The Jarvik-7, also known as the Utah Heart and the Symbion J-7, was a model of artificial heart developed by the University of Utah and Kolff Medical, Inc. In 1982, the Jarvik-7 became the first artificial heart to be permanently implanted into a human patient, Barney Clark, who lived with it for 112 days. Four other patients received the Jarvik-7 as a permanent heart, all of them dying within less than two years after implantation, while other patients received it temporarily as a bridge to a heart transplant. The Jarvik-7 remained in use until 1990, when its approval for both permanent and temporary implantations was revoked by the U.S. Food and Drug Administration.
Development The first temporary artificial hearts were developed in the early 1950s at the advent of open heart surgery. These devices, such as the heart–lung machine, could take over the function of the heart for long enough to allow surgeons to operate on the organ or to perform a heart transplant, but a patient could not regain consciousness or perform normal activities with any of these artificial hearts.
In 1967, the University of Utah School of Medicine established its Division of Artificial Organs. Willem Johan Kolff, who had developed heart-lung machines as well as the first functioning artificial kidney, was hired as its director.O'Brien, Joan. "U researches artificial organs; Researcher's goal is to enhance human life as well as prolong it", Daily Utah Chronicle, December 1, 1980, front page. A founding member of Kolff's research team was Clifford Kwan-Gett, who by 1971 had improved upon some of Kolff's past unsuccessful designs to produce an artificial heart which could keep laboratory animals alive for up to two weeks. However, the subjects were inevitably killed by blood clots which formed on the heart's rubber membrane."Development of plastic heart came in stages", United Press International, March 24, 1983.Bankston, John. Unlocking the Secrets of Science: Robert Jarvik and the First Artificial Heart, Mitchell Lane Publishers, 2003. Kwan-Gett left the team in 1971 after disputes with Kolff about the program's direction.Rosetta, Lisa, and Heather May. "Jarvik's claims to credit for artificial heart disputed", Salt Lake Tribune, March 9, 2008.
Robert Jarvik was hired onto Kolff's team in 1971. Jarvik drew on the work of Kwan-Gett and Kolff, as well as that of Paul Winchell, in creating new designs for artificial hearts.Swartz, Mimi. Ticker: The Quest to Create an Artificial Heart, Penguin Random House, 2018. He replaced the fibrilized silicone rubber of previous hearts with polyurethane, a smoother surface which created fewer clots. One of Jarvik's early models, the Jarvik-3, successfully kept a calf named Burke alive for three months in late 1974.
Donald Olsen, a consultant to the team and a doctor of veterinary medicine who had convinced them to use calves as their test subjects, proposed a change to Jarvik's design: keeping the natural heart valves of the subject in place and sewing them into the artificial heart, rather than removing them and replacing them with artificial valves. The first heart model using this innovation was the Jarvik-5, first tested on a calf in 1975; it lived for four months with the implant.
All of these precursor models had been designed for calves and were too large to fit in a human chest cavity. The Jarvik-7 was the first designed for humans, reducing the stroke volume of the heart from in the Jarvik-5 to . Instead of polyurethane, the Jarvik-7 used polyethylene terephthalate, widely known as Dacron polyester.
Use in humans Cadaver trials The first use of the Jarvik-7 in a human body took place at Temple University Hospital on May 3, 1981, when Kolff's team implanted it into the chest of a 54-year-old woman who had been brain dead for an hour due to an aneurysm. The woman had previously agreed to donate her body to science, but requested anonymity. The artificial heart pumped blood through the body for two hours before the experiment was stopped due to bleeding.Glab, Theresa A. "Artificial heart implanted by Temple doctor", Camden Courier-Post, May 6, 1981, front page and page 8A.
A longer experiment was performed at Temple on November 7, 1981, with the Jarvik-7 functioning in the body of a legally dead 28-year-old man for 10 hours. The implant allowed the man's corneas and a kidney to be removed for transplant. The subject's kidneys and liver functioned well, but a pulmonary edema forced an end to the experiment."Surgeon Seeks OK to Implant Artificial Hearts in the Living", Harrisburg Patriot-News, November 15, 1981, page D4. A third test lasted for one and a half hours before being terminated due to bleeding.Kolff, Jack, et al. "The artificial heart in human subjects", The Journal of Thoracic and Cardiovascular Surgery 87:825-831, 1984.Cialini, Joe. "Heart device breakthrough", United Press International, via the Latrobe Bulletin, May 13, 1982, page 16.
A further test on a legally dead subject at Temple, designated "Case 4", was conducted in May 1982. The Jarvik-7, in addition to a respirator, successfully maintained blood flow without complications for 42 hours, from 5 p.m. May 8 to 11 a.m. May 10. The experiment was terminated so that the next-of-kin could make funeral arrangements."Artificial heart keeps body working 42 hours", Associated Press, via the Philadelphia Inquirer, May 14, 1982, page 7-B.
The fifth and final of these tests at Temple occurred in December 1982, shortly after the first implant in a living patient. A 19-year-old brain-dead man received the implant on December 3, and it maintained function for 72 hours before being removed to allow next-of-kin to make funeral arrangements."Heart Worker At Temple U.", Philadelphia Daily News, December 7, 1982, page 20.
