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[ ♪♪♪ ] MAN: Lowell Edwards was a brilliant engineer and Albert Starr was a meticulous, bold surgeon.

MAN: It had to be a perfect team because Lowell didn't get discouraged very easy.

MAN: They invented a valve that replaced a moving part inside the heart.

Conceptually, that's just like a quantum leap.

Edwards felt we had something, it was lifesaving, "Now I have an obligation."

MAN: We had patients coming from everywhere.

All over the world.

MAN: There was only one surgeon in the world there for a while who could save you, and it was Albert Starr.

WOMAN: I was envisioning the end of the road, and Dr. Starr presented me with a detour.

[ ♪♪♪ ] MAN: You can hear her spirit whispering through the trees.

This is the place where she wanted to be because her spirit's already here.

NARRATOR: High in the Cascade foothills of central Washington State, John Randlett remembers his wife Yolanda.

Pioneers are people who are forced into difficult choices.

I think she would say, "Run your race.

Keep the faith.

Don't give up."

YOLANDA [ on video ]: Fifty years ago, I was a student at Pacific University in Forest Grove.

In the bloom of life-- a career, marriage, children-- all those dreams that my fellow students saw seemed to be snatched out of my reach.

As a young girl growing up in the 1940s and '50s, Yolanda had contracted rheumatic fever, a serious disease that damaged the valves in her heart.

So these children would grow and become young adults, but their heart would get more and more dysfunctional because the valves inside the heart wouldn't work.

They were deformed.

And so there were many young people who were going to die prematurely.

So this was a tremendous problem.

Most surgeons thought up until the Second World War that it's impossible to operate on the heart, that it's a moving organ.

[ heart beat echoing in newsreel ] NEWSREEL NARRATOR: Day and night in steady rhythm there operates within the human body a marvelous machine: the heart.

The heart is purely a muscular pump... [ ♪♪♪ ] The heart circulates blood in the body through four one-way valves.

The mitral valve allows oxygen-rich blood from the lungs to enter the heart, where it's pushed back out to the body through the aortic valve.

Oxygen-poor blood returns to the heart via the tricuspid valve, then pumps out through the pulmonary valve to the lungs.

In 1953, Dr. John Gibbon, known as the father of the heart-lung machine, performed the first successful open-heart surgery using the machine.

The bypass machine could take over functions of the heart and lungs by pumping oxygenated blood through a patient's body.

MULLINS: Surgeons tried to learn how to use them to do surgery inside the heart, specifically on the valves or correcting congenital abnormalities.

It was an enormous step forward, but it was difficult to do.

If you didn't do it perfectly, the patient died.

In the 1950s, Albert Starr was a young surgeon in New York City.

Born in 1926, Starr graduated from what is now Columbia University and received his medical degree in 1949.

As an intern at Johns Hopkins, he worked with pioneering cardiac surgeon Dr. Alfred Blalock.

The Korean War interrupted Starr's training but honed his skills in a MASH unit.

NEWSREEL NARRATOR: Over 25,000 men have been wounded in Korea.

But less than 2 percent of these men have died.

STARR [ on recording ]: I had calluses on my hands from operating.

We were opening abdomens and closing holes in bowels and taking out ruptured spleens and...

It was physically very demanding, but I was young.

I was about 22 or 23 years old.

And I thought it was really important.

NEWSREEL NARRATOR: There is nothing fancy about these hospitals.

They are there to save lives.

Returning to New York, Starr completed his residency and planned a career in congenital heart surgery.

[ ♪♪♪ ] Three thousand miles away, at the University of Oregon Medical School in Portland, now OHSU, chief of cardiology Dr. Herbert Griswald wanted to start an open-heart surgery program.

But first he needed someone to run it.

In 1957, Griswald sent prominent surgeon Bill Conklin on a recruiting trip.

He observed Dr. Starr in surgery and invited him to visit Oregon.

