Overview of Vascular Access Closure Devices
Minimally invasive techniques, or surgeries done with small cuts instead of large incisions, are used more and more across different types of surgery and this includes vascular surgery, which pertains to diseases of the circulatory system’s veins and arteries. Angiography is a test that uses X-rays to view your body’s blood vessels, and it’s one of the most frequently used procedures nowadays across various specialties like heart health, vascular surgery and interventional radiology, which uses imaging to diagnose and treat diseases.
Old-school, the usual way to stop bleeding at the point of access during these procedures was through applying manual pressure. But while this method continues to be reliable, many devices have been created to assist medical professionals in achieving this stoppage. These devices are particularly useful when working with larger bodies, in cases where blood-thinning or clot-preventing agents have been used, and in scenarios where a patient cannot have extended bed rest like when they have widespread bed sores.
In the case of blood thinner use or larger bodies, manual pressure needs to be applied for a longer time or much more significantly. If manual compression is not done right, complications like hematoma (a solid swelling of clotted blood) or the creation of a pseudoaneurysm, a false aneurysm, could happen. Research has shown that using these devices is safe even when patients have undergone thrombolytic therapy, treatments to dissolve dangerous clots in blood vessels.
These devices that assist in stopping bleeding can be categorized into: devices that close with stitches, mechanical devices that close without stitches, devices that seal from within the blood vessel, devices that seal from outside the blood vessel, and devices that make manual compression easier. Here’s a couple of examples. A device called Perclose by Abbott Vascular uses a pre-tied knot to close the site of the incision while making sure a guide wire can still be used. StarClose, by the same company, is a non-stitch mechanical device that uses a special metal clip to bring together the outermost layer of the artery. Mynx by CardinalHealth/Cordis provides a sealant, polyethylene glycol, which is used outside the blood vessel, while Angioseal by St. Jude Medical uses a sealant inside the blood vessel, a dissolvable anchor with a collagen plug. The Catalyst II and III devices from Cardiva Medical help with manual compression for blood clotting. Various other devices are also available in the market.
Anatomy and Physiology of Vascular Access Closure Devices
Common femoral artery closure devices are used to seal off an area in the common femoral artery. The common femoral artery is a vital blood supply route to your lower body. This artery transforms into the external iliac artery after it crosses the inguinal ligament, a band of tough, fibrous tissue in your groin. The common femoral artery also splits into two other arteries: the profunda femoris and the superficial femoral artery.
The superficial femoral artery then becomes the popliteal artery as it moves through the adductor canal. This is a tunnel in the upper part of your thigh that the artery passes through. The popliteal artery then splits into three more arteries — the tibial vessels — below the knee. These arterial divisions help distribute blood throughout the lower body.
Why do People Need Vascular Access Closure Devices
These devices have been given the green light to be used in the main artery in your thigh, known as the common femoral artery.
When a Person Should Avoid Vascular Access Closure Devices
There are certain situations where using vascular access closure devices might not be the best choice. These include cases like:
If there are hard mineral deposits, or ‘dense arterial calcifications’, in the blood vessel that needs access. This can make it difficult to properly use the device.
If the place where the doctor needs to enter the vessel is above the inguinal ligament – this is the band you can feel in your groin, where your thigh meets your body.
Lastly, if the blood vessel that needs to be accessed is too small, it might not be possible to use this type of device correctly.
Equipment used for Vascular Access Closure Devices
Here’s the medical equipment that the doctors will use:
* Sterile drapes: These are clean, surgical sheets that cover you during the procedure to keep the area germ-free.
* Local anesthetic: It’s a medication that numbs the area where the procedure will be performed, so you won’t feel any pain.
* Scalpel: This is a small, sharp knife that doctors use during surgery.
* Hemostat: A tool used by doctors to control bleeding during the procedure.
* Micropuncture kit: This tool allows doctors to reach the common femoral artery (a major blood vessel in your leg) without making a large incision.
* Ultrasound machine: This device uses sound waves to create images of your body’s insides, helping guide the doctors.
* A .035 wire: This, along with contrast (a dye that helps highlight parts inside your body), is used to guide the procedure.
* A 5F or 6F catheter short sheath: This small, thin tube helps doctors gain access to your blood vessels.
* A fluoroscopic imaging system (commonly called a C-arm): It provides real-time X-ray images to guide the doctors during the procedure.
* Lead shielding: This is used to protect you and the medical team from unnecessary exposure to the X-rays.
* Heparinized saline and heparin: These are both anticoagulants, which means they prevent blood clots from forming. They’re used to rinse and keep the blood flowing freely during the procedure.
