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First Artificial Heart Recipient

First Artificial Heart Recipient



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In 1982, Seattle dentist Barney Clark became the first human to receive a permanent artificial heart, a device known as the Jarvik 7. In an interview shortly after the implantation of the pump, Clark expresses his desire to help advance science. He survived for 112 days on the mechanical organ.


Throwback 1985: First Artificial Heart Used in Pittsburgh

It was 30 years ago on October 24 in Pittsburgh that a Jarvik-7 total artificial heart was implanted into a patient at Presbyterian University Hospital. This was the first clinical use of a mechanical blood pump in Pittsburgh, and 47-year-old Thomas Gaidosh (pictured) was the first recipient of this artificial heart. The surgery was an emergency measure to keep Mr. Gaidosh alive until a donor heart was available for him. The event was front page news in the Pittsburgh Press.

Mr. Gaidosh received a heart transplant within 4 days of the Jarvik-7 implant. He went on to live 12 more years. He was a wonderful supporter of the mechanical circulatory support program launched by Bartley Griffith, MD, and now under the direction of McGowan Institute for Regenerative Medicine faculty member Robert Kormos, MD, director of UPMC’s Artificial Heart Program and co-director of the Heart Transplantation Program. After 30 years, this exceptional program has helped almost 1,000 mechanical circulatory support patients (adult + pediatric).

UPMC’s artificial heart program is one of the first to be established in the United States and is considered one of the most experienced centers. Over the years, the center has worked with a number of device manufacturers, performing laboratory and clinical studies as well as serving as a national training center for other medical centers implementing programs. As such, the team has seen the technology evolve to better meet the needs of patients with heart failure. The team is a unique combination of clinical specialists and bioengineers who work together to optimize the patient’s therapy.


The World’s First True Artificial Heart Now Beats Inside a 75-Year-Old Patient

A 75-year-old Frenchman has just been given the gift of life as a team of surgeons have successfully completed the transplant of a revolutionary artificial heart.

The patient, so far unnamed, is reportedly recovering at Georges Pompidou European Hospital in Paris, where the 10-hour long operation was performed last Wednesday. Unlike similar devices used to keep patients alive until a donor can be identified, the "Carmat" heart is expected to operate continuously for as long as five years while enabling the recipient to resume a normal lifestyle, perhaps even allowing the person to return to work.

“We’ve already seen devices of this type but they had a relatively low autonomy,” Alain Carpentier, inventor and surgeon, told reporters, according to The Telegraph. “This heart will allow for more movement and less clotting. The study that is starting is being very closely watched in the medical field.”

Thousands of heart implants have been carried out, but Carpentier says the version he developed was the first to fully replicate the self-regulated contractions of a real heart. Inside the two-pound mechanical organ is an intricate system of sensors and microprocessors that monitors the body’s internal changes and alters the flow of blood as needed. It quickens or slows the blood flow based on the person's activity. "Most other artificial hearts, by contrast, beat at a constant unchanging rate. This means that patients either have to avoid too much activity, or risk becoming breathless and exhausted quickly," writes Gizmag. On the outer surface, the synthetic organ is partially made of cow tissue to reduce the likelihood of complications such as blood clots, which are common when fabricated materials come in contact with the blood. Patients who receive artificial heart transplants usually take anti-coagulation medication to minimize such risks.

The technology, which took 25 years to develop, started taking shape after the surgeon initially tested the feasibility of developing artificial heart valves using chemically-treated animal tissues as an alternative to plastic. Since then, he has obtained approval from authorities in France, Belgium, Poland, Slovenia and Saudi Arabia to conduct human trials that are expected to run until the end of 2014. If all goes well, meaning if the patients survive at least a month with Carmat systems, Carpentier will then have the means to seek regulatory approval to make them available within the European Union sometime in early 2015.

Ultimately, the litmus test hinges on whether the artificial heart's pumps last more than a few years. Barney Clark, the world's first heart implant patient, survived only 112 days following a milestone procedure in 1982 that replaced his failing heart with the man-made Jarvik-7 heart. The SynCardia total artificial heart, which remains the only FDA-approved heart replacement option, has made it so that patients carry on much longer, though they'd have to adjust to the burden of  "carrying around a compressor and having air hoses going in and out of your chest," says heart surgeon Billy Cohn in a CNN report.

The Carmat artificial heart is designed to mimic the dual chamber pumping action of a real human heart. Credit: Carmat[/caption]

Carpentier's half-cow, half-robotic technology takes a different approach, as compared to SynCardia's air compression method, in utilizing a hydraulic fluid to facilitate the movement of blood. A comprehensive report in MIT Tech Review explains how this mechanism works:

The device, powered by rechargeable lithium-ion batteries and worn on the outside, is about three times heavier than a human heart, which will limit its compatibility to 86 percent of men and 20 percent of women. However, Carpentier plans to develop smaller versions for women of smaller stature.

The Carmat artificial heart is expected to cost about 140,000 to 180,000 Euros (or $191,000 to $246,000).


Made in Portland: the world's first artificial heart valve, Sept. 21, 1960

During a routine physical in 1965, Philip Bryson learned that he had a life-threatening heart murmur. Follow-up exams revealed that heɽ been born with a defective aortic valve, and at age 25, the valve began to fail.

Fortunately for him, a young heart surgeon had devised a solution. Bryson became one of the earliest recipients of a mechanical heart valve developed by Portland surgeon Albert Starr and engineer Lowell Edwards.

More than 45 years later, the valve functions flawlessly inside Bryson's chest, opening and closing with a muffled tick-tock sound, audible across a quiet room. Bryson, who would not have lived long without a new valve, married and moved from California to Alaska, where he and his wife raised four children.

He became an avid hunter, fisherman and runner. At age 70, he still works part-time as a consulting engineer.

"I've really been able to do everything," Bryson says.

Fifty years ago today, Starr and colleagues performed the world's first successful valve replacement at the University of Oregon Medical School, now Oregon Health & Science University in Portland. The achievement stands as one of the most

. Before Starr and Edwards developed their mechanical heart valve, no patient had lived longer than three months after valve-replacement attempts. At least four of the earliest recipients of Starr-Edwards valves lived for more than 40 years.

"Fifty years ago, heart-valve replacement surgery did not exist. Today, it is the second-most common cardiac surgery in the United States and one of the most successful," said Joseph Goldstein, chairman of the scientific selection committee for the

when Starr received the prize in 2007. Since the inception of the awards in 1946, 72 recipients have gone on to receive the Nobel Prize.

Starr says luck played a significant role in helping win the race to produce a durable mechanical valve. His co-inventor, Edwards, dropped in out of the blue one day in 1958 looking for a partner with whom to build an artificial heart.

But Starr also attributes his success to boldness. "In surgery, either you operate or not there's no horsing around," he said in a 2007 interview. Starr, 84, remained active as a surgeon until 2006. He still keeps a hand in the Providence Heart and Vascular Institute he directed for decades at St. Vincent Medical Center. Among other jobs at Providence Health & Services, Starr directs a bioscience research and development program and a heart surgery academic research center named after him.

At St. Vincent, Starr and Dr. James Wood developed one of the largest heart surgery centers in the Pacific Northwest. Starr built a surgery teaching program that attracted trainees from around the world.

But beyond the lofty accolades and world renown, Starr is better known to thousands of people as the guy who saved the life of a child, a husband, a grandmother or friend.

Starr was born in Brooklyn, N.Y., in 1926, the son of immigrants from Ukraine and England. His father sold fine furs and built a wholesale distribution business. Starr was 16 years old when he enrolled at Columbia University.

"My greatest fear was anonymity," he said years later, reflecting on his teenage years. "I wanted not only to accomplish something important, but also to have the world recognize me for my accomplishments."

