Washington (H24N). If all continues to go well with the clinical trials of a tiny heart pump called the Jarvik 2000, heart patients everywhere will be able to breathe a sigh of relief.

The pump, which is about the size of a C battery, may eliminate the need for heart transplantation. Results of the trial’s initial findings are published in the Sept. 9 issue of The Lancet.

Although the pump has been successfully implanted on a temporary basis in several patients at the Texas Heart Institute at St. Luke’s Episcopal Hospital in Houston, the British clinical trials are evaluating the efficacy of permanent pump implantation.

"We are encouraged by the results so far," said O.H. Frazier, MD, chief of Transplant Services at St. Luke’s Episcopal Hospital. "Because the pump was originally designed for long-term use, the British study is important for the assessment of its durability and compatibility with patients. We hope this device will provide a viable treatment option for the 5 million people suffering from heart failure who cannot be helped by transplantation."

The trial is being conducted at the John Radcliff Hospital in Oxford. The first patient to receive the heart was operated on in June of this year. That patient is a 61-year-old man with a history of hypertension, chronic atrial fibrillation and renal failure.

After six weeks, the patient was able to exercise more easily, and his myocardial function and end-organ function improved significantly, report the researchers.

"Given the shortage of [heart] transplant donors, the prospect of permanent mechanical circulatory support for the increasing number of patients with end-stage heart failure is appealing," wrote Stephan Westaby, MD, a doctor at John Radcliff Hospital. "Our experience with the first patient reinforces our laboratory findings regarding safety and efficacy of the device. The symptoms and signs of heart failure disappeared rapidly, and there were objective improvements in native-heart and end-organ function."

The Jarvik 2000, which is named after its inventor, Robert Jarvik, MD, is designed to help patients suffering from end-stage heart failure. It fits into the heart’s left ventricle, and pumps oxygenated blood throughout the body at a rate of up to six liters per minute when the heart is damaged and unable to function properly on its own.

Unlike other pumps, whose installation requires doctors to open the chest through the sternum, the Jarvik is implanted through a less-invasive incision on the left side of the chest. The Food and Drug Administration granted the Texas Heart Institute at St. Luke’s Episcopal Hospital permission to begin testing the pump on patients waiting for donor hearts. The Texas Heart Institute is the only cardiovascular center in the country conducting these trials.

Lois Spiller, a 52-year-old Texas woman with an enlarged heart, was the first to have the Jarvik implanted back in April. She was sustained on the pump for 79 days while she waited for her new heart, which she received June 28. Her doctors report she is doing well. Thirty-year-old David Lancaster from Lubbock, Texas, was on the pump for 51 days before he received his new heart on Aug. 4.

Doctors in Oxford are now hoping to prove that the Jarvik is safe to implant in patients on a permanent basis, in lieu of a donor heart.

"This study of the long-term use of the device is a complementary study to the Texas Heart Institute at St. Luke’s evaluation of it as a bridge to transplant," Frazier said. "We hope this data will lead to the extension of our U.S. program to include heart failure patients who are not on the transplant list."

NEWS AND TRENDS | CAREER CENTER | EDUCATION
Home | Resources
Site Index | Contact Us | FAQs | Subscribe | Advertise