The Jarvik 2000 FlowMakerŽ is designed to provide reliable support to the ailing heart for a decade or longer. Since accelerated tests of the pump's bearings are not practical, many more years of real-time testing are required to know whether or not the pump will achieve or exceed its design objective. Presently, the Jarvik 2000 has supported one lifetime-use patient since the year 2000, longer than any other device in the world, but its ultimate durability remains unknown. To date, not a single mechanical failure has occurred in any of the more than 200 patients who have received the Jarvik 2000.
Currently, the Jarvik 2000 does not have full FDA-approval. Investigational studies of the Jarvik 2000 are approved by the FDA, but presently only for bridge-to-transplant use. In Europe, the Jarvik 2000 has earned CE Mark certification for both bridge-to-transplant and lifetime use.
The most frequent use of the Jarvik 2000 FlowMakerŽ remains the support of critically ill patients awaiting heart transplants. These patients keep the device only until a suitable donor heart becomes available. However, waiting time is growing longer as the demand for donor hearts increases. Once on the heart transplant waiting list, a patient typically waits months for the transplant to be performed, depending on his or her status on the list, blood type, and other factors.
The potential for the Jarvik 2000 FlowMakerŽ to provide a bridge to recovery to certain severe heart failure patients is very good. Some patients improve so dramatically while supported by a VAD that a transplant is no longer necessary. Their hearts rest and heal while the pump toils away, and eventually the pump can be explanted and the patient removed from the transplant waiting list.
If such improvement is to occur, it may take place within a short span of time. A 2001 study looked at the time scale for reverse remodeling, for example, and determined that maximum recovery is usually reached in 40 days of VAD support.* Other studies show a recovery process that takes up to six months. In some patients, drug treatments successfully facilitate recovery of the natural heart muscle.
Both the bridge-to-recovery use and lifetime use of the Jarvik 2000 FlowMakerŽ are viable now but will require the successful completion of the clinical trial process before becoming widely available in the United States. Dr. O.H. Frazier, a surgeon at the Texas Heart Institute who prefers the Jarvik 2000 to other LVADs, recently commented in an article by the Associated Press that "The problems now aren't scientific. This pump works beautifully." Dr. Frazier notes that the "problem" is regulatory, referring to the long time necessary to conduct clinical trials, review the data, and obtain full approval.
The longest-running Jarvik 2000 FlowMakerŽ patient was supported by the device longer than any patient in the world with any other type of mechanical heart, either total artificial heart or ventricular assist device — seven and a half years.
*"Time course of reverse remodeling of the left ventricle during support with a left ventricular assist device." Madigan J.D., Barbone A., Choudhri A.F., Morales D.L., Cai B., Oz M.C., Burkhoff D. Journal of Thoracic and Cardiovascular Surgery, 2001 May (121: 902-8).