He earned a medical degree at Columbia's College of Physicians and Surgeons at 22, and served as a U.S. Army combat battalion surgeon in Korea. "He looked too young to be a doctor but turned out to be a hard-working and effective little guy," heart surgeon Denton Cooley, said of his first meeting with Starr in 1949 at Johns Hopkins Hospital in Baltimore, Md.

Starr was an up-and-coming surgical resident at Bellevue and Presbyterian hospitals in New York when Oregon's only medical school offered him the chance to launch an open-heart surgery program in 1957. Starr focused on children's heart defects and hadn't seriously considered artificial heart valves until Edwards, the engineer, showed up.

Starr convinced Edwards that an artificial heart was beyond reach and talked him into a more realistic goal: building a replacement heart valve. Within a few weeks, Edwards returned with a prototype.

In experiments on dogs, Starr's medical team found that the first valve designs became clogged with blood clots. Most dogs died within days. He and Edwards abandoned the idea of copying biological heart valves, which have a set of flaps. They turned to a ball-and-cage design: Pulses of blood push the ball away from the opening to allow flow, then as pressure drops, the ball falls back into a ring to form a seal.

By 1960, the team achieved lasting survival in several dogs. Starr said he remained reluctant to try the device in people, but Herbert Griswold, the medical school's chief of cardiology, urged him to go forward. There was no other hope for patients dying from valve disease.

The team suffered a tragic setback with their first patient, a 33-year-old woman. Ten hours after surgery, Starr helped her turn on her side, and she suddenly lost consciousness and died. The team quickly figured out that a large air bubble had formed inside one of her heart chambers. Changing position allowed the trapped air to slip through an artery to her brain, causing immediate death. "I was numb," Starr said. "It was a complication we never saw in the dog."

Knowing what happened, Starr swore heɽ never let it happen again, "a promise that allowed me to sleep that night."

Shaken, but convinced that the surgery could be performed safely, the team stuck with its commitment to perform five cases before drawing conclusions.

The second patient, Philip Admunson, a 52-year-old truck dispatcher from Spokane, lived for 15 years with his valve and died after falling from a ladder at home.

Starr astounded heart surgeons when he presented the first success at a meeting of the American Association of Thoracic Surgery. Cooley said the historic operation unleashed a frenzy of efforts by other surgeons and medical device companies to develop prosthetic valves and surgical techniques that have saved millions of people with damaged hearts.

Starr's The successes led to international acclaim, and patients needing heart-valve replacement came to Portland from around the world.

Edwards, who died in 1982, started a medical devices company in Southern California. Sales by publicly traded Edwards Lifesciences totaled

surpassed everyone's expectations, including the inventors'.

"We were operating on patients whose life expectancy was less than one year," Starr said in a recent interview. "Even if they lasted only five or ten years it would be a great advance."

The caged ball design, however, suffered from one major downside: The ball created too much turbulence in the flow of blood, requiring recipients take blood-thinning drugs to prevent clots from forming. In the late 1960s, French surgeon Alain Carpentier pioneered so-called bio-prosthetic valves that freed patients from the need to take blood thinners. Carpentier processed heart valves taken from pigs with preservatives and bound them to a metal frame to preserve their functional shape.

Others developed competing mechanical valves that offered less resistance to blood flow and allowed patients to reduce blood-thinner doses. Valves using a tilting disk instead of a caged ball appeared in the late 1960s, the first produced by Donald P. Shiley, a University of Portland engineering graduate and former collaborator with Starr and Edwards.

Mechanical designs such as the St. Jude heart valve achieved even better performance in the 1970s using leaflets that flap open and closed. Edwards Lifesciences stopped making the caged ball valves in 2007 and has become a leading maker of bioprosthetic valves.

Inherited valve defects continue to present a dire challenge. Children outgrow prosthetic valves and require repeat surgery.

"If we could develop a valve that would grow and develop normally, that would be great," Starr says. But it's likely to take decades of research to make living, tissue-engineered replacement valves a realistic option. In Starr's view, the next big advance will be perfection of valve replacement without surgery, using catheters threaded through an artery. Edwards Lifesciences is the front-runner in the race to get federal approval, followed by Medtronic Inc.

When asked for his thoughts on the 50th anniversary of the first successful prosthetic valve, Starr hesitated.

"To hear from all of the patients, seeing the patients who have had the surgery, seeing how well they are doing, realizing this life-supporting devise is keeping them alive -- being able to have that impact has been a great experience," he said.

"I'm glad I'm still around to celebrate. I was just a kid the first time around."


Timeline of Artificial Heart Implants

The following are landmarks in the development of the artificial heart:

1953: A heart-lung machine designed by Dr. John Gibbon is used in a successful open-heart surgery, demonstrating that an artifical device can temporarily mimic the functions of the heart.

1964: The National Heart, Lung and Blood Institute sets a goal of designing a total artificial heart by 1970.

1966: Dr. Michael DeBakey of Houston successfully implants a partial artificial heart.

1967: Dr. Christiaan Barnard performs the first successful human heart transplant. The patient, 53-year-old dentist Louis Washkansky, dies 18 days after surgery in South Africa.

1969: A total artifical heart is implanted into a patient by Dr. Denton Cooley of the Texas Heart Institute. The patient gets a heart transplant three days later but then dies 1 days afterward.

1982-85: Dr. William DeVries carries out a series of five implants of the Jarvik total artificial heart. The first patient, Barney Clark, survives for 112 days. Only four others received the Jarvik as a permanent replacement heart one, William Schroeder, lived 620 days, dying in August 1986 at age 54. Other patients received the Jarvik as a temporary device while awaiting heart transplants.

1994: The Food and Drug Administration approves the Left Ventricular Assist Device, which helps failing hearts continue to function.

2000: A man in Israel becomes the first recipient of the Jarvik 2000, the first total artificial heart that can maintain blood flow in addition to generating a pulse.

2001: Doctors at Jewish Hospital in Louisville, Ky., implant the first self-contained, mechanical heart replacement into a patient. The device, called the AbioCor, is battery powered and the size of a softball.


First Artificial Heart Recipient - HISTORY

Beginning around the 1970s, heart diseases of various sorts became among the leading causes of death in the United States. It was not that suddenly an epidemic of heart disease appeared, but rather that advances in medicine allowed people to live long enough to where heart diseases became an issue. Advances in medicine were beginning to conquer that problem, too — the heart had been pretty well mapped out, and could be replicated on an artificial level. It could not be implanted into the body – not permanently anyway – as the organism would reject it as a foreign body, but as a temporary measure it could serve.

On this day, April 4, in 1969, the world’s first artificial heart was implanted into Haskell Karp of Skokie, Illinois. Karp’s own heart was failing him, and the search for a donor heart for transplants was taking too long. The physician in charge, Dr. Denton A. Cooley, had to act, and he decided on the never-before-tried procedure.

Karp survived the transplant, and the artificial heart that kept him alive 50 hours until a suitable transplant could be found. Unfortunately, he did not survive long with the new natural heart. 30 hours after the procedure, Karp died, leaving a legacy as the first successful recipient of an artificial heart.


Robert Jarvik, MD on the Jarvik-7

In 1982, the first implantation of the Jarvik 7 in patient Barney Clark caught the attention of media around the world. The extraordinary openness of this medical experiment, facilitated by the University of Utah, fueled heated public debate on all aspects of medical research. But as doctors learned how to achieve excellent clinical outcomes in subsequent patients with the Jarvik 7, the press and public largely lost interest in the subject. As a result, outdated and erroneous accounts have made their way into mainstream discussions of the Jarvik 7 time and time again. I sat down with Dr. Jarvik to discuss common mistakes and misimpressions about the first permanent artificial heart, a device that is still used today and has the highest success rate of any mechanical heart or assist device in the world.

