0:01

So what types of closure devices actually exist?

0:03

Well, there are compressive devices, um, like

0:06

the FEMSTOPS of the world, um, or topically

0:09

agents, that, you know, once you've actually

0:11

sort of, uh, um, achieved hemostasis,

0:14

you know, you can sort of help achieve sort

0:16

of hemostasis with sort of a little bit of,

0:19

sort of a little adjunctive sort of maneuver.

0:21

But closure devices usually

0:23

come in sort of realms.

0:24

You know, there's these, these topical

0:26

agents that are not quite closure

0:27

devices, but they achieve hemostasis.

0:29

So we're not going to include

0:30

these in the category.

0:31

But for the sake of sort of completionist,

0:33

sort of being comprehensive and inclusive,

0:36

you know, we've sort of listed them here.

0:37

But there are a little bit more

0:39

invasive devices, and these are the

0:40

ones that we're sort of talking about.

0:42

When we talk about closure devices, they

0:44

often have sort of different mechanisms.

0:47

There's ones that are suture-based.

0:49

There's ones that are sort of collagen-based.

0:52

There's ones that are sort of metal-based.

0:54

And we have pretty sort of clear closure devices

0:57

that are sort of seminal and representative

0:59

in each category, which we'll talk about.

1:01

Here we see a perfect example of how you perform

1:04

manual compression that we've sort of addressed.

1:06

And sort of these compressive devices do

1:08

exactly what you or me would be doing even

1:11

if we were applying linear compression.

1:13

So, the FEMSTOPS.

1:15

Their whole goal is to mimic what we

1:17

or you would be doing in this setting.

1:20

So it may be an inflatable cuff if you

1:22

decided, all right, you know, actually,

1:23

you know, we're going to go old school,

1:24

just put a little inflatable cuff in the

1:26

case of, you know, radial artery access.

1:28

There are certain device

1:29

manufacturers that sort of have.

1:31

Nice little sort of cuff that you inflate, a

1:33

little bit of air, you know, you apply a little

1:35

pressure until you see a little bit of bleeding,

1:37

remove your sheath a little bit more, boom,

1:39

and then that applies pressure to the access,

1:42

and you sort of decrease the amount of pressure

1:43

over time and letting out air out of the sort

1:46

of balloon until hemostasis has been guaranteed.

1:51

And these have a pretty high rate of success.

1:53

Similar, superior to invasive

1:54

closure devices as well.

1:56

This is the kind of thing that once you

1:57

use it, it's particularly effective.

2:00

So we decided to use a compressive device

2:02

after radial artery access for MSG.

2:05

And so what we're doing now is we're

2:06

assessing the proximal and distal radial

2:08

pulses, simultaneous compression of the ulnar

2:10

artery, actually allows us to ensure that

2:13

hemostasis without an occlusion results.

2:17

We also are propagating the radial

2:18

artery pulse distal to the access site.

2:22

And if we do that, and we don't compress it

2:25

sort of on both sides, proximal and distal,

2:27

we may actually sort of miss the fact that

2:30

they may actually be backfilling from the

2:32

ulnar artery collaterals that can occur.

2:34

Right, so we want to be very, very clear that

2:36

what we're feeling is what we're feeling.

2:38

So, we want to assess the

2:40

proximal and distal pulses.

2:43

So what are topical agents?

2:44

Okay, so these are sort of, as I mentioned,

2:46

the collagens or thrombins that can be

2:48

directly sort of applied to an arteriotomy.

2:51

Alright, and with closure devices

2:52

themselves, they're usually deployed,

2:54

boom, right actually at the arteriotomy.

2:56

Thrombin, there are often these thrombin powders

2:58

and again, they're considered topical

3:00

agents and not considered closure devices, but

3:02

again, we're going to lump these two together and

3:05

they're suited, you know, for superficial artery

3:07

punctures, all right, small diameter punctures,

3:10

in the case of dialysis access as well.

3:12

Typically not used independently, but

3:14

used to augment manual compression.

3:17

So what are invasive devices?

3:18

These are the ones that I talk about, and

3:20

when people say a vascular closure device,

3:22

this is kind of what they're referring to.

3:24

They're referring to these that sort of, you

3:26

know, are deployed, usually over a wire, and

3:29

they usually insert some foreign substance.

3:31

Again, collagen.

3:32

They usually suture-based.

3:34

Patch-based or sort of metallic or membrane-based

3:38

to tether the front and back of the sort

3:40

arterial wall together such that that ventral

3:43

surface that's been traversed is now pulled

3:46

together, almost like a little purse string

3:48

that is used to accomplish closure in the same

3:51

mechanism that that arteriotomy no longer exists.