* Vascular access closure device: Used to seal the small hole made to access your blood vessel.
Who is needed to perform Vascular Access Closure Devices?
To carry out the medical procedure, a team of different medical professionals is needed. This includes a specialized doctor known as a vascular surgeon, who performs operations on blood vessels. There’s also a first assistant, who could be a doctor-in-training (resident), a specialist in training (fellow), a cath lab technician who specializes in heart-related tests, or a physician assistant who works under a doctor’s supervision. A radiology technician, who operates imaging machines to look inside your body, is also required along with nursing staff who help out in many different ways. Depending on what the procedure involves, an anesthesiologist (a doctor who gives medicine to help you sleep or makes a specific part of your body numb during the operation) may or may not be present.
Preparing for Vascular Access Closure Devices
Before the medical procedure starts, doctors prepare both groin areas. It’s a standard practice to check the pulse in your leg first, to have a baseline or starting point for comparison. This way, doctors can check if anything changes after they use the vascular access closure device, a medical device that helps stop bleeding after a procedure. They use a special tool called a Doppler, which helps them find the pulse in your foot, and mark the location with a pen. This all ensures that everything is safe and working as it should be during the procedure.
How is Vascular Access Closure Devices performed
When using vascular access closure devices, which are tools used to close the site of a medical procedure, there are some general rules to remember. First, the common femoral artery, a large artery in the thigh, should be located with the help of an ultrasound. This helps guide the doctor to the right spot alongside their knowledge of anatomy and additional imaging techniques.
The doctor will use a special kit for the first step of the procedure. They’ll aim to create a small hole beneath the groin ligament and the uppermost part of your thigh bone, being careful to steer clear of any severely hardened parts of the artery or other nearby arteries. Once the doctor has carefully placed the small needle and wire, a tiny cut is made in the skin at the entry point.
Then, the doctor will use a tool to gently separate the tissues down to the artery. This helps to reduce any extra tissue between the skin and the artery, making it easier to place the closure device later on. Once a small tube is in place, the wire is removed.
A type of X-ray called a femoral angiogram is then done. This helps the doctor to make sure that the procedure site is in the right place, and that the vessel is suitable for the closure device (particularly considering the size and any hardened artery plaque). This also helps to rule out any complications, such as tearing or dissection, from creating the access point.
Possible Complications of Vascular Access Closure Devices
There can be three types of complications with devices used to close blood vessels during a procedure. These complications include :
Issues related to poor blood supply (Ischemic), bleeding related issues (Hemorrhagic), and infections.
– Poor blood supply (known as ischemia) in the lower extremities from these devices can be related to the narrowing or blockage of the access artery, or to bits of something blocking blood vessels further downstream. The type of device used, according to the features of the access artery, is important to reduce this complication. Most of these problems can be managed with open surgery, but in some cases, less invasive, endovascular approaches are also used.
– Bleeding (hemorrhagic complications) risks are higher if the device is used in a vessel that has hard deposits called “calcifications”, or placed at an inappropriate location in the body (above a part called the inguinal ligament). Other factors can also increase the risk of bleeding, like age, type of procedure done, and advanced kidney disease. If the device fails and causes continuous bleeding, it can lead to serious complications like blood loss leading to anemia and unstable blood pressure which may require an open surgical exploration. If the device used is small and the patient’s condition is stable, applying pressure manually to stop the bleeding could be enough. An incomplete closure could cause a false aneurysm (pseudoaneurysm) at the site. Depending on the situation, it can be treated by injections guided by ultrasound or through surgery.
– Vascular access closure devices introduce foreign material into the body. This could serve as a focus for infection in rare cases. So, maintaining sterile conditions throughout the procedure to avoid issues of infection is crucial.
What Else Should I Know About Vascular Access Closure Devices?
Doctors have many different tools available to help stop bleeding (achieve hemostasis) at the point where a blood vessel was accessed for a procedure. It’s important for the doctor performing the procedure to understand which situations each tool is best suited for, as well as when they should not be used. These tools can help patients start moving around sooner and potentially leave the hospital earlier when compared to the traditional method of applying manual pressure to the wound.
Typically, after a doctor has manually applied pressure to stop bleeding, patients are asked to rest in bed for 4 to 6 hours. However, if one of these special tools is used to close the wound, this resting time can be reduced to 1 to 2 hours. It’s important to note though, that no one tool has been proven to be the best choice for every situation.
Also, using these tools has not been shown to reduce the risk of complications related to accessing blood vessels, when compared to manual pressure. These devices are designed to be used in a large blood vessel in the thigh called the common femoral artery, but doctors sometimes use them in other places such as the arteries in the arm or shoulder.