PANEL

Barry T. Katzen, MD, is Medical Director, Baptist Cardiac & Vascular Institute, in Miami, Florida. He has disclosed that he is a paid consultant to Gore & Associates, Medtronic, Inc., and Boston Scientific Corporation. Dr. Katzen may be reached at barryk@baptisthealth.net.

Brian G. Peterson, MD, FACS, is Associate Professor of Surgery, Division of Vascular Surgery, at Saint Louis University in St. Louis, Missouri. He has disclosed that he is a paid consultant to Gore & Associates. Dr. Peterson may be reached at (314) 577-8310; bpeters1@slu.edu.

Gustavo Paludetto, MD, is Head of Endovascular and Interventional Radiology, Heart Institute in Brasilia, DF, Brazil. He has disclosed that he has no financial interests related to this article. Dr. Paludetto may be reached at (+55) 61 81260777; drgustavo.endovascular@gmail.com.

Jean-Pierre Becquemin, MD, is Professor of Vascular Surgery at Henri Mondor Hospital in Créteil, France. He has disclosed that he is a paid consultant to Gore & Associates, Medtronic, Inc., and Cook Medical. Dr. Becquemin may be reached at jpbecquemin@hotmail.com.

Paul Bachoo, MBChB, FRCS, MSc, is Consultant Vascular Surgeon, Aberdeen Royal Infirmary in Aberdeen, United Kingdom. He has disclosed that he has no financial interests related to this article. Dr. Bachoo may be reached at paulbachoo@nhs.net.

A slow or controlled deployment technique has been described in regard to both the GORE® SIM-PUL Delivery System's (Gore & Associates, Flagstaff, AZ) deployment and many competitors' deployment systems. How does repositioning differ between these options?

Dr. Katzen: Repositioning is really very different than the slow deployment systems and techniques that many operators employ. The GORE® C3 Delivery System's (Gore & Associates) ability to reconstrain the proximal part of the implant makes this device a game-changer. In fact, I don't see the two techniques as being directly related. Many operators use slow deployment as a way to get a more predictable location of the implant. But the reconstrainable or repositionable device is really orders of magnitude better.

Dr. Peterson: Even with slow deployment, the orientation or how a device opens up and behaves within the aorta is somewhat unpredictable. Repositioning offers a much more reliable and accurate deployment option, especially when dealing with angulated proximal necks.

Dr. Paludetto: With the competitors' systems we can only move the device before fully opening the proximal part (the first covered stent). Sometimes, after the device is opened, it does not accommodate to the anatomy as we had wished. The big difference is that the GORE® C3 Delivery System's deployment is the only one that makes it possible to fully open the device at the proximal neck in order to see how the device will be accommodated in the aortic wall. If the device won't accommodate as planned, we can close the proximal part and push up, pull down, and/or rotate the device to achieve the optimal position.

Dr. Becquemin: I would add that the ability to reposition gives a feeling of safety and is a great improvement.

How would you describe the transition or learning curve in adopting the GORE® C3 Delivery System for you, your partners, and trainees?

Dr. Katzen: Even if you've never used a GORE® EXCLUDER® Device (Gore & Associates) before, the GORE® C3 Delivery System is extremely simple to use. If you have used it before, I think you'll be very appreciative of the retained simplicity and the control the handle provides.

Dr. Peterson: Exactly. A lot of physicians really were attracted to the GORE® EXCLUDER® Device because of its simplicity. One concern with this new delivery was that the simplicity would be lost, but it certainly isn't. It's the same turn-and-pull motion, but now it's in triplicate, with the added benefit of being able to reposition if you don't like the initial device positioning.

The transition hasn't been an issue for me or for our general surgery residents and vascular fellows. In fact, using the new repositionable delivery system seems to increase some physicians' confidence in being aggressive, and therefore more accurate, on initial deployment.

Learning any new stent graft system seems intimidating at first. Once you get your hands on this device, however, it becomes evident that there is a very small learning curve needed to adapt to the new delivery system.

Dr. Bachoo: I also think it's been relatively straightforward, because I was familiar with the GORE® EXCLUDER® Device. The main learning challenge is really to identify the best use of repositioning (eg, whether you are repositioning up or down to the renal artery). It took about 10 to 12 cases for me to fully understand the utility of the repositioning. It isn't in the delivery process, but it has more to do with the expanded ways that you can now use and reposition it.

Dr. Paludetto: For us, the new system seems familiar. The steps are simple to understand. We've had no trouble.

How did the GORE® C3 Delivery System meet your expectations? Did it work as expected, or did it surprise you in some way?

Dr. Katzen: I think many of us weren't sure what to expect with the new delivery system. But, having used it, the GORE® C3 Delivery System really works exactly as expected—it's very easy to deploy, reconstrain, and rotate and move the implant up and down to get fine levels of precision in deployment.

Dr. Paludetto: It achieved even more than we expected. We were surprised by the ability to easily close and change the device's position. We performed our first case with an extremely challenging anatomy, and it was only possible because the delivery system can close and change position.

Dr. Peterson: I'd say that the thing that surprised me most is that I was expecting it to be a little bit more difficult and complicated, but really it was quite easy to pick up the deployment and reconstraining sequence. As we became more familiar with the steps, how the device acted, and its characteristics, we have been able to get creative and tackle more difficult proximal neck anatomy, perhaps shorter or angulated necks. Ideally, the device's repositioning aspect is going to allow us to treat more patients who have challenging proximal neck anatomy.

We were also pleasantly surprised by the GORE® C3 Delivery System's ability to aid in parallax correction and gain additional seal. An example of this was a case we performed today. We used a straight anteroposterior projection, and when we deployed the device at the renal arteries, we noticed that the gold markers at the top of the device didn't line up very well. When we put the image intensifier in the appropriate cranial orientation, however, we were able to reconstrain the device and gain an additional 5 mm of seal.

