Hello, my name is Sean Lyden and I am the Chairman of Vascular Surgery at the Cleveland Clinic.

What is the reasoning behind the PATCH study?

So large-bore access has become the standard of care for doing TVAR, TAVR, and EVAR. And we really still have very few devices available for us and there's still a lot of need for better devices than we have today.

Could you tell us about the unique features of the PerQSeal vascular closure device?

So the PerQseal closure device has several unique features. One, it's a fully absorbable patch— by 120 days the patch is fully absorbed. And the second unique feature is that it doesn't have to be started before the procedure begins. It can be completely placed when you're completely done with the procedure and it'll close up to a 26 French arteriotomy.

What was the study design and patient population?

So the PATCH study was a prospective, single-arm, adaptive study design, but it looked at the ability to use this device in large-vessel access for both TAVR, TVAR, and EVAR. And it was looking at closing vessel arterotomies between 14 and 22 French in terms of sheath size, but 26 French as the largest diameter actual opening in the vessel.

What are your key findings?

If we look at what's out there, the risk of large-bore complications is up to 14%. So that was the performance goal. And so we looked at the ability to actually close the vessel for both safety and effectiveness. And the safety was excellent. There was a median time to closure of zero minutes. There was only a small percentage of the patients that needed 10 minutes to achieve vessel closure.

And so the other important part was the risk of hematoma or pseudoaneurysm was around 2%. So much less than the performance standard that is out there from the peer-reviewed literature of 14%.

How should these findings impact clinical practice?

So we're hopeful; the entire goal of this study was to achieve FDA approval. And once we have FDA approval, it will hopefully provide another alternative for these patient populations. When you use suture-mediated devices, many times if the vessel is calcified, the needles won't puncture the vessel and so the ability to put a closure device in at the end of the procedure and to actually have it come up against the vessel wall and seal the vessel and then be fully bioabsorbed within 120 days really provides another treatment option to broaden the ability to use percutaneous procedures for our patients.

What further study is needed in this area?

When you get a device FDA approved, that doesn't mean you know everything about the device. And so really this is the first step to get it available in the United States. There were two prior iterative studies in Europe that were done that showed a good success rate, but really, once the device is out and available, people can start to innovate in how they use it and really find out where else it can be used and what other kind of anatomies that it might be used in.

Really, it had to be 15 millimeters above the SFA profunda bifurcation, and the vessel really had to be disease-free. And so once we get the device out in clinical practice, that's where we as clinicians can start pushing the boundaries of devices to find out where actually it performs best, and those patients will really have no other alternatives.