What is Ellipsys Procedure for Endovenous Fistula Creation?
The Ellipsys procedure for endovenous fistula creation is a minimally invasive non-surgical procedure performed to create a percutaneous arteriovenous fistula using the Ellipsys Vascular Access System.
Arteriovenous (AV) fistula creation is a traditionally invasive vascular access procedure in which a surgical connection is made between an artery and a vein usually in the arm by a vascular specialist for the purpose of receiving hemodialysis treatment.
The Ellipsys Vascular Access System is a unique single-catheter, nonsurgical option for vascular specialists to create an AV fistula and replaces surgery with a needle puncture in the vein underneath the elbow. The system allows physicians to percutaneously access the proximal radial artery in the forearm for AV fistula creation. Under ultrasound guidance, the Ellipsys System utilizes an innovative outer access cannula, guidewire, and vessel capture construct that creates a connection of the vein to the artery utilizing an intravascular (endovenous) approach.
Indications for Ellipsys Procedure for Endovenous Fistula Creation
The Ellipsys procedure for endovascular AV fistula creation (endoAVF) is usually indicated for patients with end-stage renal disease/kidney failure, a condition characterized by progressive loss of the kidney’s ability to filter and purify the blood, requiring hemodialysis treatment.
Hemodialysis or dialysis is a procedure performed to manage patients suffering from kidney failure. A dialysis machine takes over the function of the diseased kidneys by filtering the blood of waste.
The creation of the AV fistula connects the proximal radial artery and perforating vein to allow safe and effective purification of the blood by passing it through a dialysis machine connected to the body through the AV fistula.
Preparation for Ellipsys Procedure for Endovenous Fistula Creation
Pre-procedure preparation for Ellipsys endovenous fistula creation may involve the following steps:
- A Doppler ultrasound test is performed to map the radial artery. The diameter of the radial artery should be at least 2 mm and the distance between the artery and adjacent vein should be no more than 1.5 mm.
- You need to inform your physician if you have allergies to certain medications, local anesthetic, or latex.
- You should also inform your doctor of any medications or supplements you are taking or any conditions you have such as blood disorders, heart or lung disease.
- You may be asked to stop taking certain medications such as blood-thinners temporarily for about a week before the procedure.
- You should not consume solids or liquids at least 6 hours prior to the procedure.
- Arrange for someone to drive you home after the procedure as you may not be fit enough to drive yourself.
- Written consent will be obtained from you after the procedure has been explained in detail.
Procedure for Ellipsys Endovenous Fistula Creation
In general, the procedure for Ellipsys endovenous fistula creation will involve the following steps:
- The skin over the AV fistula site is cleaned with an antiseptic solution and local anesthesia will be administered to numb the area.
- With local anesthesia, you remain awake and may feel some pressure at the site, but no pain.
- Under ultrasound guidance, a micropuncture needle of the Ellipsys Vascular Access System is used to access the vein in the elbow.
- The needle is then advanced into the radial artery and a guidewire is passed through the needle into the artery.
- The Ellipsys catheter is passed over the guidewire into the radial artery and slight tension is applied to ensure the catheter tip is against the radial artery wall.
- The catheter is activated to produce thermal energy that fuses the walls of the blood vessel producing a permanent anastomosis or connection between the artery and vein.
- The catheter is then removed, and a bandage is placed over the puncture site. The entire procedure takes about 30 minutes.
- It takes about 2 to 3 months before the fistula is developed and mature enough to be used for hemodialysis.
Recovery and Post Procedure Care
AV fistula creation can be performed in an outpatient setting and most patients can expect to be discharged after being monitored for 60 to 90 minutes in the recovery room. There may be slight bruising, swelling, and pain at the needle puncture site. You will be given medication for any postoperative pain and advised to keep the arm elevated to reduce swelling. For the first 24 hours after the procedure, you should avoid any strenuous activity, driving, operating heavy machinery, drinking alcohol, or wearing any clothing that presses against the puncture site. You can return to routine activities a day after the procedure. Specific instructions will be given on how to care for the fistula access site. These include:
- Wash the vascular access site every day and keep it clean and dry.
- Ensure that your doctor checks the access site before each hemodialysis treatment.
- Use the access site only for dialysis.
- Be careful not to bump or injure the access site.
- Check for the thrill (a rhythmic vibration) over the access site, which indicates the AV fistula is healthy.
- Do not put a blood pressure cuff, tight clothing, or jewelry over the access site.
- Do not lift heavy objects with the access arm.
- Avoid sleeping with the access arm under your head or body.
- Report any signs of infection such as redness, swelling, or pus drainage to your doctor as soon as possible.
Benefits of the Ellipsys Vascular Access System
Some of the benefits of Ellipsys Vascular Access System include:
- Nonsurgical alternative for fistula creation
- Utilizes patented tissue fusion technology
- Enables venous access using a single catheter
- No foreign material is implanted into the body
- No sutures are placed
- Can be done under local anesthesia
- Can be performed in an outpatient setting
- Ensures a fast recovery and return to routine activities.
Risks and Complications
The Ellipsys procedure for endovenous fistula creation is a relatively safe procedure; however, as with any surgery, some risks and complications may occur, such as:
- Bruising and soreness
- Post-procedure pain
- Hematoma (abnormal collection of blood outside of a blood vessel)
- Formation of clots that may slow down or block blood flow through the AV fistula
- Failure to achieve fistula maturation