Patients Who Need It

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. Presently twice as many patients receive VADs as receive transplants. In the future the need for heart assist is expected to continue to increase, while the number of transplants available remains dramatically insufficient.

The Jarvik 2000 FlowMaker® is made to satisfy this increasing need for long term mechanical heart support, in patients for whom transplants are not available. 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 CAP 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 600 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 13 years later, Ms. Spiller is doing well.

The first patient given lifetime use of the Jarvik 2000 or lifetime use was Peter Houghton. He 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.

The longest surviving patient is Pascal Dugue who lives in Normandy, France. Early in December, 2013 he will celebrate his eight year anniversary. We are hopeful that Mr. Dugue will become the first person to survive more than ten years with any mechanical circulatory assist device.

Over two hundred patients are surviving up to seven years and more, some following transplant, some still waiting for transplants, and others supported by the device permanently.

The Jarvik 2000 and heart recovery

Doctors have found that heart failure patients who receive VADs show reduced symptoms and an improved quality of life. One 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 uses of the Jarvik 2000 FlowMaker® are already underway. With CE Mark certification, the Jarvik 2000 is available for lifetime use to more patients who are ineligible for transplant; or opt not to have — a heart transplant. Jarvik Heart has recently begun a lifetime-use trial of the Jarvik 2000 in the U.S. In this destination therapy (DT) study, 204 patients will receive the Jarvik 2000 behind the ear connector model, and 202 patients will receive the HeartMate II as the control.

*”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).