the subclavian vein (Deep vein thrombosis)
• A hole is accidentally made in the heart or heart (perforation) – This will need surgery to repair
• Blood clot in the lung (pulmonary embolus)
• Heart attack
• A stroke. This can cause long term disability
• Death is possible due to the procedure or other heart problems
• Tricuspid regurgitation

 How do I prepare for the procedure?

You will receive a letter with instructions and steps required prior to your procedure including, date of admission, fasting instructions, medications to stop and items to bring with you. You will usually need recent blood test for your kidneys and blood count prior.

In General, do not eat or drink for 6 hours before your procedure. Ask your doctor about taking your usual medications. Blood thinners maybe discontinued for 24hrs. If you take SGLT2 (dapagliflozin / empagliflozin) medicine for heart failure or diabetes, you will need to stop taking them at least 3 days before your surgery. Leave any personal items of value such as jewellery at home.

What happens when you arrive at the hospital?

Once you arrive at the hospital for your procedure, you will usually be directed to the cardiac catheter laboratory / operating theatre admission area where you will be formally admitted as a hospital patient. You will be asked to change into hospital gown and put away all your valuable belongings. You will have some basic tests such as ECG, have your vitals recorded, upper chest shaved and have a cannula inserted into your arm to assist with the procedure. The technologists will check your device to ensure it is functioning normally and to check your hearts underlying function. In some people, your heart may not beat while the generator is being replaced.

What happens during the procedure?

Generator replacement is a very common procedure and takes approximately 30 minutes. Procedure is usually performed in the catheter laboratory or operating theatre. You will be lying on a narrow bed under the X-ray machine arm that can move in and out of position.

The procedure is generally performed under sedation. Medication to make you sleepy will be given through the cannula to keep you relaxed during the procedure. General anaesthesia may be considered in some cases and may require an arterial line to monitor your blood pressure. Antibiotics are usually given prior to the procedure.

Once you are comfortable, the upper chest is usually shaved again if needed, cleaned with a special antiseptic wash and once dry, a long sterile drape is placed over the site. The drape covers you from head to toe. You will have someone to assist you if needed. Local anaesthetic is administered at the incision site which numbs the area. You’ll feel an initial sharp and burning or pricking sensation when the local anaesthetic is injected but it quickly becomes numb in less than a minute. You may feel a pulling / pushing sensation during the operation which is normal.

A 5 to 8cm cut is made just below your collarbone over the existing device. The tissue under the skin is carefully dissected until the existing generator is reached. The generator is pulled out of the body, but the leads remain in place. There is usually adequate amount of slack on the wires to allow this. The leads are then removed from the old device and attached to the new device. The device and leads are checked prior to the replacement and not in-between. The new device is placed within the same space and wound closed with absorbable sutures. In some cases, new devices are of different shape and size which might mean that the existing space will have to be extended to accommodate the new device. It may also not look or feel the same as your old device.

If you do not have an underlying heart rhythm, a temporary pacing wire may be required in selected cases. This is usually passed through the vein on the top of your right leg and placed in the heart prior to the procedure.

You’ll maybe asked to stay overnight and can usually go home the next day. If the procedure is performed early in the day, you could potentially go home the same day.

What are the costs associated with the procedure?

If you are having this procedure in a public hospital as a public patient, the cost is covered by Medicare.  If you are having this procedure in a private hospital, there is no additional out of pocket cost for our specialists. The usual hospital excess applies. Some anaesthetists have an out-of-pocket cost that we encourage you to discuss prior to your planned procedure.

What happens after the procedure?

At the end of your procedure, a simple dressing is applied over the pacemaker site. You may have a larger dressing applying pressure at the site overnight in some cases. You’ll be watched closely in a recovery area, and depending on how you feel, you might need to rest in bed for a while. You will be admitted to the ward for observation if you are staying overnight with rhythm monitoring.

What happens after discharge?

Wound Care:

1. The dressing on your wound should be left in place for two weeks. You may shower, as it is waterproof, but you cannot submerge yourself in a bath or pool.
2. Two weeks after the operation, please go to your GP to have the dressing removed. Do not remove or change the dressing before this time.
3. If the wound becomes red, hot, swollen, more painful or starts to drain fluid, see your local doctor immediately, or call the rooms.

Special Issues:

 

1. DRIVING: You may drive after two weeks. You can find out more about the driving restrictions from the Austroads website {link to website: https://austroads.com.au/drivers-and-vehicles/assessing-fitness-to-drive}
2. It is normal to take Paracetamol (Panadol) regularly for the first few days at home.

Airline Travel:

You will be given a card with the details of your pacemaker on it, please keep this in your wallet.  A permanent card (resembling a credit card) will be sent to you in about two months.  Show this to the security check at the airport, they will search you with a wand rather than walking through the usual metal detector gate.

Follow Up:

You will be sent an appointment to see me for a pacemaker check in my rooms in 2 months. Usual follow up thereafter is 6-12 monthly appointments to keep track of the device function. It is recommended that you continue your usual follow up with other treating specialists and medical practitioners involved in your care as usual.  If you do not receive an appointment, please call the rooms.

How long do pacemakers last?

The wires can last for decades but as with most things there is wear and tear over time. The battery lasts about 10-15 years depending on a few factors.

Remote monitoring:

We can monitor the function of your pacemaker while you are at home via remote monitoring. This can be through a little box (remote monitor) that you place near your bed or through your smart phone. All important information is stored within your pacemaker and the remote monitor communicates with your pacemaker wirelessly overnight at a prespecified time. It will do so every night and transmit information 1-6 monthly to a team of technologists who analyse that information. If there is an urgent issue, information will be transmitted that night and the doctor will usually be informed the next day.

Generally, almost all people will be offered remote monitoring to keep track of your device while you are at home. There is a free service and a paid service (External 3^rd party – Remote Rhythm Management). Please feel free to discuss this with your doctor.

Please contact my secretary if you have any questions or concerns at any time. I am happy to hear from you if you have any questions or concerns.

In recommending this procedure your doctor has 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 very complicated assessment.