November 13, 2019 by John Fernandez
FDA Approves Device for Heart Valve Replacement With Help from Miami Cardiac & Vascular Institute
The U.S. Food and Drug Administration (FDA) has approved a new device, the Lotus Edge, to better assist doctors when replacing aortic valves using a minimally invasive method on patients at high risk for open heart surgery.
And Miami Cardiac & Vascular Institute has again played a leading role in this latest advancement in “transcatheter aortic valve replacement,” or TAVR. Most recently, TAVR made the news when Rolling Stones frontman Mick Jagger, 75, underwent the procedure in New York City.
For years, Miami Cardiac & Vascular Institute has been performing TAVR on higher-risk patients and the Institute took part in the trials that led to the FDA’s approval of Lotus Edge, the third and most advanced TAVR system used in the U.S. Ramon Quesada, M.D., medical director of the Structural Heart and Complex Percutaneous Coronary Intervention Programs at Miami Cardiac & Vascular Institute, served as an investigator in the clinical trial of the Lotus system.
“We’re excited about this approval,” says Dr. Quesada. “It’s one step further in the evolution of the technology behind TAVR.”
The aortic valve is one of four valves that regulate blood flow through the heart. For the right candidate, TAVR replaces a diseased aortic valve with a new, biological valve. Physicians use a guide wire to move the new valve (collapsed and placed inside a catheter and wire mesh) through the leg artery, and ultimately into the heart. With current TAVR systems, surgeons then expand a small balloon which is used to open the diseased valve wider.
However, the newly approved Lotus Edge, manufactured by Boston Scientific, allows surgeons to reposition the new valve mechanically — and completely recapture the valve – and remove it if necessary — once it has been fully deployed. It is designed primarily for high-risk patients with severe “stenosis,” or narrowing of the aortic valve opening.
“As far as TAVR goes, anything that provides the patient with more options represents a major advancement,” says Niberto Moreno, M.D., emeritus chief of cardiothoracic surgery at Miami Cardiac & Vascular Institute.
Currently, there are two FDA-approved devices in the market — one is balloon-expandable and the other is self-expandable and partially retrievable.
“With the Lotus Edge, you can control deployment and remove the valve completely,” says Dr. Quesada. “This is something new in terms of the other two systems.”
Why is having the option to remove the new valve important? Complications can develop requiring such an option, says Dr. Quesada. The Institute took part in more than a dozen TAVR procedures during the clinical trial phase using the Lotus system. All of them were successful. But in one of the procedures, Dr. Quesada’s team had to fully retrieve the new valve and replace it with a balloon-expandable version.
The Lotus Edge provides the flexibility that the other existing systems do not provide, he says. Otherwise, valve replacement patients with complications may have to undergo higher risk surgeries.
“The more devices that we have available to us, the more choices that we have,” says Dr. Quesada. “That way we can adjust to particular anatomies and that will make TAVR more successful for more patients.”