Healthcare Industry News:  Mitral Valve 

Biopharmaceuticals Cardiology

 News Release - January 30, 2007

Statins Can Slow Progression of Aortic Valve Disease

Study Provides First Prospective Clinical Evidence That a Medical Therapy Exists for Valve Disease

CHICAGO, Jan. 30 (HSMN NewsFeed) -- Statins can slow the progression of aortic valve stenosis, a condition in which the heart valve that pumps blood out into the body becomes hard and narrow, in people with mild to moderate disease. To be published in the February 6 issue of the Journal of the American College of Cardiology, the trial provides the first prospective clinical evidence that aortic valves have an active biology that can be targeted with medical therapy and contradicts research published in 2005 in the New England Journal of Medicine, which concluded statins did not halt the progression of aortic stenosis.

"For decades, the medical community has accepted that aortic valve disease was part of the aging process and that replacing valves surgically was the only treatment," says senior investigator Nalini Rajamannan, MD, director of the Center for Heart Valve Disease in the Bluhm Cardiovascular Institute of Northwestern Memorial Hospital and assistant professor of medicine, Northwestern University Feinberg School of Medicine. "Now we have clinical evidence showing a medical treatment can delay the need for surgery. I see a lot of patients in their 50s being diagnosed with early stage valve disease that don't like hearing that the next step is watchful waiting until eventually they'll require open heart surgery. For them, this is great news."

The RAAVE (Rosuvastatin Affecting Aortic Valve Endothelium to Slow the Progression of Aortic Stenosis) trial was conducted at the Hospital Pedro Hispano in Portugal and led by principal investigator Luis Moura, MD, and followed 121 patients with asymptomatic moderate to severe narrowing of the aortic valve for 18 months. Sixty-one patients with elevated cholesterol levels were given 20mg/day of the statin Crestor, an average daily dose, while the other 60 patients who did not have elevated cholesterol levels received no statin. The statin group showed significant improvement in cholesterol levels as well as a 50% improvement in the slowing of the progression of the valvular heart disease at 1.5 years.

Last year's widely publicized study done by researchers in the United Kingdom called SALTIRE discredited the idea that statins had a role as an aortic stenosis therapy. "But the patients in that study had largely advanced aortic disease," says Dr. Rajamannan. "If patients' valves are already significantly narrowed, you're not going to be able to reverse it and patients are going to progress to surgery. The key is to catch them early."

Aortic valve stenosis usually results in a heart murmur, so timely diagnosis can be made simply by using a stethoscope, says Dr. Rajamannan. "Currently, such murmurs are often dismissed as clinically unimportant. But based on this study, I would advise people diagnosed with early aortic stenosis and elevated cholesterol to take statins. In addition to lowering cholesterol levels, they are likely to get the added benefit of slowing the progression of their aortic valve disease." Currently, there is not an FDA indication for the treatment of this disease with statins but with this publication and the outcome of future trials these results will guide the future management of this patient population.

Dr. Rajamannan opened the door to the idea that medical therapies may be able to play a role in preventing or slowing the process of valve disease seven years ago. She began studying the diseased valves of animals and humans because she suspected an underlying biological process, not calcium build-up caused by 'wear-and-tear,' was causing the damage. Earlier this year she published research that provided the first explanation of this active process, saying heart valve disease is caused by inflammation likely triggered by high cholesterol that stimulates certain cells to reprogram into bone cells in the aortic valve and cartilage cells in the Mitral Valve.

"Essentially, there are only three things that can go wrong with the heart: coronary artery disease, muscle dysfunction or valve disease," says Rajamannan. "We've made great strides in treating the first two medically, and finally, we're making inroads with the third."

Valvular heart disease is on the rise among the aging of the United States population, and is second only to coronary artery disease as a cause for open-heart surgery. Aortic valve stenosis afflicts 2-3 percent of the population by age 65. Aortic valve disease can lead to heart failure, arrhythmia, infections in the heart, and sudden death may occur in 15 to 20 percent of people who have symptoms.

About Northwestern Memorial Hospital

Northwestern Memorial Hospital is one of the country's premier academic medical centers and is the primary teaching hospital of the Northwestern University Feinberg School of Medicine. Northwestern Memorial and its Prentice Women's Hospital and Stone Institute of Psychiatry have 744 beds along with 1,424 affiliated physicians and 6,464 employees. Providing state-of-the-art care, Northwestern Memorial is recognized for its outstanding clinical and surgical advancements in such areas as cardiothoracic and vascular care, gastroenterology, neurology and neurosurgery, oncology, organ and bone marrow transplantation, and women's health.

Northwestern Memorial received the prestigious 2005 National Quality Health Care Award and is listed in six specialties in this year's U.S. News & World Report's issue of "America's Best Hospitals." The hospital has also been cited as one of the "100 Best Companies for Working Mothers" by Working Mother magazine for the past seven years and has been chosen by Chicagoans for more than a decade as their "most preferred hospital" in National Research Corporation's annual survey.

Source: Northwestern Memorial Hospital

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