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The HeartMate II was first approved in 2008 as bridge to transplantation.
It was developed as a new generation of the HeartMate device that has been around since
mid 1990s. They thought about creating a more durable, smaller device that will last longer
and will be available to more people in terms of body size. It was approved as destination
therapy in 2010.
Destination therapy means that patients that otherwise are not a transplant candidate because
either of the age, or other comorbid conditions have the ability of having an improved quality
of life by receiving this device called Left Ventricular Assist device, HeartMate II as
the last option for advanced and stage heart failure.
Heart transplantation, while the gold standard for treating severe end-stage heart failure,
is not the answer for many, even most patients with end-stage severe heart failure. The ability
in certain Left Ventricular Assist devices for this disease is going to have more of
an impact population-wise in the United States than heart transplantation has.
The device works in conjunction with the heart is implanted via open heart surgery. It’s
connected to the heart via tube. And then it basically sucks the blood out of the heart
and it pushes it into the circulation via another tube that’s connected to the aorta,
which is the big blood vessel that travels through the body and distributes the blood
to the vital organs.
It’s been pre-consistently shown that the overwhelmingly majority of patients go into
surgery in class four or class three heart failure, and come out in class one or class
two heart failure. But most people with heart failure are limited in what they can do many
times to the point where it can’t even engage in the activities of daily living.
Now individuals can reengage in life and can do a lot of the things that they weren’t
able to do typically for many years.
They only have mild limitation with extreme activities, but a lot of them can return to
work, can return to doing their daily activities and their hobbies. They can go shopping, go
to the movies. We had somebody that roofed their entire house. We currently have somebody
out in the community that’s farming for the time with the device.
The device has one single limitation; you cannot go swimming with the device. You can,
however, fish from the shore or in the waters. The device is completely quiet, so it doesn’t
interfere with your daily living activities. Overall, the device weighs less than a pound.
Most of the people won’t feel it; it doesn’t interfere with their activities and it is
so small and it can be so well hidden, that we have people that actually get married with
the device.
We don’t know how long they’re going to last. Technology is always changing. We know
there are very durable, much more durable than the first generation devices.
The longest device in the United States that has lasted has been about six years since
the device is pretty new. However, this device can be replaced with a usually easy operation.
There’s no limitation into how many devices you place. Obviously, your body has to be
in good shape.
A lot of the patients that have been younger patients have chosen not to pursue transplantation
and continue to live on these devices because of limited medications that they have to take.
Less follow-up, less invasive procedures, and the ability of changing this device and
still receiving the transplantation at the back and if it’s necessary. Therefore, having
the higher chance of expanding their life expectancy.
A lot of times what we’re finding is that individuals who may not have been candidates
for heart transplantation may become candidates for transplant and in a certain number of
individuals, there may also be recovery. There are a minority of patients out there who do
seem to get recovery of heart function after a period of time on the Left Ventricular Assist
device.
It opens the door for improving quality of life to a lot of local patients that otherwise
they would have no hope.
The results from Left Ventricular Assist device have been improving incrementally, and we
may see the point where these devices may rival the results that we’re seeing with
heart transplantation, which to this day remains a gold standard.
We, as medical community, are able to provide patients here in Nebraska with the therapies
that otherwise they would have had to travel long ways. I think that is a great achievement
for the community and I’m proud to be part of the team at Nebraska Medical Center.