Heart transplantation is currently established as the most effective permanent treatment for end-stage heart failure. However, the number of people who need new hearts greatly exceeds the number of heart donors, a gap that shows no sign of closing. As demand grows and donor hearts remain in short supply, average waiting times for new hearts may lengthen from months to a year or more. More and more patients who need donor hearts will not receive them no matter how long they wait. Some heart failure patients, moreover, are too sick or too old to qualify for transplantation. In the future, a greater number of heart failure patients will need a long-term or permanent treatment option other than transplant surgery.
The Jarvik 2000 FlowMakerŽ is made to satisfy that need. It is designed to support the failing hearts of severe heart failure patients for five, ten, or even twenty years, although the primary use of ventricular assist devices (VADs) today is to sustain patients who are waiting for donors. Such "bridge-to-transplant" use of VADs has become almost commonplace. The Jarvik 2000 is used as a bridge to transplant in the U.S. under a clinical study and received the European Union's CE Mark certification in 2005, making it available throughout Europe and elsewhere for both bridge-to-transplant and lifetime use.
The Jarvik 2000 has been used in more than 200 patients so far. Lois Spiller, the first patient bridged to heart transplant by the device, was supported on the Jarvik 2000 for 78 days before a donor heart was found. Now several years later, Ms. Spiller is doing well.
The first patient given lifetime use of the Jarvik 2000, Peter Houghton was supported by the device for seven and a half years and rehabilitated to a nearly normal life. Mr. Houghton had been suffering acute cardiomyopathy and was given only weeks to live by his doctors. Though he had already given up on life, doctors offered Mr. Houghton the option to participate in the Jarvik 2000 clinical trial. That was in June 2000. Through 2007, Mr. Houghton worked full time, walked three miles several times a week, and made numerous trips abroad. He hiked at high altitude in the Swiss Alps, and also in the southwestern United States. His natural heart, which was massively enlarged before surgery, returned closer to normal size and greatly improved in function. Mr. Houghton died of acute renal failure in December 2007. His heart was still healthy.
Dozens of other patients are surviving up to three years and more, some following transplant, some still waiting for transplants, and others supported by the device permanently.
Doctors have found that heart failure patients who receive VADs show reduced symptoms and an improved quality of life. A 2002 study found that VAD patients may even be better equipped to utilize transplanted hearts than patients who do not receive mechanical circulatory support.* In a handful of cases, doctors have witnessed the full recovery of VAD-supported hearts — so much so that the VAD could be removed and the patients taken off the transplant waiting list altogether.
In light of these successes, doctors and researchers envision wider application of mechanical circulatory support technology. Namely, they hope to be able to rehabilitate certain types of heart failure patients to normal and support others over the long term, even in lieu of a transplant.
In Europe, such ambitious uses of the Jarvik 2000 FlowMakerŽ are already underway. With CE Mark certification, the Jarvik 2000 is now available for lifetime use to more patients who are ineligible for $mdash; or opt not to have — a heart transplant. Soon, we will launch a lifetime-use trial of the Jarvik 2000 in the U.S.
*"Left ventricular assist device therapy improves utilization of donor hearts." Keith D. Aaronson, Michael J. Eppinger, David B. Dyke, Susan Wright, Francis D. Pagani. Journal of the American College of Cardiology, 17 April 2002 (39: 1247-54).