The Gore Together Aortic Registry: Collecting Real-world Data for Endovascular Aortic Products in Standard Medical Practice

In this episode of Vascular Voices, we talk about the Gore Together Aortic Registry with Dr. John Henretta, a principal investigator for this new registry. Dr. Henretta is a vascular surgeon in Asheville, North Carolina with extensive experience in thoracic aortic aneurysm, abdominal aortic aneurysm, carotid artery disease, carotid artery surgery, and aneurysm repair. He is board certified in vascular surgery and is a member of the Society of Vascular Surgeons and American College of Surgeons. His clinical research consists of co-authoring more than 20 peer-reviewed articles and participating in numerous clinical trials over his 21 years of experience. This episode is also available on Spotify and Apple Podcasts.

Moderator: Welcome to Vascular Voices, the podcast of Vascular Disease Management, the peer-reviewed online journal that educates readers on the latest advancements in endovascular treatment strategies. In this episode, we talk about the Gore Together Aortic Registry, a prospective post-market registry, with Dr. John Henretta, a principal investigator for this new registry.

Dr. Henretta is a vascular surgeon in Asheville, North Carolina with extensive experience in thoracic aortic aneurysm, abdominal aortic aneurysm, carotid artery disease, carotid artery surgery, and aneurysm repair. He's board certified in vascular surgery and is a member of the Society of Vascular Surgeons and American College of Surgeons. His clinical research consists of co-authoring more than 20 peer-reviewed articles and participating in numerous clinical trials over his 21 years of experience. Welcome to the podcast, Dr. Henretta.

Dr. Henretta: Thank you. 

Moderator: We're going to talk about the Gore Together Aortic Registry today. There are multiple registries underway; what makes this registry unique? 

Dr. Henretta: I think it is a registry that continues a previous registry that we were involved in with Gore, and it allows us to look at some of the newer devices that they've brought out such as the iliac branch endograft, as well as their conformable device, two devices that we enjoy using, and it will allow us to gather information about how that is functioning in the real world experience.
The fact that it's global is certainly very nice. 

Moderator: Can you tell us about the number of patients, minimal inclusion/exclusion criteria, number of pathologies, etc.? 

Dr. Henretta: Yeah, it's a very large volume. There is very minimal inclusion and exclusion criteria. It allows you to include patients using those devices, and then you collect data and allow the company to review that data so that we can get a better understanding of how the devices are used in the real world and how they're benefiting patients and any potential challenges that they also present. 

Moderator: I understand enrollment for the Gore Together Aortic Registry is planned to be up to 10,000 patients. Why is the number of patients important?

Dr. Henretta: Well, when you do a standard clinical trial, you have a set number of patients. Usually it's a couple hundred patients. You're looking at a very specific goal in terms of trying to figure out, is that device safe and is it something that can be used in certain circumstances? The nice thing about a registry is it's a very, very large volume of patients over an extended period of time, but you don't go into it with just a set number of things that you're looking at. It allows you to sort of evaluate the experience that different people have had, a global experience, and then interpret those situations in terms of, you know, what specific areas it can be very beneficial in, and, you know, how people are using these devices in different parts of the world. And we can then learn from each other different techniques that can benefit our patients. 

Moderator: This registry follows on the heels of the GREAT Registry, which is also sponsored by Gore. How does this registry build on that? 

Dr. Henretta: We were fortunate enough to be involved in the GREAT Registry, and we had a very nice experience. We gathered a lot of information and understanding of the device. It was looking at the repair of infrarenal abdominal aortic aneurysms using the Gore classic endograft. It builds upon that with newer devices that Gore has come out with including their Iliac branch endograft, their conformable device as well as their thoracic device. Our experience as far working with Gore Medical has been excellent and we certainly look forward to continuing that experience with these newer devices. 

