1.What is it?
- Edwards life sciences’ FDA approved Sapien 3 Transcatheter Aortic Valve Implantation (TAVI) is a revolutionary aortic valve replacement method that provides a significantly less invasive alternative to open heart surgery, in the treatment of aortic valve disease
2.Why is it important?
- With an ageing population worldwide, the incidence of valvular heart disease is predicted to double in the next 25 years (1)
- The current most widely used procedure available for aortic valve stenosis is a heavily invasive open-heart surgery, performed under general anaesthetic, where a large incision around 25cm is made on the patient’s chest and the heart is stopped with a bypass machine for the surgeon to replace the faulty valve (2)
- This procedure takes a few hours and involves a long recovery time along with high risks such as; infection of the wound, lung or valve from significant exposure; blood clots; stroke or arrhythmias (2)
- The mortality risk and complication rate of these procedures is higher in elderly patients and involves a prolonged hospital stay, especially in those with a previous history of cardiovascular-related problems (3)
- The Sapien 3 valve can be implanted remotely through a small incision in the femoral artery via a catheter with minimal risks/ complications and rapid discharge, as seen in the clinical trial (4)
- Clinically, the partner II trial run on over 3,000 patients to observe the clinical significance of this therapy against surgery, proved to be strongly significant with a 75% lower complication risk within 12 months than traditional surgery (1)
- These results may prove the TAVI to be useful for those patients who do not qualify for the open-heart surgery due to previous conditions and raised risk factors such as the elderly
- Furthermore, with the mentioned increasing incidence of valvular heart disease, the benefits of introducing this option to the majority of patients may also help to decrease discharge times and decrease theatre time, improving efficiency significantly which could help save the NHS and healthcare services valuable time and money
3.How does it work?
- The Sapien valve is made of cow tissue and polyester supported with a stainless-steel mesh frame
- This is compressed into the end of a long thin tube-like delivery catheter around a balloon
- A small incision is made in the leg above the femoral artery
- A catheter is threaded through the femoral artery up through the arch of the aorta to the aortic valve
- Once it has passed through the defunct valve, a balloon expands and pushes the Sapien valve around to the walls of the aorta where it attaches and becomes immediately functional
- There is already some use of this technology for the replacement of the other heart valves as well in a very similar method
All images are the property of Edwards Lifesciences Corporation
Shahmeer Noori – Medical Student