Transcatheter Aortic Valve Replacement (TAVR)

What’s transcatheter aortic valve replacement (TAVR/TAVI)?

Historically aortic valve disease has been managed with open heart surgery through a cut in the chest through the breast bone and new valve implanted. Transcatheter aortic valve replacement / implantation (TAVR / TAVI) is a technique that has been developed over the last decade where the new valve (made of a metal frame with cow and or pig tissue) is taken up to the heart through a tube in the leg artery (or sometimes the arteries under the collar bone or in the neck). After careful assessment and because of your particular health situation your doctors in consultation with a heart team of multiple specialists (including an interventional cardiologist and a heart surgeon) may recommend this procedure for treatment of your condition as less invasive alternative to open heart surgery.

What happens during the TAVR procedure?

The care we give has been designed by cardiology specialists across the world.

Procedures are always easier when you know what to expect. Here’s a summary of what generally happens during this procedure:

Anaesthetic is administered (this may be a full general anaesthetic and including being put onto a breathing machine, the specifics of which your doctors will discuss with you).

An ultrasound probe (transoesophageal echocardiogram probe) is placed down your food pipe to visualise the heart.
Tubes (sheaths and catheters) are inserted into the arteries in each of your legs, the vein in your neck and / or leg and sometimes in your wrist or arm. In certain settings this may require a ‘cut down’ where a cut is made in the skin by a surgeon to get to the artery.
A temporary pacemaker wire is threaded through one of the tubes in your veins into the heart.
Through a tube in the leg a wire is threaded up to the heart under x-ray across your diseased heart valve (the aortic valve). The valve is then prepared for a new valve by ballooning it open to reduce the narrowing in the valve.
Through the same tube in the leg as that used for the balloon a new valve is taken up to the heart over a wire and positioned into where your own diseased valve is and released or balloon into place.
- There are two major types of TAVR / TAVI valve. One self-expands into position (self-expanding valve) and the other type of valve is ballooned into position (‘balloon expandable’). Both are potentially effective treatment options with similar long-term outcomes. The choice of valve is dependent on your aortic and aortic valve’s particular shape, size and degree of hardening. Examples of these are shown in figure 2 below. The valve tissue is made of cow, pig or both.
The wires and tubes are removed from your body. A stitching device is used to close the hole in the leg arteries.

a) Portico self-expanding valve

b) Edwards balloon-expandable valve

Are there any risks with transcatheter aortic valve replacement (TAVR/TAVI)?

The procedure has many potential risks. The information supplied here is for general reference only based on the published data around the procedure from across the world. Risks specific to your condition and overall situation need to be discussed with your treating doctor. It should be understood that even though TAVR / TAVI is potentially a less invasive treatment option than open heart surgery, it is still associated with real risks.

Common risks and complications that can occur 5 % of the time or more include:

Bruising, swelling and pain around the access sites.
Where a vascular cut-down is used there will be a wound with sutures / stitches and residual scar in the order of 10 to 15 cm long (or longer). There will be a permanent scar. There can be altered sensation around the scar and in the leg as a result of the procedure.
Unplanned major vascular surgery on the leg, arm or internal vessels can occur up to 10 % of the time.
Unplanned requirement for permanent pacemaker implantation (up to 30 % of the time).
Development of an abnormal heart rhythm that can require treatment with blood thinning drugs, other drugs and possibly an electric shock to the heart under an anaesthetic.
Post procedural memory loss or confusion (delirium) which usually resolves but can sometimes result in residual permanent reduced cognitive / brain function.
Physical deconditioning and disability that usually resolves with time and allied health assistance but can sometimes result in permanent residual deficits and in some cases may result in a need for nursing home placement.
Greater than 30% or patients have some degree of leaking next to their new heart valve. So long as this is no more than a mild amount of leak no treatment of this is required.

Less common risks and complications that can occur 1-5 % of the time include:

A stroke, or embolism (which can occur up to 2 – 5% of the time) that can cause permanent disability, visual loss, brain damage, limb compromise, limb loss and death.
Death is possible due to this procedure (1 – 3%). This can be as a result of the procedure, or because of a complication, or progression of your underlying heart disease despite the procedure being technically successful.
Unplanned angiogram and ballooning / stenting procedure to the heart arteries if they become blocked because of the valve replacement procedure (1 – 2%).
Bleeding around the heart that requires emergency insertion of a tube into the space around the heart or open-heart surgery to prevent death (1 – 2%).
Unplanned open-heart surgery which can include valve surgery, bypass surgery or reconstructive surgery on the heart or blood pipes including with artificial materials (1%).
Renal / kidney failure, especially if you have abnormal kidney function already or if you have diabetes. This can also lead to a requirement for temporary or permanent dialysis.
Blood clot formation in the leg (DVT) causing pain and swelling. Sometimes part of the clot can break off and go to the lungs which can be life threatening.
Infection of the wound, new heart valve or other organs (for example kidneys, bladder or lungs). This usually requires antibiotics (often into a vein) and can require a surgical procedure.
Bleeding that leads to a requirement for blood transfusion. The spread of an infection from a blood transfusion is possible but rare.
Rupture of the aorta or aortic root (main blood pipe out of the heart) which can result in death even with urgent surgery (1 – 2%).
The new heart valve embolising / travelling into other parts of the body or heart and require major surgery to retrieve and / or require placement of an additional valve.
Lack of clinical improvement in your overall condition despite a technically successful procedure (especially if you have multiple other health problems).
Significant leaking of the valve which can sometimes require further procedures or surgery (2 – 5%).
Early failure of the device requiring repeat procedures or surgery in the first 12 to 36 months.