STARR: So here I am from New York City and dressed up in a three-button suit, and I have an appointment to meet Clare Peterson, who's acting chairman of the Department of Surgery, at about 9:00 in the morning.

He breezes in about 9:30.

He's dressed in his fishing outfit, and he's got a basket filled with trout, and this was my interview.

And he had just gotten in a little early-morning fishing before coming to the office.

So it was, you know, astonishing!

MULLINS: Starr knew his first job was to organize a team that would work together to get this heart-lung machine to work.

And so he got a small grant from the Oregon Heart Association and he began doing animal surgery, practicing exposing the heart, putting the dogs on bypass.

MAN: This is our heart-lung machine.

Dr. Fernando Leon was a young resident in Starr's research lab, assisting in the experimental surgeries and caring for the dogs post-op.

This is Dr. Starr, and this is myself... and Blackie.

The laboratory where we were working was in the old building, and I would stay there until the animals were stable.

Every day there was something to be learned.

And when Dr. Starr came, things really changed very fast and we were able to do more things in a very more safe situation.

MULLINS: Starr was emphatic that he developed a series of steps that he wanted his team to follow.

He called it like choreography of a ballet dancer.

You follow the steps.

In the spring of 1958, Starr successfully repaired a hole in the heart of a 7-year-old girl.

It was Oregon's first pediatric open-heart surgery.

That same year, retired engineer Miles Lowell Edwards turned 60.

He was a modest man.

He was quiet.

He had a gentle nature.

Born in 1898 to a pioneering Quaker family in Newberg, Oregon, his grandfather was one of the founders of what is now George Fox University.

Lowell's father, Clarence, started the town's first electric power company and put his sons to work.

At a very early age, both Lowell and Lloyd were climbing poles and reading meters and repairing lines.

Always curious, young Edwards built his own wireless communication set and learned Morse code.

Lowell was not a very good student in school.

In fact, he got very poor grades.

He had dyslexia, so he couldn't read very well.

So he made it through school with hard work.

Edwards graduated from Oregon Agricultural College, now Oregon State University, in 1924 with a degree in electrical engineering.

In his spare time, he built himself a car on a Model T chassis.

It was known as The Bug around campus and it was quite popular.

He landed a General Electric apprenticeship in upstate New York but soon returned to the Northwest, where he began designing pumps.

Hello, everybody, from Longview, Washington.

In the late 1930s, Edwards joined the Weyerhaeuser Timber Company and built a log-debarking system using high-pressure jets of water to strip off bark without damaging the wood.

World War II sparked a new invention.

He designed a special booster pump for aircraft that kept fuel flowing as planes rapidly ascended to higher altitudes.

He always had a workshop in his home.

My grandmother was concerned about the safety of his experiments out in the driveway because he was boiling gasoline and there were pipes and tubes and... [ chuckles ] Edward's creativity would soon outgrow his home workshop, so he started Edwards Development Lab in southwest Portland, where he hired a few good men.

MAN: We used to call Lowell a deep thinker.

He was a true engineer scientist.

He burned up the slide rules doing his calculations and how these things work.

And he had a sixth sense of how nature did things.

[ chuckling ] He could just solve problems.

By the early 1950s, 75 percent of American military aircraft flew with booster pumps invented by Edwards.

Royalties from his more than 60 patents made him a wealthy man.

He'd been lucky, too.

As a boy, Edwards had suffered two bouts of rheumatic fever, but he'd dodged permanent damage to his heart.

MULLINS: Here's the way he thought: "People I know are dying of heart failure.

I ought to be able to replace their heart with a mechanical heart."

So he figured that a heart is a pump.

And he knew a lot about pumps.

In the spring of 1958, Mr. Edwards approached Dr. Starr with an idea, a chance meeting that would have profound consequences.

STARR: He was interested in the circulation as a hydraulic problem and said he wanted to develop an artificial heart.

I told him I thought it was a bit too early.

That, yes, we would need one and it's a great idea, but let's do one valve at a time.

Because by then I had done enough exploration of valves to realize that we really needed to have a valve replacement.