Artificial Hearts in Context

In essence, two types of artificial hearts exist: the total artificial heart — which is implanted after the natural heart is removed — and the ventricular assist device — which is implanted to assist the natural heart, leaving the patient’s own heart in place and still functioning.

“Removing a person’s heart is one of the most dramatic surgical procedures one can imagine,” says Dr. Jarvik, who began developing a tiny ventricular assist device, the Jarvik 2000, in 1988. “It is no surprise that more public attention is given to replacing a heart than to assisting one. But consider this question: If you had a failing arm or leg, would you rather have the best-possible artificial limb or a device that allowed you to keep your own arm or leg?”

The question is rhetorical. But while ventricular assist devices find wider application in patients than total artificial hearts, experts view the two as complementary treatments. For example, a total artificial heart is required when an assist device will not do, as in cases of biventricular failure when both sides of the natural heart falter.

In the 60s and 70s, mechanical hearts were being developed by the National Institutes of Health (NIH) but were largely unknown to the public. Then in 1967, Christian Bernard performed the first human heart transplant, an event that generated worldwide interest: People were suddenly aware of heart replacement as a way to treat a failing heart. In 1969, Denton Cooley performed the first implantation of a temporary total artificial heart, and the primitive device sustained the patient for almost three days until a donor was found through an urgent appeal in the press. After another decade and a half of NIH-supported research, the Jarvik 7 heart became the first total artificial heart implanted as a permanent replacement for a hopelessly diseased natural heart.

The First Jarvik 7 Patients

At the University of Utah on December 2, 1982, William DeVries, MD implanted the Jarvik 7 total artificial into Barney Clark, a Seattle dentist who volunteered to undergo the pioneering procedure because he wanted to make a contribution to medical science. Dr. Jarvik recalls that, before the surgery, Dr. Clark told doctors that he didn’t expect to live more than a few days with the experimental heart, but he hoped that what the doctors learned might help save the lives of others someday.

Dr. Jarvik, who headed the company that manufactured the Jarvik 7 heart, agreed with University administrators to give no information to the press directly: no press releases and no interviews. Information would flow through the University press office, instead. The stated goal was to adhere to the highest ethical principles and to conduct this important medical research openly, with no effort to influence or restrict the press. Little press was desired or expected. The University held a briefing before the historic surgery, and attendance was moderate.

“The news about Barney Clark stunned the doctors by making headlines around the world”, Dr. Jarvik says. “Enormous public interest developed, and hundreds of reporters converged on Salt Lake City to cover the story, and the University began to give them daily briefings, which were completely uncensored. All medically significant events in the post-operative course were reported, successes and setbacks alike.”

The briefings were educational and contained much medical information, including explanations of basic physiology, interpretations of laboratory tests and x-rays, and lengthy question-and-answer sessions. All of the complications were fully reported, as well as the effectiveness of the mechanical heart at maintaining Dr. Clark’s normal blood flow and sustaining his life.

“The sheer volume of information and the extraordinary degree of transparency created a sort of medical experiment in a fishbowl,” Dr. Jarvik says. The University of Utah achieved its research and educational goals, but the press coverage seemed to leave its readers with unreasonable hopes and expectations: Many began to believe that artificial hearts would soon be commonplace and all but solve the problem of heart disease. The intense attention also attracted critics who apparently knew nothing of Dr. Clark’s generous intentions and labeled him a “human guinea pig.” Later, Dr. Clark’s widow attempted to change this misimpression in order to give her husband the humanitarian credit he deserved. But Mrs. Clark received much less press than the critical commentary, and her mission ultimately foundered. Before another case could be conducted, Dr. DeVries, the surgeon, accepted an offer to join the research program at Humana Hospital in Louisville, Kentucky, and took his expertise there.

The next several implantations of the Jarvik 7 heart, conducted by Humana — a national hospital chain — were handled like the first: with the release of extensive medical information and an open press policy. The second Jarvik 7 implant took place in 1985. Bill Schroeder, the patient, did so well initially that when President Ronald Reagan phoned him with get-well wishes a week later, he asked the president why his social security check was late. (It was hand-delivered the next day.) Mr. Schroeder gave optimistic interviews to reporters and even joked that his noisy drive console “sounded like an old fashioned thrashing machine.” But only two weeks after surgery, he suffered a serious stroke that left him unable to speak. Mr. Schroeder later moved from the hospital and lived with his wife in a nearby apartment, which had been outfitted with the special equipment he needed, including an air compressor and emergency generator. When traveling, he used a portable, compressed-air power system, which weighed about fifteen pounds. During his time on the Jarvik 7, he visited his hometown in Indiana and rode down Main Street in a parade, attended a basketball game, and went fishing, but in a limited way: He had many medical problems, including other serious strokes and infections. In all, Mr. Schroeder lived 620 days with his heart function restored but handicapped by his complications.

Three other patients received the Jarvik 7 heart for permanent use over the next year — two more in Louisville and one in Sweden. One patient died of bleeding a week following the operation the others lived 10 months and 14 months. As it turned out, the Swedish patient was a man accused of tax evasion, but after his heart was removed, he was declared legally dead because under Swedish law, a person was dead when his or her heart stopped beating. The charges against him were officially dropped. The day he received the news, the patient was elated: He joked to his doctors that the old saying about nothing being certain but death and taxes isn’t true.

The Jarvik 7 Today

After the first five permanent cases, the Jarvik 7 heart became more widely used as a temporary total artificial heart, bridging patients to transplant. The sixth patient lived five years after a donor heart was found, and the seventh patient lived eleven years with his donated heart. Another patient was bridged from the Jarvik 7 heart to a human heart that gave him fourteen more years of normal life. The press was unaware of these successes, or perhaps considered the subject old news, which, Dr. Jarvik says, was “more than fine” with the doctors involved. But as time went on, the press began reporting erroneously that use of the Jarvik 7 heart had halted after the first five. Later this turned into reporting erroneously that the Food and Drug Administration (FDA) had banned its use. Still later, this turned into reporting erroneously that the Jarvik 7 heart was a failed experiment: The press had begun to believe its own errors.

Since 1982, more than 350 patients have used the Jarvik 7 heart, and it remains in use today. The first few patients lived an average of 10 months (when their life expectancy was only days to weeks). Complication rates were high. “That’s where the press stopped doing research and checking facts and instead began to publish mistake after mistake after mistake,” Dr. Jarvik notes. All aspects of the experience, from the role of public funding of the research, to the ethics of human experimentation, were debated, but often on a foundation of misinformation. Newspaper and magazine articles with outdated and mistaken accounts appeared. Books with numerous errors were published. In the meantime, doctors gained experience with the Jarvik 7 and learned how to manage their patients more effectively and with fewer complications.

“Knowledgeable doctors watched with amazement as glaring errors appeared in print and then were repeated again and again as newspapers and magazines copied earlier stories and each other and didn’t take the time to get information from original sources,” says Dr. Jarvik. “Very rarely did I receive a phone call to check the facts. For example, the press wrote repeatedly that Dr. Clark died of a stroke. In fact, he never had a stroke at all. The press wrote over and over that the console a patient needed to power the heart was ‘as large as a refrigerator.’ In fact, the home console is about half that size, but more significantly — the portable power system was only the size of a briefcase.”

And there’s more, says Dr. Jarvik. “The press also wrote that the Jarvik 7 heart caused a high rate of strokes and infections. The press didn’t notice that as more cases were done, these rates plummeted, yet the device was the same. So the device alone was never responsible for the earlier complications. Rather, doctors needed to learn how to manage their patients more effectively: That is the point of such research in the first place.”

