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For Patients with New Heart Device the Beat Goes On

by Debra Gibson

Photo of Chronicle IHMWith the Chronicle IHM, the world's first medical monitor for patients with heart failure, doctors can measure their patient's condition from anywhere by using a secure Web site.

Susan Levy, a 62-year-old mother of five and grandmother of two, rang in 2002 in Vail, Colorado, celebrating with family and friends. Later that month, she flew to California to see her brother. When she is not traveling, Levy is likely to be found showing homes to a real-estate client, at the bridge table with friends, or at temple with her granddaughter. She has standing get-togethers with other groups of friends on Tuesdays, Wednesdays, and Fridays. Her life, she happily admits, is teeming with activity.

Just a year ago, however, life was dramatically different for Levy. She couldn't walk across a room without having difficulty breathing. She was tied to an oxygen tank and slept on a hospital bed at home to keep her head elevated enough so she could breathe. In short, she was not able to lead a normal life.

Photo of Susan Levy, her daughter and grandson at Six FlagsSusan Levy (left) was one of the first two Kentuckians to have the Chronicle IHM implanted in her chest. She is pictured here with her daughter, Cathy Wolfson, and her grandson, Eli, at Six Flags Great America near Chicago last October, six weeks after having the implant.

Levy had been diagnosed with heart failure, a diagnosis she shared with almost five million Americans, including an estimated 60,000 Kentuckians. In fact, over 400,000 new cases of heart failure are diagnosed each year, a 160 percent increase over the past two decades. This increase is due, ironically in part, to improved treatment of heart attacks, although longer life spans and diets high in fat also play a significant role in this increase.

Despite its name, heart failure is not a sudden stop in the heart's ability to keep beating. Rather, it is the heart's inability to pump powerfully enough to circulate oxygen-rich blood adequately throughout the body. Symptoms include shortness of breath, fatigue, and fluid accumulation.

Heart failure is the most common cause of hospitalization for adults in the United States and is the only type of heart disease on the rise. The estimated cost of inpatient and outpatient care is $56 billion a year. In Kentucky, heart disease is the leading cause of death among men and women, black and white, and in the United States about 250,000 people die of heart failure each year.

And for those who live, the impact of heart failure on the quality of life can be grim. The disease typically impairs physical functions and can lead to anxiety and depression.

Levy knows these facts all too well, but today these realities come to mind only when she has an occasional setback in her otherwise good condition. "I'm a healthy person," she says. "I don't even think of myself as sick."

The marked difference came from a new investigational device the size of a typical pacemaker known as the Chronicle Implantable Hemodynamic Monitor (Chronicle IHM, Medtronic Inc.). It is the world's first implanted monitor for the medical management of patients with heart failure.

Levy was one of the first two Kentuckians to have the device implanted in her chest and one of approximately 100 Chronicle IHM patients nationwide. The Linda and Jack Gill Heart Institute at the University of Kentucky is one of only eight centers across the country approved to implant the device, and the only site in Kentucky.

With the Chronicle IHM, physicians can monitor their patient's condition from anywhere by using the World Wide Web. The patient simply passes a magnetic device over the implant, and electronic signals from the Chronicle IHM are transmitted over telephone lines to a Web site accessible only to the physician and his staff. The physician receives vital information about the patient's condition, including heart rate, body temperature, fluid levels, pulse, and, most importantly, the diastolic and systolic pressures in the heart—important measures of the heart's strength.

William T. Abraham, co-director of the Linda and Jack Gill Heart Institute and chief of cardiovascular medicine, is the principal investigator for the study at UK and a member of the national committee overseeing development of the device. On August 22 of last year, Westby Fisher, a UK electrophysiologist, implanted the device in Levy and Wanda Moore. By the end of December, UK physicians had implanted the IHM in 13 more patients.

"This device has the potential to revolutionize the way we take care of patients," says Abraham. "The biggest advantage is that we can monitor remotely what is going on with the patient's heart. We can know how they are doing in another part of the state without having them go to an emergency room or drive to Lexington."

