Can you tell us about your practice and facility?
I work for the VA Pittsburgh Healthcare System, located in western Pennsylvania. We are a referral center, with patients coming from western Pennsylvania, West Virginia, Ohio, and areas west of Philadelphia. Our hospital is affiliated with the University of Pittsburgh Medical Center. Our cath lab volume is approximately 1100 to 1200 cases per year, of which 250 to 350 are interventions. We also do peripheral cases as well. I do about 50 peripheral cases per year.
How long have you been using the Mynx Ace for vascular closure?
I began using it in the middle of December 2013, so it has been over 5 months. On an average, I do about 50 cases per month, and I have probably used this device in at least 150 femoral cases.
How does it work?
The Mynx Ace (Figure 1A-B) uses the Grip Technology sealant, which is composed of two different components of polyethylene glycol. The tip is unreacted and not cross-linked. Upon deployment, human body temperature and pH level cause this component to become reactive and interlock with the contours of the vessel wall. This is the Grip component. The additional sealant component consists of cross-linked and reactive polyethylene glycol that is freeze-dried and porous. It absorbs the blood and subcutaneous fluids, expanding up to three to four times its initial size and filling the tissue tract.
The Mynx Ace is a next-generation device?
Yes, it is AccessClosure’s latest generation closure device. The company initially launched the Mynx, followed by the Mynx Grip (which introduced the Grip Technology), and their newest device is the Mynx Ace. Although the Ace uses the same Grip Technology, its delivery system is different.
What is different about the delivery system?
The Mynx Ace uses a simpler delivery system that takes away the operator variability. There is no operator dependence on shuttling the sealant or on the amount of pressure applied during the sealant deployment. It is a 3-step process that is well labeled, and easy to follow and use. The Mynx Ace provides the same, if not better, safety and efficacy in achieving hemostasis as the first generation of the device.
Can you describe how the device is deployed?
The Mynx Ace comes with its own sheath, so the first step involves changing out the sheath used for the procedure and placing the sheath that comes with the closure device. It has a backflow opening to ensure that you are in the true vessel. Once the sheath is placed and confirmed, you introduce the device and inflate the balloon. Then the device is pulled back until some resistance is felt, indicating that the balloon is anchored against the arteriotomy site. The operator then activates the first two steps to deploy the sealant to the extravascular arteriotomy site. After the first two steps are accomplished, it takes about 2 minutes of waiting for the sealant to start forming an interlock surface with the arteriotomy. The balloon is then deflated and the third step is performed, during which the device is removed.
How does use of the Mynx Ace affect ambulation times?
At our hospital, if there is a manual hold, ambulation is usually about 3-4 hours after a diagnostic case, and 4-5 hours after an interventional case. With the Mynx Ace, it is just two hours after deployment before the patient can ambulate, and this is true whether it is a diagnostic or interventional case. There is also no patient discomfort associated with the deployment of this device. Patients are able to get out of bed sooner and they are more appreciative of being able to do so.
Do the patients experience any lump from the polyethylene glycol?
No, there is no lump. Once it expands, it fills up the tissue tract. It is very soft and dissolves within 30 days, leaving no remnants.
Have you experienced any complications?
No. I have used the Mynx Ace for both diagnostic and interventional cases since its launch in December 2013, and I have not experienced any complications. We usually do a follow-up phone call to both our diagnostic and our interventional patients, and they have not had any bleeding or other complaints thus far.
How would you describe the learning curve?
If the operator understands the concept behind the device, the learning curve is very short, and he or she will be very comfortable within the first few cases.
Can the Mynx Ace be used by staff?
Yes, similarly, if technologists understand and are comfortable with the device, and there is no hospital policy that a physician needs to deploy the device, I think staff can also help with the deployment. I have heard that in certain hospitals, the technologists are deploying the device. However, in our hospital, it is performed by the physician.
How does staff feel about the Mynx Ace?
The support staff feels very comfortable with the device, probably because of its efficacy and the success we have had thus far. Setting up the device is quite easy and our overall volume of Mynx Ace usage has increased since its launch.
Is there anything that you have learned while using the device that you’d like to share?
For patients with peripheral vascular disease, I recommend filling the balloon with a 50% contrast and 50% saline mixture so that you can observe the balloon under fluoroscopy as it is being retracted in the vessel until it is anchored against the arteriotomy. If the balloon remains intact and is not affected by the calcified plaques, there is a good probability that you will be able to achieve hemostasis. This is a technique I have often used that has provided good results.
Calcification is really the bane of achieving hemostasis in many peripheral vascular disease patients.
That is correct, and one of the advantages of this device is that it is extravascular, so you do not have to worry about disrupting the inner lumen in an already calcified vessel. This minimizes the risk of acute abrupt closure with a calcified plaque rupture in patients with peripheral vascular disease.
What about re-access?
The recommendation from the company is that the polyethylene glycol dissolves within the tissue tract in 30 days and you should be able to re-access at that time without difficulty. Although I have not had to re-enter the artery in any of my patients who received a Mynx Ace, I do not see any reason why one would not be able to re-enter sooner, because the sealant is very soft. Regardless, I would follow the company guidelines and wait 30 days.
What other advantages do you see with the Mynx Ace for your veteran patient population?
Patient comfort, safety, and efficacy are important for our veterans, because some have post-traumatic stress disorder. If we are using the femoral artery as the access site, close contact with the groin can make patients uncomfortable. Using a device where patients usually do not feel anything during deployment makes it easier for them. Patients are also able to get up and ambulate within 2 hours, which is something they enjoy.
Any final thoughts?
The Mynx Ace is simple to use. It provides more consistency in deployment when compared to the prior generations, as it takes away the operator variability in terms of how much pressure the operator needs to apply. I recommend that operators watch the video (available at accessclosure.com/resources-media/videos/) to better understand the concept and basics involved in the deployment of this device. I think there has been a tremendous advancement in the development of AccessClosure devices. Ideally, we want to have a device that is very comfortable for the patient and is mostly extravascular, but that provides the same safety and efficacy in achieving hemostasis. We also want to be able to use it in a wide variety of patients, and I think the Mynx Ace comes close to this ideal.