Permanent implantation On June 11, 1980, Dr. William DeVries, chair of thoracic and cardiovascular surgery at the University of Utah Medical Center, asked the hospital's Review Committee for Research with Human Subjects to approve the use of the Jarvik-7 as a permanent replacement for the heart of a patient who would die without it. At the time, DeVries believed that a Jarvik-7 recipient was likely to recover from the operation and return to their home within 10 to 12 days after receiving the implant. After seven months of deliberation, the committee gave its approval, which DeVries publicly announced on January 27, 1981.O'Brien, Joan. "Artificial heart approved for human use", Daily Utah Chronicle, January 28, 1981, front page.
DeVries and Kolff then sought the approval of the U.S. Food and Drug Administration's Bureau of Medical Devices. Their first application was rejected by the FDA on March 25, 1981, stating that the application had "deficiencies" and that not enough information had been provided. One issue raised was that the team did not clearly indicate that the device would exclusively be used on patients with irreversible heart damage."FDA rejects heart application; Utah researchers to try again", Logan Herald Journal, March 26, 1981, page 3."FDA requests additional data", Daily Utah Chronicle, March 31, 1981, front page.
A revised application was approved by the FDA on September 10, with narrow restrictions on how the Jarvik-7 could be used. The agency would not permit an operation to be performed with the intent of implanting an artificial heart. The only scenario in which it could be implanted was if DeVries' team was performing open heart surgery on a patient, then determined that the patient would die unless their heart was replaced with the Jarvik-7."FDA Approval: U. Gets Artificial Heart Go-Ahead", Salt Lake Tribune, September 11, 1981, page B-1.
Due to the stringent requirements, no Jarvik-7 implant surgeries were performed for over a year after FDA approval was received. Dale Lott, a firefighter from Miami with severe cardiomyopathy, was one of 14 patients who requested a Jarvik-7 implant and were turned down by DeVries' team. As his condition was medically considered inoperable, DeVries could not begin open heart surgery and thus could not implant the heart. In response, Lott began a media campaign advocating for the FDA's rules to be loosened. As a result of Lott's advocacy, the university agreed to reconsider its policy in May 1982.Silva, Mark. "Dale Lott gives up fight for new heart", Miami Herald, May 28, 1982, front page and page 16A. The following month, the FDA approved the change, allowing the Jarvik-7 to be implanted in cases of inoperable heart degeneration. Lott himself never received the implant he had campaigned for, as his condition unexpectedly improved; he died in December 1983.Luening, Bill. "Deaths: Dale Lott, fire fighter who lost battle to get an artificial heart", Miami Herald, December 29, 1983, page 3C.
Barney Clark
Barney Clark, a retired dentist from Seattle who had severe congestive heart failure, became the first living patient to receive the Jarvik-7 implant on December 2, 1982. Clark's case was highly publicized and received much media attention, garnering attention from television networks, newspapers and periodicals. Clark lived for 112 days with his Jarvik-7 tethered to a pneumatic drive console, a device weighing some . During that time, Clark required several re-operations, suffered seizures, experienced prolonged periods of confusion and a number of instances of bleeding, and asked several times to be allowed to die. Clark, however, still believed his being part of the initial experiment was an important contribution to medicine, and maintained an overall positive outlook on his condition. Clark died on March 23, 1983, of multiorgan system failure. Despite the complications, DeVries considered Clark's case a success.Renee C. Fox and Judith P. Swazey. Spare Parts: Organ Replacement in American Society. New York: Oxford University Press; 1992
William Schroeder
After Clark's implant failed to meet the high expectations that had been placed on it, DeVries' team had difficulty raising money for further implant operations at the University of Utah. DeVries was approached by representatives of Humana Inc., then the world's largest for-profit hospital operating company, who offered to cover all the expenses associated with the next 100 Jarvik-7 implants, at an estimated cost of $25 to $30 million (equivalent to $ to $ million in ). Humana CEO David Jones said that he did not expect the artificial heart to turn a profit for the company, but that the publicity associated with the Jarvik-7 would give Humana an "enhanced reputation" that would be worth the money. DeVries accepted the offer, joining the faculty of Humana Hospital Audubon in Louisville, Kentucky, in 1984."Artificial heart means increased prestige for hospital", United Press International, November 25, 1984.
William J. "Bill" Schroeder was the second patient to receive a Jarvik-7 as a permanent implant, and the first to receive it in Louisville. DeVries replaced Schroeder's failing heart with a Jarvik-7 on November 25, 1984. Like Clark, Schroeder suffered from bleeding that required re-operation to resolve. In the first weeks, the outlook was good and Schroeder was allowed to have a can of Coors beer. He received a phone call from President Ronald Reagan, in which he famously asked the president for an update on a late Social Security check. However, 19 days after the operation, Schroeder suffered the first of four strokes. Despite this, his recovery continued, and he was allowed to live in a specially outfitted apartment near the hospital for a period of time, as well as use a newly developed battery-powered portable drive unit for the heart which allowed him to venture out of the hospital for short periods. Schroeder's health continued to decline as three more strokes plagued his time with the artificial heart. He died on August 6, 1986, from complications from a stroke, respiratory failure and sepsis, after 620 days with the artificial heart.