Implant-Free, Self-Sealing Access Procedure — Organic Approach Enhances Hospital Throughput at Sinai Hospital of Baltimore

What do you like about the AXERA device?

We have been very impressed with the AXERA for many reasons. The number-one thing I like about it is the fact that there is nothing left behind. There is no product left behind: no collagen, no string, nothing. We could consider this an “organic” approach to access and closure.

What about gaining access with the AXERA?

You just use the standard percutaneous access system. You can use the needle that comes with the device, which is slightly smaller, but you can just access the artery just as you would in any other place. Which is another nice part of the device.

How did you find the learning curve? 

A little steeper than with some of the other devices, because you have to do things in the right sequence, and interventional cardiologists like to get in and get out. Once you stick some and do it for a few cases, however, it can be mastered. 

What other benefits do you see?

If there is a problem, it is easy to switch back to conventional access. Because nothing needs to be done at the end of the procedure, room turnover time isn’t delayed. In our lab, the patient moves out and the procedure is handled as though there was no device whatsoever. It is a conventional pull — but it happens more quickly and with fewer complications.

What about time to access?

Compared to no device whatsoever, it adds about 1 minute. Compared to all other devices, it is probably the same amount of time once you are comfortable. Of course, the time in the recovery area is much shorter.

Are there particular patients you tend to consider for the AXERA?

Generally, for conventional diagnostic procedures, I use 5 French and I do most cases through the leg. I am now using the AXERA on all my diagnostic procedures. The other beauty of the AXERA is that it doesn’t matter whether you are performing angioplasty or a diagnostic procedure; it is the same device. One size fits all. If you upsize the sheath, you still use the same fenestration. 

For those who haven’t yet used the AXERA, what would you say?

If you make a commitment to spend a little time learning the device, once you are comfortable with it, access goes very quickly. It is very safe, reproducible, and patients love it. 

I have had troubles with some devices where materials are left behind. We had allergic reactions to one particular device a few times. With another device, we experienced adverse vascular closure. There is no risk of these things occurring with the AXERA. I don’t really see any down side to the procedure. Once the procedure is finished, the patient is recovered in our recovery area. Our complications data in AXERA patients is pretty impressive. We are becoming more and more comfortable with the device and are using it more frequently. 

How would you compare it to the safety and efficacy of transradial access?

That is an interesting question. When we talk about transradial safety, the data we have compares it to older technology femoral approaches. It would be very interesting to compare the complication rate with the AXERA device in the leg versus radial. I would bet the complication rates are no different, and that the AXERA cases would require less radiation and contrast. 

What about patients with peripheral vascular disease?

I generally do not use closure devices in peripheral cases. By definition, peripheral patients have lower extremity vascular disease, so I don’t like to put in any closure devices. I have used the AXERA twice in peripheral cases, with no problems in those two patients, although that is a small population.

What do you see happening in the future with access and closure?

The price of all these devices is roughly the same. The AXERA does not leave anything behind and the complication rate is extremely low. The upside is tremendous. 

I do like vascular closure devices; I think they have made things better than standard closure. With the AXERA, once you put up with the slightly longer learning curve, the downstream benefit is tremendous. We have been using it with real frequency in the last 3 to 4 months after adopting it 10 months ago.

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