Transfemoral Axera Access Procedure is Competitive with Transradial Approach in Fluoro Time, Complication Rates, Patient Satisfaction, and Throughput

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

Can you tell us about your practice and facility?

Anderson Heart is a small to mid-size practice serving a relatively small area in South Carolina. Our area hospital does on the order of 1,000 to 1,200 coronary interventional cases per year, with probably an additional 500 to 700 peripheral cases. I probably do 300 to 400 cases (coronary and peripheral) on a yearly basis. We serve a relatively small area in South Carolina, and see a lot of tobacco use, diabetes, and obesity. 

Do you perform both radial and femoral access?

Yes, radial represents probably 10% of my cases. I have done radial since 1998 or 1999, but I prefer the femoral approach because of the speed factor. I am much faster at a femoral approach than a radial approach. It is a little awkward for me doing radials, and I know other people don’t have that experience or tend to get over that, but at least personally, I prefer femoral access. There are also more avenues for device utilization using a femoral approach as opposed to radial. You are not constrained by catheter size or equipment, which can be an issue in a radial scenario. We do have patients asking for a radial approach just to minimize their bed rest, but the Axera Access procedure has nullified that argument in large part (Table 1).

What are the benefits of femoral access?

There are quite a few, mostly revolving around the issue of guide support. The majority of the commercial guides on the market today were designed for a femoral approach. At times, a radial approach, even for diagnostic purposes, does not give the catheter or guide support that you would hope for or need. As a result, the procedure can be longer and/or more risky if you don’t have excellent guide support to help facilitate delivery of equipment or contrast injections. A good picture is certainly worth a thousand words. If you have poor pictures as a result of your choice of access site, it means using more contrast, more radiation and potentially putting that patient in harm’s way. If you talk to operators that favor the radial approach, they would strongly argue that catheters are available to overcome these sorts of obstacles. That is true, but my interest is speed and getting it right the first time. 

What appealed to you about the Axera?

I thought the second-generation Axera 2 Device would fit well in the confines of my practice, and it has turned out to do so. The second generation has a molded needle track that guides the micropuncture needle into the correct position. Use of the Axera does not mean you are abandoning the traditional femoral access approach; this device is an attempt at modifying and hopefully improving it (Figures 1-3). I like the idea of earlier ambulation as compared to manual pressure, and even though that is an important aspect, my main thrust for using the Axera was trying to reduce my complication rate, mainly from pseudoaneurysms and hematomas, and similar problems resulting from catheter access.

What was your complication rate was prior to Axera use?

We probably had a 4-5% hematoma rate and 1.5% pseudoaneurysm rate with traditional arterial access. It seemed to vary depending on staff experience, i.e., were there new graduates coming in that weren’t used to holding pressure? It almost seemed to vary with the month, which was interesting. We tried to track whether there was a specific user or a specific group of users that had more of a complication rate, and couldn’t find one. Introducing the Axera device was an attempt to unify the access site tract with a reduction in complications by taking the manual hold out of the equation, or at least to minimize that aspect. 

We have probably used the Axera in close to 150 or 200 cases, for roughly 4-6 weeks. Since we began use, there has been a single pseudoaneurysm and a single hematoma, and so from that standpoint, it has been a nice decline in our complication rate. Cath lab throughput has improved as a result of the 1-hour bed rest. With the reduction in complication rate, the Axera is now, in my mind, on even footing with radial. Now it is purely operator preference as to choice of access site. 

What are your post procedure ambulation times with the Axera?

For diagnostic patients, we raise the head of the bed to 45˚ at 15 minutes, and ambulate at 1 hour (Table 1). For interventional patients, I use bivalirudin 99.9% of the time, so the sheath pull is 2 hours and 15 minutes after the cessation of bivalirudin, and then we use the same algorithm; it will be an hour after that sheath pull that the patient can sit up or ambulate. It does depend on the sheath size. If I have to upgrade to a 7 or 8 French sheath, then I will extend that time a little bit. 

Is there a post procedure protocol in place?

Yes, we have a set of preprinted orders, and the company clinical representative has spent a great deal of time training a core focus group of staff, and those staff members have then gone out and trained others. 

How receptive has staff been to the device?

There was some initial resistance, because everybody is used to holding for 15 minutes and then bed rest for 3 hours, depending on institutional protocol, but as soon as a few patients did well and ambulated with no problems, the staff wholeheartedly embraced it. They actually get a little mad at me if I don’t use the Axera Device, because they don’t want to hold pressure any longer than they have to.

Do you have any tips or tricks based on your experience thus far?

If the patient has a significant amount of peripheral arterial disease, the Axera can be a little more difficult to use, because an integrated micropuncture needle inside the device is used to make the low-angle arteriotomy. If you happen to hit a lump of calcium, sometimes it is a bit harder to get the micropuncture needle in, or if you happen to hit an area of significant fibrosis, that can make it difficult as well, so it is more of a local problem. If the iliac artery is very tortuous, sometimes that makes it a little tougher to get the attached Latchwire in the artery to fully deploy the device. The nice thing is that even if the device can’t be deployed, you don’t have to pull it out. The J wire will separate from the distal end of the Axera Device. Using hemostats on their tightest setting, you simply detach the Latchwire from the distal tip of the Device, and then it can be used as a traditional J wire. 

Are you screening patients prior to Axera use? 

No, I am using the Axera Device on all comers, and part of that decision is based on the fact that I am in the midst of my own evaluation period. I had planned on giving this device a 6-month trial, then evaluating the difficulties and the complication rates to make a determination as to whether I will continue use. However, as it stands right now, the Axera is most likely a permanent part of my armamentarium. The Axera is well suited for a busy cardiologist with a high cath lab volume. It allows the operator to have less lead and fluoro time, less contrast utilization, can lower the groin complication rates, and improve hospital throughput, yet doesn’t give up any of the perks of femoral access that we have all come to enjoy. It is a nice advance in the access and closure space.