Cardiovascular disease
and specifically heart failure
is the number one cause of death
in men and women across just about every demographic.
If we had a patient with a bad heart
and we could take their heart out
and replace it with a machine, we'd do it all the time.
For the last half century,
scientists have been working tirelessly to create a machine
that can accurately mimic the function
of a beating human heart,
envisioning devices
they hope will one day rid us
of the number one cause of death in the world.
Every technology goes through a sigmoidal adoption curve.
5% of people are doing it, then 10, then 15,
then suddenly it saturates and goes vertical.
And only now in the last decade
or so have we had the technology to make devices
that potentially could last a decade or more.
If we had a practical, permanent, total artificial heart,
it would be one of the biggest accomplishments
in modern medicine.
When it comes to heart failure,
there's currently only one gold standard of treatment:
replacing the failing heart with a healthy donor.
And while there are nearly 6,000 heart transplants
done annually,
there are about a million requests
for donor hearts each year,
600,000 of which are in the U.S. alone.
So the main limitation to heart transplantation
is having a donor heart that we can place in a patient
who's destined to die from heart failure.
Dr. William Cohn is a heart surgeon
at the Texas Heart Institute
and an innovator in artificial heart technology.
And if you think about it,
it's gotta be a healthy heart
from a patient who's died in such way
that it didn't affect their heart.
And that doesn't happen that frequently.
So to be able to save the lives of all these patients
that are dying of heart failure,
we need something other than a transplanted heart.
Your heart's just a pump.
Every cell in your body needs nutrition, needs oxygen,
it gets that through the blood
that goes through every blood vessel in your body.
The heart is the pump that makes the blood move.
So a heart is a very simple device by some metrics,
but incredibly complex by others.
So a lot of scientists looked
at the heart function and tried to mimic it.
The really first artificial heart
was designed by a guy named Domingo Liotta,
brilliant Argentinian scientist who was working
at the Cleveland clinic then came down
to work with Michael DeBakey,
pioneering heart surgeon in Houston.
And they developed a device that DeBakey
had implanted in seven cows.
The longest went about 12 hours.
While DeBakey was in Washington DC asking
for additional funding,
his then partner, Denton Cooley implanted
it in a desperate ill human patient, Haskell Karp.
April 4th, 1969,
that was the world's first clinical use
of a total artificial heart.
The possibility has been established
as a reality, the fact that Mr. Karp
has regained organ function in terms of cerebral function
and kidney function indicates
that it's, a mechanical heart is a feasibility.
Unfortunately,
the valves that they'd put in this version of the heart
were breaking up the blood,
the broken up blood was causing the kidneys to fail,
and after 64 hours on the device,
they did an emergency transplant
and tragically 36 hours later died of an infection.
But it showed us that that type of thing was possible.
The heart had bladders that filled
and emptied with compressed air
that drove the blood forward.
One way valves made it so that when the bladders collapsed,
blood poured into the device,
when the bladders filled,
it went out through the great vessels.
Based on that technology,
that device continued to evolve and evolved
into what we now have, the SynCardia device,
which is the world's first approved device,
just like the one implanted in 1969,
but much better membranes, much better valves,
much better material and manufacturing techniques.
Now we've just heard that the Carmat device
has been approved for commercial sale in Europe,
and that's great, that's a step forward,
but it's still approved for temporary use.
SynCardia and Carmat
are the only approved artificial hearts
in the world right now.
But they're currently approved only as bridge
to transplant devices,
temporary hearts that work to keep patients alive
until a real donor heart becomes available.
The longest an artificial heart has ever lasted
in a patient is 1,374 days or roughly four years,
the real limitation being long-term durability.
Think about it now,
if your heart is beating 80 times a minute,
that's 132,000 times in a day,
that's 42 million times in a year.
So the challenge with all the artificial hearts
that have been developed so far is, it wears out.
Anything that has to flex over and over again
to make it so it never fails,
I think this is a tall order.
The durability factor has led other groups
to rethink their approach
to how an artificial heart mimics our own.
BiVACOR, a startup from Brisbane, Australia
that's headquartered in Houston Texas,
has come up with a device that hardly resembles
a human heart at all.
Their radical new approach has helped them to raise more
than $20 million
and has won over industry heavy hitters like Dr. Cohn,
who serves as their chief medical officer.
My name is Daniel Timms,
I'm a mechanical engineer
with a PhD in biomedical engineering.
During my PhD,
I invented the BiVACOR device and have been developing
that device ever since.
The artificial heart that we're creating
is what's called a rotary total artificial heart,
which has a spinning disc,
which is magnetically levitated within a cavity
to pump the blood to both the lungs
and to the body simultaneously.