And I do think that, you know, the changes in medicine are pretty dramatic in that when I was in medical school, a long time ago, as well as residency, it was relatively rare to have a female in general surgery, or a female in certainly in vascular surgery, whereas now we just hired a new partner, but as we did so, we realized that greater than 50% of the people being trained now in both general surgery and vascular surgery are females, and I'm glad to hear that the company has recognized this as well, and that they are participating, and I like to think that we're fairly blinded to color or sex, but at the same time, I do think it's nice that there is a substantial representation, and it's also excellent that a female physician is actually the PI on a global experience like this.

Moderator: I understand another significant difference is that prospective imaging will be collected for most patients. Why is that impactful? 

Dr. Henretta: A lot of registries will look at the patient once the device has been implanted and try to see how the device functions and how the patient benefits in this. It's nice because it actually looks at the patient's information before the device is placed, and it allows you to understand what the physician's thought process is, as well as the planning of the procedure itself, and that can be very helpful in trying to communicate to other physicians when and how the devices may be beneficial. It is certainly a little bit more resources required to do such, and certainly a little bit more costly, but I think the benefits will be substantial.

Moderator: How will that make a difference in reporting out registry results? 

Dr. Henretta: I think it will not only give you what happened after the implant, but it will also give you an idea of what was the patient's challenges going into the implant itself. 

Moderator: Why don't registries typically include imaging collection? 

Dr. Henretta: I think, again, it's probably because of the substantial increased resources required in gathering that information. 

Moderator: You and your team in Asheville recently completed the first case as part of this new registry. Why is that an exciting step? 

Dr. Henretta: Well, it was nice to get things rolling. We had a very good experience with the previous GREAT Registry and being able to participate in this, and getting started early was very helpful. I think one of the nicest things about being a part of a registry is not only that we get to experience the different devices and exchange ideas with other investigators, but the nice thing is our patients are frequently excited to find out that their procedure not only will help them but can help other people better understand the devices that we're using. Certainly, what we have available to us in our lab here in Asheville, North Carolina can be very different from what might be available and being used in the West Coast or in a different country. And I think that exchange of ideas is very beneficial.

Moderator: With multiple pathologies being treated as part of the registry, what specific procedures or therapies are included? 

Dr. Henretta: It will continue with the repair of abdominal aortic aneurysms but this time with perhaps more angulated necks and other neck challenges used in the conformable device. It will also include the iliac branch endograft looking at aneurysmal disease in the iliac arteries and how to try to maintain perfusion into the internal iliac artery with that device. And it will also include a thoracic and endovascular repair of pathology such as aneurysmal disease as well as dissections.

Moderator: What are you most looking forward to in terms of participating in the registry and/or the data gathered? 

Dr. Henretta: Again, I think the nicest thing is discussing the situation with the patients, letting them feel like they are participating and learning about the devices and helping physicians better treat their patients. I think as a physician that enjoys research, our primary goal is to provide a patient with state-of-the-art treatment but also ideally enhance their medical care, and registries such as this greatly do that by sharing ideas and better understanding how the devices work on a real-world, day-to-day basis. 

Moderator: Why are real-world results important? 

Dr. Henretta: Because that's, in reality, how the devices are being used on a day-to-day basis. And we learn how to do different parts of the procedure more safely, understanding different techniques that other physicians may use as well. 

Moderator: What insights are you hoping to gain? 

Dr. Henretta: I think the best thing that we can gain is just how to better treat our patients as safely as possible and understand the limitations as well as the advantages of these different devices that we're using. 

Moderator: Thank you for taking the time to speak with us today, we really appreciate it. 

Dr. Henretta: Oh, well thank you very much.

Moderator: That does it for this episode of Vascular Voices. Thank you to Dr. Henretta for being our guest. To find more podcast episodes, visit our website at vasculardiseasemanagement.com or you can find us on Apple Podcasts and Spotify. Thanks for listening.

Only commercially approved devices are included in the Gore Together Aortic Registry and some products may not be available in all markets. If an adverse event occurs with a Gore device, it must be reported to Gore. Contact Gore Product Surveillance by email at medcomplaints@wlgore.com or call +1 800-528-1866, Ext. 44922.

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