Dr. Bachoo: It certainly met our expectations, but we were also surprised by the trackability of the GORE® C3 Delivery System, which was very significant. What I mean is, during vertical repositioning, a small movement of the hand was described equally on the x-ray machine in terms of position of the graft. So, a small movement of the hand produced an equally small movement of the graft; there was no need to be very forceful. I was also surprised by how reliable the whole process is, in that the various steps of repositioning are very smooth as you transition between deployment and repositioning.

What is your favorite aspect or benefit of the GORE® C3 Delivery System and why?

Dr. Peterson: My favorite aspect of the device is that it really allows you to be aggressive on your initial deployment. Whereas before, we would always be concerned about encroaching upon the renal artery orifices, now we can be very aggressive because we know that we can reposition and move the device down a little bit if needed.

Dr. Bachoo: I think the biggest benefit of the GORE® C3 Delivery System is its ability to handle challenging anatomy. With this system, we are now able to take on short, angled necks, and we're also able to approach tortuous iliac anatomy with confidence. These are things we couldn't do as confidently before we had the GORE® C3 Delivery System, so it's quite easy for me to say that taking on more difficult anatomy is a clear outcome of using the new device.

Dr. Becquemin: The device can help to catheterize the contralateral limb, thanks to the ability to rotate the main body and bring the graft down closer to the ostium of the iliac artery.

Dr. Katzen: I think the strongest aspect of the new delivery system is the predictability of where the proximal part of the implant is going to wind up. In the previous iteration, we pulled the string and guessed a little bit about where the proximal part of the implant would land. It almost always landed where you expected it to, but you really didn't feel that you knew for sure. All guesswork has now been removed with the new deployment system.

Dr. Paludetto: For me, the strongest benefit is the possibility to fully open and then close the proximal part of the device, which makes it possible to change the position. This feature allows me to confirm position and see how the device accommodates the aortic wall.

Many physicians hoped that the GORE® C3 Delivery System would increase their deployment accuracy, limiting the need for aortic extender cuffs. How would you describe your experience in this regard?

Dr. Bachoo: First of all, I would agree that the final deployment accuracy is greatly improved, and that's a result of repositioning. The role of the cuffs has changed completely. Aortic extender cuffs were previously used as a second step or salvage intervention for migration. Currently, we use extender cuffs in a planned fashion and in difficult angled necks.

Dr. Paludetto: I agree. In most past cases, if we needed to use extender cuffs, it was because the device wasn't accommodated in the way we had hoped. Usually, the extender cuffs were used to make corrections. With this new and secure system, extender cuff use will certainly decrease.

Dr. Peterson: This is interesting; we just presented data at the Annual Winter Meeting of the Peripheral Vascular Surgery Society. We looked at our experience in treating patients with unfavorable proximal aortic neck anatomy and have clearly seen a significant reduction in our aortic extension cuff usage. Despite the slightly higher cost of the GORE® C3 Delivery System, a cost analysis showed that it doesn't take many cases to realize the cost savings for a hospital. On average, in patients with unfavorable neck anatomy, we had to do fewer than eight cases using the GORE® C3 Delivery System to really see a cost benefit because we are not using as many aortic extension cuffs.

Are there things that you are able to do technique- wise with the GORE® C3 Delivery System that either were impossible previously, or were much more difficult?

Dr. Peterson: I think gate cannulation has certainly been made easier, especially when the aneurysm is very large or when, say, there is an hourglass-shaped aneurysm and the contralateral gate is going to open up in the narrowest portion of the aorta. Another classically difficult gate cannulation situation happens when there is a short distance between the lowest renal artery and the aortic bifurcation.

The GORE® C3 Delivery System makes those situations easier to deal with. Not only can the device be reconstrained and repositioned to achieve an optimal proximal seal, but it can also be reconstrained with the idea that the gate can be moved to cannulate more effectively. As you know, the GORE® EXCLUDER® Device hasn't changed, so the complete gold ring on the contralateral gate remains unchanged. Combine that with the repositionable aspect of the GORE® C3 Delivery System, and gate cannulation is now that much easier.

Dr. Bachoo: As I mentioned earlier, we can now address many anatomic presentations with the GORE® C3 Delivery System.

Dr. Paludetto: Certainly. With the GORE® C3 Delivery System, treating short and angulated necks, as well as performing contralateral leg catheterizations, becomes easier because you can move and find the best position. With other systems, repositioning is impossible. The GORE® C3 Delivery System makes it possible to treat highly complex aneurysms and emergent cases.

Dr. Becquemin: Yes, I've also been able to more easily manage emergent AAAs with this device.

People have come up with different analogies to describe the benefits of repositionability—a rewind button, an insurance policy, etc. What analogy works best to describe its impact on your practice, and why?

Dr. Becquemin: I would call it a second chance, that is there if needed.

Dr. Bachoo: I would say it is like an insurance policy.

Dr. Paludetto: Yes, “insurance policy” is a good way to describe the GORE® C3 Delivery System. It seems like it can help predict the future, because this system enables us to deploy the top of the device and see how it will be positioned on the aortic wall. If it is not properly positioned, we have the assurance that we can come back, close, relocate, and reopen the device in order to more effectively exclude the aneurysm.

Dr. Katzen: If I had to pick a phrase, I'd simply say proximal deployment—precise proximal deployment. Dr. Peterson: I like all of those descriptions, but I kind of think of the repositionable aspect of the GORE® C3 Delivery System as a guardian angel sitting on my shoulder that is ready to help out in difficult situations.