0:00

Next we're gonna talk about TAVR devices. Uh,

0:03

there are really two major devices in the United States that have been used for

0:07

several years,

0:08

and these served as the basis for much of the randomized trial data that we have

0:12

on tavr. Um, these devices, uh,

0:15

have undergone multiple updates over the years,

0:17

including features to reduce the risk of leakage around the valve and decrease

0:22

the size of delivery mechanism. However, despite all these updates,

0:26

the same sort of basic structure of the device has, uh,

0:30

persisted over the years, um, within the different, uh, device types,

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um, of which there are two. As I mentioned,

0:37

there are multiple different sizes available. Um,

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and so depending on which device you're using,

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they may have sizes that are down from 20 to 34 millimeters. Um,

0:46

and the size tells you the size of the diameter of the device itself,

0:50

so for smaller, uh, aortic canula up to larger aortic canula.

0:55

Um, and then, uh,

0:57

very recently another device has been released and was F D A approved in the US

1:01

uh, in January, 2023. And I'll mention that at the end. Um, honestly,

1:06

we're still growing our clinical experience with this device,

1:08

so I don't have as much to say about it as the other two.

1:12

The first device is the sapien valve. This is from Edwards.

1:15

This was actually the first one in clinical trials in the United States. Um,

1:19

it's a low profile device, so it's very short. Um,

1:22

and one important thing to consider with these devices is how are the coronary

1:26

arteries, uh, receiving blood flow? Um,

1:28

because one of the risks of TAVR that we, um,

1:31

always worry about is obstruction of the coronary arteries. Um,

1:34

and so for the sapien valve,

1:36

the way the coronary arteries receive the blood flow is that the valve sits

1:40

below the level of the coronaries. Um, so for this reason,

1:43

coronary heights are critical to evaluation, uh,

1:46

of patients who are being considered for the sapien valve. Um,

1:49

there have been multiple different versions through the years. Originally,

1:52

the Sapien and the Sapien XT three and now Ultra, and again, those are all, um,

1:57

minor modifications of the structure, um, to reduce, uh,

2:01

size of the sheath and reduce, uh, leakage around the valve in many cases. Um,

2:06

this device is different from the other device we're gonna discuss because it's

2:09

balloon expanded. Um, so it's sits on a, a wire, um,

2:13

and is inserted and balloon expanded, um, whereas the other device, um,

2:17

that's the core valve here for Medtronic. Um, this is actually a self-expanding,

2:21

uh, valve. So it has this, uh, metal memory. Um, and basically, you know,

2:26

as soon as the sheath is removed and the device is released,

2:28

it's sort of expands into place. Um,

2:31

this device is obviously a little bit taller and has this sort of unusual kind

2:35

of, uh, tulip shape to it. Um,

2:38

there are portions of the device that sit both below the annulus and above the

2:42

annulus. Um, and importantly the way the coronary arteries receive, uh,

2:45

blood flow in this device is that there's backflow blood around the top of the

2:49

device into the sinuses. Um,

2:51

so the sinuses become really important for maintaining coronary blood flow in

2:55

these patients. Um, and so sinus widths and heights are

2:59

Critical for measurement, um, to, uh, assess for these patients, uh,

3:02

and their suitability for the core valve device. Uh, again,

3:06

this one has undergone multiple evolutions from the original core valve.

3:09

Then more recently to these devices called the Evolut. Um, same structure,

3:14

uh, just a different name. And then finally,

3:17

the most recently approved device released January, 2023.

3:20

It's a self-expanding device from, uh, Navor. Um,

3:24

and also at the same time low profile. Uh, honestly, um,

3:28

we're still learning a lot about this device, so I,

3:30

I don't have a whole lot of detail. Um,

3:32

but certainly more to come in the coming years.