Tell us about your cath lab.
Del Sol Medical Center’s cath lab has three rooms and is very active. We have 10 cardiologists on staff and each cardiologist does between 400-500 procedures annually. We perform cardiac catheterizations and interventions, peripheral vascular diagnostic procedures and interventions, and also have a very active interventional radiology service performing vascular and non-vascular procedures in the same lab. Del Sol Medical Center is currently building a hybrid lab; construction began in November. This lab is planned for structural heart disease procedures such as transcatheter aortic valve replacement, left atrial appendage occlusion, and eventually, mitral valve closures.
What is the percentage of peripheral procedures?
I would estimate we do 40% coronary procedures and 60% peripheral procedures. Diabetes is very prevalent in south Texas, so we have a great many peripheral vascular disease patients.
What prompted your interest in the Axera access procedure?
One of the reasons is that I am uncomfortable with closure devices where material is left behind. Sometimes the material is gone in a few weeks, but in reality, it may stay in the body for months. I wanted to use a device where nothing is left behind, and once the patient is closed, that is the end. I was also interested in the Axera because I thought that beginning with a different type of access, one that uses a very low angle of entry, would decrease the incidence of complications.
In the beginning, there was a good deal of hesitation on the part of the recovery staff, because externally, nothing about the Axera patient appeared different from a regular arteriotomy and manual compression patient.
The Axera device itself is actually not a closure device; it is an access device. Over time, we witnessed Axera patients present with a much lower rate of hematomas and ambulate in a much shorter period of time. The nurses and technologists in the recovery room actually push for us to use Axera Access whenever we can to improve patient flow and comfort. During the evaluation phase, we expected to use Axera Access as an alternative; now, I use it preferentially over any other type of access, or closure, when feasible.
Prior to this self-sealing access device, did you prefer closure devices or manual compression?
I used closure devices only occasionally, when a patient requested it or had back pain that would prevent them from lying flat for a long time. So I generally used manual compression prior to Axera, but manual compression meant a longer time for the patient lying flat and longer times for staff to hold the groin after pulling the sheath. Now, with Axera, these times have improved.
There is a protocol at your facility specifically for Axera device access. How did it come about?
We adopted our Axera protocol based on the studies that have been conducted with the device, including the RECITAL trial.1 Our electronic patient order forms have a new check-box specifically for the Axera Access protocol. Once that box is clicked, staff taking care of the patient in the recovery room holds pressure for the amount of time specified in the protocol, which dictates five minutes holding good pressure and then light pressure for another five minutes. The patient can ambulate two hours after hemostasis. Recovery room staff loves to see that box checked, because they are not going to work as hard. The patient is going to ambulate more quickly and discharge in a shorter period of time. Because the patients are going home sooner, hospital resources are being freed up, making our holding area much more efficient. Everybody loves it.
What steps did you go through at your facility to implement the protocol?
Initially, we conducted a 100-patient validation of the Axera procedure, testing not only the device, but the shortened time to hemostasis, ambulation, and discharge. The company supported this process with physician, technologist, and nurse education. Arstasis representatives demonstrated best practices in manual compression techniques and helped implement our more aggressive hold time and ambulation protocol. After 100 cases, we reviewed how many complications occurred and quickly determined our new Axera Access procedure had excellent results and therefore, implemented the protocol.
Though the company reports over 50,000 to date, it takes time for everyone involved to trust any new procedure or device. The staff initially approached a 5 French diagnostic patient with the perspective that “we used to hold for 20 minutes, and now you tell me that I only need to hold it for five minutes, and the other five minutes it’s light pressure. I don’t know about this….” Yet after the first 100 procedures, everybody became comfortable, from the physicians to the nurses and technologists.
How was the protocol approved?
Our physicians suggested following the protocol in the RECITAL study. We first sought to determine if the device was worth using. We wanted to see if the study results applied to our hospital, which is why we asked Arstasis do the first 100 cases with us. After we felt comfortable, we adopted the technique and put it in the orders as a protocol.
How long has the protocol been implemented?
About 6-7 months.
What advantages have you seen to having a protocol for the Axera device?
The big advantage is that everything becomes standard. The recovery staff knows exactly what to do when we say to use the Axera Access protocol. Since we converted to Axera Access, we are not only comfortable with the device, but the results are great, both for the patient, in safety and comfort, and for the hospital, in staff and patient comfort. Our protocol is standard and reliable.
Has the hospital been able to reduce resources use as a result?
Instead of manual compression patients staying 6 hours, Axera patients only stay in the hospital two to three hours post procedure. We can send the Axera patients home much more quickly post procedure. These newly found staff hours can then be used to see more patients and reduce personnel. It is very beneficial for the hospital.
What have you seen regarding complications?
Complications have drastically reduced over the past several years, even beyond our use of the Axera device. Ever since staff has become very familiar with holding manual pressure and doing it the right way, the rate of complications has decreased significantly. When I came here 10 years ago, the rate of hematomas was high, perhaps 4%. Now our average rate of hematomas is <1% of all procedures. This is true not only for the cases where Axera Access is used, but also for other patients that require closure devices or manual pressure. The incidence of complications has decreased, simply because we have better technique. Now the physician checks where the puncture is going to be. Everybody is more careful with the access when you are simply paying attention to it.
Do you have the same Axera device protocol for both coronary and peripheral patients?
Yes, we use the Axera device on our coronary and peripheral patients, and we have seen a similar high rate of success in our peripheral and coronary diagnostic patients. Many peripheral patients have difficult access, calcified or tortuous vessels, or vessels that are already diseased. I don’t like to use closure devices in these peripheral cases, because these patients are very sick, and if implant closure device material is left behind, the risk of complications increases. Axera Access has been very good for patients with peripheral vascular disease, because of the type of difficult anatomy that we encounter when we see those patients. However, even in our interventional patients, results have been beneficial and similar between coronary and peripheral procedures.
At this point though, we are only using Axera for diagnostic procedures, as the device has not yet been approved for interventional use. The ASPEN study is actively enrolling patients nationwide to validate the safety of the Axera device for interventional procedures. In this study, the device will be used in patients requiring anticoagulation for known interventional procedures. We are trying to get approval from our IRB [Institutional Review Board] committee to start enrolling patients into the ASPEN study and we are anxiously awaiting the response. If the device is then approved for interventions, we will use it in those instances as well.
Do you use Axera in antegrade sticks?
Yes. The company recently introduced a version of the Axera device where the Latchwire, the initial insertion 0.035” wire, now comes in a steerable, angled-tip configuration.We did some of the first few antegrade sticks with this device, which were very successful. No other closure device is ideal to use in an antegrade stick; however, Axera is not a closure device, but an access device. We feel comfortable using it for antegrade access.
Do you have any advice for other facilities?
First, try to have a super user or a representative from the company educate the staff and guide the operators through the first series of cases. In our case, we felt that 100 cases would be appropriate to get our operators up to speed with this new access procedure. This super user should follow the patient from the procedure to where the sheaths are pulled, and teach the personnel how to properly pull the sheath and hold pressure in Axera patients. Once the Axera device is validated using this protocol, I am sure it is going to become a tool that many labs are going to love.
Disclosure: Dr. Munoz reports no conflicts of interest regarding the content herein.
Oscar Munoz, MD, can be contacted at email@example.com.
- Turi Z, Wortham D, Sampognaro G, Kresock F, Held J, Smith R, Veerina K, Hinohara T, Kaki A. Use of a novel access technology for femoral artery catherterization: results of the RECITAL trial. J Invasive Cardiol. 2013. Jan; 25(1): 13-18.