Artificial heart patient dies

Artificial heart patient dies

On March 23, 1983, Barney Clark dies 112 days after becoming the world’s first recipient of a permanent artificial heart. The 61-year-old dentist spent the last four months of his life in a hospital bed at the University of Utah Medical Center in Salt Lake City, attached to a 350-pound console that pumped air in and out of the aluminum-and-plastic implant through a system of hoses.

In the late 19th century, scientists began developing a pump to temporarily supplant heart action. In 1953, an artificial heart-lung machine was employed successfully for the first time during an operation on a human patient. In this procedure, which is still used today, the machine temporarily takes over heart and lung function, allowing doctors to operate extensively on these organs. After a few hours, however, blood becomes damaged by the pumping and oxygenation.

In the late 1960s, hope was given to patients with irreparably damaged hearts when heart-transplant operations began. However, the demand for donor hearts always exceeded availability, and thousands died every year while waiting for healthy hearts to become available.

On April 4, 1969, a historic operation was performed by surgeon Denton Cooley of the Texas Heart Institute on Haskell Karp, a patient whose heart was on the brink of total collapse and to whom no donor heart had become available. Karp was the first person in history to have his diseased heart replaced by an artificial heart. The temporary plastic-and-Dacron heart extended Karp’s life for the three days it took doctors to find him a donor heart. However, soon after the human heart was transplanted into his chest, he died from infection. Seven more failed attempts were made, and many doctors lost faith in the possibility of replacing the human heart with a prosthetic substitute.

In the early 1980s, however, a pioneering new scientist resumed efforts to develop a viable artificial heart. Robert K. Jarvik had decided to study medicine and engineering after his father died of heart disease. By 1982, he was conducting animal trials at the University of Utah with his Jarvik-7 artificial heart.

On December 2, 1982, a team led by Dr. William C. DeVries implanted the Jarvik-7 into Barney Clark. Because Jarvik’s artificial heart was intended to be permanent, the Clark case drew worldwide attention. Clark spent his last 112 days in the hospital and suffered considerably from complications and the discomfort of having compressed air pumped in and out of his body. He died on March 23, 1983, from various complications. Clark’s experience left many feeling that the time of the permanent artificial heart had not yet come.

During the next decade, Jarvik and others concentrated their efforts on developing mechanical pumps to assist a diseased heart rather than replace it. These devices allow many patients to live the months or even years it takes for them to find a donor heart. Battery powered, these implants give heart-disease patients mobility and allow them to live relatively normal lives. Meanwhile, in the 1990s, the Jarvik-7 was used on more than 150 patients whose hearts were too damaged to be aided by the mechanical pump implant. More than half of these patients survived until they got a transplant.

In 2001, a company called Abiomed unveiled the AbioCor, the first completely self-contained replacement heart.


Artificial heart patient dies

LOS ANGELES, California (CNN) -- A 74-year-old man who received a self-contained artificial heart has died, 56 days after being fitted with the pioneering device, UCLA Medical Center announced Thursday.

The patient, whose name was not released, died Wednesday. He was one of five patients who was successfully fitted with the AbioCor artificial heart and the second to die after living with the device for several weeks. A third AbioCor heart patient died while being fitted with the device and never made it out of surgery.

The artificial heart had continued to function, but the man was on life support because of multiple organ failure, and his family requested that the support be withdrawn, according to a statement from the hospital.

"The patient and his family showed great courage," said Dr. Hillel Laks, chief of cardiothoracic surgery at UCLA's School of Medicine and director of center's Heart, Lung and Heart-Lung Transplant Program. "We are all grieved that we could not extend his life further and return him to a better quality of life. His participation in this clinical trial was of enormous value in proving the effectiveness and reliability of this artificial heart."

The patient underwent the procedure October 17.

He is survived by his wife, seven children and 10 grandchildren, according to the hospital.

The first patient in the world to receive the self-contained artificial heart, Robert Tools, died November 30 at Jewish Hospital In Louisville, Kentucky. He survived 151 days -- nearly five months -- with the device.

The sixth artificial heart recipient died November 27 due to severe bleeding during surgery to implant the device at the Texas Heart Institute in Houston.

According to Abiomed, the heart's manufacturer, the three remaining patients are recovering well.

Tom Christerson, who has had the artificial heart for three months, is able to walk with assistance and breathe on his own, his doctors at Jewish Hospital said.

The other two patients, who are at two different hospitals, also have had "no meaningful clinical problems," after 77 and 37 days, Abiomed said.

All the patients received the artificial heart as part of clinical trials of the device. To be eligible, patients must have no other options for treating their severe heart failure and be unlikely to survive more than 30 days. Four additional implants have been approved by the Food and Drug Administration, but have not yet been carried out.


