Willis Knighton Medical Center Delivers Implant-Free Femoral Closure for PAD Patients: The AXERA Access Procedure improves hospital throughput and reduces groin complications.

Can you describe your lab and practice?

Willis Knighton Medical Center has 4 cath labs and 2 electrophysiology (EP) labs, including a brand-new hybrid room. We perform standard peripheral procedures with stenting almost anywhere in the arterial anatomy, but primarily we focus on the area below the groin, and more specifically, therapy below the iliac-inguinal ligament. Most of the patients in our practice tend to be recurrent. They come back for recurrent lesions as well as de novo lesions, so we frequently perform multiple procedures on our peripheral arterial disease (PAD) patients. I typically do between 250 to 400 peripheral procedures a year, and also do some cardiac procedures. Probably 30-40% of my cardiac procedures are done from the radial approach, and the rest of my cardiac procedures are from the femoral approach. My peripheral procedures, however, are all almost all done from the femoral approach, with a minority of cases demanding a popliteal approach.  

Is that simply because radial access is too far away?

Yes, we don’t have catheter systems or therapeutic devices yet that can travel that far distal. Plus, working from the groin area is just a little easier on the operator. It means less radiation and is a little more time efficient. Plus, most of our catheter systems are best utilized from the femoral approach, because that is the way they have been designed. 

What are some of the difficulties with access and closure that led you to the Axera Device? 

Many peripheral patients have already been intervened upon multiple times, and each time an external or internal closure device is used, a great deal of scar tissue is left behind, not only on top of the vessel, but also in the tract. It makes it more difficult to obtain femoral access in the future. In addition, we have subsequently seen further and further plaque buildup, and other further narrowing of the common femoral artery, which is our access point. 

We like to utilize the Axera Access Device because it can be used to gain access across multiple procedures in the same patient. After the case, the Axera procedure works in a very similar fashion to standard manual compression, but the overlap within the arterial wall of the Self-Sealing Arteriotomy delivers a much more secure bond.  The Axera Device, simply put, creates a very low angle arteriotomy, and that significantly longer path through the arterial wall allows for much greater tissue-on-tissue adhesion than the short path of a standard arteriotomy. The natural tension in the femoral artery wants to always pull apart the standard arteriotomy, and that is why standard arteriotomies need sutures, staples or other implants to plug the hole.  Axera Access does not create a hole and instead uses the overlapping tissue in the vessel wall for very secure closure. It is like an organic approach to closure.    

In our experience of over 300 cases, once the sheath is pulled and hemostasis has been achieved, it is very unlikely to see a rebleed in the hospital and there has never been a reported post-discharge late-bleed with the Axera procedure.  Once that tract has been sealed, it is virtually impossible to open it up again, even with patient non-compliance, such as being up a little bit too early, rolling over in the bed, or Valsalva with either coughing or a bowel movement. This gives me great confidence in the procedure.

When I speak with my surgical colleagues, who do many endarterectomies and other surgical procedures on our peripheral arterial disease patients, they tell me they can quickly assess which patients have been instrumentalized with closure devices. They speak of the scar tissue on both the outside and the inside of the vessel, as well as scarring in the tract itself, that results from the use of active closure devices. That is something that we as interventionalists see a lot of as well. Using the Axera Access Device in our peripheral patients means we don’t have to worry about leaving a scar and infection-causing nidus in the vessel. 

Which peripheral patients are most appropriate for Axera use?

I tend to shy away from any closure device when treating patients who have a high degree of calcium in the common femoral region. Calcium makes an arteriotomy difficult anyway, and it certainly makes it difficult for any closure implant to work appropriately. To assess the disease in the common femoral artery before I start the case, I always put a hemostat or some sort of metallic marker up near the groin area, so I can find the lower edge of the femoral head. Once I find that inferior border, at the same time, when I take a quick fluoroscopy shot, I also try to visualize if there is any calcium in that region. If I see a high degree of calcium, I simply won’t use a closure device. I also used to have difficulty advancing the Axera Device through these heavily diseased vessels, but with the new angled-tip Latchwire they bundle with the device, I am able to treat patients I have never treated before. Once the Axera Device is in the patient, there are rarely any issues with deployment and the creation of the self-sealing arteriotomy.   

I also stay away from using closure devices and the Axera Device in patients with any prior surgical procedure. If the patient has had a femoral-popliteal bypass, for example, or if they have had an endarterectomy with a patch placement from a previous surgery on that common femoral region, then I stick with a standard arteriotomy and delivery standard manual compression. If the vessels are not extremely calcified and I can visualize the vessel well on my fluoroscopy evaluation, then I generally use the Axera Device on all my femoral access patients. 

How long have you been using the Axera?

I was one of the first operators to handle the device two years ago when Arstasis did their first trial, called RECITAL.¹ RECITAL showed that the Axera is very safe and very comparable in terms of patient throughput to any of the other closure methods, and is probably better than manual compression on a standard arteriotomy. The primary author of the RECITAL Study was Dr. Zoltan Turi. I was the primary investigator at our institution and I began using the original device at the time of the RECITAL trial, and moved to the new Axera device when Arstasis released their second-generation device last year. The second-generation Axera offers the operator a choice between a J-tip and angled-tip Latchwire. The angled-tip Latchwire makes it easier to navigate up smaller, more diseased, or more tortuous blood vessels such as what you might find in small, elderly female patients that come in with peripheral vascular disease. Also, the distal shaft of the Axera 2 Device received an update as well.  The micropuncture needle that forms the self-sealing arteriotomy is captured in the distal end of the device. This new design has made for much more reliable deployments in my patients and even more consistent outcomes post-procedure. I have found the new Axera 2 Device to be much more effective and much more predictable. 