Photo of Dennis McDonald and his familyDennis McDonald (far right) says he "got a lot of good use" out of the Chronicle IHM before his recent heart transplant. He is pictured here after his daughter Amy's wedding. Left to right are granddaughters Meghan and Emily, his wife Agnes, and his grandsons Jesse and Teddy.

The Chronicle IHM also greatly improves the physician's diagnostic capabilities. Making treatment decisions about heart patients is often difficult, Abraham says. "We may think patients are retaining too much fluid when they are really dehydrated. With this device, we know exactly what is going on with fluid levels and other critical measures."

Another patient and a pepperoni pizza gave the Chronicle IHM a good test.

"He called in not feeling well, and thanks to the device, we knew he had greatly elevated fluid levels," Abraham recalls. "We kept quizzing him about what he had done or eaten, but he denied doing anything out of the ordinary. We knew his numbers were not right, told him what medication to take, and his condition improved. Later he confessed that he had been anxious so he had eaten an entire pepperoni pizza. All that salt caused him to retain too much fluid."

Although she has no plans to eat an entire pizza in one sitting any time soon, Levy says she has had similar concerns.

"My symptoms are not always the same as other people's," she says. "Sometimes I appear to be dehydrated when I am actually overloaded on fluids and need to get rid of water. This device tells my doctors what is happening. I haven't had to go to the hospital since I've had it. I don't think I would have survived without it."

Levy was indeed disabled by heart failure, according to Abraham, but she was also a good candidate for the device because she has what cardiologists call moderate-to-severe heart failure. If her case had been mild, she could have probably been treated with medication alone. If she had been in end-stage heart failure, her probability for success with the device wouldn't have been good either, and she would have likely faced multiple hospitalizations.

Keeping patients out of the hospital will likely nullify the estimated $10,000-$12,000 the device will cost if and when it receives FDA approval. Abraham says that this cost would be about the equivalent of two typical hospital stays for a patient with heart failure.

Photo of William T. AbrahamWilliam T. Abraham, the Gill Foundation Professor in Interventional Cardiology

Patients do not even need to be admitted to have the Chronicle IHM implanted. The one-hour surgery is an outpatient procedure during which the oval-shaped device is implanted just below the collarbone and a single wire is run to the heart. There is less than a one percent risk of infection from the implantation and minor risks of local bleeding, the only complications found thus far. No long-term complications have been discovered during the Phase II clinical trial; Abraham expects to begin Phase III trials this spring.

Perhaps the greatest benefit of the device is its potential to let patients lead normal lives again.

"They push me to have quality of life," Levy says of Abraham and her other physicians and nurses. "I'm basically having a wonderful life. If I have a problem, I call them, and they tell me what to do. The Chronicle has given me my life back. I can do anything I want to now. It has been a miracle."

More Heart Devices in Clinical Trials
The Chronicle IHM is not the only heart device undergoing clinical trials at the University of Kentucky Hospital. William T. Abraham says UK physicians are testing around 20 diagnostic or therapeutic devices and investigational drugs—all aimed at helping patients with heart failure.

Abraham led the U.S./Canadian trial of an implantable device known as Insync, and the FDA has now approved that device for general use. Similar in size and weight to a pacemaker, this device resynchronizes the beating of the patient's right and left ventricles—the heart's pumping chambers. This correction increases pumping power and improves cardiac output, thereby allowing blood to circulate throughout the body.

Abraham designed and organized the clinical trial for Insync, taking the device from concept to FDA approval. The clinical trial followed severely ill patients for almost two years. At the end of six months, 68 percent of patients were judged to be improved, and 33 percent who used the device were able to walk significantly longer distances.

"For many patients, that is the difference between performing almost no daily activities and performing some or all daily activities," Abraham said during a presentation at a medical conference last March.

Insync ICD, a second-generation Insync device, is also now in clinical trial at UK. Insync ICD not only resynchronizes the heart, but also incorporates defibrillator technology for patients prone to sudden cardiac arrest.

"Heart failure is a serious problem in Kentucky," notes Abraham. "Kentucky ranks first, second, or third in every measure when it comes to the prevalence of heart disease. These devices make it possible to treat more heart-failure patients. Our goal is for UK to become a prominent center for the treatment of heart failure."

More on UK Heart Research: Quicker Treatment for Heart Attack Victims