Schroeder Dies at 54 After 620 Days on Jarvik Heart

William J. Schroeder, the “tough old nut” with a strong chin and a strong will, but a heart so weak that he had only hours to live when he received the world’s second artificial heart, died Wednesday.

The 54-year-old Indiana father of six had survived one year, eight months and 12 days--longer than any person thus far--on the plastic-and-metal Jarvik-7 heart, and was the last survivor among five patients who had received the pump as a permanent substitute for a human heart.

Doctors at Louisville’s Humana Hospital Audubon said Schroeder died after a series of strokes that impaired his ability to breathe.

Schroeder became lethargic and was having difficulty breathing Tuesday morning and required resuscitation, said Dr. William C. DeVries, the chief implant surgeon. Schroeder’s wife, Margaret, and the Schroeder children were called to his bedside after his condition worsened. He died at 1:35 p.m., said Donna Hazle, a hospital spokeswoman.

Schroeder’s family issued a brief statement Wednesday night saying: “We have been through many rough times in the past 21 months, but the past two days have been the hardest. We are all saddened by the loss of our father, a truly great person.

“Six-hundred (and) twenty days ago we came to Humana and to Dr. DeVries to take a desperate chance to give new life to a father we loved so very much. We leave today taking the sweet memories of this brave and pioneering man.”

The length of Schroeder’s survival and his ability to live outside the Kentucky hospital were signs of progress in the experimental implant program. But three earlier strokes, all apparently related to the man-made pump, left his speech and mobility severely impaired and raised questions about the risks of the device and the quality of life recipients might expect.

“He volunteered for the artificial heart because he loved life and the people around him, and he wanted to help others,” said DeVries.

“Bill set many milestones during his 620 days with the heart. But the main one, the one we’ll remember, is the way his indomitable spirit lit the path for those who will come after.”

Dr. Phil Dawkins, one of Schroeder’s doctors, said his patient’s legacy would be that “a major amount of knowledge has come from his experience” on the artificial heart.

Schroeder’s new life began with promise and remarkable progress, only to be set back by a debilitating stroke. After four rocky months, Schroeder was released from the hospital and moved into a specially equipped apartment across the street.

Although still suffering speech problems caused by his stroke, Schroeder seemed to be on the mend. He traveled frequently around Louisville in a van and even went fishing on a sunny Saturday in April. But on May 6, 1985, he suffered a second stroke, which left parts of his body temporarily paralyzed, and he was readmitted to the hospital.

He returned to the apartment Aug. 11 and within weeks was eating and shaving without assistance. As the one-year anniversary of his implant approached, his doctors began making plans to allow Schroeder to move permanently back home to Jasper, Ind.

But there was another setback. On the weekend of Nov. 9, he suffered a third severe stroke, and was again hospitalized. His neurologist, Dr. Gary Fox, marveled at the strength of Schroeder’s will to live. Asked how much more Schroeder could take, Fox responded: “I don’t know. He has amazed me.”

From his first request after his initial surgery--for a beer--Schroeder’s wit and down-to-earth manner delighted his doctors and the millions of people around the world who followed his progress, sent cards and gifts and wished him a speedy recovery.

Schroeder and his family handled the worldwide attention without pretension. He cried tears of gratitude when discussing what his doctors had done for him and telling how happy he was to be alive.

Within days after his surgery, he was touring the hospital in his wheelchair, his Jarvik pump frequently powered by a portable driver designed to give artificial heart patients near-normal mobility when they go home from the hospital.

Whether he was showing off his surgical scar, inviting a visitor to put a hand on his chest and “feel my heart,” or reassuring a fellow Jasper native awaiting heart surgery, Schroeder was by all accounts a delightful presence around the hospital.

When President Reagan called to wish him well, Schroeder bent the chief executive’s ear about the runaround he was getting from the folks at Social Security.

Those first two weeks with the heart were good times for the retired federal employee. Schroeder himself said he felt “fantastic.”

But on the evening of the 19th day, Dec. 13, only a few hours after receiving a hand-delivered Social Security check spurred by his complaint to Reagan, he suffered the stroke.

He was unconscious for about an hour and he awoke paralyzed on his right side and unable to speak. DeVries said later he feared he might have lost his patient.

Although Schroeder awoke, he had difficulty recognizing his family and remembering what day it was, and his speech was slurred. Neurological tests indicated that Schroeder had actually suffered small strokes, severely damaging three areas of his brain.

