Comparison of Two Vascular Closure Device Strategies for Transfemoral Transcatheter Aortic Valve Replacement Using Suture-Based and Collagen-Plug-Based Techniques and Associated Vascular Complications: An Interview With Christian D. Nagy, MD

Dr Christian D. Nagy shares background and insights on his article, "Comparison of Two Vascular Closure Device Strategies for Transfemoral Transcatheter Aortic Valve Replacement Using Suture-Based and Collagen-Plug-Based Techniques and Associated Vascular Complications".

Transcript:

Good morning. My name is Christian Nagy and I'm the Structural Heart Disease Director at George Washington University in a partnership with the Veteran Affairs Medical Center in Washington, DC, where I'm also director of the cath lab. We performed a study in the TAVR arena, and I'm going to present it to you: it's called Comparison of Two Vascular Closure Device Strategies for Transfemoral Transcatheter Aortic Valve Replacement, using two different vascular strategies. One is a suture-based strategy, and one is a collagen-based strategy. We compared those two strategies in terms of vascular complications.

01:07: Could you please tell us what inspired your group to conduct this study?

Essentially, we wanted to contribute to the field. This has been an amazing development over the last decade now. TAVR, when it started, was very regimented. The workup is very clear, the valve choice, and the criteria are important, and of course the procedure itself. However, it's less clear what to do at the end of the procedures and how to close somebody's leg once the procedure is performed, with less guidance from guidelines and the literature. So, there was a sort of a need for more clarity, and we just wanted to contribute a little bit to the field with our study. We want to accomplish good outcomes, and I hope that this study contributes a little bit to fill this gap.

02:35: How do these strategies impact the recovery time and comfort of patients undergoing TAVR procedures?

Transcatheter aortic valve replacement has undergone several steps in improving the process and getting the patients out. The goal is to perform a safe procedure with as little complications as possible and get the patients home as soon as we can. At our institution, the current protocol is that patients come in, most of the time, on the day of the procedure. We do the procedure, they spend the night in the hospital, and then go home the very next day. This is about close to two-thirds, probably three-quarters of the patients. Everybody is a little different. Older patients tend to have more comorbidities and sometimes need a little longer time. But anything that essentially helps transition the patients home safely in a quicker manner should be the goal.

04:01: Are there specific patient populations that may benefit more from one vascular closure strategy device over the other?

Over time, TAVR has been approved to different patient populations. In the beginning, it was approved only for the highest risk patients. Over time, as effectiveness and efficacy were proven in the field, the indications were broadened, and now we can perform TAVR in anybody. The sicker patients are and the older they are in general, have more comorbidities with more vascular complications. I would say that it is that patient population where the vessels are more diseased, and they're smaller as the patients get older, where patients would benefit from less invasive procedures. Obviously, the easiest way to perform TAVR is to gain access to the leg artery and then close the leg artery after the procedure and be done. There are several alternatives available: you can come from the carotid, from the subclavian, from transcaval, or a transapical approach, but every procedure has sort of its own set of complications. Obviously, the less complications somebody can have, the better the outcomes are. One specific patient population would be the older patients , sometimes smaller patients, just by body habitus, and in particular smaller women, who tend to have higher vascular complications.

06:00: Have there been any updates in this space since the completion of the study? And is your team currently engaged in any upcoming research?

I think there there are updates coming in all the time. What we've been working on is trying to refine and understand a little better the difference between these two populations. This study is very valuable. It was done in a time when TAVR was in flux -- we started with very large-bore devices, and, over time, companies made improvements and devices got smaller. Vascular access sheaths got smaller and that facilitated a lot of people to become eligible for transfemoral TAVR access who weren't before. In the beginning, the patient population was higher risk and had a lot more comorbidities. And now, TAVR is open to lower risk patients with better outcomes. So, when we conducted the study, there was a change in patient population over time, and what devices we used. The devices became smaller. And then, second, the TAVR indications have broadened so that we could do not only that very high-risk population that we started with, but also lower risk  So, some of those nuances are reflected in this study and still need to be teased out.

The transcript has been edited for clarity and length.