Jarvik 2000 Study Again Extended and Now Expanded

The Food and Drug Administration has granted Texas Heart Institute and St. Luke's Episcopal Hospital physicians permission to extend clinical trials of the Jarvik 2000 heart-assist device. Permission was also given to expand the study to include another well-known cardiovascular center, The Cleveland Clinic.

"We are excited about the continuation of this study which shows great promise for the future of the device," said Dr. O.H. Frazier, chief of cardiopulmonary transplantation and director of surgical research at the Texas Heart Institute, and chief of transplant service at St. Luke's Episcopal Hospital. "We are also pleased to welcome the members of The Cleveland Clinic team who were recently trained at our facility in preparation for their participation in the trials."

The FDA granted the Texas Heart Institute and St. Luke's Episcopal Hospital permission to evaluate the Jarvik 2000 in five patients as a bridge to transplant in April of last year. In October, the FDA gave permission to extend the study by five more participants. This new extension allows for 20 new implants to be performed between the two centers.

"I believe heart-assist devices such as the Jarvik 2000 represent the future for people with end-stage heart disease," said Dr. Patrick McCarthy, who will oversee the Jarvik 2000 study at the Cleveland Clinic. "We are very anxious to begin formal participation in this study."

Texas Heart Institute and St. Luke's physicians have successfully implanted 11 U.S. study participants with the Jarvik 2000 heart-assist device. The pump successfully sustained seven participants until donor hearts were found. All seven survived the transplant without difficulty and all have been discharged. Four patients died due to complications unrelated to the device. An additional patient received a Jarvik 2000 under emergency conditions, and recently received a donor organ.

The Jarvik 2000 heart sustained the first participant and transplant recipient, Lois Spiller, for 79 days. The second used the device for 51 days before a donor heart was found. The longest a patient in this U.S. study has used the device is 214 days. That patient received a heart transplant and was discharged.

"The Jarvik 2000 has performed well and has consistently improved patients' overall health prior to transplantation," said Dr. Frazier. "This improvement is known to enhance the success of transplantation and is important to patients' prognosis after transplant surgery. It also shows promise for the device's potential use in the future as a long-term treatment option."

Last summer, Dr. Frazier traveled to Oxford, England where he, along with physicians at John Radcliffe Hospital, implanted a Jarvik 2000 intended not as a bridge to transplant, but for permanent use.

"The Oxford patient is doing extremely well and has returned to normal activity including a hobby he gave up a few years ago, hiking in the mountains," said Dr. Frazier. "We hope to start U.S. trials here looking into use of the Jarvik 2000 as a long-term implant toward the end of this year."

Seven patients have been treated in Europe. Two have died and the rest have been discharged from the hospital.

To be eligible for the current U. S. study, a patient must have end-stage heart failure and be on the transplant waiting list. About the size of a "C" battery, the Jarvik 2000 is a valveless, electrically powered miniature axial flow pump that pushes oxygenated blood throughout the body at a rate of up to six liters per minute. (At rest, the natural heart pumps four to five liters per minute.) It fits directly into the left ventricle, which may lessen problems with clotting. The outflow graft connects to the descending aorta behind the heart.

The device itself does not provide a pulse. As it assumes some of the work of the failing heart, however, the natural heart begins to work more normally. This response improves the ability of the heart to generate a normal pulse.

Jarvik Heart Inc. and the Texas Heart Institute have been developing the Jarvik 2000 for more than 10 years.

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©2006 Texas Medical Center

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