DeVries said he thought the strokes resulted from a blood clot that formed in or near the heart and broke into pieces en route to the brain. Dr. Robert K. Jarvik, inventor of the artificial heart, agreed.

But both men said they would probably never be sure whether the Jarvik-7 heart was to blame for the strokes. Future implants might shed some light on the link between the heart and strokes, they said.

While the strokes set back Schroeder’s progress, and apparently caused a temporary sag in his spirits, his doctors remained optimistic that he would be able to leave the hospital, something the first mechanical pump recipient, Barney Clark, never did.

Even before Schroeder was discharged from the hospital, DeVries resumed his research project, implanting an artificial heart in Murray P. Haydon, a retired auto worker from Louisville, on Feb. 17, 1985.

Haydon died on June 19 of this year. Clark died 112 days after receiving the device in Utah on Dec. 2, 1982.

DeVries’ fourth patient, Jack C. Burcham, 63, a retired railroad engineer from Le Roy, Ill., died on April 24, 1985, 10 days after receiving his artificial heart. His death was caused by pressure from clotted blood that collected over the remnants of his natural heart and shut off the blood flow, an autopsy indicated.

DeVries has not performed the procedure since then, although he has federal approval for three more permanent mechanical heart implants. The procedure was performed in Sweden, however, on Leif Stenberg, who became the fifth person to receive a permanent artificial heart. He had the operation on April 7, 1985, and died seven months later.

Although DeVries remains committed to using the man-made heart as a permanent device, doctors in Arizona, Pennsylvania and Minnesota have used mechanical heart pumps as temporary measures to keep failing patients alive until human donor hearts could be found for transplantation.

Schroeder, a strapping six-footer, was a religious, strong-willed man and “pure mid-America, small town Mid-America,” said Dr. Allan M. Lansing, the chief medical spokesman for the implant team at Humana. “His roots are in everything that is strong and basic about the United States of America.”

His positive attitude was as important as his physical condition in choosing him for the experimental procedure, the doctors said.

Schroeder’s heart condition wasn’t diagnosed until he had a heart attack at age 50. He had a double coronary bypass operation a year later, in 1983, but the progressive weakening of his heart muscle continued.

He was rejected as a heart transplant candidate, because he was over 50, generally considered the age limit for transplants, and because he was a diabetic.

In November, DeVries and other doctors at Humana told Schroeder in detail about the experimental alternative.

They did not try to talk Schroeder into it. “It could leave you a vegetable,” DeVries told him. DeVries and Schroeder discussed the 17-page consent form, which contained a detailed recitation of what went wrong in Clark’s case and what could go wrong in a second heart implant.

“We just kind of sat down and asked, ‘Dad, what do you want to do?’ ” said his wife, Margaret. “He said, ‘I have no other thought. I want to go all the way.”

However, a year after the implant, Mrs. Schroeder told The Times that she wished she and her husband had discussed--before the implant--"how far down the line he wanted us to go.”

“To me, a year in a wheelchair is a lot better than six feet under the ground,” she said. “But, for Bill, I don’t know whether he’s gone through hell or not.”

Toward the end of the first year, Margaret Schroeder said, she had begun trying to ask him, even though the effects of the strokes had made communication difficult.

“I say, ‘Honey, have you had enough? Is it too bad?’ He never indicates that it’s too much or that he doesn’t want to go on,” she said. “I think if he didn’t want to go ahead he would let me know by blinking his eyes or squeezing my hand.”

Nevertheless, his children, who frequently drove the 90 miles from Jasper to Louisville to see him, said they did not regret their father’s decision to receive the Jarvik-7 heart. They listed a wedding, picnics, fishing outings and birthday parties as examples of events Schroeder was able to attend only because his life had been prolonged.

Schroeder was born in Jasper and he raised his family in the same house his parents had owned. He graduated from Jasper High School in 1950 and served in the Air Force for 15 years, most of that time as a military air traffic controller. With the Air Force, he spent time in Texas, Michigan, North Carolina, Newfoundland and Saudi Arabia.

After retiring from the Air Force, he was a production worker, then an ammunition inspector and most recently a quality control specialist in pyrotechnics with the Crane Army Ammunition Activity in Crane, Ind.

Dick Garvey, director of administration for the Crane Center, said Schroeder was “kind of a tough old nut who would be good for something like this.” Schroeder’s nickname at work had been “The Bull,” because he tended to be bull-headed about things and unwilling to let anything get him down.

He was also a member of the American Federation of Government Employees Union, and was president of the chapter representing workers in Indiana, Kentucky and Ohio. He joined the Knights of Columbus and helped found a chapter in Michigan when he lived there.

