The Roving Reporter : 3 Heart-Disease Treatment Breakthroughs That Are Changing Lives

By Steven Nissen, MD, Special to Everyday Health

Nearly 27 million people in the United States have heart disease. It remains the leading cause of death for both U.S. men and women. However, during the last several years, there have been some truly significant advances in heart disease treatment that are now moving quickly toward widespread availability.

After a decade of failed efforts at developing new heart drugs, two important therapeutic breakthroughs are nearing FDA approval in 2015. These overdue advancements have the potential to change the practice of medicine. They can help patients who have not benefited adequately from existing therapies.

1. A Better Drug for Heart Failure

Congestive heart failure is a common disorder characterized by a failure of the heart muscle to forcefully pump blood to the body’s tissues. Heart attacks, high blood pressure, or diseases that weaken the heart muscle are common causes. Patients often have severe shortness of breath or fatigue that limits their ability to enjoy life. This disorder is the most common reason for hospital admission among Medicare patients.

In a large clinical trial, known as Paradigm-HF, the new drug LCZ696 was used to treat heart failure, and it was highly effective. It achieved a substantial 20-percent reduction in death or repeat hospitalization compared with the best currently available therapies. Although the benefits of a reduction in deaths are self-evident, the importance of reducing readmission to the hospital should not be underestimated. Currently, 20 percent or more of patients hospitalized for heart failure are re-admitted within 30 days. This represents a significant burden for patients and the healthcare system.

LCZ696 will probably be approved this year, providing a new, promising option for the 5.7 million Americans with heart failure.

2. New Treatment for High Cholesterol

The second innovative drug therapy is known as a PSCK9 inhibitor. This class of drugs has moved from discovery to the clinic more rapidly than any cardiovascular advancement in recent memory.

The single most important risk factor for developing coronary heart disease is an elevated level of “bad” cholesterol, also known as LDL-C. Currently, the best available drugs for reducing cholesterol, statins, have been shown to lower the risk of heart attack or stroke up to 35 percent.

Statins have been available for more than 25 years and have been enormously successful at reducing the burden of heart disease. Unfortunately, some patients cannot tolerate statins or can’t take large enough dosages to adequately reduce cholesterol levels. In other cases, LDL-C is very high due to an underlying genetic cause, and even the most powerful statins cannot reduce it to safe levels.

PSCK9 inhibitors have been shown to reduce bad LDL-C by as much as 50 percent to 70 percent and demonstrated few, if any, adverse effects. Although these drugs are given by injection every two weeks or once a month, they are injected through very small needles that produce little or no pain. Patients can easily self-inject these drugs using an automated injector.

This new class of drugs appears to be well tolerated even in patients who cannot take statins due to adverse effects. The FDA is considering applications from two pharmaceutical companies for drug approval in 2015.

3. Less Invasive Surgery for Heart Valve Disease

In 2011, the FDA approved a new procedure to treat heart valve disease without a major surgical operation, known as TAVR, or transcatheter aortic valve replacement. This device is approved for patients who need an aortic valve replacement, but who are too high risk for standard open-heart surgery.

This new approach is an important advance for patients who are too ill to withstand an open-chest procedure or for older patients. In the United States, patients currently undergoing TAVR typically include people with lung or kidney disease who would be less likely to tolerate major heart surgery to replace the aortic valve. TAVR was initially performed only at large academic medical centers. It is now moving gradually toward mainstream treatment throughout the world.

A catheter (small hollow tube) is placed in the groin (femoral artery) and guided into the heart chambers using advanced imaging techniques. Through this catheter, a collapsed tissue heart valve is guided into position and placed directly inside the diseased aortic valve. Once the new valve correctly positioned, a balloon is inflated to deploy the valve, incredibly, without opening the patient’s chest.

Currently TAVR is being performed at more than 350 hospitals in the United States.

Although heart disease remains the No. 1 cause of death in the United States, these treatment breakthroughs and other developments offer new hope to patients, providing long-awaited advances that are already making a difference.

Steven Nissen, MD, is the Chairman of the Robert and Suzanne Tomsich Department of Cardiovascular Medicine at Cleveland Clinic’s Sydell and Arnold Miller Family Heart & Vascular Institute, in Cleveland, Ohio. He has more than 35 years experience as a physician and is world-renowned for his work as a cardiologist, patient advocate, and researcher.



The Roving Reporter