The arstaotomy procedure with the Axera Access device creates a surgically precise, ultra-low angle arteriotomy through the arterial wall and into the artery. The procedure begins with a thin-wall needle to puncture into the lumen of the femoral artery. Then a J-tipped, 0.032” latchwire is passed through the needle and into the true lumen. The needle is removed, and the Axera device is attached to the latchwire and advanced into the artery. Once in the artery, a small heel on the device is deployed, and tension is placed on it to prepare the artery for the low-angle arteriotomy. A secondary needle is then plunged into the arterial wall, creating an ultra-low angle (5-10 degrees) access point through the muscular wall of the artery, called the Arstaotomy. This shallow-angle arteriotomy tract is utilized to place the procedural sheath. This surgically engineered entrance through the arterial wall is what provides hemostasis, because when the case is concluded and the sheath and the hardware are removed, simply by means of the way that the access was created through the arterial wall, it seals up and thromboses.
What appeals to you about the Axera Access device?
The “holy grail” of closure has always been to get successful closure and not leave anything behind, and not have hematomas and so forth. It looks like we have come the closest with the Axera Access device. This device allows you to get out without leaving anything in the artery, obtain hemostasis 99% of the time without any post-op complications like hematomas or pseudoaneuryms, and another beautiful thing is that you get closure at the beginning of the procedure. This is the only device I can think of where you start the case by basically finishing your closure. In most other cases, the closure is the last step of the procedure. Here you start the case by basically finishing your closure. You put your sheath, finish up, and have the peace of mind that you are done.
You followed 750 patients over 6 months who received this device at your center. What did you find?
In 750 patients, we had 2 hematomas, no pseudoaneuryms, and no retroperitoneal hemorrhages. Of course, it was not a controlled, randomized trial, but a single-center experience. For 5F diagnostic cases, our time to hemostasis was 3-4 minutes. For patients who crossed over to interventional procedures, after the activated clotting time (ACT) was reversed, time to hemostasis was 6 minutes.
Some of the other closure devices like Angio-Seal (St. Jude Medical, Minnetonka, Minn.) or Perclose (Abbott Vascular, Redwood City, Calif.) offer instant hemostasis with no holding, which is a big difference. However, these devices are leaving something behind in the body, and they are not suitable to be deployed in every procedure if the artery is calcified, if the stick is a little high or low, or if the artery is small. There are multiple limitations, plus something is left behind. At this point, it almost seems that there are no limitations to using the Axera device. If you get access and deploy your initial needle, no matter where you get access, no matter how you do it, it seems successful closure can be done.
You mentioned calcified arteries.
In clinical practice, it is very possible to use the Axera device in calcified arteries. In the trials,all companies have been more leery to include this patient subset, but we have done all-comers. Severe calcification is definitely a limitation, but in practice, this is the only device we use for very calcified lesions. If there is a lot of calcium, and if you can get access with the Axera device, you have closure. We have done at least 100 cases that were highly calcified. If there is extreme calcification, you probably will have some limitations with Axera, but moderate calcium has not been a problem with this device.
Is any of your staff involved with the Axera device?
Yes, our staff is fantastically cross-trained. Our techs, in fact, have been credentialed to do closure, especially one of our technologists who is very senior, with over 20 years of experience in interventional cardiology, over 10 more years than I have. He has done closure as well and reports the same experience with the Axera device.
We do many endovascular cases, including carotid stenting and abdominal aortic aneurysms, in conjunction with cardiac cases. We probably expect to do about 1,700 cases this year in our two-room cath lab. It is a sizable volume in this day and age for a lab of our size. We have a comprehensive lab. People say Opelousas is a small town, but then they come in and are flabbergasted by all that we do. I am grateful to be able to work here.
How long did it take you to be comfortable using the Axera device?
There is a learning curve, but I think with the newer device (we used the older ArstasisONE generation initially), the learning curve will be a lot shorter for most operators. It probably took about 25 cases before I got the nuances. There is a little operator skill involved, but not that much. It is fairly straightforward. Typically, your whole closure, your entire maneuvering of this catheter, will take you 20 seconds on average. With the latest-generation device, I expect most operators to be comfortable within 20+ cases.
Inserting the device takes 20 seconds?
I would say 20-25 seconds, but of course, we have done multiple cases and are very comfortable. Initially, we probably were more deliberate with all our steps and perhaps it took 30-40 seconds to complete everything, because we wanted to be certain. I think under 30 seconds to perform the arstaotomy would definitely be very reasonable.
How are patients being managed post procedure?
If you are using Perclose or Angio-Seal, you have hemostasis on the table, but with the Axera device, the sheaths are managed by our recovery area staff. They are managing 99% of these cases without any hematomas. We have found the Axera to be very predictable, with no major hematomas, no pseudoaneurysms at all and no retroperitoneal hemorrhages. Patient experience has been very reproducible and positive.
What about the patient’s ability to sit up and/or ambulate after the procedure?
In the trial that we did, for the diagnostic procedures, we had patients sit up and do minor things within 10 minutes, and we ambulated them fairly quickly. We do sedate patients with conscious sedation and don’t allow them to walk right away, but we know they can be sat up quickly. Once the interventional trial is complete, we can see the results with Axera device and anticoagulation on board. At our center, post intervention, we have sat patients up to have minor fluids or simply to semi-recline. We are not pushing the envelope; we are not trying to break any records, but all in all, our experience has been fairly predictable. We go by a 10-minute window. We are not sitting patients up immediately, but as time goes by and we get more comfortable, we might be doing so.
What about re-access, if needed?
Yes, in some instances we had to go back in, and had no problems. I personally have not incorporated intravascular ultrasound, but re-accessing has not been a problem. We have gone in on the site fairly soon after the intervention and have had no problems, and accessed it again with the Axera device, in fact.
Many physicians think, “You are dissecting the artery — you are creating a dissecting plane.” This couldn’t be farther from the truth. This newer, ultra-low angle arteriotomy, or Arstaotomy, as it is called, is highly controlled and does not have any arterial compromise. Not leaving anything behind is also important.
Do you believe the Axera device makes femoral access more competitive with radial access?
I think so. Certainly most the operators in this country are more comfortable doing femoral access. They are trained in femoral access, and the learning curve with radials is also not insignificant. With radial access, you can do hearts and the more experienced operators can probably do carotids, but it has a significant learning curve. Radials, even for experienced operators, involve significant training. A portion of my cases are radials, and I like to do the more uncomplicated cases radially, but if you have more complicated cases, such as coronary bypass grafts or carotids with a lot of disease in the arch, I try to stay away from radials because it is not as simple.
What about cost?
If you are using femoral access, this definitely could become a go-to device. If you look at the cost when you have hematomas and/or other problems, managing about 10 hematomas will probably pay for a whole year’s use of the Axera Access device. If you have one major hematoma or one major arterial problem, the patient is in the hospital for 5 days, receiving transfusions, and we are exploring and following them with different scans. All of these put together are extremely expensive and the human cost is not even factored in. The patient is suffering, anxious and may become reluctant to have any further procedures, even though more procedures may be necessary in the future. It is not insignificant. I do believe it is a viable cost.
The access site is the only visible spot on the patient’s body showing that they had a procedure, and if your closure was uncomfortable or if they had a hematoma, that is what the patient remembers, even if you did a fairly complex procedure. Patients will come back and complain about having a big bruise or that the site was very painful. None of those things have happened with the Axera device so far, and it is very rewarding. That’s a sign that things are headed in the right direction.
Dr. Veerina can be contacted at email@example.com.
Disclosure: Dr. Veerina reports no conflicts of interest regarding the content herein.