Perhaps the most glaring error of all is one that pops up from time to time in the diatribes of some self-proclaimed pundits: that the Jarvik 7 heart was a failed experiment. In fact, it has achieved the highest success rate of any type of artificial heart or assist device that has ever been developed. (See details below.) Today, the Jarvik 7 heart is available at about ten medical centers in the United States, Canada, France, and Germany under the name CardioWest total artificial heart. (Ownership has changed hands several times, but the device design remains essentially unchanged.)

Comparison of the Jarvik 7 with Other Devices

In 1986, Dr. Jarvik was Chairman and CEO of Symbion, Inc., a public company that manufactured the Jarvik 7 heart. A venture capital firm that had financed Symbion made a hostile takeover bid. Dr. Jarvik opposed the takeover and filed a complaint with the Securities and Exchange Commission because the venture capital firm had access to confidential information. He did not succeed in stopping it, though, and lost his position as a result. He then founded Jarvik Heart, Inc., and began work in a different direction to create the Jarvik 2000 heart, a ventricular assist device. Production of the Jarvik 7 heart continued without him.

In 1990, after the Jarvik 7 had been used in 198 patients, Symbion stopped production of the device because the company was no longer in compliance with FDA record-keeping and reporting requirements. The press falsely reported that the FDA removed the Jarvik 7 from the market because the device had a high failure rate. In fact, failures of the Jarvik 7 were extremely rare. The implanted Jarvik 7 heart is more reliable and has had fewer mechanical failures than any implanted positive displacement artificial heart (less than 2% diaphragm failure in the 81-patient FDA study). As a comparison, Dr. Jarvik notes that the HeartMate device had a rate of re-operation for repair or replacement of over 75% within two years in a large randomized clinical trial called REMATCH. The Novacor device has a rate of re-operation for replacement or repair of 16% between two and three years, based on review of the records of 1077 patients. Also, almost all Novacor devices experience failure of the main bearing between three and four years and must be replaced with a new device.

Later in 1990, Symbion transferred its rights to the MedForte Research Foundation, which in 1991, formed CardioWest Technologies, Inc., in collaboration with University Medical Center in Tucson, Arizona. The Jarvik 7 heart was then renamed the CardioWest heart, and Symbion closed its doors. The CardioWest heart is identical to the small size Jarvik 7 heart developed for use in women and smaller men in the mid-1980s. The device uses the same blood pump design, the same Medtronic-Hall valves, and the same external power system as used with the original small size Jarvik 7 heart. The only changes are the use of smaller diameter air power tubes entering the body, and an up to date laptop computer replacing the portable Compaq computer originally used.

In 1993, CardioWest Technologies received approval to conduct a clinical investigation of the heart as a bridge to transplant at five U.S. medical centers. The study demonstrated that the Jarvik 7 heart (CardioWest) is safe and effective. When the study was completed in 2003, the company again changed its ownership and name, this time to SynCardia, Inc., its present status.

The FDA study took ten years to complete and involved 95 patients. It showed a 79% success rate for bridge to transplant and excellent overall survival including transplant (70% at one year, 50% at five years, and 45% at eight years). So, in the U.S. study, the Jarvik 7 (CardioWest) has a better rate of bridge-to-transplant success than any other total artificial heart or any ventricular assist device ever developed. The success rate in foreign countries is lower, but still better than other devices. On March 17, 2004, an FDA review panel recommended PreMarket Approval (PMA) of the heart for bridge-to-transplant use. On October 18, 2004, that approval was granted, making the Jarvik 7 the first total artificial heart to receive full FDA approval for any indication for use. “Far from being a failure,” says Dr. Jarvik, “the [Jarvik 7] heart is a documented success.”

Comparison of the Jarvik 7 and AbioCor Total Artificial Hearts

The only other total artificial heart now available for use in a patient is the AbioCor, which was approved by the FDA for investigational use in 15 patients. The AbioCor has been implanted in 14 patients over the three years following the first case. If a PMA study with the AbioCor were conducted at this enrollment rate — assuming about 95 patients as in the Jarvik 7 (CardioWest) clinical trial — the study would take 20 years to complete.

“The Jarvik 7 is inherently more reliable than the AbioCor because of the simplicity of the Jarvik 7 components and because the multi-layer low-stress design of the most critical component — the flexing diaphragm,” says Dr. Jarvik. “The Jarvik 7 has been run on the bench for over six years without failures, and one early prototype at the University of Utah was run continuously on the bench for over ten years.”

By contrast, the AbioCor is a highly complex device with numerous implanted components subject to failure. In fact, the second implanted AbioCor heart had two malfunctions: the first requiring re-operation to replace the implanted battery, which weakened prematurely and the second involving a worn diaphragm — one of the critical components of the device — which caused the death of the patient when it failed.

According to Dr. Jarvik, the major advantage of the Jarvik 7 heart is its hemodynamic effectiveness as a rescue device in patients suffering extreme heart failure and serious secondary damage to other organ systems. It provides higher blood flow than the AbioCor heart in actual patient use (about 10L/min for the Jarvik 7 compared to about 7 L/min for the AbioCor). Higher flow is beneficial for recovery of kidney, liver, lung, and gastrointestinal function, all of which are seriously compromised in near-death conditions. Moreover, the Jarvik 7 is more effective in patients with multi-system organ failure than any left-ventricular assist device.

Another advantage of the Jarvik 7 is that it adjusts the pumping of the right and left sides of the heart independently, permitting optimal filling and ejection on each side. The AbioCor, on the other hand, alternately pumps the right and left sides, filling one while emptying the other. Its design does not permit independent right/left control and therefore can force blood into the lungs at an excessively high pressure, harming lung function. “Almost all AbioCor patients who survived the surgery have required respirators for a month or two,” Dr. Jarvik says, “whereas Jarvik 7 patients are usually off the respirator within a few days.”

The main drive console used with most Jarvik 7 patients is large, but it is actually smaller than the console used with more than a thousand Thoratec device patients. Although the main console is not suitable for a truly mobile lifestyle and presently is limited to in-hospital use, a small, portable, battery-run power system has been developed for the Jarvik 7 and used in patients — like Mr. Schroeder — outside the hospital. With modern lithium-ion battery technology, a portable power unit could feasibly be built weighing about 8 pounds and lasting several hours between battery changes. It would be the same weight as the AbioCor battery and electronics components.

A significant advantage of the AbioCor is that it is much quieter than the noisy Jarvik 7, which has four mechanical heart valves. By contrast, the AbioCor uses quiet trileaflet plastic valves. Also, the two tubes that provide compressed air to power the Jarvik 7 heart are a potential source of infection, especially in long-term use (meaning 2-5 years or more). With careful management, they were not a serious problem in the Jarvik 7 (CardioWest) clinical trial: There were 17 driveline infections in 81 patients, most of which were superficial skin infections treated with routine dressing changes.

The AbioCor, though, is designed with no drivelines penetrating the skin. Rather, it uses radio-frequency transmission of power from an external transmitter coil (about the size of a CD case) to an implanted receiver coil. Although this design may prevent infections associated with wires piercing the skin, Dr. Jarvik and others note its serious drawbacks:

  • It necessitates highly-complex, bulky implanted components that greatly increase the trauma of the implant surgery and compress internal organs. Almost five pounds of hardware must be implanted into the chest and abdomen of the patient, and that hardware is typically very difficult and expensive to make reliable.
  • The transcutaneous power transmission system wastes about 40% of the external battery power, requiring the patient to carry a large and heavy external battery.
  • The implanted battery must be replaced every year or two, requiring major surgery that carries a significant risk of bleeding and infection. Plus, the internal battery runs the AbioCor for less than 30 minutes. It is not like a pacemaker battery, which runs for years.