They shook hands and agreed on this.

They're going to go forward.

That's how they-- Dr. Starr would say, "That's how they do it out in the West, just shake hands."

It was a big gamble.

Surgical teams across the U.S. were designing artificial heart valves to replace diseased valves in humans, but with limited success.

A big problem was clots would form and the valve would stop working.

And it just speaks to this is very high risk.

You have to be precise, you have to know exactly what you're doing to achieve success both in the design of the valve and in the techniques of putting it in.

Starr and Edwards picked the mitral valve to tackle first.

STARR: At that time, there were some leaflet valves that could be used for aortic valve replacement, but there was no method of replacing the mitral valve, so-- And that looked like a more difficult project.

MULLINS: They agreed that they would have to use materials that are already being used in human beings.

So that amounted to silastic, Dacron, acrylic plastic.

Lowell Edwards, a millionaire, goes back to his shop and makes a valve... and he brings it to Albert Starr.

And Albert Starr takes it to the animal lab and puts it in an anesthetized dog.

STARR: It looked good initially.

But the dogs have a very vigorous clotting mechanism, and they would clot almost anything that you'd put in the mitral area within a matter of days.

Starr and Edwards abandoned the bi-leaflet design for a Lucite cage enclosing a silicone rubber ball that would move up and down, allowing blood to flow one way only, falling back to block its return.

The Lucite cage was injected on an injection-molding machine that he owned at the facility in Multnomah.

Lowell did all of the original assembly.

He cut the cloth out and sewed the sewing rings.

Oh, absolutely.

Lowell always felt that the best way to understand the problem is he had to do it himself the first time.

Edwards assembled the original prototypes in his workshop, this one at the family's summer home on the Sandy River.

ALLEN: Sometimes my grandmother would wake up during the middle of the night, and she'd look out the window and see the tall fir trees illuminated and she knew that he was out there in his workshop trying out another idea.

He was communicating back and forth with Dr. Starr, writing very detailed correspondence with him.

STARR: It was back and forth constantly.

We were collaborating-- Three or four times a week, we'd have discussions.

One time I was on the coast of Oregon, and the forest ranger knocks on my tent at 11:00 at night on a Saturday night-- It's Edwards.

He has some ideas he wants to run past me.

It was that kind of collaboration.

One of the keys to his success with Lowell Edwards and vice versa is the two communicated.

They were different people, but when they talked, they listened to one another and said, "We need to do this."

"I've got this problem."

"How can I change that?"

STARR: We'd go back to the drawing board, and maybe five or six days later, Edwards has got a new model, and then five or six days after that, another one.

There was no bureaucracy to deal with.

I mean, it was just the two of us.

And he was obsessed with this problem, worked on it constantly.

After a year of intense collaboration and experimental surgery with dogs, encouragement arrived.

LEON: Finally we had this dog that was able to survive for a significant amount of time.

And so we were all happy.

Blackie fully recovered and became the team mascot.

But blood clots still hindered survival rates in most of the animals.

MULLINS: Dr. Starr had an insight.

He said, "Why not put a skirt of silastic over the top of the sewing ring after we've sewn it in, and it would block the development of the clots?"

And it worked.

Within a few months, 70, 80 percent of the animals were surviving with this valve, and the stage was set for the next phase.

During the summer of 1960, Dr. Herbert Griswald paid a visit to Dr. Starr and his team.

STARR: Dr. Griswald came to the animal lab and saw what we were doing, mainly a kennel full of really active dogs.

They all seemed so healthy and friendly, and they all had valve replacements.

And he said, "You know, we have patients in the hospital-- I have one right now, a young woman, who's in an oxygen tent.

She's been there for months.

I can't-- We can't do anything with her.

I think you should consider operating on her."

And at that time, I thought we would be another year or two in the lab.

MULLINS: Starr was very acutely aware that this was experimental.

He talked to the patient.

She was very courageous, had terrible rheumatic fever, and was confined to a hospital type of life for years.

