(WECT) - Five million Americans suffer from debilitating heart failure.
The FDA has approved a new device that could buy the most critical patients more time while they wait for a heart transplant.
This technology may even extend lives for patients who are out of options.
Bob Dewitt said doctors took one look at his heart and gave him a death sentence. He had end stage heart failure and needed a heart transplant, but time was running out.
"My left side wasn't pumping and I was just completely dying," said Bob.
"We've been very limited in how to treat people effectively with congestive heart failure -- how to extend their lives," said Dr. Cedric Sheffield.
Sheffield offered Bob a chance to try something different through a clinical trial. Doctors implanted the Heartmate Two, a ventricular assistive device, into Bob.
The device combines an internal pump with an external computer, designed to do the work Bob's failing heart couldn't. It serves as a bridge for people waiting for a transplant.
The device is also being tested as a last resort for people who are too sick to have a transplant.
"That is, I think, the holy grail of this entire field -- to have an engineering solution, a mechanical circulatory support, that is equal to or better than heart transplantation for a very large population," said Sheffield.
More than a year after doctors implanted the device, Bob is back to work, feeling better than he has in years.
The device is designed to last up to ten years, and Bob is grateful for every moment.
For more information, please contact:
Ellen Fiss, Public Relations Manager
Tampa General Hospital
BACKGROUND: An estimated five million people across the nation are suffering from congestive heart failure, according to the American Heart Association. That figure is expected to double in the next 30 years. More than half a million new cases are diagnosed every year. The hearts of patients suffering from heart failure fail to pump efficiently and deliver essential oxygen-rich blood to the body. Congestive heart failure occurs when fluid accumulates in the lungs and other body tissues, which usually leads to hospitalization of those patients. Heart failure is the number one reason older individuals are hospitalized. An estimated $33 billion was spent in 2007 on management of the disease.
Prognosis for patients with advanced heart failure is grim, with one-year mortality rates higher than those of other terminal diseases like AIDS, leukemia and lung cancer. Half of all patients with heart failure die within five years, and only about 20 percent survive longer than eight to 12 years. Heart failure can be caused by a variety of different medical conditions. According to the National Institutes of Health, the most common causes are high blood pressure and coronary heart disease. Other causes include valvular heart disease, congenital heart disease, dilated cardiomyopathy, lung disease and heart tumors. Age, being overweight, having diabetes, smoking cigarettes, abusing alcohol and using cocaine are all contributing risk factors or the deadly condition.
TREATMENT: The overall objective of heart failure treatment is to treat underlying causes, relieve symptoms, and prevent the condition from worsening. Symptom relief can come from removing excess fluid in the body, improving blood flow and heart muscle function, and increasing oxygen delivery throughout the body. Transplants offer help to about 2,000 advanced heart failure patients every year, but others are left with no options.
BRIDGE-TO-TRANSPLANT: Recently 46 centers throughout the United States and Canada completed a clinical trial of the Thoratec HeartMate II Left Ventricular Assist System (LVAS), which gained FDA approval in April 2008 as a bridge-to-transplantation (BTT) treatment option for patients with advanced-stage heart failure awaiting transplant. The device is the first continuous flow chronic LVAS to be approved in the United States for BTT. Experts say the device promises durability and long term effectiveness in restoring patients to a fairly normal lifestyle while waiting for a transplant. The LVAS was created with the goal of providing up to 10 years of circulatory support for a broad range of advanced heart failure patients.
The clinical trial involved 450 BTT participants and demonstrated improved survival rates and quality of life for a range of patients. The median time patients in the trial were on the support system was 132 days. At six months, 80 percent of patients had survived transplantation to recovery while 77 percent had at one year. Adverse effects including infections, stroke and bleeding were found to be significantly lower than previous BTT studies of the HeartMate VE LVAS, an earlier version of the device, revealed.