He retired in 1984 after two years of heart trouble. At the time of that heart attack, Schroeder was about 50 pounds overweight and was smoking one pack of cigarettes a day. He had smoked for 30 years but quit after the heart attack.

Schroeder’s family had a history of heart disease. His mother died at age 57 of a heart attack. His father also had heart disease but died of lung cancer at 63.

The night before his surgery, Schroeder was so weak that his doctors feared he might not survive until the morning.

A few days after the implant, Mrs. Schroeder said that no matter what happened in the future she thought her husband’s life had already been longer and richer than it would have been without the artificial heart.

Schroeder will be buried in Jasper on Saturday.

Scott Kraft, now based in Kenya for The Times, covered the Humana Hospital artificial heart program while a Midwestern correspondent for this newspaper.

As managing editor, Scott Kraft oversees the Los Angeles Times newsroom, including Column One, enterprise, investigations and Sports. During more than three decades at The Times, Kraft has been a national and foreign correspondent as well as deputy managing editor/news and national editor. He was a New York-based national writer for the Associated Press before joining The Times as a staff writer in its Chicago bureau. He later was The Times’ bureau chief in Nairobi, Johannesburg and Paris. He covered the release of Nelson Mandela and the end of apartheid as well as the ill-fated U.S. military mission in Somalia, among other major stories. His story for the Los Angeles Times magazine on the AIDS epidemic in Africa won the SPJ Distinguished Service Award for Foreign Correspondence. As national editor, he directed work that won four Pulitzer Prizes. He has been a Pulitzer Prize finalist in feature writing, and was a Pulitzer Prize juror in international reporting in 2014 and chair of the public service jury in 2015 and the international reporting jury in 2020. He also is on the Board of Governors for the Overseas Press Club of America. Kraft was born in Kansas City, Mo., and has a bachelor’s degree in journalism from Kansas State University.

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WILLIAM SCHROEDER DIES 620 DAYS AFTER RECEIVING ARTIFICIAL HEART

William J. Schroeder, the world's last remaining and longest-surviving recipient of a permanent artificial heart, died here today at Humana Hospital-Audubon after a series of strokes.

Mr. Schroeder, the second of five patients who permanently received the experimental Jarvik-7 artificial heart, suffered several strokes in the 620 days he survived after Dr. William C. DeVries implanted the device at Humana on Nov. 25, 1984. [ Page A25. ] His survival, and that of Murray P. Hayden, a recipient who lived for 488 days, showed that people could live long-term on the plastic and metal device. But the strokes and other complications they suffered impaired the quality of their lives and blunted initial enthusiasm for the heart.

Mr. Schroeder's wife, Margaret, and their six children were with him when he died at 1:35 P.M., according to Donna Hazle, a hospital spokesman.

The family was called to his bedside Tuesday after doctors determined that he had suffered a series of strokes, Dr. DeVries said. The family decided to request doctors not to resuscitate Mr. Schroeder if he suffered any more strokes, Dr. DeVries told reporters at a news conference tonight. ''When he stopped breathing, we honored their decision,'' he said.

At the time of his death, Mr. Schroeder was suffering from chronic infections and lung problems, according to Tom Noland, a hospital spokesman, who would not be more specific.

In a statement by the family, Mr. Schroeder's eldest son, Mel, said: ''We came with the thought of benefiting people in the future period. We leave with the knowledge of 21 recipients of bridge-to-transplants throughout the world. The future will speak for itself on the contributions Bill Schroeder and the other permanent heart implant patients have made to mankind.''

Mr. Schroeder will be buried Saturday in his hometown of Jasper, Ind. Re-Evaluating Use of Heart

The seriousness of the complications suffered by artificial-heart recipients has prompted suggestions that developers of the device take another look at its basic design.

But the artificial heart has in recent months been used successfully in several instances as a bridge to keep patients alive until a human heart was available for transplant. For the time being, most medical experts believe that use of the artificial heart as a bridge is its chief value.

Doctors have not implanted a permanent artificial heart since 1985.

Dr. DeVries has said he intends to continue using the device. The Federal Food and Drug Administration has given him permission to implant a total of seven permanent artificial hearts. It has also given surgeons in several other medical centers permission to implant two types of artificial hearts, the Jarvik-7 and one developed at Penn State University.

But, acting on the recommendations of an advisory panel, the Federal agency decided last year to allow the implants only under heightened Government supervision. As a result, the agency now requires added reporting on patient care and a case-by-case review of proposed recipients.

Dave Duarte, a spokesman for the agency, said Dr. DeVries has proposed no new candidates for the operation. ''They will tell us when they have a patient,'' Mr. Duarte said.

