Patients suffering with heart failure caused by a faulty heart valve, called a mitral valve, are often refused surgery due to issues with their general health or advanced age. Tendyne is a ground-breaking new technology that can replace the mitral valve while avoiding open heart surgery, offering a safe and effective treatment option when others are limited or too high-risk.

The Tendyne* Transcatheter Mitral Valve Replacement (TMVR) positioned in the heart

Alternative treatment options are needed

The mitral valve plays an important role in helping the heart pump oxygen-rich blood around the body. However, sometimes it can become leaky which leads to blood flowing backwards – a condition called mitral regurgitation (MR).

MR is the most common heart valve disease in developed countries and often develops due to advancing age (‘wear and tear’ over time), heart failure, or untreated high blood pressure.

As oxygenated blood doesn’t flow forwards around the body as it should when MR is present, patients can feel tired and breathless. The condition can be debilitating, greatly reducing a patient’s ability to take part in activities they enjoy and may result in progression to worsening heart failure.

Mitral valve surgery is strongly recommended for patients experiencing symptoms, yet studies suggest that only 50% of patients with severe MR undergo conventional surgery due to prohibitively high risk – for example, poor health caused by other conditions they may also have.

Medical therapies can be used in patients who are considered unsuitable for conventional mitral valve surgery, and these can help to relieve symptoms, but they do not correct the underlying faulty mitral valve in the way surgery can.

The mitral valve is one of the heart’s four valves.

The valves of the heart are important in letting blood flow in one direction.

Tendyne: a ground-breaking new technology

Tendyne™ Trancatheter Mitral Valve Replacement (TMVR) is an innovative first-in-class technology that offers select patients with severe MR the opportunity for a safe and effective replacement of their faulty mitral valves.

The procedure is less invasive than conventional mitral valve surgery, requiring only a small 5cm incision between the ribs rather than splitting of the breastbone.

Also, unlike conventional mitral valve surgery, it does not require a patient’s heart to be stopped and supported by a heart-lung bypass machine (which temporarily performs the job of the heart and lungs for the patient during surgery).

During the Tendyne TMVR procedure, the artificial valve is inserted with a catheter – a tube like device – directly into a patient’s beating heart.

A recent research study on 100 patients with severe MR treated with Tendyne showed positive results two years after surgery.

99% of patients experienced no symptoms of MR 30 days after surgery and 93% of patients continued not to experience any symptoms after two years. Most patients also had a significant improvement in their quality of life, such as being able to do more physical activity than they could before surgery.

The Tendyne* TMVR valve is inserted into a patient’s beating heart with a catheter and secured in place with a tether that is attached to a pad (2) outside the heart.

The future of mitral valve surgery

“We have the longest follow-up of patients of any centre in the world and we continue to see great safety and effectiveness for this procedure. We are hopeful that the availability of Tendyne will be expanded so that it may benefit many more patients around the world,” says Mr Cesare Quarto, consultant cardiac surgeon at Guy’s and St Thomas’ Specialist Care who was instrumental in pioneering the first Tendyne TMVR procedures and continues to do so.

Dr Alison Duncan, associate specialist in cardiology and transcatheter valve therapies at Royal Brompton Hospital, is the UK Chief Investigator of the Tendyne Global Early Feasibility Study and performed the first procedure in the world with her surgical colleagues at Royal Brompton Hospital in 2014. She said: “This is a game-changer in mitral valve surgery. Patients who previously had limited treatment options now have one that is safe and effective in eliminating their mitral valve regurgitation.”

“I have patients who were previously suffering from heart failure due to mitral regurgitation who are now able to go to the gym three times a week and are very active and full of life,” she says of her experiences.

As Royal Brompton Hospital is the only centre in the UK that offers the procedure, both Mr Quarto and Dr Duncan offer training for other clinicians and healthcare teams around the world in its use.

The technology is the first of its kind available for wider use outside of clinical trials. It is currently not available on the NHS but is available privately at Guy’s and St Thomas’ Specialist Care.

*Tendyne is a trademark of Abbott or its related companies. Reproduced with permission of Abbott, © 2021. All rights reserved.

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