With support from the medical school's chiefs of cardiology and surgery, Starr and his team mobilized for the medical school's first implant of an artificial heart valve in a human being.

They were pretty much on their own.

The Food and Drug Administration, the FDA, was not yet regulating medical devices.

And the team faced unprecedented legal issues.

I told Edwards.

He was surprised at the speed.

His lawyer designed the first informed consent form that I'd ever seen, and it listed the potential problems of having a valve replacement.

But Starr still faced a difficult choice.

Two big decisions were made.

One was not to use the valve that was successful in the dogs.

I felt that humans could-- We would be able to use the unshielded valve because they don't clot as readily but that we should use long-term anticoagulation.

MULLINS: Albert Starr took her to the operating room, put her on the bypass machine, and did an operation no one had ever done before: sewed in the valve that Lowell Edwards had made in his workshop.

And closed her heart, took her off bypass, and her heart functioned spectacularly.

So he learned immediately in the operating room that the valve worked inside her heart and that the heart could recover.

She came out of the operating room in good shape.

But the patient tragically died ten hours later.

By sitting her up, this air escaped from the heart, went to the brain, and she died almost instantly.

Um, I-- I remember the, uh... You know, the sleepless night after that.

And it just highlights if you're going to be a pioneer, if you're going to try something new, you're going to encounter problems that you have never encountered before.

But stopping the trials was not an option.

There were other critically ill patients who wanted the surgery.

When they decided to go forward with the human phase, they organized a team.

And so Starr worked very collaboratively with cardiologists.

They had meetings, regular weekly meetings, and would review the cases and decide.

And about five weeks after the first patient, a patient was referred from Spokane who was near death.

And so the next patient was the first survivor.

[ ♪♪♪ ] He became an instant celebrity, living for another ten years.

In December 1960, Starr's third patient survived, too, her modified valve sporting a curved metal cage.

Within two years, the surgeon and the engineer had gone from an idea to successfully implanting an experimental device in humans.

The results would stun the world.

In the spring of 1961, Starr presented a paper at the American Surgical Association outlining in detail the outcomes of his first eight patients who'd received the new Starr-Edwards mitral valve.

MULLINS: The five who survived were highly functional.

It was a spectacular presentation from a 35-year-old young surgeon.

It became a landmark, one of the top 100 papers published in Surgery in the 20th century.

I think it was beyond anybody's dream that we were going to have that kind of success early on.

Lowell, of course, knew there was a good chance there was a product there and somebody needed to be thinking about manufacturing.

STARR: Edwards was a very interesting guy from the ethical point of view.

He was a Quaker, a very moral man, who felt we had something, it was lifesaving, "Now I have an obligation."

He didn't look at it as a business opportunity.

So it was only a question of where he would do it.

To meet the growing demand, he established Edwards Laboratories in Santa Ana, California, where the valves were initially produced, improved upon, and tested for durability.

MULLINS: He had excellent design.

He was attentive to so many details that were critical to making the valves durable.

SOLBERG: Lowell took the initiative right from the word "go" that we needed to make the highest quality product that we knew how to make.

It was needed, and we were saving lives.

This industrial base for surgery was absolutely essential to the further development of surgery, and Edwards was the prototype of that.

MULLINS: He realized that in the function of a valve, it needed to be lubricated like you put machine oil in a gearbox.

STARR: As an engineer, he was the first one in the world to look at blood as a lubricant.

And what he found was that he could design the valve so that the blood film is never broken, and that's why the valve is so durable.

It doesn't wear out because it's constantly lubricated with blood.

And it doesn't corrode because it doesn't have any iron.

The second thing is it's important to understand that the process, the choreographed insertion of a valve that Starr used, was very detailed.

And people wanted to know, "How'd you do it?"

MAN: He trained his residents to do the cases just exactly the way that he did it.

Because you didn't want to argue with success.

I learned from him.

And there were many other residents from all over the world that have come to Portland and learned from him.