He said he did not believe that Mr. Schroeder's death would result in other restrictions. The advisory panel was aware that he was seriously ill, Mr. Duarte said. First to Live Outside Hospital

Mr. Schroeder, a 54-year-old retired Federal worker, was the first heart-implant patient to live outside a hospital. His artificial heart, an air-powered device, pumped flawlessly despite a number of medical setbacks, including the debilitating strokes he began to suffer within a month of the implant surgery.

Mr. Schroeder, who lived in a specially equipped apartment near the hospital for two brief periods in 1985, suffered another stroke Nov. 10, 1985, and had been hospitalized since Nov. 11. His condition worsened Tuesday and members of his family were summoned to his bedside.

Four other people received permanent Jarvik-7 artificial hearts. Dr. DeVries implanted three of them.

The first was in Dr. Barney B. Clark, a Seattle dentist, in December 1982 at the University of Utah. Dr. Clark lived for 112 days on the device and died of multiple organ failure on March 23, 1983. The complications were not directly related to his mechanical heart. Move to Louisville

In 1984, Dr. DeVries moved to Louisville to the Humana Hospital-Audubon, where he implanted Jarvik-7's in Mr. Schroeder and two other patients.

One, Jack Burcham Sr., 62, of Le Roy, Ill., was the fifth permanent artificial heart recipient. He died of massive bleeding on April 24, 1985, after living 10 days.

The other was Mr. Hayden, 59, of Louisville, who received his artificial heart on Feb. 17, 1985. Mr. Hayden, who required the use of a mechanical ventilator because of a chronic lung problem, lived in the hospital's intensive care unit for more than a year. He was declared brain dead June 19. He left the hospital for brief periods on rare occassions.

Leif Stenberg of Sweden became the world's fourth Jarvik-7 recipient in an operation performed April 7, 1985, at the Karolinska Hospital in Stockholm. He died Nov. 21, 1985. The Jarvik-7 heart, named for its designer, Dr. Robert Jarvik of Salt Lake City, is manufactured by Symbion Inc., which he heads. The device is powered by a 323-pound air compressor about the size of a small refrigerator. It was also designed to be powered by a portable 11-pound system the size of a large camera bag. Dangers of Device

Although it is an experimental device, it consists in part of four artificial valves that the Food and Drug Administration has licensed for use in heart surgery. Artificial valves can cause several medical problems ranging from anemia resulting from the destruction of red blood cells to the formation of clots in and near the valve. Such clots can break off and lodge in arteries supplying the brain and other organs, depriving them of life-sustaining oxygen.

Scientists have not yet developed a synthetic material that rivals the inside lining of human blood vessels for its ability to allow blood to flow freely without clotting.

The strokes that have developed among artificial heart recipients have resulted from either blood clots that lodge in the arteries of the brain or from bleeding resulting from anticoagulant therapy. Computer Model of Blood Flow

In research undertaken independent of the artificial heart that could have a bearing on the design of future models, researchers at New York University's Courant Institute have devised what they describe as the first computer model of the flow of blood through the heart. The model has already led to a new valve design that is being tested by Carbo-medics, a Houston company that is the world's largest supplier of heart-valve components.

The Courant computer generates diagrams that the researchers use to make dramatic motion pictures of a vividly recognizable beating heart. Hundreds of dots, representing particles of blood, stream through the valve, stretching the elastic walls of the heart and creating whirling vortices.

The pictures enable researchers to spot areas of pooled blood where clots can form.


Transplant waiting list

Artificial hearts have been used for decades, but usually as a means of helping a failing heart to pump blood around the body.

Several companies are working on devices which entirely take over from the damaged organ until a donor heart becomes available.

In 2011 Matthew Green became the first patient in Britain to have his heart completely replaced by an artificial organ.

The 40-year-old was suffering from a severe heart condition, which meant he could have died at any time.

Mr Green said the artificial heart, made by the US firm SynCardia, had 'revolutionised' his life, allowing him to go out for walks and to the local pub.

Last summer surgeons at Papworth hospital in Cambridgeshire replaced his plastic device with a donor organ.

Mr Green told the BBC the artificial heart had ɽone the job very well for two years' allowing him to survive while waiting for a suitable heart.

The need for artificial hearts is driven by the shortage of donor organs.

It is common for patients to wait well over a year for a suitable heart and it is estimated that three people a day die while waiting for an organ transplant.


Pioneering heart patient dies

Robert Tools, 59, died Friday, doctors at Jewish Hospital in Louisville, Kentucky, said.