It's a similar process to a fan where your ceiling fan
will spin and air will come down at a constant flow rate.
Instead of air we're pumping blood.
But it's very similar impellers, effectively,
that's inside the artificial heart.
And so that approach is radically different
from utilizing compressing sacks.
A spinning disc that is magnetically levitated,
meaning that there's no touchdown of any
of those moving parts, can affectively last forever.
BiVACOR's artificial heart works off
of rapidly spinning pump technology,
developed by scientists Rob Jarvik and Rich Wampler
in the mid 1980s.
In their device,
small turbines sat outside unhealthy hearts
to assist with blood flow to a single ventricle.
Timms' device builds on that idea
by using a spinning disc, or impeller,
to push and regulate the flow of blood to both ventricles.
The impeller inside,
it's a single disc with veins on one side to pump the blood
to the body and veins on the other side,
to pump the blood to the lungs.
And they look different because the requirements of pressure
are different in the body and the lungs.
The magnetic levitation system interfaces
with two ring shape magnets.
That magnetic bearing detects this radar
and if the radar moves further away,
coils will energize to bring it closer.
And if it gets too close, they'll de-energize.
And we'll do that 2000 times a second to read the position
and then keep the disc levitated well away from the casing,
therefore eliminating any of the mechanical wear.
BiVACOR is currently testing its device
in this system that circulates liquids
to replicate the functions of the human body.
There's one big question, though,
that they won't be able to answer before human trials:
whether BiVACOR patients will have a pulse.
While we tend to think of the pulse as fundamental
to the heart's function,
BiVACOR's device can actually propel blood
in a continuous stream,
which works fine in the lab and an animal trials,
but no one knows exactly what its effects
would be on the human body.
So Timms is exploring other options as well.
Right now the device is operating
in a continuous flow mode.
But then we want to introduce pulsatility into that system.
So we can turn on pulsatility in that regard.
You'll see this device is running in a pulsatile mode,
once every second.
And we reproducing that pulsatility by taking
the spinning disc and rapidly spinning it up and down,
up and down once a second.
And that reproduces that pulsatile outflow,
now that we can observe.
What we then have the ability for this device to do
is even change that beat rate.
And where alternatively the patient is exercising
and there might be a higher beat rate required there.
And this is at a 90 beats per minute now.
Resting and sleeping,
and so that pulse rate will be lower.
Eventually BiVACOR intends
for these changes in heart rate
to be automatic based on blood pressure changes that occur
when a patient moves from one type
of physical activity to another.
This is a project that I've worked on now
for almost two decades.
During my undergraduate studies, around about that time,
my father had heart failure.
In the early days the whole goal
was to try to make something, a little naively,
to help his failing circulation.
We decided that we'd do some of the work
in our garage or in our home.
My father was a plumber.
So he was very adept with circulation systems.
So what we decided to do was make a prototype
of this device.
So this is one of the very first prototype iterations
of the BiVACOR device.
So you'll see here,
we have an ability to put in different horseshoe magnets,
on this side is where the motor can fit inside,
then of course we look inside the pump
and we can see one of the very first impeller designs
that was actually made by my dad.
He machined this on a mini lathe, right next to the TV.
So he could work on the mini lathe while watching TV.
Although we are now creating a device
and obviously not in time for him,
there's many other people out with heart failure
and not only does it touch the patient
with the heart failure,
but their immediate family,
which is something that my mum and and myself
have been dealing with now for now 15 years since that time.
So that really catalyzed
the motivation and the passion really
to get this into those patients that need it.
BiVACOR is currently working with the FDA,
undergoing durability and animal studies.
They're also poised for their first human implant
to take place in 2022.
Meanwhile, France based Carmat received approval
from the EU at the end of 2020
and has started manufacturing
its hearts for commercial sale.
Hopes are high that Carmat's heart will prove longer lasting
than earlier artificial hearts,
and the company intends for its product to eventually become
a permanent replacement, not just a stopgap.
As promising as these technologies are,
one big remaining downside
is the briefcase-sized power packs
that have to stay permanently connected
to the hearts through the patient's skin.
Advancements like extending battery life
and replacing cable drive lines
with wireless charging technology
would have to be realized,
before an artificial heart patient's freedom
is truly on par with a healthy transplant recipient.
You could argue that we're still in this low phase,
we haven't gone vertical yet,
because there are four or 5,000 pumps implanted a year,
but 400,000 people dying of heart failure.
It's a whole bunch of technical forces
that are converging on having an artificial heart
that lasts a long time, that doesn't have a wire
through the skin.
And then, maybe heart failure
won't be the number one cause of death in the world.