Tendyne: A revolutionary technology for mitral valve replacement

Patients with severe mitral regurgitation (MR) have limited treatment options and are often refused surgery due to the condition of their health or advanced age. Tendyne™ Transcatheter Mitral Valve Replacement (TMVR) is a revolutionary mitral valve replacement technology that offers a safe and effective treatment option when others are not available.

Alternative treatment options are needed

MR is the most common heart valve disease in developed countries. The condition can be debilitating, with symptoms of breathless and fatigue that greatly reduce a patient’s ability to take part in activities they enjoy and may result in progression to heart failure. 

Mitral valve surgery (repair or replacement) is strongly recommended in current national guidelines for symptomatic patients with severe MR, yet data suggests that only 50% of patients with severe MR actually get to undergo conventional surgery.  

Reasons why patients are denied mitral valve surgery includes factors such as advancing age, multiple comorbidities, hostile chest, and high-risk surgical technique. Medical therapies can be used as an alternative in patients who are deemed unsuitable for conventional mitral valve surgery, and while these can help to relieve symptoms, medical therapy does not rectify the underlying structural problem of mitral regurgitation in the way surgery can.

An alternative to conventional mitral valve surgery is therefore needed to provide a much-needed minimally invasive treatment option in patients with severe MR. 

Tendyne: a first-in-class technology

Tendyne™ Transcatheter Mitral Valve Replacement (TMVR) is a technology that offers select patients with severe MR the opportunity for a safe and effective replacement of their mitral valves, without the need for undergoing conventional heart surgery. 

The Tendyne TMVR procedure is less invasive than conventional cardiac surgery, requiring only a small 5cm incision on the left-hand side of the patient’s chest between the ribs just below nipple. Moreover, unlike conventional mitral valve surgery which requires a patient’s heart to be stopped and the circulation supported on cardiopulmonary bypass), the Tendyne TMVR procedure facilitates insertion of the valve directly into a patient’s beating heart via a catheter with no requirement for cardiopulmonary bypass or sternotomy. 

An analysis of three-year outcomes data on the first 100 patients treated with the technology for severe symptomatic MR as part of the Global Feasibility Study demonstrated complete elimination of MR in 99% of patients at 30 days and sustained MR elimination in 93% of patients at three years. 

In addition, the procedural technical success of 96% was high with significant  patient-reported improvements in symptom and quality of life measures: 82% of patients were in NHYA Class I/II at two years compared with 34% at baseline and there was an average 19-point increase in quality of life (KCCQ) scores over the same period.

The future of mitral valve surgery

“It is very important to be able offer patients with severe MR  a range of options to treat their MR, especially in patients who are not suitable for mitral valve surgery or other wire-based therapies to repair their mitrfal valve, The Tendyne TMVR procedure is safe and effective in eliminating mitral valve regurgitation in these types of patients,” explains Dr Alison Duncan, associate specialist in cardiology and transcatheter valve therapies.

Dr Duncan 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 The Royal Brompton Hospital in 2014. “I have patients who were previously suffering from heart failure due to mitral regurgitation who are now able to go the gym three times a week and are very active and full of life,” she says of her experiences. We also have patients living a full and active life now 10 years after their Tendyne procedure, with good durability of the Tendyne device during follow-up.

Mr Cesare Quarto, consultant cardiac surgeon at The Royal Brompton and Harefield Hospitals was instrumental in pioneering the first Tendyne TMVR procedures and continues to do so. He says: “We have the longest follow-up of patients of any centre in the world and we continue to see great safety and effectiveness. We are hopeful that its availability will be expanded so that it may benefit many more patients.” 

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 gained its CE Mark in January 2020 and is the first of its kind available for wider use outside of clinical trials. It is awaiting NICE approval 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