“A further advantage of the Jarvik 7 heart,” Dr. Jarvik adds, “is that it fits in more than 90% of the U.S. population, both men and women. By contrast, the AbioCor fits in less than 10% of the population and only a few percent of American women.”

Table Comparison of the First Jarvik 7 Clinical Results with the First AbioCor Clinical Results

The data table below compares the initial Jarvik 7 patients with the initial AbioCor patients. It only includes the first seven patients because, at the time of this writing, data on the later Jarvik 7 patients is not available.

“With all the effort expended and complex modern technology used, the AbioCor has not achieved better results than the Jarvik 7 did twenty years ago,” Dr. Jarvik says. He points out that the Jarvik 7 patients survived longer, with better quality of life, than the AbioCor patients. No Jarvik 7 patients died at surgery, but two AbioCor patients did. No Jarvik 7 patients died of device failure, but two AbioCor patients died as a result of mechanical failures. Both devices had a serious problem with stroke in the early patients, which was greatly reduced in later Jarvik 7 patients. Abiomed made changes in the design intended to avoid strokes, but patients continued to have them.

“Not to mention,” Dr. Jarvik adds, “that present results with the Jarvik 7 (CardioWest) are much better than the initial results many years ago.”


Dr. Willem Johan Kolff begins research to develop a heart-lung machine and an artificial heart.

Dr. Kolff emigrates from the Netherlands with his wife and their five children to begin work at Cleveland Clinic as a research assistant.

Cleveland Clinic morning meeting*

Dr. Kolff finishes development of one of the first heart-lung machines.

At the Cleveland Clinic, Dr. Kolff and Dr. Tetsuzo Akutsu conduct a series of animal implants with the artificial heart a dog survives for approximately 90 minutes.

Kolff-Akutsu Heart*

Ventriloquist Paul Winchell is granted the first patent for an artificial heart. Winchell’s work is aided by Dr. Henry Heimlich, who later develops the Heimlich maneuver to save choking victims. Years later, Winchell signs over his patent rights to Dr. Kolff at the University of Utah.

Dr. Kolff leaves the Cleveland Clinic to start the Division of Artificial Organs at the University of Utah. He continues developing the artificial heart with surgeon Dr. Clifford Kwan-Gett and engineer Thomas Kessler.

Dr. Kolff and Dr. Kwan-Gett*

The first successful heart transplant is performed in Cape Town, South Africa, by Dr. Christiaan Barnard.

Dr. Denton Cooley at the Texas Heart Institute becomes the first heart surgeon to implant an artificial heart in a human subject. The patient lives on the artificial heart, designed by Dr. Domingo Liotta, for 64 hours, but dies 32 hours after transplantation of a donor heart.

Three important figures join Dr. Kolff’s team: veterinarian Don Olsen (leads the animal implants), medical engineer Robert Jarvik (designs various artificial hearts) and surgeon Dr. William DeVries (leads the transition from animal implants to human implants).

L to R: Don Olsen, Dr. Kolff, Dr. Robert Jarvik*

Calf “Tony” lives 30 days on an early Kolff Total Artificial Heart (TAH).

Calf “Abebe” lives for 184 days on the Jarvik 5 TAH.

The Jarvik 5 TAH*

Calf “Alfred Lord Tennyson” lives for 268 days on the Jarvik 5 TAH.

Don Olsen with “Alfred Lord Tennyson”*

Dr. Kolff submits a request to the FDA to implant a TAH into a human subject.

On December 2, the Jarvik 7 is implanted into 61-year-old dentist Dr. Barney Clark, who lives for 112 days. The surgery is led by Dr. DeVries and Dr. Lyle Joyce.

Dr. Barney Clark and his wife, Una Loy*

Dr. Kolff steps down from the board of Kolff Medical, manufacturer of artificial hearts in Utah, including the Jarvik 7. Kolff Medical is renamed Symbion, Inc. on the initiative of Dr. Robert Jarvik, CEO of Kolff Medical at the time.

William J. Schroeder becomes the second human recipient of the Jarvik 7 and survives 620 days before dying of a lung infection. At the time, this was the longest that anyone had survived with an artificial heart.

March: Dr. Jack Copeland at University Medical Center (UMC) in Tucson, Ariz., implants a prototype artificial heart, known as the Phoenix heart, in a patient who had rejected a recently transplanted heart. The patient, 33-year-old Michael Creighton, lived on the Phoenix heart for 11 hours, but died 60 hours after transplantation of a second donor heart.

August: Dr. Copeland becomes the first surgeon to successfully use the Jarvik 7 as a bridge to human heart transplant. His patient Michael Drummond, 25, lives nine days on the Jarvik 7 before receiving a donor heart.

Richard Smith and Dr. Jack Copeland with patient Michael Drummond

The FDA closes Symbion, Inc. operations due to violations of FDA guidelines and regulations. The Investigational Device Exemption (IDE) for the clinical study of the TAH is withdrawn.

To save the TAH technology, UMC and MedForte Research Foundation form a new corporation and joint venture, CardioWest Technologies, Inc. Symbion, Inc. transfers the Jarvik 7 technology to UMC, where the Jarvik 7 is subsequently renamed the CardioWest™ Total Artificial Heart.

UMC initiates a new FDA IDE clinical study of the Total Artificial Heart.

The 10-year, IDE pivotal clinical study of the CardioWest Total Artificial Heart begins at five centers.

SynCardia Systems, Inc. is formed by interventional cardiologist Dr. Marvin J. Slepian, biomedical engineer Richard G. Smith, MSEE, CEE, and cardiothoracic surgeon Dr. Jack Copeland with private funding to continue the IDE clinical study with a goal of achieving commercial approval of the CardioWest Total Artificial Heart.

The pivotal clinical study of the CardioWest Total Artificial Heart is completed.

October 15: The CardioWest Total Artificial Heart receives FDA approval, becoming the first TAH to do so. The official name given to the device through the FDA approval process is the SynCardia temporary CardioWest™ Total Artificial Heart.

May: The Centers for Medicare & Medicaid Services (CMS) reverses its 1986 national non-coverage policy for artificial hearts and approves reimbursement for the SynCardia TAH when implanted as part of an FDA study that meets CMS specifications.

July: CMS issues its final decision to reimburse the SynCardia TAH through the highest paying Diagnostic Related Group codes, plus new technology add-on payments.

*Images courtesy of Special Collections Department, J. Willard Marriott Library, University of Utah


Timeline: Artificial Hearts

1953:
A heart-lung machine designed by Dr. John Gibbon is used in a successful open-heart surgery, demonstrating that an artifical device can temporarily mimic the functions of the heart.

1964:
The National Heart, Lung and Blood Institute sets a goal of designing a total artificial heart by 1970.

1966:
Dr. Michael DeBakey of Houston successfully implants a partial artificial heart.

1967:
Dr. Christiaan Barnard performs the first successful human heart transplant. The patient, 53-year-old dentist Louis Washkansky, dies 18 days after surgery in South Africa.

1969:
A total artifical heart is implanted into a patient by Dr. Denton Cooley of the Texas Heart Institute. The patient gets a heart transplant three days later but then dies a day and a half later.

Trending News

1982-85:
Dr. William DeVries carries out a series of five implants of the Jarvik total artificial heart. The first patient, Barney Clark, survives for 112 days. Only four others received the Jarvik as a permanent replacement heart one, William Schroeder, lived 620 days, dying in August 1986 at age 54. Other patients received the Jarvik as a temporary device while awaiting heart transplants.

1994:
The Food and Drug Administration approves the Left Ventricular Assist Device, which helps failing hearts continue to function.

2000:
A man in Israel becomes the first recipient of the Jarvik 2000, the first total artificial heart that can maintain blood flow in addition to generating a pulse.

2001:
Doctors at Jewish Hospital in Louisville, Ky., implant the first self-contained, mechanical heart replacement into a patient. The device, called the AbioCor, is battery powered and the size of a softball.

