Innovative Transcatheter Aortic Valve Replacement Program Marks 10th Anniversary

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A decade ago, open-heart surgery was the only available treatment for an aging adult with severe aortic stenosis, a life-threatening condition causing chest pain, fatigue and shortness of breath. But many high-risk patients whose diseased aortic valves were unable to pump an adequate flow of blood could not undergo surgery and faced a bleak outlook.

From left, Tomas Salerno, M.D., Eduardo J. de Marchena, M.D., Mauricio G. Cohen, M.D., and Carlos E. Alfonso, M.D.

Today, it’s possible to replace an aortic valve through an interventional cardiovascular procedure pioneered in the United States at the University of Miami Miller School of Medicine in partnership with its affiliated cardiac institute, Clinica Angiografia de Occidente in Colombia. Since the first South Florida patient was treated on April 17, 2008, the Transcatheter Aortic Valve Replacement (TAVR) procedure has opened the door for patients from their 60s to their 90s to get new heart valves and enjoy a much higher quality of life.

“We have shown that TAVR is highly effective in patients who are at an increased risk for aortic stenosis or cannot be treated surgically,” said Eduardo J. de Marchena, M.D., professor of medicine and surgery, associate dean for international medicine, and director of interventional cardiology. “For patients, the benefits of the TAVR procedures include faster recoveries, shorter hospitalization times and a reduced need for transfusions.”

TAVR surgery involves the placement of a medical device into the damaged heart valve using a catheter inserted into an artery in the groin or leg. The interventional cardiologist then implants the device, which takes over the task of pumping blood through the valve. About 85,000 aortic valve replacement procedures are performed in the U.S. each year. De Marchena noted that the number of TAVR procedures recently surpassed open-heart procedures for isolated surgical aortic valve replacements.

In the past decade, the Miller School team has treated more than 700 patients at UHealth Tower. During that period, many studies involving UHealth researchers have demonstrated the safety and effectiveness of the TAVR procedure.

Mauricio G. Cohen, M.D., professor of medicine and director of the cardiac catheterization laboratory, said that the TAVR procedure has brought new hope to many patients and their families.

“Many seniors are physically frail, but mentally very sharp,” he said. “When we are able to fix the valve problem, they can lead a normal life. A 90-year-old patient has been able to attend family weddings and see her new grandchildren since being treated six years ago. Another elderly patient calls me every December and thanks me for extending his life one more year.”

Leading the way

Back in 2007, interventional cardiologists in Europe received approval to begin clinical trials of a new procedure for implanting artificial aortic valves in high-risk patients. Recognizing the potential benefits for patients, a Miller School team led by William O’Neill, M.D., professor of cardiology, and Tomas Salerno, M.D., professor of cardiothoracic surgery, became co-principal investigators for a clinical trial of the Edwards Sapien heart valve in Miami.

“We felt this would be a major development in cardiovascular surgery,” said Salerno, who is now chief of the Division of Cardiothoracic Surgery and vice chair for faculty development and mentoring. He noted that nearly half of the 200,000 Americans who need a new heart valve were not able to undergo surgery.

In early 2008, the Miller School was approved as one of the first 25 U.S. centers for the procedure. On April 17, the team implanted the new valve in Harold Schoendorf, 81, of Coral Gables, and Kenneth Horstmyer, 86, of Key Biscayne, at University of Miami Hospital (now UHealth Tower) – the first such procedures in Florida. After the procedure Schoendorf and Horstmyer both said they felt fine, and were looking forward to walking, swimming and traveling again.

Since those groundbreaking procedures, Miller School faculty and collaborators have published more than 71 articles in major medical journals and made more than 80 abstract presentations and 40-plus clinical presentations at major national and international medical conferences on TAVR-related topics, said de Marchena, who is program director of the International Structural Heart Interventional Training Program and director of the Miami Valves conference.

Collaboration with Colombia

The launch of the Miller School’s International Medicine Institute (IMI) in 2007 laid the groundwork for collaboration and affiliation with a clinical research team at Angiografía de Occidente S.A., in Cali, Colombia, on the initial TAVR trials for CoreValve (a start-up later bought by Medtronic).

“We wanted to find a site for cutting-edge cardiovascular procedures and research in South America,” said de Marchena, who reached out to Antonio Dager, M.D., a graduate of the Miller School’s William J. Harrington Programs for Latin America and the Caribbean. “Dr. Dager’s team performed the first TAVR procedures with us in Colombia during the same time period as our procedures in Miami. This close working relationship led to a research and education affiliation with the University of Miami International Medicine Institute and prolific research productivity.”

Dager had stayed in close touch with the Miller School after completing his Harrington fellowship in cardiology in 1988. “When CoreValve wanted to introduce its technology to South America, the UM cardiologists recommended our institute,” Dager said. “On March 24, 2008, we successfully completed our first TAVR case working with and in front of a large audience of UM physicians and Colombian interventionalists. That first patient, Anita R., did very well and lived nine more years with her new valve.”

After Medtronic purchased the CoreValve and began doing clinical trials in the U.S., the University of Miami was selected as a study site partially because of its participation in Colombia. De Marchena and Salerno were local co-principal investigators in U.S. CoreValve pivotal trials.

Training other specialists

With the rapid success of the Miller School’s TAVR program, de Marchena and other faculty members began training other specialists in the new interventional techniques. This led to the establishment of a unique fellowship, the International Structural Heart Interventional Training Program, in which fellows rotate through Miami, Colombia and the Netherlands.

“We recently celebrated the tenth anniversary percutaneous valve implant in Colombia,

at a meeting with the inventors and clinical scientists that worked on the early TAVR valves,” de Marchena said. “Our first three structural interventional fellows presented highlights of their experiences in this area of structural heart disease.”

Carlos E. Alfonso, M.D., assistant professor of medicine and cardiology fellowship program director, observed the first TAVR procedures in 2008 as he was finishing his training. “We have been on the leading edge of cardiovascular education, as well as clinical therapies, for the past 10 years,” he said. “We are one of about 45 structural heart fellowship programs and the only international structural program in the U.S. There is a great deal of interest in this field, which offers a beacon of light for cardiovascular specialists, as well as their patients.”

On a personal note, Alfonso said his grandmother, Ernestina Alfonso, was given a new aortic valve six years ago at age 94. “She is still going strong, and we are hoping to celebrate her 100th birthday this September,” he said. “This is truly a wonderful procedure for our patients.”

Looking ahead

Through the years, there have been steady improvements in artificial valves and advances in cardiac catheterization procedures to simplify the process and minimize potential side effects. “There has been an explosion in these percutaneous procedures,” said Salerno. “We are able to close holes in the heart and address problems with the mitral and tricuspid valves using cardiovascular techniques that were pioneered on transcatheter procedures.”

Cohen says the success of the TAVR program has invigorated the field of interventional cardiology. “It has opened up new horizons in structural procedures and several companies are racing to develop innovative solutions for other heart valve conditions,” he said.

Meanwhile, the Miller School’s TAVR program continues to grow. This interventional procedure is now available for intermediate-risk as well as high-risk patients, and de Marchena recently completed enrollment for a new clinical trial for low-risk patients. As Salerno said, “TAVR has become a relatively simple procedure with a well-trained and experienced team at an approved medical center like UHealth Tower.”