Helping Broken Hearts

When Gail G. Dicus underwent a battery of tests to determine the nature of her heart condition in the fall of 2000, she and her family hoped she had a valve problem or a clogged artery. Instead, they received the news they most dreaded: Dicus had viral myocardiopathy-a virus had attacked her heart and caused serious damage.

"We were praying for something more fixable than mine, but it wasn't. It was heart failure," says Dicus. Medical experts say the only way to permanently correct heart failure is through a heart transplant, which, because of the limited availability of donor hearts, is only used for around 2,000 patients per year in the U.S.

Dicus's reaction was understandable. Health care professional have been battling heart failure and its delibitating consequences for years, devoting double the money spent to fight cancer each year.¹ A sizable portion of the financial resources consumed by the treatment of heart failure go to hospitalization costs, since it has been so difficult to find treatment methods that keep patients out of the hospital.

Still, Dicus had reason for optimism. Treatments have advanced so rapidly in recent years that those diagnosed with heart failure have opportunities to extend their lives and improve their quality of life like never before. And they can do that with technologies that are less invasive, less costly, and allow quicker recoveries.

Dicus was quick to take advantage of those advances. An active, self-described Type A personality, Dicus was just as aggressive about her treatment as she is with the rest of her life. The Baby Boomer owner of a successful commercial and residential real estate company in the Kansas City area took her doctor's advice and sought treatment at a hospital on the cutting edge of heart treatment.

Dicus was enrolled in a clinical trial for a technology, a pacemaker-like device that addresses the two most life-threatening byproducts of heart failure-malfunction of the heart's pumping mechanism and sudden and life-threatening rapid heartbeat. Her approach has paid off-though Dicus admits her life will never be the same as it was before the onset of her condition-she still owns her business and remains somewhat physically active.

A damaged heart
Though many people equate heart failure with heart attack, the two are very different. Heart failure is an ongoing condition that typically begins to develop when a patient's heart is damaged, either by a heart attack, coronary artery disease, chronic high blood pressure or another medical problem-like the virus that affected Dicus. That damage to the heart causes it to pump inefficiently, meaning it does not have enough strength to deliver oxygen-carrying blood to the rest of the body.

Because of inadequate pumping the heart has to work even harder, and that usually leads to an enlargement of the heart muscle. As the heart muscle grows, it further strains and weakens the heart, aggravating the problem even more. As the disease progresses, it often affects the heart's rhythm as well.

Heart failure affects nearly 5 million Americans² , and the American Heart Association estimates nearly 550,000 new cases are diagnosed each year. Approximately $40 billion is spent annually to treat heart failure in the U.S.³ .

Despite the financial resources dedicated to treating it, the prognosis for those with heart failure is discouraging. The five year survival rate for heart failure patients is only 50 percent.⁴ The average survival is just 1.7 years for men, and 3.2 years for women. ⁵

The outlook is poor because in most heart failure patients the disease continues to worsen. That is because the strength of the heart and its ability to pump in a coordinated way-the way a healthy heart does-typically declines further with time. Often, life-threatening rhythm disturbances develop as well. The result is that about half of heart failure patients die because their heart's pumping mechanism fails. The other half die because of complications with the heart's rhythm-the heart either stops completely, or begins accelerated, uncontrollable beating or fibrillation, leading to sudden cardiac death.⁶

Common treatments
Most heart failure patients are treated aggressively with medication. Some drugs are designed to slow the production of a hormone that is responsible for the constriction of blood vessels and the retention of water. Others reduce the heart size, allowing it to pump more efficiently and slow the heart rate. Some improve exercise tolerance and others remove excess fluid from the body-a common symptom of heart failure patients. These drugs often have serious side effects.

Still, many patients reach a point where medication fails to adequately correct their symptoms. In other cases, if heart failure has advanced to the point that the heart's coordination is off-meaning the different chambers of the heart are not working together, but against each other-more dramatic intervention is needed.

That was the scenario Dicus faced. Her heart's pumping ability was so severely damaged that parts of it were working against each other. Her heart was working harder, but its output-meaning the amount of oxygenated blood it was able to circulate through her body-was declining.

In fact, that's how Dicus discovered she had a problem. The fatigue she experienced because of her heart's reduced efficiency led her to a number of physicians, and ultimately to a cardiologist who made the unwelcome diagnosis.

Breakthrough technology
In healthy hearts, the two pumping chambers-the left and right ventricles-contract at the same time. The right ventricle pumps blood to the lungs while the left ventricle pumps oxygenated blood to the rest of the body.