© MMI The Associated Press. All Rights Reserved. This material may not be published, broadcast, rewritten, or redistributed

First published on July 3, 2001 / 1:23 PM

© 2001 The Associated Press. All Rights Reserved. This material may not be published, broadcast, rewritten, or redistributed.


Contents

Origins Edit

A synthetic replacement for the lungs remains a long-sought "holy grail" of modern medicine. The obvious benefit of a functional artificial heart would be to lower the need for lung transplants because the demand for organs always greatly exceeds supply.

Although the heart is conceptually a pump, it embodies subtleties that defy straightforward emulation with synthetic materials and power supplies. Consequences of these issues include severe foreign-body rejection and external batteries that limit mobility. These complications limited the lifespan of early human recipients for hours to days.

Early development Edit

The first artificial heart was made by the Soviet scientist Vladimir Demikhov in 1937. It was implanted in a dog.

On 2 July 1952, 41-year-old Henry Opitek, suffering from shortness of breath, made medical history at Harper University Hospital [1] at Wayne State University in Michigan. The Dodrill-GMR heart machine, considered to be the first operational mechanical heart, was successfully used while performing heart surgery. [2] [3] Ongoing research was done on calves at Hershey Medical Center, Animal Research Facility, in Hershey, Pennsylvania, during the 1970s.

Forest Dewey Dodrill, working closely with Matthew Dudley, used the machine in 1952 to bypass Henry Opitek's left ventricle for 50 minutes while he opened the patient's left atrium and worked to repair the mitral valve. In Dodrill's post-operative report, he notes, "To our knowledge, this is the first instance of survival of a patient when a mechanicaly heart mechanism was used to take over the complete body function of maintaining the blood supply of the body while the heart was open and operated on." [4]

A heart–lung machine was first used in 1953 during a successful open heart surgery. John Heysham Gibbon, the inventor of the machine, performed the operation and developed the heart–lung substitute himself.

Following these advances, scientific interest for the development of a solution for heart disease developed in numerous research groups worldwide.

Early designs of total artificial hearts Edit

In 1949, a precursor to the modern artificial heart pump was built by doctors William Sewell and William Glenn of the Yale School of Medicine using an Erector Set, assorted odds and ends, and dime-store toys. The external pump successfully bypassed the heart of a dog for more than an hour. [5]

Paul Winchell invented an artificial heart with the assistance of Henry Heimlich (the inventor of the Heimlich maneuver) and held the first patent for such a device. The University of Utah developed a similar apparatus around the same time, but when they tried to patent it, Winchell's heart was cited as prior art. The university requested that Winchell donate the heart to the University of Utah, which he did. There is some debate as to how much of Winchell's design Robert Jarvik used in creating Jarvik's artificial heart. Heimlich states, "I saw the heart, I saw the patent and I saw the letters. The basic principle used in Winchell's heart and Jarvik's heart is exactly the same. [6] " Jarvik denies that any of Winchell's design elements were incorporated into the device he fabricated for humans which was successfully implanted into Barney Clark in 1982.

On 12 December 1957, Willem Johan Kolff, the world's most prolific inventor of artificial organs, implanted an artificial heart into a dog at Cleveland Clinic. The dog lived for 90 minutes.

In 1958, Domingo Liotta initiated the studies of TAH replacement at Lyon, France, and in 1959–60 at the National University of Córdoba, Argentina. He presented his work at the meeting of the American Society for Artificial Internal Organs held in Atlantic City in March 1961. At that meeting, Liotta described the implantation of three types of orthotopic (inside the pericardial sac) TAHs in dogs, each of which used a different source of external energy: an implantable electric motor, an implantable rotating pump with an external electric motor, and a pneumatic pump. [7] [8]

In 1964, the National Institutes of Health started the Artificial Heart Program, with the goal of putting an artificial heart into a human by the end of the decade. [9] The purpose of the program was to develop an implantable artificial heart, including the power source, to replace a failing heart. [10]

In February 1966, Adrian Kantrowitz rose to international prominence when he performed the world's first permanent implantation of a partial mechanical heart (left ventricular assist device) at Maimonides Medical Center. [11]

In 1967, Kolff left Cleveland Clinic to start the Division of Artificial Organs at the University of Utah and pursue his work on the artificial heart.

  1. In 1973, a calf named Tony survived for 30 days on an early Kolff heart.
  2. In 1975, a bull named Burk survived 90 days on the artificial heart.
  3. In 1976, a calf named Abebe lived for 184 days on the Jarvik 5 artificial heart.
  4. In 1981, a calf named Alfred Lord Tennyson lived for 268 days on the Jarvik 5.

Over the years, more than 200 physicians, engineers, students and faculty developed, tested and improved Kolff's artificial heart. To help manage his many endeavors, Kolff assigned project managers. Each project was named after its manager. Graduate student Robert Jarvik was the project manager for the artificial heart, which was subsequently renamed the Jarvik 7.

In 1981, William DeVries submitted a request to the FDA for permission to implant the Jarvik 7 into a human being. On 2 December 1982, Kolff implanted the Jarvik 7 artificial heart into Barney Clark, a dentist from Seattle who was suffering from severe congestive heart failure. Clark lived for 112 days tethered to an external pneumatic compressor, a device weighing some 400 pounds (180 kg), but during that time he suffered prolonged periods of confusion and a number of instances of bleeding, and asked several times to be allowed to die. [12]

First clinical implantation of a total artificial heart Edit

On 4 April 1969, Domingo Liotta and Denton A. Cooley replaced a dying man's heart with a mechanical heart inside the chest at The Texas Heart Institute in Houston as a bridge for a transplant. The man woke up and began to recover. After 64 hours, the pneumatic-powered artificial heart was removed and replaced by a donor heart. However thirty-two hours after transplantation, the man died of what was later proved to be an acute pulmonary infection, extended to both lungs, caused by fungi, most likely caused by an immunosuppressive drug complication. [13]

The original prototype of Liotta-Cooley artificial heart used in this historic operation is prominently displayed in the Smithsonian Institution's National Museum of American History "Treasures of American History" exhibit in Washington, D.C. [14]

First clinical applications of a permanent pneumatic total artificial heart Edit

The first clinical use of an artificial heart designed for permanent implantation rather than a bridge to transplant occurred in 1982 at the University of Utah. Artificial kidney pioneer Willem Johan Kolff started the Utah artificial organs program in 1967. [15] There, physician-engineer Clifford Kwan-Gett invented two components of an integrated pneumatic artificial heart system: a ventricle with hemispherical diaphragms that did not crush red blood cells (a problem with previous artificial hearts) and an external heart driver that inherently regulated blood flow without needing complex control systems. [16] Independently, Paul Winchell designed and patented a similarly shaped ventricle and donated the patent to the Utah program. [17] Throughout the 1970s and early 1980s, veterinarian Donald Olsen led a series of calf experiments that refined the artificial heart and its surgical care. During that time, as a student at the University of Utah, Robert Jarvik combined several modifications: an ovoid shape to fit inside the human chest, a more blood-compatible polyurethane developed by biomedical engineer Donald Lyman, and a fabrication method by Kwan-Gett that made the inside of the ventricles smooth and seamless to reduce dangerous stroke-causing blood clots. [18] On 2 December 1982, William DeVries implanted the artificial heart into retired dentist Barney Bailey Clark (born 21 January 1921), who survived 112 days [19] with the device, dying on 23 March 1983. Bill Schroeder became the second recipient and lived for a record 620 days.

Contrary to popular belief and erroneous articles in several periodicals, the Jarvik heart was not banned for permanent use. Today, the modern version of the Jarvik 7 is known as the SynCardia temporary Total Artificial Heart. It has been implanted in more than 1,350 people as a bridge to transplantation.