Rare risks and complications that can occur less than 1% of the time include:

Risks of a general anaesthetic which rarely can lead to life threatening adverse and allergic reactions and death.
A hole in the food pipe or stomach as a result of the ultrasound probe being placed down your food pipe. This is rare (< 1%).
The procedure is performed using X-ray type radiation. Theoretically any radiation exposure can increase the life-time risk of cancer although this risk is more relevant for patients under the age of 40 years old. In addition, radiation exposure can be associated with skin changes (hair loss, colour change). Very rarely the radiation exposure can result in skin burns, non-healing ulcers and pain that can require surgical management.

Common risks and complications that can occur 5 % of the time or more include:

Bruising, swelling and pain around the access sites.
Where a vascular cut-down is used there will be a wound with sutures / stitches and residual scar in the order of 10 to 15 cm long (or longer). There will be a permanent scar. There can be altered sensation around the scar and in the leg as a result of the procedure.
Unplanned major vascular surgery on the leg, arm or internal vessels can occur up to 10 % of the time.
Unplanned requirement for permanent pacemaker implantation (up to 30 % of the time).
Development of an abnormal heart rhythm that can require treatment with blood thinning drugs, other drugs and possibly an electric shock to the heart under an anaesthetic.
Post procedural memory loss or confusion (delirium) which usually resolves but can sometimes result in residual permanent reduced cognitive / brain function.
Physical deconditioning and disability that usually resolves with time and allied health assistance but can sometimes result in permanent residual deficits and in some cases may result in a need for nursing home placement.
Greater than 30% or patients have some degree of leaking next to their new heart valve. So long as this is no more than a mild amount of leak no treatment of this is required.

Less common risks and complications that can occur 1-5 % of the time include:

A stroke, or embolism (which can occur up to 2 – 5% of the time) that can cause permanent disability, visual loss, brain damage, limb compromise, limb loss and death.
Death is possible due to this procedure (1 – 3%). This can be as a result of the procedure, or because of a complication, or progression of your underlying heart disease despite the procedure being technically successful.
Unplanned angiogram and ballooning / stenting procedure to the heart arteries if they become blocked because of the valve replacement procedure (1 – 2%).
Bleeding around the heart that requires emergency insertion of a tube into the space around the heart or open-heart surgery to prevent death (1 – 2%).
Unplanned open-heart surgery which can include valve surgery, bypass surgery or reconstructive surgery on the heart or blood pipes including with artificial materials (1%).
Renal / kidney failure, especially if you have abnormal kidney function already or if you have diabetes. This can also lead to a requirement for temporary or permanent dialysis.
Blood clot formation in the leg (DVT) causing pain and swelling. Sometimes part of the clot can break off and go to the lungs which can be life threatening.
Infection of the wound, new heart valve or other organs (for example kidneys, bladder or lungs). This usually requires antibiotics (often into a vein) and can require a surgical procedure.
Bleeding that leads to a requirement for blood transfusion. The spread of an infection from a blood transfusion is possible but rare.
Rupture of the aorta or aortic root (main blood pipe out of the heart) which can result in death even with urgent surgery (1 – 2%).
The new heart valve embolising / travelling into other parts of the body or heart and require major surgery to retrieve and / or require placement of an additional valve.
Lack of clinical improvement in your overall condition despite a technically successful procedure (especially if you have multiple other health problems).
Significant leaking of the valve which can sometimes require further procedures or surgery (2 – 5%).
Early failure of the device requiring repeat procedures or surgery in the first 12 to 36 months.

Rare risks and complications that can occur less than 1% of the time include:

Risks of a general anaesthetic which rarely can lead to life threatening adverse and allergic reactions and death.
A hole in the food pipe or stomach as a result of the ultrasound probe being placed down your food pipe. This is rare (< 1%).
The procedure is performed using X-ray type radiation. Theoretically any radiation exposure can increase the life-time risk of cancer although this risk is more relevant for patients under the age of 40 years old. In addition, radiation exposure can be associated with skin changes (hair loss, colour change). Very rarely the radiation exposure can result in skin burns, non-healing ulcers and pain that can require surgical management.