3:55

They often have procoagulant solutions

3:58

that, again, are prothrombotic.

4:00

They may actually have a balloon occlusion

4:02

that, again, tries to achieve that

4:04

manual compression that we're achieving

4:06

when we employ manual compression.

4:08

There may be a suture closure of their arteriotomy,

4:10

or maybe a combination of each of those.

4:12

And the whole goal for this, particularly

4:14

when we're dealing with common femoral

4:15

artery access, which for me is sort of my

4:17

staple, we want to know that complications

4:20

can occur if deployed in other vessels.

4:22

And so these are typically indicated for common

4:25

femoral access, but not for other access sites.

4:28

So what are some benefits of

4:29

using an invasive closure device?

4:31

Well, hemostasis is achieved more rapidly

4:32

compared to binding compression.

4:34

One minute versus ten minutes?

4:37

That sounds like a benefit to me.

4:39

If you're dealing with a large vessel, 9 French

4:40

to 24 French, or two centimeters, it can be

4:42

challenging to successfully achieve hemostasis.

4:44

So, it's a pretty good option to use,

4:47

particularly when you're deploying

4:48

endografts, aortic endografts, for example.

4:51

By design, you want to make sure that you use

4:53

a closure device and probably hold pressure

4:56

for about 20 minutes as well, which, which

4:57

is pretty customary for folks that sort of

4:59

deploy endografts, abdominal aortic endografts.

5:02

Overall complication rates are pretty

5:03

similar between a closure and a compression

5:05

device, although a significant heterogeneity

5:07

actually exists when we look at devices.

5:09

So when we're looking at arterial puncture,

5:12

and we're looking at closure devices, we're

5:13

comparing them, you know, sort of their

5:15

efficacy with standard manual compression.

5:18

We look at sort of a 2004 meta-analysis to get a

5:21

little idea of sort of how this shapes up.

5:23

And what we've been told by the office is

5:25

that, you know, the relative risk when we're

5:28

using closure devices is—the groin hematoma,

5:30

the bleeding complications, and the risk of

5:33

developing an arterial fistula have odds ratios as

5:36

represented here, and so what we're seeing is that

5:39

the closure devices are particularly effective in

5:42

reducing bleeding, in reducing groin hematomas.

5:46

So we want to be very, very, very mindful of

5:49

this relative benefit as it relates to sort of

5:51

complications, but also the time to hemostasis

5:54

that's shorter, notably with closure devices.

5:58

So when we use a percutaneous closure

6:00

device in sort of accidental arterial

6:03

accesses, it's been demonstrated in a few

6:05

studies to actually have some efficacy.

6:07

You know, here's a case, as I mentioned before, of a port

6:08

168 00:06:10,335 --> 00:06:11,715 that was intended to be placed in the

6:11

subclavian vein by a surgeon who was using

6:14

landmarks and ended up sticking and placing

6:16

the port in the artery, subclavian artery.

6:18

Pulled the port, placed it in the vein.

6:20

Patient developed a massive sort of

6:22

expanding hematoma in the neck.

6:24

This is a site that in the past, actually,

6:26

a closure device has actually been used.

6:28

You know, in this case, I placed a stent graft,

6:30

but people have actually noted that closure

6:32

devices, if you have access to the vessel through

6:36

this inadvertent arterial access, you could

6:38

consider a closure device off-label in that setting.

6:42

So, multiple case studies, as mentioned,

6:45

demonstrate that particularly the collagen

6:48

based devices can have utility in this setting.

6:52

So what complications can

6:53

occur with invasive devices?

6:55

You can dissect an artery, you can result in

6:59

sort of an arterial thrombosis, these invasive

7:02

devices can provoke pseudoaneurysms, you can

7:05

have hematomas and bleeding, they can form

7:07

niduses for infection, or they can provoke

7:10

pain because of a granulomatous reaction

7:13

to this foreign substance in the body.

7:16

And so what we want to do is, before we deploy

7:18

or close the device, we want to perform what

7:20

we call a limited common femoral arteriogram.

7:23

What that allows us to do is the following.

7:25

We want to make sure that, one, the artery

7:28

that we access is the intended artery.

7:29

So in the case of a common femoral access,

7:31

not the superficial femoral artery.

7:34

But if that is the case, the most important

7:36

next question is, what is the size?

7:39

What is the caliber?

7:40

Is it four millimeters or more?

7:41

Is it three millimeters or less?

7:43

If it's three millimeters or less, then no go.

7:47

So when we're dealing with closure

7:48

devices, as I mentioned before, 5 mm, 4 mm

7:52

is usually sort of the threshold caliber.

7:54

And if we go below that point, then,

7:57

we're risking vessel thrombosis.