In the mid-1980s, artificial hearts were powered by dishwasher-sized pneumatic power sources whose lineage went back to Alfa Laval milking machines. Moreover, two sizable catheters had to cross the body wall to carry the pneumatic pulses to the implanted heart, greatly increasing the risk of infection. To speed development of a new generation of technologies, the National Heart, Lung, and Blood Institute opened a competition for implantable electrically powered artificial hearts. Three groups received funding: Cleveland Clinic in Cleveland, Ohio the College of Medicine of Pennsylvania State University (Penn State Hershey Medical Center) in Hershey, Pennsylvania and AbioMed, Inc. of Danvers, Massachusetts. Despite considerable progress, the Cleveland program was discontinued after the first five years.

First clinical application of an intrathoracic pump Edit

On 19 July 1963, E. Stanley Crawford and Domingo Liotta implanted the first clinical Left Ventricular Assist Device (LVAD) at The Methodist Hospital in Houston, Texas, in a patient who had a cardiac arrest after surgery. The patient survived for four days under mechanical support but did not recover from the complications of the cardiac arrest finally, the pump was discontinued, and the patient died.

First clinical application of a paracorporeal pump Edit

On 21 April 1966, Michael DeBakey and Liotta implanted the first clinical LVAD in a paracorporeal position (where the external pump rests at the side of the patient) at The Methodist Hospital in Houston, in a patient experiencing cardiogenic shock after heart surgery. The patient developed neurological and pulmonary complications and died after few days of LVAD mechanical support. In October 1966, DeBakey and Liotta implanted the paracorporeal Liotta-DeBakey LVAD in a new patient who recovered well and was discharged from the hospital after 10 days of mechanical support, thus constituting the first successful use of an LVAD for postcardiotomy shock.

First VAD patient with FDA approved hospital discharge Edit

In 1990 Brian Williams was discharged from the University of Pittsburgh Medical Center (UPMC), becoming the first VAD patient to be discharged with Food and Drug Administration (FDA) approval. [21] The patient was supported in part by bioengineers from the University of Pittsburgh's McGowan Institute. [21] [22]

Approved medical devices Edit

SynCardia Edit

SynCardia is a company based in Tucson, Arizona, which currently has two separate models available. It is available in a 70cc and 50cc size. The 70cc model is used for biventricular heart failure in adult men, while the 50cc is for children and women. [23] As good results with the TAH as a bridge to heart transplant accumulated, a trial of the CardioWest TAH (developed from the Jarvik 7 and now marketed as the Syncardia TAH) was initiated in 1993 and completed in 2002. [24] The SynCardia was first approved for use in 2004 by the US Food and Drug Administration. [25]

As of 2014, more than 1,250 patients have received SynCardia artificial hearts. [26] [27] The device requires the use of the Companion 2 in-hospital driver, approved by the FDA in 2012, or the Freedom Driver System, approved in 2014, which allows some patients to return home, to power the heart with pulses of air. [25] The drivers also monitor blood flow for each ventricle. [28]

In 2016, Syncardia filed for bankruptcy protection and was later acquired by the private equity firm Versa Capital Management. [29]

A January 2019 report in Europe stated that "there is only one fully artificial heart currently in the market, developed by US-based SynCardia". [30]

Carmat bioprosthetic heart Edit

On 27 October 2008, French professor and leading heart transplant specialist Alain F. Carpentier announced that a fully implantable artificial heart would be ready for clinical trial by 2011 and for alternative transplant in 2013. It was developed and would be manufactured by him, biomedical firm CARMAT SA, [31] and venture capital firm Truffle Capital. The prototype used embedded electronic sensors and was made from chemically treated animal tissues, called "biomaterials", or a "pseudo-skin" of biosynthetic, microporous materials. [32]

According to a press-release by Carmat dated 20 December 2013, the first implantation of its artificial heart in a 75-year-old patient was performed on 18 December 2013 by the Georges Pompidou European Hospital team in Paris (France). [33] The patient died 75 days after the operation. [34]

In Carmat's design, two chambers are each divided by a membrane that holds hydraulic fluid on one side. A motorized pump moves hydraulic fluid in and out of the chambers, and that fluid causes the membrane to move blood flows through the other side of each membrane. The blood-facing side of the membrane is made of tissue obtained from a sac that surrounds a cow's heart, to make the device more biocompatible. The Carmat device also uses valves made from cow heart tissue and has sensors to detect increased pressure within the device. That information is sent to an internal control system that can adjust the flow rate in response to increased demand, such as when a patient is exercising. [35] This distinguishes it from previous designs that maintain a constant flow rate. [ citation needed ]

The Carmat device, unlike previous designs, is meant to be used in cases of terminal heart failure, instead of being used as a bridge device while the patient awaits a transplant. [36] At 900 grams it weighs nearly three times the typical heart and is targeted primarily towards obese men. It also requires the patient to carry around an additional Li-Ion battery. The projected lifetime of the artificial heart is around 5 years (230 million beats). [37]

In 2016, trials for the Carmat "fully artificial heart" were banned by the National Agency for Security and Medicine in Europe after short survival rates were confirmed. The ban was lifted in May 2017. At that time, a European report stated that Celyad's C-Cure cell therapy for ischemic heart failure [38] "could only help a subpopulation of Phase III study participants, and Carmat will hope that its artificial heart will be able to treat a higher proportion of heart failure patients". [39]

A January 2019 update in Europe stated that the only fully artificial heart currently in the market was the SynCardia device and that Carmat's artificial heart ("designed to self-regulate, changing the blood flow based on the patient’s physical activity") was still in the early stage of trials. That report also indicated that Carmat was, in fact, still hoping to "gain market approval for its implant this year, but is now aiming to achieve this next year. One reason for this is that the complex technology has been undergoing refinements in the manufacturing process". [30]

The Carmat artificial heart was approved for sale in the European Union, receiving a CE marking on December 22, 2020. [40] Its stock price increased over a third upon the announcement of the news. [41]

Historical prototypes Edit

Total artificial heart pump Edit

The U.S. Army artificial heart pump was a compact, air-powered unit developed by Dr. Kenneth Woodward at Harry Diamond Laboratories in the early to mid-1960s. [42] [43] The Army's heart pump was partially made of plexiglass, and consisted of two valves, a chamber, and a suction flapper. [42] The pump operated without any moving parts under the principle of fluid amplification – providing a pulsating air pressure source resembling a heartbeat. [43]

POLVAD Edit

Since 1991, the Foundation for Cardiac Surgery Development (FRK) in Zabrze, Poland, has been working on developing an artificial heart. Nowadays, [ when? ] the Polish system for heart support POLCAS consists of the artificial ventricle POLVAD-MEV and the three controllers POLPDU-401, POLPDU-402 and POLPDU-501. Presented devices are designed to handle only one patient. The control units of the 401 and 402 series may be used only in hospital due to its big size, method of control and type of power supply. The control [44] unit of 501 series is the latest product of FRK. Due to its much smaller size and weight, it is significantly more mobile solution. For this reason, it can be also used during supervised treatment conducted outside the hospital. [ citation needed ]

Phoenix-7 Edit

In June 1996, a 46-year-old man received a total artificial heart implantation done by Jeng Wei at Cheng-Hsin General Hospital [45] in Taiwan. This technologically advanced pneumatic Phoenix-7 Total Artificial Heart was manufactured by Taiwanese dentist Kelvin K. Cheng, Chinese physician T. M. Kao, and colleagues at the Taiwan TAH Research Center in Tainan, Taiwan. With this experimental artificial heart, the patient's BP was maintained at 90–100/40–55 mmHg and cardiac output at 4.2–5.8 L/min. [46] The patient then received the world's first successful combined heart and kidney transplantation after bridging with a total artificial heart. [47]

