Good Closure Starts With Good Access

Can you tell us about your practice?

We do all kinds of vascular procedures, both arterial and venous. On the arterial side, we of course perform coronary interventions and also peripheral vascular interventions. We do a great deal of lower extremity work using atherectomy, treat renal disease and mesenteric disease, and perform carotid stenting. My work is probably about 70% peripheral arterial disease-related.

How long have you been using the Axera device?

We have been using it for five months. Several physicians have championed the device at our hospital. We went through an evaluation process, and looked at the numbers very critically as far as complication rates. At this point, for me, the use of Axera has become standard on both interventional and diagnostic cases.

What drove you to consider the Axera device?

The main thing was that we did not want a device where the operator had to be so positionally dependant. Prior to the Axera, we had a closure device that we felt fairly comfortable using. Our success rate was probably about 90% if we were able to deploy it, but 30-40% of the time, we were not in a location where it was possible, because we were too close to the profunda or branch vessels.

The Axera is an excellent device, because first of all, no material is left behind, which I like. I also like the fact that if it initially doesn’t deploy, you have a bailout (similar to our previous closure device), because you still have a wire in place and have the option of a standard pull.

Approximately how many patients have you done with the Axera device?

We have probably done over 300 patients at this point.

What are the benefits you have seen with Axera?

The huge advantage for us with Axera has been both patient and nursing satisfaction. In the past, we used standard pull techniques. With that standard pull technique, we did not have very many complications; on the other hand, we had many nurses experiencing problems with their wrists and carpal tunnel syndrome. Plus, tying up a nurse for 30-40 minutes was a real issue, particularly with our interventions. Now the nurses are begging us to use Axera.

The Axera is the first device that I have used where I have been satisfied with the results in my interventions using 6, 7, and 8 French sheaths. The Axera reproducibly closes very well and patient satisfaction is excellent.

What has been your experience with the more complex patients — calcific arteries, patients that have had multiple caths, and obese patients?

We have had no problems using Axera on obese patients or multiple cath patients. If the patient is morbidly obese and you are afraid you will not be able to reach with the device, that is an issue, but it is also very rare. If we have a very heavily calcified artery, then we do not use the Axera in that patient, and certainly if I am concerned about a lot of iliac tortuosity or a possible high-grade lesion at the common iliac, then I avoid using it as well. I have had problems with advancing the J wire, the tip of the device, through those situations. Typically you can manipulate it, but I will avoid using the Axera if the anatomy is very tortuous as shown on CT or initial angiograms, or if I am concerned with an iliac lesion.

Do you have any advice for those who are beginning the learning curve with this device?

The main thing is to be patient. There is a short learning curve to this device. We have had a great deal of support here for Axera use, fortunately. It can take 10-15 procedures before you are truly comfortable. Many people, after one or two failures, typically try to throw a device out the window. I would say be patient, because we did have some initial issues early on, but I don’t think they were device related. Rather, they were more technique related, because looking back, there are things that I do now that could have salvaged certain situations. Be patient, work through the different anatomies of your patients, then your success rate with this device will be very high.

Can you describe more about what you learned as your technique progressed?

I have learned quite a few things that work for me. First, once you get the initial blood flow, stop advancing the device. Initially, I was advancing slightly too deep and then I would deploy the foot pedal. The foot pedal would then catch on the back side of the vessel and I couldn’t pull it back up to the arteriotomy site. Now I just go until I start seeing the blood return, then I deploy the foot pedal. I think that helps out quite a bit and results in very little drag pulling back. The second thing I am doing now is advancing the plunger only until I see flow come back, and not all the way to the hub. Initially, I think I was deploying the plunger a little too deep, and in doing that, the second wire was not going up as smoothly as it should.

Has the Axera device affected patient discharge?

If we do the procedure early in the day and the patient lives nearby, I am very comfortable sending patients home in the afternoon after an intervention. Typically, once the device is out and after the anticoagulation has worn off, the patient is able to sit up and ambulate, and go home a few hours later.

Have there been any changes in the follow-up care for your patients in regard to pain or lumps at the groin site that you might see a week or several days post procedure?

We have not seen any with this device. We have not seen any inflammatory response or late complications. Any problems have been early on, usually in older, small females, which always have a tendency to have some bleeding issues and so we are just extra careful with those patients and watch them slightly longer.

How would you compare this to the other closure device options you have in your lab?

I think the Axera is less difficult to place than our other devices; however, there is a learning curve. Our response has been better. We have had fewer complications, and a higher rate of deployments and success rates than with other devices. Out of all the closure devices we have used, Axera has given us our highest success rates although we have only been using it for a few months. Our success rates of deployment continue to improve. We now have a high comfort level with the device and in our ability to make changes to our deployment so that we are more successful in complicated patients. I look forward to changes in the device in the future that will make it even better.

Any final thoughts?

It is a huge advantage to the hospital if you can discharge patients on the same day. As time goes on, I think it will be standard of care after interventions, particularly peripheral interventions, to discharge patients home the same day. Initially, we weren’t comfortable with doing same-day discharge until we knew from experience that it was going to be safe. We have in fact been very overcautious, so now, having several months behind us, and initially just sending home just the first or second patients of the day, I think that is going to turn into more and more patients going home the same day as our comfort level continues to grow.

Dr. Foster can be contacted at rfoster@birmingham.com.

Can you tell us about the areas you manage at St. Vincent’s East?

Shannon Vaughn, RN, RT(R), Cath Lab Manager: I manage the cath and electrophysiology (EP) labs.  We have four total labs: three for cardiac and peripheral cases and one for the EP lab. We average around 700-850 procedures for our monthly volume.