What is your protocol for use of the Axera Device?

My protocol, first of all, is to make sure that the patient doesn’t have any complicating factors, i.e., no surgery or graft placement in their groin, and no severe degree of calcium in the site. I will use the Axera Device in patients requiring up to a 7 French sheath and I do so commonly, but use of a much larger sheath size is not recommended, so I try to stay away from using 8, 9, or 10 French sheath sizes with the device (which I use in some of my peripheral interventions and endograft placements for abdominal aortic aneurysms). 

For interventional patients, if the patient is heparinized, the nurses will first check the activated clotting time (ACT). The ACT must be less than 180 before the nurses pull the sheath. Once the sheath is pulled, the nurses hold manual pressure for about 5 minutes. Then they are able to take what I call a ‘peek.’ If there is hemostasis at the puncture site, they stop holding pressure, assess the groin and dress the site.  If it is a diagnostic-only patient study, the nurses can pull the sheath in the lab and only hold pressure for about three to five minutes, then take a peek. Within 30 minutes we sit all our patients up, diagnostic and interventional, to 45 degrees.  For diagnostic patients we will ambulate them 1 hour post-hemostasis and our interventional patients are ambulating 2 hours post-hemostasis. We essentially follow the protocol of the RECITAL study, and have found it to be effective and beneficial for our patient throughput.

Have you seen Axera Access benefits for patient throughput?

Yes. Our recovery area has 15 beds, servicing 4 cath labs and 2 EP labs. We get pretty overwhelmed at times in terms of patient numbers, and so if we have a 35- to 40-patient day, it is nice to have our peripheral patients that are being treated actually go home at that hour to hour and a half mark after ambulation, versus staying and laying flat for four hours with standard arteriotomy and manual compression. The diagnostic studies are fabulous — they are heading home typically 2 hours post-procedure. It is very helpful to open up that space in the cath lab. The nurses love the Axera Access cases, and the hold times are much shorter and the patients are leaving in half the time of our standard manual compression cases.  

Have you seen an impact on cost?

We are a hospital-owned lab and I have not gotten much feedback on cost, but we are clearly saving money, because it is less patient time in the holding areas and this has allowed our nursing staff to be much more productive.  

What about recurrent access in your peripheral arterial disease patients?

By making a very narrow, shallow tract in the vessel wall with the Axera Access procedure, you are not left with a blunt hole as with a standard arteriotomy. You are also not left with the remnants of a closure device implant, which seem to be a nidus for an inflammatory reaction, potential infection, and subsequent scarring and narrowing of the vessel. I have not experienced any limitations on being able to perform immediate or longer-term re-access on my Axera patients.  Most of our peripheral arterial disease patients are repeat offenders and keep coming back with new lesions in their vessels. These tend to be the vascular disease patients who do not do well with closure devices, and often are the ones who have groin complications. Axera Device use has really decreased the number of groin complications that we have seen — as the implant-free Axera procedure eliminates all implant-related complications. I appreciate being able to use the Axera Device over and over again on these patients, knowing I am not leaving anything behind. The vessel has the opportunity to heal normally rather than having an active closure device to have to heal around.

How long does it take to gain femoral access with the Axera Device?

From the time that we enter the artery to the time that we have the sheath placed, it is probably less than 30 seconds. 

How does length of stay for Axera patients compare to your transradial patients?

In terms of timing, both groups are about the same. The intervention patients I treat radially can sit up almost immediately. The radial procedure seems to be slightly more painful during the introduction and pulling of the sheath, so I tend to sedate my radial patients a little more, and as a result, they don’t ambulate for at least an hour after their procedure. I don’t have to heavily sedate my femoral patients receiving an Axera Device so the ambulation time is very comparable — both can get up within an hour.

My feeling is that when you are doing coronary-based interventions, femoral access is still the best approach as the guide catheters sit very nicely with femoral access. The biggest advantage to Axera use is when we are doing difficult coronary interventions. We have the ability to upsize our catheter sheath size, which is more difficult to do in the radial. The patient experience seems to be very good with the Axera Device for our coronary interventions. Patients also have less time in the lab, and their ambulatory times are very quick — just about the time that the sedation has worn off, they are able to sit up at 45 degrees and ambulate very soon after that. It is very similar to how our radial procedures work. 

You mentioned nurses have a shorter hold time. What has been the impact on staff with the use of the Axera?

Staff likes the device. They like the quick patient ambulation and the low number of problems we have experienced with the device. The staff has really welcomed the Axera procedure, because it means less hold time and is less strenuous on them. With a traditional arteriotomy in a heparinized patient, we are on pins and needles for a few hours after the procedure. We have to rely on patient compliance, asking patients not to get up or move around too much in the bed. With the Axera Device, we don’t worry as much about complications. We have confidence that once the tract is closed, it is truly closed.

Disclosure: Dr. Smith reports no conflicts of interest regarding the content herein.

Dr. Ray Smith can be contacted at: drraydsmith@gmail.com

Reference 

1. Turi ZG, Wortham DC, Sampognaro GC, Kresock FD, Held JS, Smith RD, Veerina KK, Hinohara T, Kaki A. Use of a novel access technology for femoral artery catheterization: results of the RECITAL trial. J Invasive Cardiol. 2013 Jan;25(1):13-18.