"Bob became a dear friend to all of us. We will miss Bob's laugh, his sense of humor and his fighting spirit," said Dr. Robert Dowling, one of the surgeons who implanted the artificial heart. "Our sympathy and support go out to his family and to all those who knew and loved Bob. His pioneering spirit will long live on in the fight against heart disease."

Earlier in the day, doctors announced Tools had developed severe abdominal bleeding and multi-organ failure from which he was not expected to recover.

The hospital said the bleeding was not related to the AbioCor artificial heart, nor to the stroke Tools suffered on November 11, but was linked to blood clotting problems caused by Tools' chronic illness. On July 2, 2001, Tools became the first person in the world to let doctors cut out his entire heart and replace it with the completely implanted, battery-powered AbioCor artificial heart.

Without the plastic and titanium device, doctors gave Tools a slim chance of surviving even a month. He had exhausted all other options for treating his heart failure, and with kidney failure and diabetes complicating his condition, was too sick to qualify for a human heart transplant.

But within days of the operation, surgeons saw improvement in Tools' health.

"Certainly the progress with the patient has been extremely pleasing, and I think it really surpasses any expectations that I've ever had," Dr. Laman Gray, one of the surgeons who conducted the implant, said at the time.

Tools received the artificial heart as part of a clinical trial of the device, manufactured by Abiomed of Danvers, Massachusetts.

Although the risks were great, Tools said the choice to participate in the experiment was an easy one.

"There was no decision to make," he said in his first public appearance, seven weeks after the surgery. "I mean, I had a choice. I could sit at home and die or come here and take a chance. I decided to come here and take a chance, and my family went along with me."

Since his procedure, five other men have followed in his footsteps. The most recent patient died during surgery the other four are in various stages of recovery.

Doctors described Tools as very determined to recover. He had been gaining weight in the past few weeks, and had taken some 20 excursions away from the hospital during his recovery.

"It's phenomenal," said Dr. Robert Dowling, who was also on the surgery team. "It's what we had hoped for, but we often hope for the best possible scenario. You don't often get it, but in this case we got it."

Tools had hoped to spend the holidays at home in Franklin, Kentucky, but suffered the stroke before doctors could grant his wish.

Still, Tools got more time than he bargained for by getting the AbioCor transplant.

His wife, Carol, said they had more fun during the last few months than in the two years he struggled with a weak heart, and that neither she nor Tools had any regrets.


The Artificial Heart: Prototypes, Policies, and Patients (1991)

BY THE LATE 1990s, patients with heart failure may be able to receive a fully implantable device to assist their weakened hearts. A small battery pack will be the only visible evidence of the technology, in contrast to the large console needed to power earlier models of these devices. Five to ten years after assist devices are perfected, a fully implantable total artificial heart (TAH)&mdasha device that replaces the natural heart instead of only assisting it&mdashmay be technologically possible.

As soon as 1992, the first patient will receive a fully implantable, long-term ventricular assist device (VAD). The implant will begin a clinical trial of a VAD developed by the Novacor Division of Baxter Healthcare Corporation and is the result of a major effort by the artificial heart program of the National Heart, Lung, and Blood Institute (NHLBI). In the trial, 20 patients will receive the device over a 2-year period, 10 at St. Louis University and 10 at the University of Pittsburgh each patient will be followed for up to 2 years, and extensive data analysis will be performed. Formal reports of the trial's outcome thus will be available in the latter half of the 1990s.

The longest use of a temporary Novacor VAD (similar but externally powered) in either animals or human beings has been about one year, but the cumulative experience since the first human use in 1984 suggests that the forthcoming trial of the fully implanted model will yield positive results in some patients. Because the two technologies have similar components and face similar problems, the Novacor trial results will have considerable relevance not only for VAD development but also for the future of TAHs. Nevertheless, TAHs are very different devices replacing a natural heart presents many more challenges than does supporting left ventricular function.

At present, four TAH developers are just beyond the mid-point of NHLBI contracts for continuing R&D. If NHLBI funding continues, the next phase of extensive device readiness testing might require up to five years this would be followed by another five or more years of clinical trials. TAHs are not likely to be a candidate for wide use until at least 2005.

This report of an Institute of Medicine (IOM) study is primarily intended to help NHLBI determine the extent of its support of the next step of TAH development after the current contracts end in September 1993. The report also considers the need to continue developing additional VAD models and examines issues related to both types of devices, such as appropriateness of technology use and access by patients to this technology. Finally, the report suggests several methods that can assist NHLBI in allocating resources among R&D programs and examines related R&D policy issues. (Temporary-use devices are not considered, except as their experience provides a basis for projecting the performance of long-term devices.)