Abiomed hearts Edit

The first AbioCor to be surgically implanted in a patient was on 3 July 2001. [48] The AbioCor is made of titanium and plastic with a weight of 0,9 kg (two pounds), and its internal battery can be recharged with a transduction device that sends power through the skin. [48] The internal battery lasts for half an hour, and a wearable external battery pack lasts for four hours. [49] The FDA announced on 5 September 2006, that the AbioCor could be implanted for humanitarian uses after the device had been tested on 15 patients. [50] It is intended for critically ill patients who cannot receive a heart transplant. [50] Some limitations of the current AbioCor are that its size makes it suitable for less than 50% of the female population and only about 50% of the male population, and its useful life is only 1–2 years. [51]

By combining its valved ventricles with the control technology and roller screw developed at Penn State, AbioMed designed a smaller, more stable heart, the AbioCor II. This pump, which should be implantable in most men and 50% of women with a life span of up to five years, [51] had animal trials in 2005, and the company hoped to get FDA approval for human use in 2008. [52] After a great deal of experimentation, Abiomed has abandoned development of total official hearts as of 2015. [53] Abiomed as of 2019 only markets heart pumps, [54] "intended to help pump blood in patients who need short-term support (up to 6 days)", [55] which are not total artificial hearts.

Frazier-Cohn Edit

On 12 March 2011, an experimental artificial heart was implanted in 55-year-old Craig Lewis at The Texas Heart Institute in Houston by O. H. Frazier and William Cohn. The device is a combination of two modified HeartMate II pumps that is currently undergoing bovine trials. [56]

Frazier and Cohn are on the board of the BiVACOR company that develops an artificial heart. [57] [58] BiVACOR has been tested as a replacement for a heart in a sheep. [59] [60]

So far, only one person has benefited from Frazier and Cohn's artificial heart. Craig Lewis was suffering from amyloidosis in 2011 when his heart gave out and doctors pronounced that he had only 12 to 24 hours to live. After obtaining permission from his family, Frazier and Cohn replaced his heart with their device. Lewis survived for another 5 weeks after the operation he eventually succumbed to liver and kidney failure due to his amyloidosis, after which his family asked that his artificial heart be unplugged. [61]

Current prototypes Edit

Soft artificial heart Edit

On 10 July 2017, Nicholas Cohrs and colleagues presented a new concept of a soft total artificial heart in the Journal of Artificial Organs. [62] The heart was developed in the Functionals Materials Laboratory at ETH Zurich. [63] (Cohrs was listed as a doctoral student in a group led by Professor Wendelin Stark at ETH Zurich.) [64]

The soft artificial heart (SAH) was created from silicone with the help of 3D printing technology. The SAH is a silicone monoblock. It weighs 390g, has a volume of 679 cm 3 and is operated through pressurized air. "Our goal is to develop an artificial heart that is roughly the same size as the patient’s own one and which imitates the human heart as closely as possible in form and function" says Cohrs in an interview. [65] The SAH fundamentally moves and works like a real heart but currently only beats for 3000 beats (which corresponds to a duration of 30 to 50 minutes for an average individual's heart beat) [66] in a hybrid mock circulation machine. [67] Following which the silicone membrane (2.3 mm thick) between the Left Ventricle and the Air Expansion Chamber ruptured. [68]

The working life of a more recent Cohrs prototype (using various polymers instead of silicone) [67] was still limited, according to reports in early 2018, with that model providing a useful life of 1 million heartbeats, roughly ten days in a human body. [69] At the time, Cohrs and his team were experimenting with CAD software and 3D printing, striving to develop a model that would last up to 15 years. "We cannot really predict when we could have a final working heart which fulfills all requirements and is ready for implantation. This usually takes years", said Cohrs. [70]

A centrifugal pump [71] [72] or an axial-flow pump [73] [74] can be used as an artificial heart, resulting in the patient being alive without a pulse. Other pulse-less artificial heart designs include the HeartMate II from Thoratec, which uses an Archimedes screw and an experimental artificial heart designed by Bud Frazier and Billy Cohn, using turbines spinning at 8,000 to 12,000 RPMs. [75]

A centrifugal artificial heart which alternately pumps the pulmonary circulation and the systemic circulation, causing a pulse, has been described. [76]

Researchers have constructed a heart out of foam. The heart is made out of flexible silicone and works with an external pump to push air and fluids through the heart. It currently cannot be implanted into humans, but it is a promising start for artificial hearts. [77]

Hybrid assistive devices Edit

Patients who have some remaining heart function but who can no longer live normally may be candidates for ventricular assist devices (VAD), which do not replace the human heart but complement it by taking up much of the function. [ citation needed ]

The first Left Ventricular Assist Device (LVAD) system was created by Domingo Liotta at Baylor College of Medicine in Houston in 1962. [78]

Another VAD, the Kantrowitz CardioVad, designed by Adrian Kantrowitz, boosts the native heart by taking up over 50% of its function. [79] Additionally, the VAD can help patients on the wait list for a heart transplant. In a young person, this device could delay the need for a transplant by 10–15 years, or even allow the heart to recover, in which case the VAD can be removed. [79] The artificial heart is powered by a battery that needs to be changed several times while still working. [ citation needed ]

The first heart assist device was approved by the FDA in 1994, and two more received approval in 1998. [80] While the original assist devices emulated the pulsating heart, newer versions, such as the Heartmate II, [81] developed by The Texas Heart Institute of Houston, provide continuous flow. These pumps (which may be centrifugal or axial flow) are smaller and potentially more durable and last longer than the current generation of total heart replacement pumps. Another major advantage of a VAD is that the patient keeps the natural heart, which may still function for temporary back-up support if the mechanical pump were to stop. This may provide enough support to keep the patient alive until a solution to the problem is implemented. [ citation needed ]

In August 2006, an artificial heart was implanted into a 15-year-old girl at the Stollery Children's Hospital in Edmonton, Alberta. It was intended to act as a temporary fixture until a donor heart could be found. Instead, the artificial heart (called a Berlin Heart) allowed for natural processes to occur and her heart healed on its own. After 146 days, the Berlin Heart was removed, and the girl's heart functioned properly on its own. [82] On 16 December 2011 the Berlin Heart gained U.S. FDA approval. The device has since been successfully implanted in several children including a 4-year-old Honduran girl at Children's Hospital Boston. [83]

Several continuous-flow ventricular assist devices have been approved for use in the European Union, and, as of August 2007, were undergoing clinical trials for FDA approval.

In 2012, Craig Lewis, a 55-year-old Texan, presented at the Texas Heart Institute with a severe case of cardiac amyloidosis. He was given an experiment continuous-flow artificial heart transplant which saved his life. Lewis died 5 weeks later of liver failure after slipping into a coma due to the amyloidosis. [75]

In 2012, a study published in the New England Journal of Medicine compared the Berlin Heart to extracorporeal membrane oxygenation (ECMO) and concluded that "a ventricular assist device available in several sizes for use in children as a bridge to heart transplantation [such as the Berlin Heart] was associated with a significantly higher rate of survival as compared with ECMO." [84] The study's primary author, Charles D. Fraser Jr., surgeon in chief at Texas Children's Hospital, explained: "With the Berlin Heart, we have a more effective therapy to offer patients earlier in the management of their heart failure. When we sit with parents, we have real data to offer so they can make an informed decision. This is a giant step forward." [85]

Suffering from end-stage heart failure, former Vice President Dick Cheney underwent a procedure in July 2010 to have a VAD implanted at INOVA Fairfax Hospital, in Fairfax Virginia. In 2012, he received a heart transplant at age 71 after 20 months on a waiting list.