October 15, 2019 by John Fernandez
First in Florida: Team at Miami Cardiac & Vascular Institute Implants New Device to Replace Aortic Valve
A team at Miami Cardiac & Vascular Institute is the first in Florida, and the second in the Southeast U.S., to perform an aortic valve replacement on a patient using a new device, the Lotus Edge, which was recently approved by the Food and Drug Administration (FDA).
Primarily designed for high-risk patients with severe “stenosis,” or narrowing of the aortic valve opening, the Lotus Edge (pictured above) was approved by the FDA in April.
The Institute’s team was led by Ramon Quesada, M.D., medical director of the Structural Heart and Complex Percutaneous Coronary Intervention Programs at Miami Cardiac & Vascular Institute, and interventional cardiologist Bernardo Lopez-Sanabria, M.D. Dr. Quesada served as a principal investigator in the clinical trials of the Lotus system prior to the approval.
In the Institute’s first “transcatheter aortic valve replacement,” or TAVR, using the Lotus Edge, Drs. Quesada and Lopez-Sanabria were assisted by Niberto Moreno, M.D., emeritus chief of cardiothoracic surgery, who also served as an investigator in the trials, and Elliott Elias, M.D., a cardiologist with a focus on interventional echocardiography at Miami Cardiac & Vascular Institute.
The patient, Rafael Ponce, 80, is recovering well after the Lotus Edge was implanted to replace his diseased aortic valve. He had been diagnosed with severe aortic stenosis. The Lotus Edge provides the flexibility that the other existing TAVR systems do not provide, Dr. Quesada says. Otherwise, valve replacement patients with complications may have to undergo higher risk surgeries.
“The most important factors about the Lotus Edge are that it is completely retrievable and repositionable, allowing us more options when implanting the device,” explains Dr. Quesada. “Another advantage with this device is that it seals completely, virtually eliminating paravalvular leak (PVL).”
The aortic valve is one of four valves that regulate blood flow through the heart. During a TAVR procedures, 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. PVL, or “paravalvular regurgitation” can lead to serious complications after transcatheter aortic valve replacement, including heart failure. The Lotus Edge features a braided wire valve frame and a seal that minimizes paravalvular regurgitation or leaking by conforming to the patient’s native aortic valve.
Manufactured by Boston Scientific, the Lotus Edge allows surgeons to reposition the new valve mechanically — and completely recapture the valve – and remove it if necessary — once it has been fully deployed
The TAVR procedure has been in the news lately, in part because Rolling Stones frontman Mick Jagger, 75, underwent the procedure in New York City about three months ago. Mr. Jagger is now touring with the band.
Pending more trials, the Lotus Edge will likely be used to treat a broader range of patients. That’s because TAVR is poised to become a superior option to those heart-valve replacement candidates who are considered “low risk” for open-heart surgery. The expansion of this procedure will follow the recent release of large clinical trials that found TAVR to be more effective — compared to traditional surgery — for younger, healthier patients. “It’s one step further in the evolution of the technology behind TAVR,” says Dr. Quesada.