Rhonda R. Ash, RN, Vascular Care Unit and Cardiac Progressive Short Stay Manager: I manage a total of three departments, but the two departments relevant to our discussion are the pre and post areas of the cath lab. One is a 20-bed unit called the Vascular Care Unit (VCU). In the VCU, we get the patients ready, send them to the cath lab, receive them back, and send them home. I also manage our overnight stay unit, a 10-bed unit called Cardiac Progressive Short Stay (CPSS). The CPSS receives patients who had interventions in the cath lab and need to spend the night. It is basically a 23-hour admit unit. These patients may actually start out in the VCU. We will prep them, get them ready, send them to the cath lab, the cath lab will do the intervention, and then the patients will go to CPSS to spend the night and go home the next day.

When did you first start using the Axera device?

Shannon: In February 2012. Initially we trialed the device on 100 patients, and then we decided to do our own in-house three-month trial, which was recently finalized with almost 300 patients.

Did you expect that the Axera device would have the impact it did?

Shannon: From the beginning, we loved the thought of anything to help us with holding pressure — anything that lessens hold times. We have, in the past, tried several different closure devices, but seemed to move back to holding manual pressure for majority of our patients, due to an inability to deploy devices because of the location in the artery, inability to obtain hemostasis, or just physician preference in terms of not leaving any foreign material behind. We have been doing manual compression for many years. 

How does manual compression affect patients and staff?

Rhonda: Holding pressure over someone’s groin for 40 minutes, which is the hold time for our interventional procedures, can be very uncomfortable for the patient, and it is difficult for that staff member holding that pressure. We have had staff get injured and have to go through workman’s comp. As a result, they might need to be on some type of leave or have their work duty changed, because they cannot hold pressure until they heal. It has been a huge issue for us.

Can you tell us about patient groin prep and post procedure care before and after the Axera device?

Rhonda: Once physicians knew they were going to use the Axera device, it is possible they could plan on sending the patient home rather than have them stay overnight. However, that is not something the physician determines until the procedure takes place.

Post procedure care has changed. It used to be that when we got a diagnostic case, the patient would come back from the cath lab, we would pull the patient’s line, and they had to stay flat until it came out. Then we would pull the sheath, hold pressure for 20 minutes, and then raise the bed up about 30 degrees. Patients would get a pressure dressing, sandbag, and could go home in 6 hours. With the Axera device, the staff likes it because it decreases their hold time. The patients love it, because they don’t have to lie flat for a long period, and then don’t have a staff member pressing on their groin for 20 minutes or longer. Patient bed rest time is shorter and our patients are much happier, because whether they get to go home or not, they can get up and walk to the bathroom, versus using a bedpan.

How specifically have hold and ambulation times changed with the Axera device?

Rhonda: With manual compression, we hold 20 minutes for diagnostic cases and 40 minutes for interventional. If patients receive an Axera device, we hold 5 minutes for diagnostic cases. For our interventions, mostly we have been holding 10 minutes. Sometimes it is 15 minutes to hemostasis, but most percutaneous coronary interventions are a 10-minute hold, meaning with Axera we save at least 30 minutes time in holding pressure. Diagnostic patients with the Axera device sit up at 15 minutes and interventional patients sit up at 45 minutes. Ambulation for diagnostic patients receiving manual compression is 6 hours, but with the Axera device, our diagnostic patients ambulate at one to one and a half hours. For our interventional patients, there is really no consistency as far as when we are ambulating them, but I would say it is generally at about 2 hours with the Axera device, versus 6 to 12 with manual compression. Peripheral cases with Axera ambulate at 4 hours, while those with manual compression must wait 10 hours before ambulating. We frequently use the Axera for our peripheral atherectomy cases and for the late in the day cases, too. It helps across the board.

Has throughput been affected as a result of the Axera device?

Shannon: I would say our throughput has definitely increased.

Rhonda: Yes, there has been a definite increase. It has certainly helped get patients in and out. If you can get a patient’s line out sooner, and get them sitting upright and eating, and get them out the door, a bed is freed up that much sooner. It also reduces the time that staff has to actually spend in the room one-on-one. When you are pulling a sheath, whether it is a tech or RN that is pulling it out, that person is tied up for anywhere from 20 to 45 minutes at a minimum. Sometimes a 20-minute hold might turn into a 30-minute hold, and a 40-minute hold might turn into 50 minutes or an hour. The shortened hold times with Axera have certainly helped a great deal.

How is staff that previously suffered injuries from holding manual compression reacting to the Axera device?

Rhonda: They are still holding pressure and it is much easier.

Shannon: The decreased hold times make it much easier for the RNs and patient care technicians (PCTs), so they definitely prefer that the Axera access device be used.

Rhonda: Staff really likes it, because it doesn’t tie them up in a room for 40-plus minutes. They are definitely happier. Patients are happy, because they are not lying flat as long, and they can go home sooner. It’s a win-win.

Things seem optimistic.

Shannon: It has been a good trial with good results. We were able to send some interventional patients home the same day and patients discharged home 2-3 hours post diagnostic procedures.

Rhonda: We have seen some patients that have had arteriograms and interventions in the past and who went through the traditional method that we use here, come back for an additional intervention with the Axera, and they loved it. We have also had some patients who had a procedure with the Axera, and then were sent home for a few weeks. When they came back, and the Axera wasn’t used, for whatever reason determined by the physician, these patients were not happy. They made comments like, “Oh, why didn’t he use that again?” or “It would have been so much better [with the Axera].” They said they enjoyed being able to sit up and eat, and get up and go to the bathroom. These things are the two most important abilities for patients. They really enjoy the Axera.

Shannon Vaughn can be contacted at Shannon.Vaughn@stvhs.com.

Rhonda Ash can be contacted at Rhonda.Ash@stvhs.com.