New heart valve for mitral regurgitation can be implanted by catheter

By John Murphy, MDLinx
Published October 8, 2015

Key Takeaways

Researchers have developed a novel prosthetic heart valve, called VeloX, which can be implanted through a small incision for the treatment of mitral regurgitation. The valve is particularly intended for patients at high surgical risk or those not suited for existing interventions.

An estimated 12 million people worldwide suffer from mitral regurgitation, with nearly 250,000 new patients diagnosed annually. If left untreated, 1 in 3 patients with the severe form will die within 6 years, the researchers noted.

The standard operation to treat severe mitral valve regurgitation is open-heart surgery. But, elderly patients or those with multiple chronic diseases are not candidates. Current mitral valve interventions can be done via a small incision surgery, but these are applicable for only a select group of patients who have mitral valve leaflets of a particular shape.

The new heart valve addresses the clinical gap in the treatment of mitral regurgitation because it suits different mitral annulus sizes of patients, and is implanted using a minimally invasive transcatheter approach. This device could therefore be a viable option for patients who aren’t suitable for surgeries or the standard treatment, the researchers said.

The Velox valve was developed by a team led by Leo Hwa Liang, MS, PhD, Associate Professor in the Department of Biomedical Engineering at National University of Singapore (NUS), and Jimmy Hon, MB ChB, of the Department of Surgery at the NUS Yong Loo Lin School of Medicine. It is made of pericardial tissue attached within a self-expanding, polymer coated nickel-titanium alloy stent frame. The valve can be compressed to the thickness of a pencil to be inserted into the catheter.

The device is designed to be retrievable and repositionable to facilitate accurate placement. “The mitral annulus has a very complex structure, so it is particularly challenging to deploy and anchor a prosthetic valve into the constricted region,” Dr. Leo said. “Optimal positioning is crucial as any malpositioning can be detrimental for patients. One of the unique features of VeloX is its ability to be self-centering, hence enabling it to achieve an optimal position after being implanted.”

Once positioned, the valve restores the unidirectional flow of the blood in the left heart and alleviates symptoms associated with mitral regurgitation. “This transcatheter valve offers palliative treatment for the patients who were denied surgery, especially those with multiple co-morbidities,” said Dr. Hon, who is also a Senior Consultant at the Department of Cardiac, Thoracic, and Vascular Surgery at the National University Heart Centre Singapore.

The investigators are now planning in vivo studies to acquire data on the technical performance of the device.

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