Plain language summary

Aortic stenosis is a heart condition where the main valve that lets blood flow out of the heart becomes narrowed. Symptoms of aortic stenosis include chest pain, tiredness and breathlessness. Severe aortic stenosis can lead to heart failure. Aortic stenosis is more common in older people.

The standard treatment for severe aortic stenosis is open heart surgery to replace the affected heart valve. TAVI is a less invasive alternative to surgery.

The TAVI procedure places a new valve inside the patient’s own heart valve. TAVI does not require open heart surgery. The new valve is inserted through blood vessels in the groin or sometimes using a small incision in the chest wall.

Aortic stenosis is the most common heart valve disease in adults in Europe. Without treatment, people with severe aortic stenosis have an average life expectancy of 2 to 3 years after diagnosis.

Evidence has shown that TAVI is as effective, or more effective, than open heart surgery in people with severe aortic stenosis who have a high or intermediate risk of dying after surgery.

We looked at the evidence on using TAVI to treat people who have severe aortic stenosis who are at low surgical risk and compared this to evidence on surgery. We looked at whether the treatments were effective, safe and good value for money. We also explored patient experiences of TAVI.

Is TAVI effective and safe?

We found evidence from five trials comparing TAVI with surgery. The combined results of the trials showed that there was no difference in the risk of dying after TAVI or surgery. In one trial, this was true for up to 10 years after patients had TAVI or surgery.

There were three more trials that had been published recently. These trials also found that there was no difference in the risk of dying after TAVI or surgery.

We found evidence of differences in the safety of TAVI and surgery.

• People who had TAVI were more likely than people who had surgery to need a pacemaker afterwards.
• People who have TAVI might have more blood leaking around the new valve compared with people who have surgery.
• People who had surgery were more likely to develop a condition called atrial fibrillation, to have kidney problems or to experience bleeding.

These safety findings were true across all the studies we looked at.

Quality of life improved more quickly for people who had TAVI compared with people who had surgery. One year after treatment, quality of life was similar for people who had TAVI or surgery.

People who have TAVI generally spend less time in hospital after their procedure compared with people who have surgery.

Value for money

We found conflicting evidence on whether TAVI is good value for money.

• Thirteen studies found that TAVI was good value for money. These studies were mostly from European countries or the United States where TAVI valves are cheaper than in Scotland.
• One study in the UK found that TAVI was not good value for money. This may be because TAVI valves are more expensive in the UK than Europe or the US.
• Another study from the UK found that TAVI was good value for money when taking into account what happens to patients for a longer time following their procedure (that is, based on information gathered over 4 years instead of 1 year).
• The main things that affect whether TAVI is good value for money are the cost of the valve, survival benefits, complication rates and long term care costs for people with aortic stenosis.

Patient experiences and views

We found that people in England who lived in less wealthy areas, were of African or south Asian descent or women, were less likely to get aortic valve replacements (TAVI or surgery).

Some people continue to experience mental and physical symptoms after their TAVI procedure. This is often because they have other health problems. For many people this led to feelings of disappointment, isolation and vulnerability.

People were often motivated to have TAVI so that they could regain a normal life and continue to live independently in their own home. Trial results suggest this would be quicker with TAVI.