END-STAGE HEART DISEASE

Consideration of the future role of TAHs and VADs&mdashreferred to collectively as mechanical circulatory support systems (MCSSs)&mdashis helped by a basic understanding of the heart's functioning. As Figure 1.1 illustrates, the heart is a double pump. Oxygenated blood from the lungs flows into the left atrium and from there into the left ventricle. The left ventricle pumps the blood via the aorta into arteries throughout the body. After oxygen has been removed in organs and capillaries, the blood flows through veins back to the heart's right atrium and then to the right ventricle. This chamber sends the venous blood to the lungs to be oxygenated, completing a pumping cycle that normally occurs 70 to 90 times per minute.

Because considerably more pumping force is needed to move arterial blood throughout the body than to move venous blood through the lungs, the left ventricle's muscle strength is greater than the right ventricle 's and it is also more likely to fail than is the right ventricle. Heart failure is identified as left-sided, right-sided, or both (biventricular) end-stage heart disease occurs when one ventricle (or both) is unable to perform the necessary pumping function. As the name indicates, the typical case of end-stage heart disease becomes steadily more severe, until death occurs.

End-stage heart disease may result from a variety of cardiovascular causes &ldquoheart failure&rdquo&mdashsometimes called congestive heart failure&mdashis, technically speaking, not itself a disease but a condition that is caused by many different disease processes. The most common causes of end-stage heart disease and heart failure are hypertension and coronary atherosclerosis (also called coronary artery disease or coronary heart disease, a constriction of the arteries that convey blood to the heart muscle itself). Viral


Haydon, Artificial Heart Patient, Dies

Murray P. Haydon, a retired auto worker who lived for 488 days with a Jarvik-7 mechanical heart, died Thursday, leaving only one survivor among the five men who have received permanent artificial hearts. He was 59.

The third recipient of the mechanical heart, Haydon was declared brain dead at 10:45 a.m., said Dr. William DeVries, the surgeon who implanted all the permanent artificial hearts used in the United States.

Haydon’s failing kidneys caused his nervous system to deteriorate over the past 10 days, DeVries said at a news conference at Humana Hospital Audubon, where Haydon had lived since he received his artificial heart on Feb. 17, 1985.

Haydon’s doctors and his family agreed not to place him on dialysis to help his kidney function, DeVries said. The family did not believe that it would improve his quality of life.

“Haydon’s deterioration and death was similar to what happened to Barney Clark,” the first recipient of the Jarvik-7 artificial heart, who died 112 days after the Dec. 2, 1982, implant at Utah Medical Center, DeVries said.

“We are sad now that he is no longer with us,” Haydon’s family said in a statement read by DeVries. “We are also grateful that he lived 16 months longer than he would have without the artificial heart.”

Haydon’s attitude remained good in his last days “and he continued to enjoy life,” DeVries had said in an earlier statement.

“We came to know him not just as a patient but also as a good friend,” he said.

Haydon, who would have celebrated his 60th birthday June 28, was the third person to receive a Jarvik-7 heart and the second longest-living recipient. He had spent most of his time in the hospital’s intensive-care unit and required a respirator to help him breathe much of the time.

William Schroeder’s artificial heart was implanted Nov. 25, 1984, and he is still a patient at Humana Audubon. DeVries said Schroeder “looked better today than he’s looked in four months.” He was told of Haydon’s death and “it did sadden him,” the doctor said.

“One of his friends had not made it,” DeVries said.

Leif Stenberg, 53, of Sweden received an artificial heart on April 7, 1985, and died Nov. 21. Jack Burcham became the fifth recipient on April 14, 1985 he died 10 days later at Humana Audubon.

“The contributions of these individuals, like Haydon, have been enormously beneficial in leading up to a better mechanical device and improved patient treatment post-operatively,” DeVries said. “There’s no doubt in my mind their participation in this research will help save thousands of lives in the future.”

Haydon left the hospital only three times, visiting neighbors in January, taking a van ride the next month and stopping briefly at his suburban Louisville home in March.

DeVries’ implant program has come to a standstill because of fewer patient referrals, stricter federal regulations and virtual abolishment of age limits for patients to qualify for heart transplants. On Jan. 8, the U.S. Food and Drug Administration adopted new restrictions on the Jarvik-7, including case-by-case approval of further implants, new procedures for treating patients and periodic reports to the government on patient status.

Haydon, a retired auto assembly-line worker known to friends as “M. P.,” had battled cardiomyopathy, a progressive deterioration and swelling of the heart, since 1981. In January, 1985, his children asked family physician Jerome Lacy about the possibility of an artificial heart.

“They had seen Haydon wasting away and becoming exhausted from such simple tasks as brushing his teeth,” Lacy said.

