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New Valves for Failing Hearts

Published: April 17, 2009

While caring full-time for his wife of almost 70 years, former Navy Captain and businessman Henry Tipton began to notice a decided difference in his health. After follow-up tests, Tipton was diagnosed with aortic stenosis—a severe narrowing of the aortic valve that restricts blood flow. When heart valves do not open normally, pressure builds up in the heart. As a result, patients may experience shortness of breath, fatigue, chest pain, and fainting.

Fortunately for Tipton, researchers were conducting a clinical trial to investigate the potential of a less invasive way to repair damaged valves, employing an investigational device called the Edwards Sapien transcatheter heart valve.

The new procedure offers a promising option for people who are not candidates for conventional open-chest surgery, due to age or other health factors, to repair the damaged valve—a process that requires placing patients on a heart-lung machine and a lengthy recovery process.

In 2007, Tipton enrolled in the study and underwent the groundbreaking procedure. The results were dramatic.

“This breakthrough technology could save the lives of patients with heart valve disease who have no other therapeutic options,” Dr. Martin Leon, associate director of the Cardiovascular Interventional Therapy (CIVT) Program at New York-Presbyterian Hospital/ Columbia University Medical Center, told the Post. “Heart valves are structures that separate chambers within the heart—like doors that separate rooms in a house. The heart valves must open and close without restrictions. If not, the valves can become narrowed or leaky. Failing heart valves can result in pressure buildup in the heart and fluid accumulation in the lungs, a condition called congestive heart failure. Well-established data show that the one-year mortality for this condition if left untreated is 40 percent worse than most cancers.”
A decade ago, doctors began to investigate the alternative procedure. ”Basically, a new valve is mounted on a stent then delivered via a catheter inserted through the femoral artery in the groin,” explains Dr. Leon. ”When in the right position, you inflate the balloon, expand the stent, and deploy the new heart valve as you push aside the old, nonfunctioning heart valve.”

While the trial is ongoing, no official data can be released, but the device is approved for use in Europe where more than 2,500 patients have been successfully treated. According to Dr. Leon, five-year follow-up data in a small number of patients reveal no reports of valve malfunction using the investigational heart valve.

”Today, we do about 60,000 aortic valve replacements in the U.S. alone,” says the leading interventional cardiologist. “If we are able to perform this procedure in the sickest patients, we should be able to refine our techniques and also apply this therapy to most patients who might require aortic valve surgery. In the next decade, we estimate that as many as 100,000 patients could benefit from this procedure annually.” As the first person to implant a drug eluting stent in the U.S., Dr. Leon is genuinely enthusiastic about this development. “I think it addresses a very needy population,” says Dr. Leon. “What impresses me most is that when we see these patients in follow-up, the magnitude of improvement is staggering. These patients were bedridden, frail, and barely able to walk across the room. A few months after the procedure, they look like different people. From a physician’s standpoint, it has been extremely fulfilling to provide a less invasive new therapy without surgery to this elderly population. If we can treat the aortic valve, we can potentially also treat the mitral valve and the pulmonary valve in children and adults with congenital heart disease. It’s the beginning of a new spectrum of therapies in patients with valvular heart disease that will not require surgery.”

Top doctors in the field are excited about the innovative new approach. The multicenter Phase 3 clinical trial, known as the PARTNER (Placement of AorTic traNscathetEr Valves Trial) led by principal coinvestigators Martin Leon, M.D., and Craig Smith, M.D., at New York–Presbyterian Hospital/Columbia University Medical Center remains open and is enrolling new patients.

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  • Wendy Braun

    On November 2, 2011, the FDA approved the SAPIEN heart valve as a preferred treatment for patients too sick to undergo traditional aortic valve surgery.

    The recent approval was based on results of the 26-center Placement of AoRTic TraNscathetER Valve (PARTNER) clinical research trial co-led by Drs. Martin Leon, Jeffrey Moses and Craig Smith at NewYork-Presbyterian/Columbia.