When the two ventricles do not contract at the same time-a common symptom of heart failure-the heart muscle is essentially working against itself, decreasing its efficiency and aggravating the condition by forcing the heart to work harder.

Heart failure patients also are at much greater risk of developing electrical rhythm problems that can lead to sudden cardiac death, the life-threatening and abrupt loss of heart function. Those with heart failure are six to nine times as likely to experience sudden cardiac death.

Facing these possible consequences after her heart failure diagnosis, Dicus took her doctor's recommendation and transferred to a regional heart specialty center. There she was enrolled in a clinical trial for a device that improves the coordination of her heart's pumping mechanisms.

The device, called a cardiac resynchronization therapy defibrillator or CRT-D, is implanted under the skin near the shoulder. The CRT-D works by delivering electrical pulses-much like a pacemaker does-to the ventricles, coordinating their contraction.

Dicus had the CRT-D implanted during an operation that took less than two hours. The physician placed the device under her skin and inserted its three leads-the wires that deliver the pulses to coordinate pumping-through veins and into her heart. She was discharged from the hospital two and a half days after her surgery and says it took a couple weeks to really feel like herself again.

Unlike a standard pacemaker, a CRT-D can pace both ventricles at the same time-a great advantage to heart failure patients who often lose the proper functioning of both pumping chambers. The device can also sense and accommodate changes in the patient's activity level, which is one reason patients like Dicus can continue many of their normal daily activities.

In addition, the CRT-D is equipped with a system that can sense a fast and erratic heart rate, and send an electrical shock that restores the heart's normal rhythm, preventing sudden cardiac death.

Working to restore normal life
Like Dicus, other patients who have received CRT-Ds have experienced improvement in their quality of life, the distance they can walk, and how much exercise they can perform. About 15 percent of patients who took part in the same trial as Dicus received a potentially life-saving electrical shock from the defibrillator component of the device as well. ⁷

In addition to improving the lives of patients, the introduction of the CRT-D promises to make a significant difference for health care professionals and payers. More than 1 million patients are hospitalized each year because of heart failure; those patients spend a total of 5.67 million days in the hospital annually. Seventy-nine percent of heart failure patients are admitted to the hospital two or more times a year.⁸

More effective treatment for heart failure could mean a considerable reduction in the time patients spend hospitalized each year. It might also mean health care professionals would spend less time treating the same patients again. Because of these outcomes, many expect the availability of the CRT-D to generate significant cost savings.

For Dicus, the impact of the CRT-D on her life has been profound. As such an active person before her heart problems, facing a sedentary lifestyle was almost unthinkable.

"Am I back to where I was before? No. But I can still participate," she says. "I can't run anymore, but I can walk as long as there are not any inclines. I can't water ski anymore, but I can ride a waverunner. I can ride a bike short distances," Dicus says. That's a big improvement from the onset of her condition, when Dicus says it took all of her effort just to get her head off her pillow in the morning.

Dicus credits the CRT-D with her ability to maintain a fairly normal life despite heart failure. "By working with my doctors and having my condition and my device monitored continually, we are able to make adjustments in my device and medications that allow me to keep living my life," she says.

Almost equally important, Dicus has witnessed the promise of medical technology, and she looks forward to further advances that will help her manage her condition. "My goal is to continue to make myself available for other treatments. I am totally willing to try new protocols," Dicus says.

¹ Hope is where the Heart Is," by Catherine Arnst, Business Week, June 26, 2000, p. 170 (referenced in "Treatment of Heart Rhythm Disorders," on file with AdvaMed.

² Congestive heart failure worldwide markets, clinical status and product development opportunities, New Medicine, Inc. 1997:1-40, as cited at www.guidant.com/newsroom

³ $40 billion figure from Morgan Stanley Dean Witter, U.S. and the Americas Investment Research, congestive heart failure: a major device opportunity? Morgan Stanley Dean Witter, 1999, cited at www.guidant.com/newsroom

⁴ National Heart Lung and Blood Institute. Congestive heart failure in the United States: a new epidemic, Data Fact Sheet, September, 1996 (cited at www.guidant.com/newsroom

⁵ Ho K, Anderson KM, Kannel WB et al., Survial after the onset of congestive heart failure in Framingham heart study subjects. Circulation, 1993; 88: 107-115. cited at www.guidant.com/newsroom.

⁶ "Background Information on Sudden Cardiac Death," from www.guidant.com/newsroom

⁷ "Current Treatments for Heart Failure," www.guidant.com/newsroom

⁸ "The Economic Burden of Heart Failure," www.guidant.com/newsroom