August 26, 2019 – Experts at Miami Cardiac & Vascular Institute are the first in Florida to perform an aortic valve replacement on a patient using a new device, the Lotus Edge. Recently approved by the Food and Drug Administration (FDA), 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 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 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 which is manufactured by Boston Scientific, will 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.
About Miami Cardiac & Vascular Institute
Miami Cardiac & Vascular Institute is the largest and most comprehensive cardiovascular facility in the region. The team of multilingual, multidisciplinary specialists pioneered the development of minimally invasive techniques used to treat aneurysms, blockages in veins and arteries and holes in the heart. The Institute leverages the power of Baptist Health’s combined resources of experts, pioneering research, compassionate caregivers and leading-edge treatments and technology.
Miami Cardiac & Vascular Institute is part of Baptist Health South Florida, the largest healthcare organization in the region, with 11 hospitals, nearly 23,000 employees, more than 4,000 physicians and more than 100 outpatient centers, urgent care facilities and physician practices spanning across Miami-Dade, Monroe, Broward and Palm Beach counties. Baptist Health has internationally renowned centers of excellence in cancer, cardiovascular care, orthopedics and sports medicine, and neurosciences. In addition, it includes Baptist Health Medical Group; Baptist Health Quality Network; and Baptist Health Care On Demand, a virtual health platform. A not-for-profit organization supported by philanthropy and committed to our faith-based charitable mission of medical excellence, Baptist Health has been recognized by Fortune as one of the 100 Best Companies to Work For in America and by Ethisphere as one of the World’s Most Ethical Companies. For more information, visit BaptistHealth.net/Newsroom and connect with us on Facebook, Instagram, Twitter and LinkedIn.