Haydon made satisfactory progress until blood began accumulating in his chest. On March 2, 1985, surgeons closed a tiny opening inside Haydon’s chest and returned him to a respirator.

Haydon spent seven years in the Army and Air Force. He operated a barber shop with an uncle, then worked at Ford Motor Co.'s Kentucky truck plant for 14 years before retiring in June, 1983, for health reasons.

He was described by friends and relatives as a quiet man, always willing to lend a helping hand. He had a passion for history and geography and enjoyed working puzzles.

Such has been the medical progress in a year that “if Haydon came to us today, we wouldn’t do him,” DeVries said. He said Haydon had been turned down by three natural-heart transplant programs because he was too old, but now men his age are routinely accepted for natural heart transplants.

In addition to his wife, Haydon is survived by a son, two daughters and five grandsons.


Artificial Heart

Heart disease is one of humankind’s most pervasive killers. Often, heart disease may be so severe that a patient has little chance of surviving while he or she awaits a donor heart. Taking their lead from the successful invention of an artificial kidney dialysis machine in the 1950s, medical scientists began to work on creating an artificial heart. At the very least they hoped artificial hearts could be used to keep people alive while they awaited a donor heart, which were, and are, always in short supply.

Willem Kolff, the Dutch-born inventor of the artificial kidney, was one of the first medical scientists to begin work on an artificial heart. In 1957 Kolff and his team of scientists tested their model in animals to identify problems. In 1969 a team led by Denton Cooley of the Texas Heart Institute used a model they had created to keep a human patient alive for over thirty-six hours. Anticipation grew that the artificial heart, which could potentially save thousands of people each year and would clearly be one of humankind’s greatest achievements, was on the verge of becoming reality.

The first artificial heart implanted in a patient was the known as the Jarvik-7, named after its designer Robert K. Jarvik, an American physician at the University of Utah. Designed to function just like a natural heart, the Jarvik-7 had two pumps (like the ventricles), each with a disk-shaped mechanism that pushed the blood from the inlet valve to the outlet valve. Though the artificial heart mimics the action of the natural heart, there is one crucial difference that cannot be avoided: the natural heart is alive, while the artificial heart is made of plastic, aluminum, and Dacron polyester. As a result, the artificial heart must rely on some external source to “live.”

In 1982, William DeVries of the University of Utah, along with a team of experienced assistants, implanted the Jarvik-7 into a patient named Barney Clark. Clark, a dentist from Provo, Utah, was too sick to be eligible for a donated heart the team decided Clark’s implant would have to be permanent. The procedure was a huge media event. People across the globe counted, undoubtedly along with Clark and his family, each day that the artificial heart continued to function and prolong his life. But though the artificial heart did prolong Clark’s life, it also cost him his freedom. Clark was bound to the washing machine-sized air compressor needed to power the heart. Tubes from the compressor passed through Clark's chest wall, binding him to his bed. Infections were common. Furthermore, Clark's blood clots kept forming as blood passed through the imperfect man-made pump. After suffering a number of strokes, Clark died 112 days after his implantation, much to the sorrow of everyone. Five more artificial hearts were placed in patients through 1985. The longest survivor was William Schroeder, who was supported by the Jarvik-7 for 620 days. By the late 1980s, surgeons at 16 centers, including the Texas Heart Institute, had implanted more than 70 Jarvik-7 devices in patients as a bridge to transplantation.


Present and future perspectives on total artificial hearts

Due to shortages in donor organ availability, advanced heart-failure patients are at high risk of further decompensation and often death while awaiting transplantation. This shortage has led to the development of effective mechanical circulatory support (MCS). Currently, various implantable ventricular-assist devices (VADs) are able to provide temporary or long-term circulatory support for many end-stage heart-failure patients. Implantation of a total artificial heart (TAH) currently represents the surgical treatment option for patients requiring biventricular MCS as a bridge to transplant (BTT) or destination therapy (DT). However, the clinical applicability of available versions of positive displacement pumps is limited by their size and associated complications. Application of advanced technology is aimed at solving some of these issues, attempting to develop a new generation of smaller and more effective TAHs to suit a wider patient population. Particular targets for improvement include modifications to the biocompatibility of device designs and materials in order to decrease hemorrhagic and thromboembolic complications. Meanwhile, new systems to power implanted driving units which are fully operational without interruption of skin barriers represent a potential means of decreasing the risk of infections. In this review, we will discuss the history of the TAH, its development and clinical application, the implications of the existing technological solutions, published outcomes and the future outlook for TAHs.

Keywords: Mechanical circulatory support (MCS) heart failure total artificial heart (TAH).