FDA Recall of Jarvik Heart Could Slow Research
WASHINGTON (AP) _ The Food and Drug Administration’s ban on use of the Jarvik artificial heart could slow research in the field but probably won’t affect patients needing temporary implants, medical experts said Thursday.
But a major user of the device said he might defy the ban.
The FDA, in a letter sent earlier this week and disclosed Wednesday, withdrew Symbion Inc.’s approval for continued investigational uses of its artificial heart, both as a permanent replacement and a temporary bridge for patients awaiting a human heart transplant.
″By removing the Jarvik, you take the first and main artificial heart player out of the ballgame,″ said Dr. Jack Kolff, a professor of cardiac surgery at Temple University in Philadelphia whose father, Dr. Willem Kolff, developed the first artificial kidney in 1943.
″That leaves a bit of a vacuum for those researchers who think there may be a future for an artificial heart,″ he said.
Dr. Antonio Gotto, chief of internal medical services at Baylor College of Medicine in Houston and past president of the American Heart Association, said that because of the availability of alternative, temporary heart-assist devices the FDA’s action probably won’t have an impact on heart patients.
″But it does represent a setback in terms of time toward eventually getting a completely implantable heart,″ he said.
The Jarvik heart, named after its inventor, Dr. Robert Jarvik of Utah, gained household recognition after it was implanted in Barney Clark on Dec. 2, 1982. He lived 112 days, his new heart tethered to a bulky external power system, before he succumbed to multiple organ failure.
Clark was the first to person to receive a permanent artificial heart. Several others since Clark received the artificial heart, but recipients have been plagued by blood clotting and strokes.
In Tucson, Ariz., Dr. Jack Copeland, head of the heart transplant program at the University of Arizona, said the ban means he and his staff could be faced with the decision of ″putting a device in anyway,″ either an artificial heart or related heart pumping helper, in a critically ill patient.
″And I think our decision right now would be to go ahead and use the device. ... we have good data, good statistics, we;re happy with the way the devices have worked, we think we can save lives,″ Copeland told a news conference at which he presented transplant candidate Paul Sicola, 48, of Old Bridge, N.J., who has been kept alive for 119 days with a ventricular assist decive.
Sicola said he would advise FDA to ″leave the system alone.″
Copeland stirred controversy once before, using a different artificial heart without approval to keep a patient alive for 11 hours while he awaited a transplant. His team has used Symbion hearts in seven patients and assistance devices in 14.
The FDA said that during two inspections of the Tempe, Ariz.-based company’s facilities last year, it had found ″some serious deficiencies″ in manufacturing quality control, monitoring of research sites, servicing of equipment, training of personnel and reporting of adverse reactions to FDA.
″The agency felt the deficiencies were great enough that risks to patients were outweighing benefits,″ said FDA spokesman Jeff Nesbit.
He said the letter was sent Monday.
Symbion’s chief financial officer, Lane Castleton, said the company was ″eager to work with the FDA to resolve any deficiencies.″ He said it was ″a little to early to tell″ whether it could win restoration of FDA’s approval.
Dr. Donald Olsen, director of the University of Utah’s Institute for Biomedical Engineering, said he was ″surprised and disappointed″ by the FDA’s action and hoped it would not hurt future federal funding of artificial heart research in general, particularly for totally implantable devices.
The permanent Jarvik heart consists of a fist-size pump that is implanted into the chest and which is attached to two plastic tubes connected to a large compressed-air power system contained in a large cart that must move with the patient.
Withdrawal of the permanent Jarvik heart leaves only one other natural- heart replacement with FDA investigational approval, but that device is used only as a temporary bridge and only at Hershey Medical Center of Pennsylvania State University.
In recent years, the Jarvik has functioned mainly as a temporary bridge in patients awaiting transplants. Alternatives to the Jarvik are available because other companies have approvals for such temporary implants and for left ventricular assist pumps that help the natural heart work without replacement.
Symbion said its hearts have been used in 159 patients, 155 of them while awaiting a transplant, and pumping assistance devices in 115.
Copeland said Symbion hearts have been used in 155 patients, and pumping assistance devices in 55.
Dr. Thomas Preston, chief of cardiology at Pacific Medical Center in Seattle and a vocal critic of permanent artificial hearts, said the Jarvik venture has been a failure.
″They’ve set the whole program back with premature useage of the permanent artificial heart,″ he said. ″Now the whole (artificial heart) program has a bad name because the thing didn’t work.″
″It’s another sad instance of people in the medical profession rushing in for fame and glory and riches with great acclaim from the media and then disillusionment,″ he said.
However, Preston said he hopes work continues on the technology ″because some day it’s going to be better.″