Dr. Starr's team was as good as any other team in the world.

By January 1961, Starr and Edwards had modified the valve to work in other positions in the heart: first the aorta, then two valves at a time.

And in 1963, Starr's team did the world's first triple valve replacement.

That same year, 20-year-old Yolanda Randlett found herself in a Portland hospital.

JOHN RANDLETT: They gave her about six months of life at that point.

One afternoon, a perky, energetic young doctor came to my hospital room.

[ crowd chuckling ] This was Dr. Starr.

He confirmed the fact that my aortic valve was failing, but he didn't stop there.

He offered hope.

Just before surgery I asked him, "How long will this valve last?"

And he answered in his matter-of-fact tone of voice, "Why, the rest of your life."

Yolanda was in surgery for seven and a half hours.

They had trouble getting her off of the heart-lung machine.

What Dr. Starr had going for him was that he had developed a team at the hospital.

It just wasn't the genius of Dr. Starr, it was the genius of the team that he put together.

YOLANDA: From June to September of that year, I graduated college, got married, had open-heart surgery, and-- surprise-- got pregnant.

Yolanda became the first woman with an artificial heart valve to give birth.

But four years later, surgeons discovered the ball inside the valve was failing because it was absorbing fatty acids from her blood.

In another first, surgeons replaced the ball with an improved model and she survived.

And so it's still the original valve... just had a tune-up.

Six years of design modifications would eventually produce the streamlined model 6120.

It would become the mechanical valve of choice for the next 20 years.

We made some very important decisions at the very beginning, and that is that we would be absolutely open about everything that happened.

And secondly, that we would establish a long-term follow-up system so that we would know what happened over the long-term.

DOBBS: In those days we didn't have computers, so we had big long sheets of paper that we put all this data on.

He had to be exact.

And if he had a failure, he reported it.

Over the decades, journal articles tracked the durability of the valve and provided patient data upon which surgeons and cardiologists could evaluate the product and continue to improve outcomes for heart patients.

Production of the ball and cage was discontinued in 2007, but it's continued to withstand the test of time.

Today, there are people alive who have Starr-Edwards valves still clicking in place 50, 55 years later.

Lowell Edwards died in 1982.

What started as an idea to solve a serious medical problem would ultimately grow into Edwards Lifesciences in Irvine, California, a multimillion-dollar company devoted to making lifesaving heart valves and other medical devices... many implanted much less invasively today than decades earlier.

ALLEN: To think that my grandfather started in his own little, small workshop, hand-sewing those valves on his own, is just amazing.

He really wanted to help people.

He was motivated.

It wasn't just engineering curiosity.

He really wanted to do good.

And Dr. Starr offered me this huge gift of life.

[ ♪♪♪ ] Over the years, Yolanda Randlett was celebrated as the longest-living patient with a Starr-Edwards valve.

We were married 56 and a half years.

Courage is being able to embrace life with its fears and insecurities even when you're scared.

That it's a leap of faith.

And Yolanda' s always had that-- that courage, that faith.

She loved life and she... She fought hard.

In 1999, Yolanda survived a third open-heart surgery to replace her heart's mitral valve and a fourth surgery in 2018.

Along the way, she created colorful quilts, this one called "Finding the Light."

She died in 2019.

Dr. Starr's a pioneer, for sure.

But I think he would be among the first to say that it's been his patients who've also been the pioneers and have taught him a great deal.

The development of the world's first successful artificial heart valve would save the lives of hundreds of thousands of people.

And through the years, both Albert Starr and Lowell Edwards have been honored with the highest regional, national and international awards.

MULLINS: They are two extraordinary human beings.

And there's an element of chance that brought them together, the unexpected event that had spectacular long-term consequence.

[ ♪♪♪ ] There's more about "Pioneering Hearts" on Oregon Experience online.

To learn more, visit opb.org.

[ ♪♪♪ ] Leading support for Oregon Experience is provided by... Major support provided by... Additional support provided by... the contributing members of OPB, and viewers like you.